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News Capsules - February 2025

Condoliase Offers Less Invasive Treatment for Patients With Lumbar Disc Herniation

Lumbar 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.

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Promising Treatment Combination for Cystic Fibrosis

Cystic 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.

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Updated Guidelines for Tuberculosis Treatment

Updated 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.

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Combination Metronomic Capecitabine and Aromatase Inhibitor as First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Breast Cancer

Treating 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.

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Drug News Abstracts Archive

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
News Capsules - December 2024
Inebilizumab Reduces Flares and Improves Remission Rates in IgG4-Related DiseaseImmunoglobulin (Ig) G4-related disease is a chronic, immune-mediated disorder characterized by inflammation and fibrosis across multiple organ systems, which can worsen over time and lead to organ failure. There are no approved therapies, and glucocorticoids, although effective for flare control, come with significant side effects.READ MORE...MITIGATE, a phase 3, multicenter, randomized, double-blind study showed that inebilizumab, a monoclonal antibody, is a promising treatment for IgG4-related disease. The trial involved 135 patients who received either inebilizumab (300 mg) or placebo, in addition to standard glucocorticoid therapy. The study evaluated inebilizumab's efficacy and safety in preventing disease flares and several secondary endpoints over 52-weeks of treatment.The results showed that disease flares were reduced by 87% in the inebilizumab group compared to placebo. Additionally, inebilizumab led to higher rates of flare-free, treatment-free (57%), and glucocorticoid-free (59%) complete remissions compared to placebo (22% for both). Participants treated with inebilizumab also required less glucocorticoid therapy to manage their disease —90% of the inebilizumab group discontinued glucocorticoids compared to 37% of the placebo group. Adverse events were similar between groups, but inebilizumab treatment led to more serious adverse events, including infection-related issues and lymphopenia, although no deaths occurred during the trial.The MITIGATE trial supports inebilizumab as an effective treatment for IgG4-related disease, demonstrating its ability to reduce flares and improve remission rates while reducing reliance on glucocorticoids. Further research, including long-term studies, will be needed to confirm these findings and establish the role of inebilizumab in the broader treatment landscape for IgG4-related disease. (Stone, J. H. [2024]. Inebilizumab for treatment of IgG4-related disease. NEJM. Advance online publication. Retrieved November 2024 from https://www.nejm.org/doi/pdf/10.1056/NEJMoa2409712)Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerInfluenza Antiviral Treatment among Higher-Risk Children and Adolescents DecliningEach year, tens of thousands of children and adolescents in the United States are hospitalized due to seasonal influenza, with the highest rates occurring in those under one year old. Antiviral treatment is critical to reduce the likelihood of severe illness, including intensive care unit admissions and death. The Centers for Disease Control and Prevention guidelines recommend antiviral therapy for hospitalized children with suspected influenza, even before laboratory confirmation. However, regardless of these recommendations, there has been a concerning decline in the percentage of children receiving antivirals.READ MORE...Reports from two U.S. surveillance networks: the Influenza Hospitalization Surveillance Network, which tracks hospitalizations for influenza, and the New Vaccine Surveillance Network, which monitors outpatient cases, highlight significant underuse of antiviral treatments. The data show that during the 2017 to 2018 flu season, 70% to 86% of children hospitalized with influenza received antivirals. However, this number declined in the 2023 to 2024 flu season, with just 52% to 59% of hospitalized children receiving antivirals, even though treatment has clear benefits in reducing severe outcomes.Demographic analysis revealed that children ages 2 to 4 were less likely to receive antiviral treatment compared to those under 6 months or older teens. Those with underlying conditions, such as asthma, were more likely to receive antiviral treatment, but even among this group, treatment was not universally administered. In outpatient settings, children under 6 months had the highest antiviral prescription rates (49%), while those ages 2 to 4 years had the lowest (21%).The findings point to the need for improved awareness and education among health care providers about