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News Capsules - September 2025

Dalbavancin Offers a Simplified IV Option for Staphylococcus aureus Bacteremia

Staphylococcus aureus bacteremia is a serious bloodstream infection that typically requires 4 to 8 weeks of intravenous (IV) antibiotics. Dalbavancin is a long-acting IV antibiotic with potential to simplify bacteremia treatment by eliminating the need for extended IV therapy. The Dalbavancin as an Option for Treatment of S. aureus Bacteremia (DOTS) trial was a phase 2b, multicenter, randomized study comparing dalbavancin with standard antibiotic therapy in adult patients hospitalized with complicated S. aureus bacteremia who had cleared their blood cultures after initial treatment.

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Multidose Ondansetron Reduces Severity of Gastroenteritis in Children After Emergency Department Visits

Vomiting from acute gastroenteritis is a common cause of emergency department (ED) visits in children. Single-dose oral ondansetron is often given in the ED to reduce vomiting and facilitate oral rehydration. However, evidence for continued ondansetron use after discharge has been limited. A randomized trial evaluated whether providing caregivers with multiple doses of ondansetron after an ED visit could reduce the severity of gastroenteritis in children during the following week.

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Behavioral Therapy is as Effective as Solifenacin for Overactive Bladder in Parkinson Disease

Overactive bladder (OAB) symptoms are common and distressing in patients with Parkinson disease (PD) and can significantly affect quality of life. Drug treatments such as solifenacin may help, but they often cause side effects that worsen PD-related morbidity. Behavioral strategies, including pelvic floor muscle training, may provide a safe, non-drug alternative.

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Spironolactone Does Not Reduce Cardiovascular Events in Patients Receiving Maintenance Dialysis

Patients with kidney failure on maintenance dialysis are at high risk for heart failure and cardiovascular-related death. The ACHIEVE trial (Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease) tested whether spironolactone 25 mg daily could reduce these risks. Spironolactone, a mineralocorticoid receptor antagonist, is known to reduce cardiovascular events in other populations but its effectiveness in dialysis patients has been unclear.

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Drug News Abstracts Archive

News Capsules - September 2025
Dalbavancin Offers a Simplified IV Option for Staphylococcus aureus BacteremiaStaphylococcus aureus bacteremia is a serious bloodstream infection that typically requires 4 to 8 weeks of intravenous (IV) antibiotics. Dalbavancin is a long-acting IV antibiotic with potential to simplify bacteremia treatment by eliminating the need for extended IV therapy. The Dalbavancin as an Option for Treatment of S. aureus Bacteremia (DOTS) trial was a phase 2b, multicenter, randomized study comparing dalbavancin with standard antibiotic therapy in adult patients hospitalized with complicated S. aureus bacteremia who had cleared their blood cultures after initial treatment.READ MORE...In this open-label trial, patients received at least 72 hours (but no more than 10 days) of initial antibacterial therapy before being randomized to receive either two doses of IV dalbavancin (1500 mg on days 1 and 8) or standard IV therapy for 4 to 8 weeks (antistaphylococcal penicillin or cefazolin if methicillin susceptible; vancomycin or daptomycin if methicillin resistant). The primary endpoint was the desirability of outcome ranking (DOOR) at day 70, which included clinical success, infection and safety complications, mortality, and health-related quality of life. Also, the primary analysis assessed whether dalbavancin was superior to standard therapy, defined as a greater than 50% probability of having a better DOOR outcome (95% CI). Secondary outcomes included clinical efficacy and safety.Of 200 study patients, 167 (84%) survived to day 70 and were evaluated for treatment efficacy. Patients without a day 70 assessment were considered treatment failures. The probability of a better day 70 outcome with dalbavancin compared with standard therapy was 47.7% (95% CI, 39.8–55.7%). Clinical efficacy was similar between groups: 73 of 100 patients treated with dalbavancin and 72 of 100 treated with standard therapy (95% CI, –11.5% to 13.5%), which met the trial's noninferiority requirement. Serious adverse events occurred in 40% of patients in the dalbavancin group and 34% in the standard therapy group. Treatment-related adverse events were uncommon in both groups.In adults with complicated S. aureus bacteremia who had cleared their blood cultures, dalbavancin was not better than standard antibiotic therapy. Efficacy and safety were similar between groups. Dalbavancin may still be a practical alternative to prolonged IV therapy, offering a simpler treatment option for appropriate patients. (Turner, N.A., et al. [2025]. Dalbavancin for treatment of Staphylococcus aureus bacteremia: The DOTS randomized clinical trial. JAMA. Advance online publication. Retrieved August 2025 from https://jamanetwork.com/journals/jama/article-abstract/2837604)Released: September 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Multidose Ondansetron Reduces Severity of Gastroenteritis in Children After Emergency Department VisitsVomiting from acute gastroenteritis is a common cause of emergency department (ED) visits in children. Single-dose oral ondansetron is often given in the ED to reduce vomiting and facilitate oral rehydration. However, evidence for continued ondansetron use after discharge has been limited. A randomized trial evaluated whether providing caregivers with multiple doses of ondansetron after an ED visit could reduce the severity of gastroenteritis in children during the following week.READ MORE...In a double-blind, placebo-controlled superiority trial, 1030 children aged 6 months to under 18 years presenting with gastroenteritis-related vomiting were enrolled at six pediatric emergency departments. Caregivers were given six doses of oral ondansetron or placebo to administer as needed for vomiting during the first 48 hours after discharge. The primary outcome was moderate-to-severe gastroenteritis, defined as a modified Vesikari score of 9 or higher (scores ranges from 0 to 20 with higher scores indicating greater severity) within 7 days. Secondary outcomes included number and duration of vomiting episodes, unscheduled physician visits, intravenous fluid administration, and adverse events.Moderate-to-severe gastroenteritis occurred in 5.1% of children who received ondansetron versus 12.5% who received placebo, representing a significant risk reduction (adjusted odds ratio, 0.50; 95% CI, 0.40–0.60). Although the presence and duration of vomiting were similar between groups, children who received ondansetron had fewer vomiting episodes in the first 48 hours (adjusted rate ratio, 0.76; 95% CI, 0.67–0.87).There were no meaningful differences in unscheduled health care visits, need for IV fluids, or adverse events between the two groups. Ondansetron was well tolerated, and safety profiles were similar.These findings support the short-term use of ondansetron at home after ED discharge for pediatric gastroenteritis-associated vomiting. Nurses can educate families on appropriate dosing and reinforce that this strategy may help reduce illness severity without increasing risk. (Freedman, S. B., et al. [2025]. Multidose ondansetron after emergency visits in children with gastroenteritis. NEJM, 393[3], 255–266. Retrieved August 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2503596)Released: September 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Behavioral Therapy is as Effective as Solifenacin for Overactive Bladder in Parkinson DiseaseOveractive bladder (OAB) symptoms are common and distressing in patients with Parkinson disease (PD) and can significantly affect quality of life. Drug treatments such as solifenacin may help, but they often cause side effects that worsen PD-related morbidity. Behavioral strategies, including pelvic floor muscle training, may provide a safe, non-drug alternative.READ MORE...A 12-week, randomized noninferiority trial evaluated whether behavioral therapy could provide similar benefit of solifenacin therapy without medication-related risks. This study enrolled participants with PD and moderate-to-severe OAB symptoms between 2018 and 2023 across four U.S. Veterans Affairs health systems. Participants received either behavioral therapy (pelvic floor muscle training and urge suppression techniques delivered by a nurse practitioner) or daily solifenacin (5–10 mg). The primary outcome was symptom severity at 12 weeks, measured by the International Consultation on Incontinence Questionnaire–OAB (ICIQ-OAB) module. A 15% noninferiority margin was prespecified. Adverse events were assessed every 2 weeks for 8 weeks and again at 12 weeks.Seventy-seven participants with PD (mean age 71 years; 84% male) were randomized to behavioral therapy (n = 36) or solifenacin (n = 41). A total of 73 participants completed the study, with four dropouts in the drug group. Baseline characteristics, including cognition and OAB symptom scores, were similar between groups.At 12 weeks, both groups showed clinically meaningful improvement in OAB symptoms, and the difference between behavioral and drug therapy remained within the predefined 15% noninferiority margin (mean score: drug 5.8, behavioral 5.5; P = .02). Adverse events were more frequent in the drug group. Dry mouth and falls occurred more often with solifenacin, while the behavioral group experienced fewer complications overall.These findings support the use of pelvic floor muscle training and urge suppression strategies as a first-line, non-drug option for managing OAB symptoms in people with PD. Nurses and nurse practitioners can play a central role in delivering this safe and effective therapy, helping reduce reliance on medications that may worsen PD-related risks. (Vaughan, C. P., et al. [2025]. Behavioral compared with drug therapy for overactive bladder symptoms in Parkinson disease: A randomized noninferiority trial. JAMA Neurol. Advance online publication. Retrieved August 2025 from https://doi.org/10.1001/jamaneurol.2025.1904)Released: September 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Spironolactone Does Not Reduce Cardiovascular Events in Patients Receiving Maintenance DialysisPatients with kidney failure on maintenance dialysis are at high risk for heart failure and cardiovascular-related death. The ACHIEVE trial (Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease) tested whether spironolactone 25 mg daily could reduce these risks. Spironolactone, a mineralocorticoid receptor antagonist, is known to reduce cardiovascular events in other populations but its effectiveness in dialysis patients has been unclear.READ MORE...This international, randomized, controlled trial was conducted in 143 dialysis programs across 12 countries. Patient enrollment and screening for inclusion was conducted from September 2017 to October 2024. Eligible patients were age 45 years or older, or 18 years or older with diabetes, and had been on dialysis for at least 3 months. All participants completed an open-label run-in phase to ensure they could tolerate spironolactone before randomization. Patients were randomized 1:1 to receive either spironolactone or placebo. Participants, clinicians, and outcome assessors were blinded to treatment assignment. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. Secondary outcomes included all-cause death and all-cause hospitalization.Of 3,689 patients screened for inclusion, a total of 2,538 patients were randomly assigned to spironolactone (n = 1260) or placebo (n = 1278). Median follow-up was 1.8 years. The trial was stopped early for futility after interim analysis. The primary outcome occurred in 258 participants in the spironolactone group and 276 in the placebo group (hazard ratio 0.92; 95% CI, 0.78–1.09; p = 0.35). All-cause mortality and all-cause hospitalizations were also similar between groups.These findings show that spironolactone did not reduce cardiovascular mortality or heart failure hospitalizations in patients receiving maintenance dialysis. Nurses should be aware that spironolactone offers no clear cardiovascular benefit in this population, and future research will need to explore alternative approaches to lower cardiovascular risk in dialysis patients. (Walsh, M., et al. [2025]. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial. Lancet, 406[10504], 695–704. Retrieved August 2025 from https://doi.org/10.1016/S0140-6736(25)01198-5)Released: September 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - August 2025