the importance of early antiviral treatment for influenza in children and adolescents. Increasing access to timely care and addressing barriers in both hospital and outpatient settings could improve treatment adherence and outcomes for this vulnerable population. (Frutos, A. M., et al. [2024]. Underutilization of influenza antiviral treatment among children and adolescents at higher risk for influenza-associated complications—United States, 2023–2024. MMWR, 73(45), 1022–1029. Retrieved November 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7345a2.htm)Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerOral Semaglutide Reduces Risk of Cardiovascular Events in Patients with Type 2 DiabetesCardiovascular disease is a serious health concern for patients with type 2 diabetes, who are at higher risk for conditions like coronary artery disease, heart failure, and stroke. Studies focusing on the cardiovascular safety and efficacy of specific antihyperglycemic medications, namely glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 inhibitors, have shown that some of these drugs reduce this cardiovascular risk.READ MORE...SOUL, a phase 3, multicenter, randomized, double-blind trial, demonstrated that oral semaglutide, a GLP-1 receptor agonist, taken daily, is more effective at reducing the risk of adverse cardiovascular events in patients with diabetes and established cardiovascular disease or chronic kidney disease compared to traditional therapy alone.The trial enrolled 9,650 participants, most of whom were on metformin and had comorbidities like coronary artery disease, chronic kidney disease, and cerebrovascular disease. The participants were randomized to receive either oral semaglutide (14 mg/day) or placebo, both added to standard care. The trial found a 14% reduction in major adverse cardiovascular events for those treated with oral semaglutide. The primary endpoint of major cardiovascular events included cardiovascular death, MI, and nonfatal strokes, with all three contributing to the positive result.Oral semaglutide was well-tolerated, showing a safety profile consistent with previous trials. The trial's success supports the potential for semaglutide to be a valuable treatment for individuals with both type 2 diabetes and cardiovascular risk. (McKeown, L. A. [2024]. SOUL: Oral semaglutide cuts CV events in diabetic patients. TCTMD. Retrieved November 2024 from https://www.tctmd.com/news/soul-oral-semaglutide-cuts-cv-events-diabetic-patients; Novo Nordisk. [2024]. Novo Nordisk A/S: Oral semaglutide demonstrates a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in the SOUL trial. Retrieved November 2024 from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=171480)Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerTirzepatide for Weight Loss and Diabetes Prevention in Patients with Obesity and PrediabetesObesity is recognized as a chronic neuroendocrine disease that increases a patient's risk of prediabetes, which can, in turn, raise the possibility of advancing to type 2 diabetes by up to 70%. Pharmacologic interventions that target obesity and dysglycemia, such as tirzepatide, have the potential to improve insulin sensitivity and pancreatic function, helping to manage obesity and prevent prediabetes from progressing.READ MORE...Tirzepatide has demonstrated major benefits in clinical trials, including SURMOUNT-1, a large, international, phase 3 study involving participants with obesity and prediabetes. In the trial, participants were randomly assigned to receive tirzepatide (5 mg, 10 mg, or 15 mg) or a placebo, with the treatment phase lasting up to 176 weeks. Outcomes of the trial included weight reduction, reversion to normoglycemia, and the incidence of type 2 diabetes. Participants in the tirzepatide group experienced substantial and sustained weight loss (average weight loss of over 20%), and those with prediabetes at baseline had lower rates of advancing to type 2 diabetes (1.3%) compared to the placebo group (13.3%).Safety data showed that tirzepatide was generally well tolerated, with mild to moderate GI side effects. Serious adverse events were rare and comparable to those observed in previous trials of similar drugs. Cardiometabolic improvements were also observed, with decreases in waist circumference, blood pressure, and lipid levels. Furthermore, quality of life scores in domains such as physical function and mental health were better in the tirzepatide group compared to the placebo group, pointing to the broader benefits of the treatment beyond metabolic health.The SURMOUNT-1 trial demonstrated that tirzepatide is an effective and safe treatment for individuals with obesity and prediabetes. It resulted in sustained weight loss, improved glycemic control, and reduced the risk of developing type 2 diabetes. The findings support the use of tirzepatide as a long-term treatment option for managing obesity and preventing the progression of prediabetes to diabetes. (Jastreboff, A. M., et al. [2024]. Tirzepatide for obesity treatment and diabetes prevention. NEJM. Advance online publication. Retrieved November 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2410819?query=TOC&cid=DM2371552_Non_Subscriber&bid=-1652766108)Released: December 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - November 2024