Orforglipron Significantly Reduces A1C and Weight in Adults with Early Type 2 Diabetes Orforglipron is a once-daily, oral small-molecule GLP-1 receptor agonist currently in development for type 2 diabetes and weight management. Unlike injectable GLP-1 medications, orforglipron offers a nonpeptide oral alternative, which may improve treatment accessibility and adherence.READ MORE...A phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of orforglipron over 40 weeks in 559 adults with early type 2 diabetes. Eligible participants had elevated glycated hemoglobin (A1C) levels of 7.0 to 9.5%, a body mass index (BMI) of at least 23 kg/m2, and were managing their diabetes through diet and exercise alone. Patients were randomized to receive one of three daily doses of orforglipron (3 mg, 12 mg, or 36 mg) or placebo. The primary endpoint was change in A1C from baseline to week 40; a key secondary endpoint was change in body weight.By week 40, patients receiving orforglipron demonstrated significant improvements in glycemic control at all doses. A1C levels dropped by 1.24 to 1.48 percentage points in the orforglipron groups, compared to a 0.41-point reduction with placebo. Final mean A1C levels were 6.5–6.7% with orforglipron. Weight loss was also greater in orforglipron groups, with dose-dependent reductions ranging from 4.5% to 7.6%, compared to 1.7% with placebo.The medication was generally well tolerated. The most common side effects were mild-to-moderate gastrointestinal symptoms, such as nausea and diarrhea, typically occurring during dose escalation. Importantly, there were no reported cases of severe hypoglycemia. Discontinuation due to side effects was low (4.4–7.8% with orforglipron vs. 1.4% with placebo).These findings suggest that orforglipron offers a promising new oral treatment option for patients with early type 2 diabetes, providing clinically meaningful improvements in both blood sugar control and weight. The oral formulation may be especially valuable for patients who prefer not to use injectable therapies. (Rosenstock, J., et al. [2025]. Orforglipron, an oral small-molecule GLP-1 receptor agonist, in early type 2 diabetes. N Engl J Med, (2025). Retrieved July 2025 from https://www.nejm.org/doi/10.1056/NEJMoa2505669Released: August 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Long-Acting Weekly Risperidone Shows Equivalent Exposure to Daily Dosing in SchizophreniaMedication non-adherence is a major barrier to successful long-term management of schizophrenia. While long-acting injectable formulations can help improve adherence, they may not be ideal for all patients. A phase 3 trial evaluated a long-acting oral formulation of risperidone (LYN-005) designed to be taken once weekly. The purpose of the study was to determine whether it delivers comparable drug exposure to daily risperidone in patients with stable schizophrenia or schizoaffective disorder.READ MORE...Participants first completed a 7-day run-in period with daily immediate-release risperidone (2 mg or 6 mg). They were then transitioned to five once-weekly doses of LYN-005 (15 mg or 45 mg, respectively), with a supplemental half-dose of daily risperidone during the first week of the switch. The primary outcome was to compare key pharmacokinetic parameters, including minimum (Cmin), maximum (Cmax), and average (Cavg) blood concentrations, between weekly and daily formulations.Among the 83 enrolled participants, 47 completed the full 5-week study. Pharmacokinetic analysis of 44 participants showed that LYN-005 provided sustained therapeutic levels of risperidone across all doses. The geometric mean ratios at week 5 met all prespecified equivalence criteria, indicating that the weekly formulation achieved similar exposure to daily dosing without unexpected fluctuations in drug levels. Participants remained clinically stable throughout the study period.Gastrointestinal side effects were the most commonly reported treatment-emergent adverse events, occurring in 66% of those receiving LYN-005. One serious adverse event was reported. No new safety signals were identified.These findings support the use of LYN-005 as a once-weekly oral option for individuals with schizophrenia or schizoaffective disorder. Nurses should consider this new formulation when helping patients who struggle with daily medication adherence and be prepared to monitor for GI-related side effects. (Citrome, L., et al. [2025]. Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial. Lancet Psychiatry, 12(7), 504–512. Retrieved July 2025 from https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00135-X/abstract)Released: August 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Perioperative Pembrolizumab Improves Survival in Locally Advanced Head and Neck Cancer Locally advanced head and neck squamous cell carcinoma (HNSCC) carries a high risk of recurrence despite treatment with surgery and adjuvant radiotherapy. The benefit of adding immunotherapy in the perioperative setting has remained uncertain. This phase 3 trial evaluated whether neoadjuvant and adjuvant pembrolizumab, a programmed death receptor-1 (PD-1) inhibitor, could improve outcomes when added to standard care in patients with resectable HNSCC.READ MORE...A total of 714 patients were randomized to receive either standard treatment alone, which included surgery followed by radiotherapy (with or without cisplatin) or standard care plus pembrolizumab. Those in the pembrolizumab group received two doses before surgery and fifteen additional doses afterward, administered every 3 weeks. The primary endpoint was 36-month event-free survival (EFS), defined as time to disease progression, recurrence, or death. Outcomes were analyzed sequentially among patients with programmed death ligand 1 (PD-L1) expression scores of CPS ≥10, CPS ≥1, and the overall population.After a median follow-up of 38.3 months, pembrolizumab significantly improved 3-year EFS across all subgroups. In the CPS ≥10 group, EFS was 59.8% in the pembrolizumab group versus 45.9% with standard care alone. Similar improvements were observed in patients with CPS ≥1 (58.2% vs. 44.9%) and in the overall population (57.6% vs. 46.4%). Surgery was completed in approximately 88% of patients in both groups, indicating that neoadjuvant pembrolizumab did not delay or prevent surgery.Serious Grade 3 or higher treatment-related adverse events occurred in 44.6% of patients receiving pembrolizumab and 42.9% of those receiving standard care alone. Immune-related adverse events of grade 3 or higher, such as pneumonitis or colitis, occurred in 10% of pembrolizumab-treated patients. Treatment-related deaths were rare (1.1% vs. 0.3%).These findings support the use of pembrolizumab before and after surgery as a way to improve survival in patients with locally advanced HNSCC. Nurses should monitor for immune-related side effects and educate patients on what to expect during long-term immunotherapy. (Uppaluri, R., et al. [2025]. Neoadjuvant and adjuvant pembrolizumab in locally advanced head and neck cancer. N Engl J Med, 393(1), 37–50. Retrieved July 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2415434)Released: August 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Upadacitinib Shows Durable Remission in Long-Term Study for Ulcerative Colitis Upadacitinib, an oral Janus kinase (JAK) inhibitor, has demonstrated efficacy for moderate to severe ulcerative colitis in short-term trials. The ongoing phase 3 U-ACTIVATE long-term extension study evaluates the sustained efficacy and safety of upadacitinib over a planned treatment period of 288 weeks. This interim analysis reports outcomes through three years of cumulative treatment. The study is being conducted at 307 centers across 43 countries.READ MORE...Patients who completed the 52-week U-ACHIEVE maintenance study were eligible for entry. Those in clinical remission continued on their maintenance dose, while others were allowed to escalate therapy. Key efficacy outcomes included clinical remission, endoscopic remission, and maintenance of both measures, assessed using the adapted Mayo score. The analysis used an as-observed approach, excluding data after dose changes.Among patients who continued into the long-term extension, 71% of those receiving upadacitinib 15 mg and 67% of those receiving 30 mg were in clinical remission at week 48. At week 96, remission rates were 76% and 74%, respectively. The majority of patients who entered the extension in clinical remission maintained their response through both timepoints. Similarly, endoscopic remission was observed in 49% (15 mg) and 46% (30 mg) of patients at week 48, and in 47% and 45%, respectively, at week 96. Most individuals who entered in endoscopic remission maintained it.The safety analysis included 467 patients with over 1,000 patient-years of exposure. Treatment-emergent adverse event rates were similar across doses (238.5 and 233.4 events per 100 patient-years). Serious adverse events occurred at rates of 11.7 and 12.4 per 100 patient-years, respectively. Common adverse events of special interest included hepatic abnormalities, lymphopenia, elevated creatine phosphokinase, serious infections, neutropenia, and herpes zoster. Three deaths were reported.These interim findings support the long-term use of upadacitinib in patients with ulcerative colitis, demonstrating durable clinical and endoscopic remission with a consistent safety profile. (Panaccione, R., et al. [2025]. Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study. Lancet Gastroenterol Hepatol, 10(6), 507–519. Retrieved July 2025 from https://www.thelancet.com/journals/langas/article/PIIS2468-1253(25)00017-2/fulltext)Released: August 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - July 2025
Initiating Injectable Buprenorphine During Hospitalization for Infection in Patients with Opioid Use Disorder Hospitalizations due to infections associated with opioid use disorder (OUD) are rising in the United States, yet few patients begin medication treatment for OUD (MOUD) during their hospital stay. A randomized clinical trial, called the Coordinating Opioid Use Treatment Through Medical Management with Infection Treatment (COMMIT) trial examined whether starting long-acting injectable buprenorphine (LAB) alongside infectious disease care during hospitalization improves MOUD use at 12 weeks compared to usual care. Buprenorphine, a partial opioid agonist, is a medication approved to treat OUD by reducing withdrawal symptoms, cravings, and the risk of relapse while lowering the risk of overdose compared with full opioids.READ MORE...The trial enrolled 171 adults hospitalized with moderate to severe OUD and a concurrent infection across three U.S. hospital systems in Connecticut, Pennsylvania, and South Carolina between August 2020 and October 2023. Participants were randomly assigned to receive either infectious disease care with LAB (ID-LAB) or treatment as usual (TAU) during hospitalization or soon after discharge. All patients also received nurse-delivered medical management for their infection. The primary outcome was the proportion of patients receiving any form of MOUD at 12 weeks after randomization.Participants in the ID-LAB group and TAU group were similar at baseline, with a median age of 39 years (IQR, 33–47), and 51.5% were men. At 12 weeks, 59.3% of patients in the ID-LAB group and 54.1% in the TAU group were receiving MOUD. This difference was not statistically significant (adjusted rate ratio, 1.01; 95% CI, 0.78–1.30).Findings from the study showed that starting LAB during hospitalization did not significantly increase MOUD uptake at 12 weeks compared to usual care. However, over half of patients in both groups did initiate or continue MOUD. These results highlight ongoing opportunities to integrate MOUD with infection treatment in hospitalized patients with OUD, with nurse-led management potentially playing an important role in care delivery. (Seval, N., et al. [2025]. Initiating injectable buprenorphine in people hospitalized with infections: a randomized clinical trial. JAMA Netw Open, 8(5), e2513000. Retrieved June 2025 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2834656)Released: July 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Empagliflozin Preserves Kidney Function and Reduces Heart Failure After Acute Myocardial InfarctionA secondary analysis of the EMPACT-MI trial (Study to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction) evaluated the effects and safety of empagliflozin on kidney function, heart failure, and mortality in patients hospitalized with acute myocardial infarction (MI). Empagliflozin is a sodium–glucose co-transporter 2 (SGLT2) inhibitor used to lower blood sugar in type 2 diabetes, and has been shown to protect the heart and kidneys in patients with heart failure or chronic kidney disease. Nevertheless, the cardiovascular and kidney benefits of empagliflozin in patients after acute MI have not been well studied.READ MORE...EMPACT-MI was a double-blind, multicenter trial that randomized 6,522 adults at risk of heart failure to receive either empagliflozin or placebo shortly after an MI. The analysis focused on kidney outcomes in a subset of 1,152 patients with longitudinal kidney function data, along with cardiovascular outcomes across the full cohort. At baseline, the average estimated glomerular filtration rate (eGFR) was 76.1 ml/min/1.73 m2 (SD 19.9).The results showed that over 24 months, kidney function remained stable in the empagliflozin group, while the placebo group experienced a decline in eGFR (P = 0.01). Empagliflozin also reduced the combined risk of heart failure events or all-cause mortality, and this benefit was consistent regardless of baseline kidney function (P for interaction = 0.30). Adverse event rates at 30 days were similar between the two groups and did not vary by kidney function, suggesting that empagliflozin was safe to start soon after an acute MI.These findings suggest that empagliflozin may preserve kidney function, lower the risk of heart failure, and improve survival when initiated early in patients with recent MI, including those with reduced kidney function. (Aggarwal, R., et al. [2025]. Secondary analysis of the EMPACT-MI trial reveals cardiovascular–kidney efficacy and safety of empagliflozin after acute myocardial infarction. Nat Cardiovasc Res, 4, 761–772. Retrieved June 2025 from https://www.nature.com/articles/s44161-025-00657-7?utm_source=chatgpt.com#citeas)Released: July 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Drug Discovered Using Artificial Intelligence, Rentosertib, Appears Safe and Effective in Idiopathic Pulmonary FibrosisFew drugs discovered using artificial intelligence (AI) have advanced to human clinical trials. A recent study reports the first phase 2a trial of rentosertib, a novel AI-generated small-molecule inhibitor of TNIK, a TRAF2 and NCK-interacting protein kinase, in idiopathic pulmonary fibrosis (IPF). IPF is a progressive lung disease marked by scarring and inflammation, with no therapies available to reverse its course. Traditional drug discovery for complex diseases like IPF is slow, costly, and constrained by the need to manually evaluate thousands of molecular pathways and compounds. In the study, researchers used an AI-driven discovery platform to systematically identify disease-driving targets, pinpointing TNIK as a critical regulator of IPF because it regulates both fibrotic and inflammatory pathways that worsen lung damage.READ MORE...The multicenter, double-blind, randomized, placebo-controlled trial evaluated the safety and early efficacy of rentosertib in 71 adults with IPF. Participants were randomized to receive 30 mg rentosertib once daily, 30 mg twice daily, 60 mg once daily, or placebo for 12 weeks. The primary outcome of the study was the proportion of patients experiencing at least one treatment-emergent adverse event (TEAE). Secondary outcomes included pharmacokinetics, lung function, symptom scores, exercise capacity, and frequency of IPF exacerbations.Results of the study showed that TEAEs occurred at similar rates across all groups, ranging from 72.2% to 83.3% in the rentosertib groups and 70.6% in the placebo group. Serious treatment-related adverse events were rare, with liver toxicity and diarrhea being the most common reasons for discontinuation. Notably, regarding lung function, patients receiving the highest dose (60 mg once daily) showed a mean increase in forced vital capacity (FVC) of +98.4 mL over 12 weeks, compared to a mean decrease of −20.3 mL in the placebo group.These findings suggest that rentosertib, a first-in-class TNIK inhibitor designed with AI, is safe, well tolerated, and potentially beneficial in improving lung function in IPF. Further research in larger, longer trials is warranted to confirm these results and assess long-term outcomes. If validated, this approach could represent an important advance in the treatment of a disease with limited therapeutic options. (Xu, Z., et al. [2025]. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nat Med, (2025). Retrieved June 2025 from https://www.nature.com/articles/s41591-025-03743-2?utm_source=chatgpt.com#citeas)Released: July 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Investigational Drug Ziresovir Improves Symptoms in Infants Hospitalized with Respiratory Syncytial VirusRespiratory syncytial virus (RSV) is a serious respiratory infection in certain populations, especially very young infants. A randomized, double-blind, placebo-controlled trial in infants aged 6 months or younger who were hospitalized with RSV examined the safety and efficacy of ziresovir, an investigational oral antiviral agent being specifically developed to treat RSV.READ MORE...The study was conducted at 28 hospitals in China between September 2020 and January 2022, with follow-up through February 2024. A total of 188 infants (125 receiving ziresovir and 63 receiving placebo) were included in the safety analysis, while the intention-to-treat infected population (ITT-i) included 150 infants (100 on ziresovir and 50 on placebo). All participants were hospitalized with RSV, began treatment within 7 days of symptom onset, and had a baseline Wang bronchiolitis clinical score (WBCS) of at least 5, indicating moderate disease severity. The WBCS is a standardized scoring system used to assess the severity of bronchiolitis in infants and young children.Patients were administered ziresovir orally, dosed by weight, twice daily for 5 days. The primary outcome was change in WBCS from baseline to day 3. Patients receiving at least one dose of ziresovir were monitored for any treatment-emergent adverse events throughout the study.At baseline, the mean age of participants was about 3.4 months, and the mean WBCS was approximately 6.8–6.9 in both groups. On day 3, the least-squares mean change in WBCS was −3.5 points in the ziresovir group versus −2.2 points in the placebo group, a statistically significant difference of −1.2 points (95% CI, −1.9 to −0.6; p=0.0004). Drug-related adverse events occurred in 18% of infants receiving ziresovir and 11% receiving placebo, but no serious drug-related events or deaths were reported.These findings suggest that ziresovir, an investigational antiviral designed for respiratory syncytial virus (RSV), is safe and well tolerated in infants aged 6 months or younger who are hospitalized with RSV. Moreover, treatment with ziresovir was associated with meaningful improvement in respiratory symptoms compared to placebo during the trial period. These results support further investigation of ziresovir as a potential therapeutic option for this vulnerable population. (Zhang, H., et al. [2025]. Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up. Lancet Child Adolesc Health, 9(5), 325–336. Retrieved June 2025 from https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(25)00067-7/abstract)Released: July 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - June 2025
Delayed Alteplase for Posterior Circulation Ischemic StrokeA randomized clinical trial conducted in China evaluated the safety and effectiveness of administering intravenous alteplase between 4.5 and 24 hours after the onset of posterior circulation ischemic stroke. The safety and potential benefits of giving intravenous thrombolysis beyond the traditional treatment window for posterior circulation ischemic stroke are not well understood.READ MORE...To investigate this, the study enrolled adults with posterior circulation strokes who showed no extensive early damage on CT imaging and had no plan for thrombectomy. Participants were randomly assigned (1:1) to receive either alteplase at a dose of 0.9 mg/kg (maximum 90 mg) or standard medical care 4.5 to 24 hours after the onset of symptoms. The primary outcome was functional independence, defined as a score of 0 to 2 on the modified Rankin scale (where lower scores indicate better recovery), at 90 days.A total of 234 adults were enrolled, and most patients had relatively mild strokes, with a median National Institutes of Health Stroke Scale score of 3. The key safety outcomes assessed were symptomatic intracranial hemorrhage and mortality. At 90 days, 89.6% of patients in the alteplase group achieved functional independence, compared with 72.6% in the standard care group. The incidence of symptomatic intracranial hemorrhage within 36 hours was rare, occurring in 1.7% of the alteplase group and in 0.9% in the standard treatment group. Mortality at 90 days was 5.2% in the alteplase group and 8.5% in the standard treatment group.Findings from this study suggest that for select patients with mild posterior circulation stroke and no indication for thrombectomy, intravenous alteplase given beyond the standard 4.5-hour window can improve long-term functional outcomes with a low risk of serious complications. (Yan, S., et al. [2025]. Alteplase for posterior circulation ischemic stroke at 4.5 to 24 hours. N Engl J Med, 392, 1288–1296. Retrieved May 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2413344)Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Oral vs Extended-Release Naltrexone for Alcohol Use Disorder in Hospitalized PatientsA randomized clinical trial investigated the effectiveness of starting oral versus extended-release injectable naltrexone for patients with alcohol use disorder (AUD) at the time of hospital discharge. The study, known as the Alcohol Disorder Hospital Treatment (ADOPT) trial, was conducted at a U.S. urban teaching hospital and enrolled participants between June 2016 and March 2020.READ MORE...The study included medical inpatients with AUD and recent heavy drinking, defined as consuming 5 or more alcoholic drinks per day for men or 4 or more for women. Participants were randomized at hospital discharge to receive either daily oral naltrexone or monthly extended-release injectable naltrexone. All participants received additional medical management from a research nurse trained in addiction care.Researchers measured changes in heavy drinking behavior by evaluating the percentage of heavy drinking days (HDDs) over the past 30 days, from hospital discharge to a 3-month follow-up. They also assessed acute healthcare use, specifically emergency department visits and hospital readmissions, at the 3-month follow-up over the prior 90 days.Of the 248 study participants, most were male (80.2%), with a mean age of 49.4 years. At enrollment, the median percentage of heavy drinking days (HDDs) in the past month was 80%. At the 3-month follow-up, both groups demonstrated significant reductions in alcohol use. Those who received oral naltrexone saw HDDs drop from 66.7% to 27.4%, while those given the extended-release injection saw a reduction from 70.7% to 23.8%. However, the differences between the two groups were not statistically significant. Similarly, no significant differences were seen in rates of acute healthcare use in the prior 3 months (oral naltrexone: 54.1% vs injectable naltrexone: 61.1%).The findings support that initiating either form of naltrexone during hospitalization can lead to meaningful reductions in heavy drinking among patients with AUD. Furthermore, since both forms of naltrexone were similarly effective, treatment choice may depend on individual factors such as adherence likelihood, patient preference, and insurance coverage. (Magane, K.M., et al. [2025]. Oral vs extended-release injectable naltrexone for hospitalized patients with alcohol use disorder: a randomized clinical trial. JAMA Intern Med, 185(6), 635–645. Retrieved May 2025 from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832702)Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Semaglutide Improves Liver Health in Patients with MASH and FibrosisA phase 3 randomized, double-blind, placebo-controlled trial investigated the effects of semaglutide in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. MASH is a progressive liver disease that can lead to cirrhosis and liver failure. Semaglutide is a glucagon-like peptide-1 receptor agonist approved for type 2 diabetes and obesity that lowers blood glucose, curbs appetite, and promotes weight loss, effects that could potentially benefit patients with MASH.READ MORE...In this ongoing multicenter trial, 1197 adults with biopsy-confirmed MASH and stage 2 or 3 fibrosis were randomized 2:1 to receive weekly subcutaneous semaglutide (2.4 mg) or placebo for up to 240 weeks. An interim analysis was conducted at week 72 based on the first 800 study participants. The primary endpoints of this analysis were resolution of steatohepatitis without worsening liver fibrosis and reduction in liver fibrosis without worsening steatohepatitis. Pre-specified secondary outcomes, adjusted for multiple testing, included combined resolution of steatohepatitis and fibrosis improvement, change in body weight, and change in bodily pain scores.At 72 weeks, 62.9% of patients receiving semaglutide achieved resolution of steatohepatitis without worsening fibrosis, compared with 34.3% in the placebo group. A reduction in liver fibrosis without worsening of steatohepatitis was reported in 36.8% of the semaglutide group versus 22.4% of the placebo group. Both resolution of MASH and fibrosis improvement occurred in 32.7% of semaglutide-treated patients, compared with 16.1% of those receiving placebo. Patients on semaglutide also experienced a significantly greater average weight loss of 10.5%, compared with 2.0% in the placebo group. There was no significant difference between groups in bodily pain scores. Gastrointestinal adverse events were more frequent in those treated with semaglutide.These results suggest that semaglutide can improve liver histology in patients with MASH and moderate to advanced fibrosis. Therefore, this pharmacologic therapy may offer a new treatment option for this challenging condition. (Sanyal, A.J., et al. [2025]. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis. N Engl J Med, 392, 2089–2099. Retrieved May 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2413258)Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Stapokibart Add-On Therapy in Moderate-to-Severe Seasonal Allergic RhinitisA phase 3 multicenter, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of stapokibart in adults with moderate-to-severe seasonal allergic rhinitis (SAR) who remained symptomatic despite standard therapy. SAR is common during pollen season and can greatly impact quality of life, particularly in those with persistent or severe symptoms unresponsive to standard treatments. Stapokibart is a humanized monoclonal antibody that targets the interleukin-4 receptor subunit alpha, thereby blocking its interaction with both interleukin-4 (IL-4) and interleukin-13 (IL-13), key cytokines in type 2 inflammatory pathways.READ MORE...This study enrolled 108 adults with moderate-to-severe SAR and elevated blood eosinophil counts (≥300 cells/μL). Participants were randomly assigned (1:1) to receive stapokibart administered subcutaneously as a 600 mg loading dose followed by 300 mg or placebo every two weeks for a total of four weeks during pollen season. All participants continued their usual allergy medications.The primary endpoint of the study was the change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) during the first two weeks of treatment. Secondary endpoints included changes in rTNSS over a four-week period and reflective Total Ocular Symptom Scores and scores from the Rhinoconjunctivitis Quality of Life Questionnaire assessed at both two and four weeks.Patients receiving stapokibart had significantly greater reductions in daily rTNSS scores compared with those receiving placebo. At the two-week point, the least-squares mean difference in rTNSS from baseline was −1.3 (95% CI, −2.0 to −0.6; P = 0.0008), and by week four, the difference increased to −1.7 points (95% CI, −2.5 to −0.8; P = 0.0002). Additionally, stapokibart treatment led to statistically significant improvements in all multiplicity-adjusted secondary endpoints, including relief of ocular symptoms and enhanced quality of life. Treatment-emergent adverse events occurred at similar rates in both groups.Pharmacodynamic and exploratory analyses suggest that the symptom improvements seen during pollen season were likely due to ability of stapokibart to reduce type 2 inflammation. Overall, the trial showed that seasonal use of stapokibart led to meaningful relief of both nasal and eye symptoms and enhanced quality of life in adults with moderate-to-severe SAR. (Zhang, Y., et al. [2025]. Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial. Nat Med. Advance online publication. Retrieved May 2025 from https://doi.org/10.1038/s41591-025-03651-5)Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - May 2025
Long-Term Effects of Atorvastatin in Cardiovascular DiseaseThe Anglo-Scandinavian Cardiac Outcomes Trial investigated the long-term effects of atorvastatin, a cholesterol-lowering drug, on cardiovascular (CV) disease in hypertensive individuals with additional risk factors. The lipid-lowering arm of the trial randomized over 10,000 participants with total cholesterol <6.5 mmol/L to receive either atorvastatin 10 mg or a placebo for an average of 3.3 years. The initial results showed that atorvastatin significantly reduced the incidence of major CV events like myocardial infarction (MI) and stroke.READ MORE...A follow-up conducted approximately 20 years after the initial randomization and 17 years after the lipid-lowering arm's closure examined both nonfatal events and mortality data from the UK participants (n=4,605). This long-term analysis aimed to assess the enduring "legacy effects" of the initial atorvastatin treatment and the association between cholesterol levels achieved during the trial and subsequent CV outcomes.The results of this extended follow-up revealed that participants initially assigned to atorvastatin still experienced a meaningful reduction in nonfatal MI and fatal coronary heart disease events (hazard ratio [HR] 0.81), total coronary events (HR 0.88), and CV mortality (HR 0.86) compared to those who received the placebo during the trial. This benefit persisted despite the fact that a majority of participants in both groups were taking statins in the years following the trial's conclusion, and their lipid profiles had become similar.Further analysis showed a strong association between the mean LDL cholesterol levels achieved during the trial in the atorvastatin group and long-term CV outcomes. Each 1 mmol/L decrease in LDL was linked to lower risks of nonfatal MI and fatal coronary heart disease, total coronary events, heart failure, stroke, total CV events, CV mortality, and even all-cause mortality. This highlights the importance of early and effective cholesterol lowering.Interestingly, although the original trial showed a reduction in stroke incidence with atorvastatin, the long-term follow-up didn't demonstrate a sizeable legacy benefit for stroke. The researchers propose this could be due to the complex and multifactorial nature of stroke. Despite some limitations in the long-term data collection, the findings strongly support the concept of a "legacy effect" of early statin intervention, suggesting that the initial period of treatment provides lasting CV protection. (Sever, P. S., et al. [2025]. Long-term benefits of atorvastatin on the incidence of cardiovascular events: The ASCOT-Legacy 20-year follow-up. Heart. Advance online publication. Retrieved April 2025 from https://heart.bmj.com/content/early/2025/03/25/heartjnl-2024-325104)Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Brexpiprazole for Adolescents with SchizophreniaA randomized, double-blind, placebo-controlled phase 3 trial evaluated the efficacy and safety of brexpiprazole in adolescents (ages 13 to 17) with schizophrenia. Participants in the trial had a confirmed diagnosis of schizophrenia, a history of illness for at least 6 months, a need for antipsychotic medication, and a score of 80 or greater on the Positive and Negative Syndrome Scale (PANSS).READ MORE...The study enrolled 316 patients and randomized them to receive either brexpiprazole (2 to 4 mg/day), placebo, or aripiprazole (10 to 20 mg/day) for 6 weeks. The primary outcome was the change in PANSS total score from baseline to week 6. The analysis primarily focused on comparing brexpiprazole to placebo, with aripiprazole included as an active reference to validate the trial's sensitivity.The study results showed that the brexpiprazole group had a greater improvement in PANSS total score compared to the placebo group at week 6 (least squares mean difference −5.33, p=0.014). The aripiprazole group also demonstrated a significant improvement compared to placebo, validating the study's design.The brexpiprazole group also showed significant improvements in secondary outcomes, such as PANSS Positive subscale score, response rate, and Clinical Global Impression-Improvement score compared to placebo. In addition, post hoc analysis revealed a meaningful improvement in the PANSS General Psychopathology subscale score in the brexpiprazole group versus placebo.The overall incidence of adverse events was similar between the brexpiprazole group and placebo. The most common adverse events reported with brexpiprazole were headache and nausea. Notably, no patients in the brexpiprazole group discontinued treatment because of adverse events.This trial demonstrated that brexpiprazole is an effective treatment for reducing overall schizophrenia symptom severity in adolescents compared to placebo, with a generally favorable safety profile. These results, combined with prior data, support brexpiprazole as a potential treatment option for adolescents with schizophrenia. (Ward, C., et al. [2025]. Efficacy and safety of brexpiprazole in adolescents with schizophrenia: A multicountry, randomised, double-blind, placebo-controlled, phase 3 trial with an active reference. Lancet Psychiatry, 12[5], 345–354. Retrieved April 2025 from https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00043-4/fulltext#tbl3)Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Cenobamate in Drug-Resistant EpilepsyA retrospective, multicenter study analyzed the real-world effectiveness and tolerability of cenobamate as adjunctive therapy for adults with drug-resistant focal-onset seizures participating in Early Access Programs. The study included 298 patients with a long history of epilepsy (median 22 years) and a high number of previously failed antiseizure medications, with 41.9% having undergone epilepsy surgery. The primary efficacy endpoint was a 50% or greater reduction in seizure frequency after 3 months of maintenance therapy.READ MORE...The study found that cenobamate demonstrated significant effectiveness in this highly refractory patient population. At the 3-month maintenance mark, 49.3% of patients achieved at least a 50% reduction in seizures, and 13.6% became seizure-free. These response rates showed a trend of improvement over time, with the 12-month maintenance period showing 60% of patients achieving a 50% or greater seizure reduction and 45% achieving seizure freedom, although the number of patients in the later time points was smaller due to the Early Access Program duration.Most adverse events were mild to moderate and consistent with the known safety profile of cenobamate, with fatigue, dizziness, and somnolence being the most frequent. Serious adverse drug reactions related to cenobamate were rare (1.0%) and occurred only during the titration phase. Cutaneous reactions, which were also mostly mild or moderate, occurred in 2.3% of patients during titration, leading to discontinuation or dosage reduction in most cases, but resolved over time.The retention rate of cenobamate was notable, with approximately 70% of patients remaining on the treatment after 12 months. A trend toward the reduction of concomitant antiseizure medications was also observed during the cenobamate treatment period, suggesting a potential for simplifying medication regimens.The study's findings suggest that cenobamate is a valuable adjunctive treatment option for patients with highly drug-resistant focal or combined generalized and focal epilepsy, offering sustained seizure reduction and improved quality of life for patients who have failed multiple prior therapies. (Rheims, S., et al. [2025]. Real-world effectiveness and tolerability of cenobamate in drug-resistant epilepsy: A retrospective analysis of the patients included into the Early Access Programs [EAP] in Germany, France, and United Kingdom. Epilepsia Open. Advance online publication. Retrieved April 2025 from https://onlinelibrary.wiley.com/doi/10.1002/epi4.70021)Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Inebilizumab in Generalized Myasthenia GravisAutoimmune myasthenia gravis is characterized by autoreactive B cells producing autoantibodies that disrupt neuromuscular transmission, leading to fluctuating muscle weakness. Current treatments include glucocorticoids, cholinesterase inhibitors, thymectomy, and immunosuppressants, which aim to reduce mortality and alleviate symptoms; however, limitations in efficacy, side effects, and poor response in some patients highlight the need for alternative therapies.READ MORE...Inebilizumab, a humanized monoclonal antibody targeting CD19 (expressed on a broad range of B cells), presents a promising treatment option. A phase 3, double-blind, placebo-controlled study, the Myasthenia Gravis Inebilizumab Trial (MINT), aimed to evaluate the efficacy and safety of inebilizumab in patients with generalized myasthenia gravis undergoing a protocol-specified glucocorticoid taper.The MINT trial enrolled 238 participants with moderate to severe generalized myasthenia gravis who were positive for either acetylcholine receptor or muscle-specific kinase antibodies. Participants were randomized to receive either inebilizumab (300 mg on days 1, 15, and 183) or placebo intravenously. The primary endpoint was the difference from baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at week 26. Secondary endpoints assessed changes in the Quantitative Myasthenia Gravis (QMG) score and MG-ADL score in each antibody-positive subgroup.The results of the trial demonstrated significant clinical improvement in the inebilizumab group (−4.8 in MG-ADL score) compared to the placebo group (−2.3). This was evident in both the combined population and the acetylcholine receptor antibody-positive subgroup at week 26, with greater reductions in MG-ADL and QMG scores. Although the muscle-specific kinase antibody-positive subgroup also showed improvement in MG-ADL scores, the difference in QMG scores was not statistically significant.As far as safety, the MINT trial showed that inebilizumab was generally comparable to placebo, with similar rates of adverse events. Common adverse events included headache and coronavirus disease-2019.The MINT trial concluded that inebilizumab demonstrated efficacy and acceptable safety in adults with generalized myasthenia gravis, highlighting the therapeutic potential of CD19+ B-cell depletion for this condition. (Nowak, R. J., et al. [2025]. A phase 3 trial of inebilizumab in generalized myasthenia gravis. NEJM. Advance online publication. Retrieved April 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2501561)Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - April 2025
Impact of Human Papillomavirus Vaccination on Cervical PrecancersThe Centers for Disease Control and Prevention has released an analysis of cervical precancer trends in the United States from 2008 to 2022, focusing on the effect of human papillomavirus (HPV) vaccination and changes in screening practices. The study used data from the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT), which tracks cervical intraepithelial neoplasia (CIN) cases in five U.S. sites.READ MORE...The researchers analyzed trends in CIN2+ and CIN3+ incidence among screened women, adjusting for changes in frequency of screenings. They found substantial decreases in precancer occurrence in 2022 compared to 2008 among younger women (ages 20 to 24), particularly a substantial decline in cases for both CIN2+ (79.5% lower incidence) and CIN3+ (80.3% lower incidence), correlating with increased HPV vaccination in this age group.Conversely, older age groups (ages 25 to 64) initially showed an increased precancer incidence, likely due to longer gaps in screening and more sensitive HPV testing. However, recent data indicates that precancer incidence in the 25 to 29 age group has begun to decrease, particularly in CIN3+ cases, suggesting the delayed impact of HPV vaccination as those vaccinated at younger ages enter this demographic.Limitations of the study include potential inaccuracies in estimated screening rates, variations in screening and management, and the nature of the data, which doesn't directly establish causality. Despite these limitations, the trends strongly suggest that HPV vaccination and appropriate screening are crucial for preventing cervical cancer.Overall, the data demonstrates the importance of HPV vaccination on reducing cervical precancers, especially in younger women. It also shows a potential future reduction in precancer in older age groups as those vaccinated at younger ages progress. The study emphasizes the importance of continued HPV vaccination and adherence to cervical cancer screening guidelines. (Gargano, J. W., et al. [2025]. Trends in cervical precancers identified through population-based surveillance—Human Papillomavirus Vaccine Impact Monitoring Project, five sites, United States, 2008–2022. MMWR, 74[6], 96–101. Retrieved March 2025 from https://www.cdc.gov/mmwr/volumes/74/wr/mm7406a4.htm)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Inhaled Versus Intravenous Sedation for Acute Respiratory Distress SyndromeAcute respiratory distress syndrome (ARDS) is a serious lung condition, requiring mechanical ventilation, and optimal sedation strategies are crucial for patient management. Propofol is commonly used in critically ill patients on ventilation; however, guidance for patients with moderate to severe ARDS is limited. A recent study investigated the effectiveness and safety of inhaled sevoflurane versus intravenous propofol for sedation in this patient population.READ MORE...The study was a multicenter, randomized, phase 3 trial which ran from May 2020 through October 2023 in 37 intensive care units in France, involving 687 adult patients with ARDS. Patients were randomized to receive either sevoflurane or propofol, with initial deep sedation and neuromuscular blockade followed by lighter sedation. The primary outcome was the number of ventilator-free days at 28 days, and secondary outcomes assessed 90-day survival and safety measures.The findings showed that patients receiving sevoflurane had fewer ventilator-free days (0.0 to 11.9 versus 0.0 to 18.7 with propofol) and a lower 90-day survival rate (47.1%) compared to those receiving propofol (55.7%). Additionally, the sevoflurane group experienced higher serum lactate levels, increased norepinephrine doses, and a higher incidence of acute kidney injury and nephrogenic diabetes insipidus.These results contradict previous studies suggesting potential advantages of inhaled volatile anesthetics in critically ill patients. The researchers' explanations for the adverse outcomes include possible hemodynamic instability and kidney injury associated with sevoflurane, as well as potential issues related to the delivery device impacting carbon dioxide levels.The study concluded that inhaled sevoflurane was associated with worse clinical outcomes than intravenous propofol in patients with moderate to severe ARDS. The findings suggest that propofol remains the preferred sedation agent in this patient population, and further research is needed to explore the effects of other volatile anesthetics and shorter durations of sevoflurane use. (Jabaudon, M., et al. [2025]. Inhaled sedation in acute respiratory distress syndrome: The SESAR randomized clinical trial. JAMA. Advance online publication. Retrieved March 2025 from https://jamanetwork.com/journals/jama/fullarticle/2831857)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Remibrutinib Improves Symptoms in Chronic Spontaneous UrticariaChronic spontaneous urticaria (CSU) is marked by itching, hives, and angioedema, which can last over 6 weeks and greatly reduces quality of life in those affected. Standard treatment is with second-generation H1-antihistamines, but only half of treated patients receive adequate relief. Two phase 3 clinical trials (REMIX-1 and REMIX-2) evaluated remibrutinib, a Bruton tyrosine kinase inhibitor, for CSU in patients whose symptoms were not well-controlled with second-generation H1-antihistamines.READ MORE...The trials were randomized, double-blind, placebo-controlled studies where patients received either remibrutinib (25 mg twice daily) or a placebo for 24 weeks, in addition to their existing H1-antihistamine therapy. The primary endpoint was the change in the Urticaria Activity Score over 7 days (UAS7) from start to week 12. Key secondary endpoints were itch and hive severity scores, as well as the proportion of patients achieving well-controlled CSU (UAS7 score of 6 or less) and complete resolution of symptoms.Results showed remibrutinib substantially improved UAS7, itch severity, and hive severity compared to placebo at week 12, with improvements seen as early as week 1 and sustained through week 24. A greater percentage of patients on remibrutinib achieved well-controlled CSU over placebo (49.8% vs. 24.8% in REMIX-1; 46.8% vs. 19.6% in REMIX-2). Likewise, remibrutinib demonstrated better rates of complete symptom resolution (31.1% vs. 10.5% in REMIX-1; 27.9% vs. 6.5% in REMIX-2).Remibrutinib also demonstrated a favorable safety profile, with adverse events similar to placebo. Most events were mild or moderate, and serious adverse events were infrequent and unrelated to the study drug.These clinical trials support the efficacy and safety of remibrutinib as an add-on therapy for patients with CSU who don't respond adequately to H1-antihistamines, offering a potential new treatment option for this condition. (Metz, M., et al. [2025]. Remibrutinib in chronic spontaneous urticaria. NEJM, 392(10), 984–994. Retrieved March 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2408792)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Tezepelumab for Chronic Rhinosinusitis with Nasal PolypsA phase 3, multicenter, double-blind, randomized, controlled clinical trial (WAYPOINT) assessed the efficacy and safety of tezepelumab, a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), in treating severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a condition defined by epithelial barrier dysfunction and type 2 inflammation that leads to symptoms like nasal congestion, facial pain, and loss of smell, greatly impacting quality of life for patients.READ MORE...Current treatments, such as intranasal glucocorticoids and surgery, often provide limited relief. Biologic therapies targeting type 2 inflammatory pathways have emerged, but unmet needs remain for patients with inadequate responses. Tezepelumab, by blocking TSLP, an upstream inflammatory driver, offers a potential new approach, as elevated TSLP levels are found in nasal polyp tissue.The WAYPOINT trial, which ran from April 2021 through August 2023, involved 408 patients with severe CRSwNP, randomized to receive either tezepelumab (210 mg at week 0 and then every 4 weeks after) or placebo, alongside standard intranasal glucocorticoid therapy, over 52 weeks. The study measured changes in nasal polyp size, nasal congestion, loss of smell, sinus opacification, and the need for surgery or systemic glucocorticoids.Results showed significantly greater reductions in nasal polyp size (mean difference, −2.07) and nasal congestion (mean difference, −1.03) in the tezepelumab group compared to placebo. In addition, tezepelumab led to improvements in loss of smell, sinus opacification, and reduced the need for surgery or systemic glucocorticoids. The treatment was well-tolerated, with adverse events similar to placebo.The study concludes that tezepelumab is an effective and safe treatment option for severe, uncontrolled CRSwNP, offering symptom relief and reducing the need for invasive interventions. This suggests that targeting TSLP could be a promising therapeutic strategy for this challenging condition. (Lipworth, B. J., et al. [2025]. Tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps. NEJM. Advance online publication. Retrieved March 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2414482)Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - March 2025
Long-Term Outcomes of Deucravacitinib in Plaque PsoriasisPlaque psoriasis, a chronic inflammatory skin condition, impacts quality of life and can lead to disability. The enzyme tyrosine kinase 2 plays a central role in signaling inflammatory cytokines in psoriasis. Deucravacitinib has been used to treat plaque psoriasis by preventing this enzyme from becoming active.READ MORE...The efficacy and safety of deucravacitinib were previously evaluated in two global, 52-week, randomized phase 3 trials (POETYK PSO-110 and PSO-211), which demonstrated that the drug was better than placebo and apremilast in reducing moderate to severe plaque psoriasis severity. Patients who completed the initial trials had the option to enter in the long-term extension trial, which involved open-label treatment with deucravacitinib. This trial started in 2019 and provided ongoing data through 2022 to assess the long-term impact of treatment.Efficacy data from patients receiving continuous treatment revealed that clinical responses were maintained throughout the 3 years. Likewise, safety assessments throughout the 3-year period revealed that adverse events and discontinuations due to adverse events remained consistent with those seen during the first year. Serious infections, major cardiovascular events, and herpes zoster were also monitored, with most findings showing either decreased or similar incidence rates compared to the first year. Laboratory parameters, such as blood counts and lipid levels, also remained stable over time.This study suggests that deucravacitinib is a reliable and effective long-term treatment option for managing plaque psoriasis, offering patients consistent relief and a manageable safety profile over an extended treatment period. (Armstrong, A. W., et al. [2025]. Safety and efficacy of deucravacitinib in moderate to severe plaque psoriasis for up to 3 years: An open-label extension of randomized clinical trials. JAMA Dermatol, 161[1], 56–66. Retrieved February 2025 from https://jamanetwork.com/journals/jamadermatology/fullarticle/2827130)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Finerenone Improves Long-Term Outcomes in Patients with Heart FailurePatients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) face reduced life expectancy, often 15 years shorter than their age-matched peers. Until recently, treatment options were limited, focusing mainly on symptom management. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and, more recently, the mineralocorticoid receptor antagonist, finerenone, have emerged as effective therapies, reducing cardiovascular events and improving patient outcomes.READ MORE...The phase 3, FINEARTS-HF trial, a large, global, randomized controlled trial, evaluated the long-term impact of finerenone on event-free survival in patients with HFmrEF or HFpEF. The trial enrolled 6,001 participants, age 40 and older, with evidence of heart disease and elevated natriuretic peptide levels. The patients were randomly assigned to receive either finerenone or a placebo. The primary endpoint of the study was cardiovascular death or worsening heart failure, while all-cause mortality was a secondary outcome. The study used actuarial methods to estimate the long-term benefits of finerenone, considering factors like patient age at randomization and adjusting for survival time free from the primary outcome.The analysis revealed notable long-term benefits with finerenone, with a 65-year-old patient gaining an estimated 2.0 years of event-free survival compared to those receiving placebo. The benefits were more pronounced in younger and middle-aged patients, who had longer life expectancies. Additionally, participants already on SGLT2 inhibitors at baseline also saw substantial benefits, suggesting that finerenone could complement current treatments.While finerenone was shown to extend event-free survival by up to 3 years in some patients, it didn't significantly improve overall survival. Despite this, the trial showed that finerenone provides meaningful long-term benefits for patients with HFmrEF or HFpEF, particularly for younger patients. The treatment has comparable benefits to SGLT2 inhibitors and offers an additional option for improving long-term outcomes in this challenging patient population. (Vaduganathan, M., et al. [2025]. Estimated long-term benefits of finerenone in heart failure: A prespecified secondary analysis of the FINEARTS-HF randomized clinical trial. JAMA Cardiol, 10[2], 176–181. Retrieved February 2025 from https://jamanetwork.com/journals/jamacardiology/fullarticle/2824342)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Iptacopan Has Potential as Targeted Treatment for IgA NephropathyIgA nephropathy, a form of glomerulonephritis, is often associated with progressive kidney function loss, especially in individuals with high urinary protein levels, and is a major cause of kidney failure. Treatments for this immune disorder often rely on glucocorticoids, which have substantial side effects.READ MORE...Iptacopan, a proximal complement inhibitor, has shown promise in clinical trials for IgA nephropathy. It works by inhibiting factor B, preventing the formation of the membrane attack complex, which contributes to kidney damage. A current phase 3 trial, APPLAUSE-IgAN, is assessing iptacopan's effects on proteinuria and kidney function in patients at risk for progression. This reports on results of the interim analysis of that trial (data collected between January 2021 to August 2023), evaluating the impact on proteinuria specifically.In the study, patients were randomized to receive either iptacopan or a placebo, in addition to supportive care. Eligibility was based on having primary IgA nephropathy confirmed by biopsy and meeting certain criteria for proteinuria. The study examined the change in the 24-hour urinary protein-to-creatinine ratio at 9 months. Various measures of protein and albumin excretion were also assessed, as well as safety outcomes.At the interim analysis, results showed that iptacopan reduced the 24-hour urinary protein-to-creatinine ratio by 38.3% compared to placebo. Additionally, more patients in the iptacopan group had a protein-to-creatinine ratio of less than 1 at 9 months. Safety data also supported iptacopan, indicating that it was well-tolerated and reporting that most adverse events were mild to moderate. In addition, fewer patients in the iptacopan group discontinued the trial due to adverse events compared to the placebo group.The trial's interim results highlight iptacopan's potential as a targeted treatment for IgA nephropathy by blocking complement-mediated kidney injury. While the current trial focuses on proteinuria, future analysis of kidney function outcomes will provide a clearer understanding of its long-term effects on kidney health. (Perkovic, V., et al. [2025]. Alternative complement pathway inhibition with iptacopan in IgA nephropathy. NEJM, 392, 531–543. Retrieved February 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2410316)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Adding Obinutuzumab to Standard Therapy in Lupus NephritisA phase 3, randomized, double-blind, placebo-controlled trial aimed to assess whether obinutuzumab could enhance renal outcomes in lupus nephritis patients who were already receiving standard treatments, such as mycophenolate mofetil and glucocorticoids. Obinutuzumab has previously shown promise in other conditions, like chronic lymphocytic leukemia and follicular lymphoma.READ MORE...The trial included 271 patients with active class III or IV lupus nephritis. The patients were randomized to receive either obinutuzumab or a placebo, with both groups also receiving standard therapy. The primary endpoint was achieving a reduction in proteinuria and maintaining kidney function without treatment failure or major adverse events at week 76.Results showed that more participants in the obinutuzumab group (46.4%) attained a complete renal response at week 76 compared to the placebo group (33.1%). Additionally, the obinutuzumab group experienced fewer intercurrent events, such as treatment failure or the need for rescue therapy. Secondary endpoints also favored obinutuzumab, with a higher proportion of patients achieving reduced proteinuria and better preservation of kidney function.While obinutuzumab demonstrated superior efficacy, the trial also showed a higher incidence of serious adverse events. These included respiratory infections and complications related to coronavirus disease 2019 (COVID-19). However, after excluding COVID-19-related events, the rate of serious infections decreased.This phase 3 trial confirms that adding obinutuzumab to standard therapy improves renal outcomes for patients with lupus nephritis. However, the treatment comes with an increased risk of infections, especially in the context of COVID-19, and this must be balanced against its benefits. Overall, the study supports obinutuzumab as an encouraging option in treating lupus nephritis, although further investigation into long-term safety and efficacy is needed. (Furie, R. A., et al. [2025]. Efficacy and safety of obinutuzumab in active lupus nephritis. NEJM. Advance online publication. https://www.nejm.org/doi/full/10.1056/NEJMoa2410965)Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - February 2025
Condoliase Offers Less Invasive Treatment for Patients With Lumbar Disc HerniationLumbar disc herniation (LDH) is a spinal condition that causes nerve root compression, leading to radicular leg pain and affecting quality of life. Although many cases resolve with conservative treatments, approximately 10% of patients require more intensive interventions. Consequently, alternative treatments like condoliase, are being explored.READ MORE...Condoliase is a glycosaminoglycan-degrading enzyme that reduces moisture retention and pressure within the intervertebral disc, alleviating nerve root compression, which is a key contributor to pain in LDH. A phase 3, multicenter, randomized, double-blind, sham-controlled trial focused on evaluating the safety and efficacy of condoliase in the United States.The study involved 352 participants ages 30 to 70 with radicular leg pain from LDH. Participants were randomized to receive either a single intradiscal injection (1.25 units) of condoliase or a sham injection. The primary endpoint was the change in worst leg pain score from baseline to Week 13, while secondary endpoints included changes in disability, herniation volume, and neurologic status. Results showed that the condoliase group had higher responder rates (50% or more reduction in pain) compared to the sham group. The condoliase group also showed improvements in disability and greater improvements in neurologic tests, such as the straight leg raise test, at Week 13.Although adverse events were reported more frequently in the condoliase group, including back pain and hypersensitivity reactions, no participants required discontinuation due to adverse events. Additionally, condoliase was associated with a lower rate of posttreatment surgery compared to the sham group, which is a promising result for patients looking for less invasive alternatives to surgery.This phase 3 trial supports condoliase as an effective treatment for radicular leg pain due to LDH, with improvements in pain relief and lower rates of surgery compared to sham treatment. Even though the drug was associated with some mild side effects, it provides a promising less-invasive option for patients who don't respond to conservative treatments. (Kim, K. D., et al. [2024]. A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 [condoliase] in patients with radicular leg pain associated with lumbar disc herniation. The Spine Journal, 24[12], 2285–2296. Retrieved January 2025 from https://www.thespinejournalonline.com/article/S1529-9430(24)00936-7/fulltext)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Promising Treatment Combination for Cystic FibrosisCystic fibrosis (CF) is a genetic disorder that's caused by mutations in the CFTR gene. The disease can manifest in early life, with symptoms such as pancreatic insufficiency and elevated chloride levels in sweat. Chronic respiratory infections and progressive lung damage are common, and poor nutrition exacerbates these issues, contributing to the overall decline in health.READ MORE...CFTR modulators are a therapeutic class designed to restore normal CFTR function, as individuals with healthy CFTR don't experience CF-related symptoms. Sweat chloride testing is a key diagnostic tool for CF, with elevated chloride levels indicating CFTR dysfunction. CFTR modulators, like vanzacaftor/tezacaftor/deutivacaftor, a new combination regimen, aim to normalize chloride transport and improve overall CFTR function.In a phase 3 trial for children ages 6 to 11 years, this combination was tested with 78 participants over a 24-week treatment period for safety, pharmacokinetics, and efficacy. In the trial, participants taking the combination therapy showed stable lung function, with no significant decline in forced expiratory volume in 1 second, a key measure of lung capacity. The treatment also led to a decrease in sweat chloride concentrations, with most children achieving sweat chloride levels below the 60 mmol/L threshold, a marker of improved CFTR function. Additionally, the Cystic Fibrosis Questionnaire-Revised respiratory domain scores improved, suggesting better respiratory health. As far as safety, the regimen was found to be well tolerated, with few serious adverse events.Overall, the 24-week trial demonstrated that vanzacaftor/tezacaftor/deutivacaftor treatment improves CFTR function in children ages 6 to 11, with a favorable safety profile. This next-generation CFTR modulator regimen offers hope for reducing the clinical burden of CF, potentially improving both quality of life and long-term health outcomes. (Hoppe, J. E., et al. [2025]. Vanzacaftor/tezacaftor/deutivacaftor for children aged 6–11 years with cystic fibrosis [RIDGELINE trial VX21-121-105]: An analysis from a single-arm, phase 3 trial. The Lancet Respiratory Medicine. Advance online publication. Retrieved January 2025 from https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(24)00407-7/fulltext)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Updated Guidelines for Tuberculosis TreatmentUpdated guidelines from the American Thoracic Society, the Centers for Disease Control and Prevention, the European Respiratory Society, and the Infectious Diseases Society of America now recommend shorter, fully oral treatment regimens for tuberculosis (TB) in both adults and children.READ MORE...The push for shorter treatments comes after years of limited drug development. Recent studies have enabled the reduction of treatment durations to 4 months for drug-susceptible TB and 6 months for drug-resistant TB, providing a more efficient approach to managing the disease. However, not all patients qualify for these shortened regimens, and the existing recommendations for some patients from previous guidelines remain in place. The updated guidelines make the following suggestions:Children ages 3 months to 16 years old with nonsevere TB should receive a 4-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by isoniazid and rifampin for the remaining 2 months.Patients age 12 and older with drug-susceptible TB should consider a 4-month regimen of isoniazid, rifapentine, moxifloxacin, and pyrazinamide.Patients age 14 and older with rifampin-resistant pulmonary TB and resistance to fluoroquinolones; and in cases of multidrug-resistant but fluoroquinolone-susceptible disease, a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin is recommended.Certain pediatric cases that don't meet the criteria for the shortened regimen should continue with the standard 6-month treatment, while children with severe TB forms may require alternative regimens. Some children may also be eligible for the 4-month rifapentine-moxifloxacin regimen. The guidelines stress that drug-susceptibility testing and close monitoring for safety and effectiveness remain essential, especially to prevent the emergence of drug resistance.The updated guidelines were largely adapted from the 2022 World Health Organization TB treatment recommendations, with a panel of 25 international experts contributing to the consensus. No new clinical trial data has emerged since the World Health Organization guidelines were published, and the U.S. guidelines align closely with the global recommendations. (Saukkonen, J. J., et al. [2025]. Updates on the treatment of drug-susceptible and drug-resistant tuberculosis: An official ATS/CDC/ERS/IDSA Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine, 211[1], 15–33. Retrieved January 2025 from https://www.atsjournals.org/doi/full/10.1164/rccm.202410-2096ST)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.Combination Metronomic Capecitabine and Aromatase Inhibitor as First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Breast CancerTreating hormone receptor-positive, HER2-negative metastatic breast cancer (MBC) is challenging, especially as resistance to endocrine therapy develops in most patients over time. Metronomic chemotherapy, which uses lower doses of chemotherapy agents at more frequent intervals, offers potential as a less toxic alternative to traditional chemotherapy.READ MORE...Capecitabine, an oral chemotherapy agent, is one such drug used in metronomic chemotherapy. The MECCA trial explored combining metronomic capecitabine with endocrine therapy, specifically an aromatase inhibitor (AI), as a first-line treatment for hormone receptor-positive, HER2-negative MBC. This phase 3 trial in China involved 254 patients and compared the combination of capecitabine and AI with AI alone in terms of progression-free survival (PFS) and other clinical outcomes.The primary endpoint was PFS, while secondary endpoints included overall survival (OS), objective response rate, disease control rate, and safety. Patients were randomly assigned to either the capecitabine (500 mg three times daily) plus AI group or the AI-only group. The study continued until disease progression, intolerable side effects, or patient withdrawal.After a median follow-up of 50.7 months, the combination group showed a meaningful improvement in PFS (20.9 months) compared to the AI-only group (11.9 months). The combination group also had an OS advantage, with a median OS not yet reached compared to 45.1 months in the AI-only group. The objective response and disease control rates were higher in the combination group as well, at 37.3% and 88.1%, respectively, compared to 25.0% and 75.8% for the AI-only group.In terms of safety, the combination therapy was generally well tolerated. Although adverse events like palmar-plantar erythrodysesthesia were more common in the capecitabine plus AI group, most side effects were mild to moderate.The MECCA trial supports metronomic capecitabine combined with AI as an effective first-line treatment for hormone receptor-positive, HER2-negative MBC, offering improvements in PFS and OS with manageable toxicity. Further research is needed to investigate its role alongside other therapies, including CDK4/6 inhibitors and targeted therapies. (Hong, R.-X., et al. [2025]. Metronomic capecitabine plus aromatase inhibitor as initial therapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer. The phase III MECCA trial. Journal of Clinical Oncology. Advance online publication. Retrieved January 2025 from https://ascopubs.org/doi/10.1200/JCO.24.00938)Released: February 2025Nursing Drug Handbook© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
News Capsules - January 2025
Blinatumomab Plus Chemotherapy Enhances Outcomes for Children with Newly Diagnosed B-Cell ALLOver the past five decades, the cure rates for acute lymphoblastic leukemia (ALL) have greatly improved, although further progress has slowed. Blinatumomab has appeared hopeful in treating children with relapsed B-cell ALL by redirecting T cells to attack these cancer cells. However, its effect on children with newly diagnosed disease remained unclear.READ MORE...AALL1731, an international, randomized, controlled, phase 3 trial conducted by the Children's Oncology Group, assessed whether adding two cycles of blinatumomab to standard chemotherapy would produce better results for children with standard-risk B-cell ALL. The study ran from June 2019 to June 2024 and enrolled 1,440 children ages 1 to 10 with standard-risk B-cell ALL and with an average or high risk for relapse. The patients were randomized into two groups: one received chemotherapy alone, while the other received chemotherapy along with two cycles of blinatumomab. The primary endpoint was disease-free survival (DFS), defined as the time from randomization to the first event of relapse, death, or a second malignancy.The results showed that adding blinatumomab improved DFS, with a 3-year DFS of 96% in the blinatumomab group versus 87.9% in the chemotherapy-only group. Additionally, blinatumomab was found to strengthen DFS across all subgroups, including those with varying minimal residual disease levels, race, and cytogenetic risk groups. Overall survival was also improved, particularly in patients with an average risk of relapse. Despite these positive results, patients in the blinatumomab group were more likely to experience severe infections, such as sepsis and catheter-related infections, although these events were relatively rare.The findings from this trial suggest that blinatumomab could produce better treatment outcomes for children with newly diagnosed standard-risk B-cell ALL, particularly those with higher relapse risks. Although further studies are needed to address the optimal number of blinatumomab cycles and the long-term effects of the treatment, the results from this trial could help refine the strategies used to treat childhood leukemia in the future. (Gupta, S., et al. [2024]. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. NEJM. Advance online publication. Retrieved December 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2411680?query=TOC&cid=DM2376567_Non_Subscriber&bid=-1601332578)Released: January 2025Nursing Drug Handbook© 2025 Wolters KluwerBrexpiprazole and Sertraline Combination a Promising Treatment for PTSDPosttraumatic stress disorder (PTSD) is a mental health condition marked by intrusive memories, avoidance of trauma-related stimuli, and negative mood shifts. It impacts quality of life and is linked to increased suicide risk. First-line treatment for PTSD is selective serotonin reuptake inhibitors (SSRIs), such as sertraline and paroxetine, though many patients don't respond to these medications.READ MORE...One promising alternative is brexpiprazole, an antipsychotic with a broad range of pharmacologic effects on neurotransmitter systems. A phase 3, multicenter, double-blind, randomized clinical study compared brexpiprazole plus sertraline with sertraline plus placebo in patients diagnosed with PTSD to assess its efficacy, safety, and tolerability. The study ran from October 2019 to August 2023 and enrolled 416 patients. Participants were randomized to either brexpiprazole (2 to 3 mg/day) with sertraline (150 mg/day) or sertraline (150 mg/day) with placebo and monitored over 11 weeks.The primary outcome of the study was the change in PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS-5). Secondary outcomes included changes in global severity, psychosocial functioning, and anxiety and depression symptoms.The results of the trial indicated that the addition of brexpiprazole to sertraline led to greater improvements in PTSD symptoms compared to sertraline and placebo. This was evident from the CAPS-5 scores, where the combination treatment showed a mean improvement of 19.2 points by week 10, compared to 13.6 points for the placebo group. The brexpiprazole group also showed improvements in anxiety and depression, psychosocial functioning, and PTSD symptom clusters.The incidence of adverse events was similar between the two treatment arms, though the brexpiprazole group had slightly higher rates of weight gain, fatigue, and somnolence, primarily of mild to moderate severity. No serious adverse events were associated with the treatments.This study supports the brexpiprazole and sertraline combination as an effective treatment for PTSD, particularly in patients who don't respond to SSRIs. Future research should explore the treatment's applicability to a broader range of PTSD patients and examine its long-term effects. (Davis, L. L., et al. [2024]. Brexpiprazole and sertraline combination treatment in posttraumatic stress disorder: A phase 3 randomized clinical trial. JAMA Psychiatry. Advance online publication. Retrieved December 2024 from https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2827796)Released: January 2025Nursing Drug Handbook© 2025 Wolters KluwerImlunestrant Improves Progression-Free Survival for Patients with Breast CancerEstrogen receptor (ER)-positive, HER2-negative is the most common subtype of breast cancer and is typically treated with endocrine therapy. Despite improvements in outcomes through selective ER modulators and degraders, resistance can develop due to mutations in the ESR1 gene.READ MORE...Imlunestrant is an oral selective ER degrader, designed to target ESR1 mutations. The EMBER-3 trial tested imlunestrant both as monotherapy and in combination with abemaciclib in patients with ER-positive, HER2-negative advanced breast cancer. The phase 3, open-label trial ran from October 2021 through November 2023 and included 874 patients across 22 countries. Of the patients, 38.7% had ESR1 mutations, which were associated with a more challenging prognosis. Participants were randomized into three groups: imlunestrant alone, standard therapy (exemestane or fulvestrant), and imlunestrant plus abemaciclib. Progression-free survival (PFS) was the primary endpoint, with secondary endpoints including overall survival and adverse events.At the primary analysis, the median PFS for patients with ESR1 mutations was 5.5 months in the imlunestrant group versus 3.8 months in the standard therapy group, showing a statistically significant benefit for imlunestrant. However, the combination of imlunestrant and abemaciclib resulted in the most improved PFS results with a median of 9.4 months, emphasizing the broader benefit of combining these therapies.Adverse events with imlunestrant were similar to standard therapy, including fatigue, diarrhea, and nausea; but the imlunestrant–abemaciclib group produced a higher incidence of serious adverse events, particularly related to neutropenia and anemia.This study showed that although imlunestrant is effective for patients with ESR1 mutations, the combination of imlunestrant and abemaciclib provided a more pronounced benefit across a broader range of patients, including those without ESR1 mutations. This combination offers an encouraging approach to overcoming resistance and improving patient outcomes in ER-positive, HER2-negative breast cancer. (Jhaveri, K. L., et al. [2024]. Imlunestrant with or without abemaciclib in advanced breast cancer. NEJM. Advance online publication. Retrieved December 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2410858) Released: December 2025Nursing Drug Handbook© 2025 Wolters KluwerUpdated Dosing Guidance for MenB VaccinationThe Advisory Committee on Immunization Practices (ACIP) recommends vaccination against serogroup B meningococcal (MenB) disease for adolescents and young adults as well as those age 10 and older who are at higher risk for severe disease. ACIP guidelines now include two licensed MenB vaccines: MenB-FHbp (Trumenba) and MenB-4C (Bexsero). This report provides updated dosing guidance for MenB-4C while maintaining other previous vaccination recommendations.READ MORE...The ACIP's Meningococcal Vaccines Work Group reviewed clinical trial data from several studies, evaluating MenB-4C's effectiveness and safety. The data indicated varying rates of immune response after different dosing schedules, with higher response rates after a three-dose series. The safety profile showed that common adverse reactions, such as pain at the injection site, headache, and fatigue, were similar across different dosing schedules. In addition, MenB vaccines from different manufacturers are not interchangeable, so it's important that all doses in a series are from the same brand.Based on this review, ACIP provides the following guidelines:MenB-4C should be delivered as two doses at 0 and 6 months for adolescents and young adults ages 16 to 23.For higher-risk individuals (age 10 and older with asplenia, complement deficiencies, complement inhibitor use, microbiologists exposed to Neisseria meningitidis, or those at heightened risk during an outbreak), a three-dose series at 0, 1 to 2, and 6 months is suggested.For individuals who start the MenB vaccine series within 6 months of a high-risk event (for example, college entry), the three-dose schedule is preferred to ensure rapid protection.Additional doses aren't recommended for those who have already received MenB-4C under previous dosing schedules, but booster doses should align with the original manufacturer. (Schillie, S., et al. [2024]. New dosing interval and schedule for the Bexsero MenB-4C vaccine: Updated recommendations of the Advisory Committee on Immunization Practices–United States, October 2024. MMWR, 73[49], 1124–1128. Retrieved December 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7349a3.htm?s_cid=mm7349a3_w)Released: January 2025Nursing Drug Handbook© 2025 Wolters Kluwer
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