Immunization Rates among Kindergarten StudentsVaccination coverage among kindergarten students in the United States for the measles, mumps, and rubella vaccine (MMR), as well as other essential vaccines, is declining. After maintaining near 95% coverage for a decade, rates dropped to approximately 93% during the 2020 to 2023 school years, prompting a summary of state and local immunization data reported to the Centers for Disease Control and Prevention (CDC) for the 2023 to 2024 school year.READ MORE...Parents are required to provide vaccination records or exemption documents to schools, which collaborate with health departments to assess compliance. The CDC utilizes data from 49 states and Washington, D.C. to estimate vaccination rates and exemptions among kindergarteners. For the 2023 to 2024 school year, the reported vaccination coverage reflects a significant drop compared to previous years, with only a few jurisdictions achieving the desired 95% coverage threshold.The analysis shows that national MMR coverage stands at 92.7%, with considerable variations among states. States with the lowest coverage reported figures below 80%, while some states exceeded 98%. Exemptions from vaccinations increased to 3.3%, primarily due to nonmedical reasons, which poses a risk for vaccine-preventable diseases and has implications for achieving public health targets.The findings underscore the need for immunization programs, health care providers, and schools to actively promote vaccination and counteract the rising exemption rates, which contribute to the potential for outbreaks of preventable diseases. Strategies, such as simplifying vaccination processes and improving access to vaccines, are essential for reversing the trends of declining coverage and increasing exemptions, ensuring the health and safety of children and communities. (Seither, R., et al. [2024]. Coverage with selected vaccines and exception rates among children in kindergarten United States, 2023—24 school year. MMWR Morb Mortal Wkly Rep, 73, 925—932. Retrieved October 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7341a3.htm)Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerNivolumab with AVD Enhances Progression-Free Survival in Classic Hodgkin LymphomaBrentuximab vedotin has been used to improve outcomes in patients with classic Hodgkin lymphoma, but toxic side effects and relapse rates remain a problem. The S1826 trial aimed to improve progression-free survival (PFS) while addressing the side effects common with current treatments. S1826 investigated the efficacy and safety of combining nivolumab (N) with doxorubicin, vinblastine, and dacarbazine (AVD) compared to brentuximab vedotin (BV) combined with AVD in patients with newly diagnosed advanced-stage classic Hodgkin lymphoma.READ MORE...The study enrolled 994 patients age 12 and older between July 2019 and October 2022. The participants were randomized with a focus on evaluating the time from randomization to disease progression or death. With a median follow-up of 12.1 months, results favored N+AVD with a 52% reduction in the risk of disease progression or death compared to BV+AVD. This trend continued with extended follow-up, showing a 92% PFS at 2 years for N+AVD compared to 83% for BV+AVD, further emphasizing the treatment's effectiveness. In addition, results demonstrated that N+AVD could reduce the need for consolidative radiation therapy, which has associated long-term risks, including secondary cancers.Adverse effects revealed a generally favorable safety profile for N+AVD compared to BV+AVD. Although neutropenia was more common in the N+AVD group, other significant adverse events, particularly those leading to treatment discontinuation, were more prevalent in the BV+AVD cohort.The S1826 trial presents compelling evidence supporting the use of N+AVD as a primary treatment for advanced-stage classic Hodgkin lymphoma, offering enhanced progression-free survival and a better side-effect profile. Given these promising results, N+AVD warrants consideration for integration into standard Hodgkin lymphoma treatment protocols. (Herrera, A. F., et al. [2024]. Nivolumab+AVD in advanced-stage classic Hodgkin's lymphoma. NEJM, 391[15], 1379—1389. Retrieved October 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2405888)Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerRegorafenib for Patients with Advanced Gastric or Gastroesophageal Junction CancerPatients diagnosed with refractory advanced gastric or gastroesophageal junction cancer (AGOC) face a dire prognosis, where the overall survival (OS) is less than 6 months, and the 2-year OS rate is below 10%. New therapies, like trifluridine/tipiracil and immune checkpoint inhibitors are shifting the treatment standards for AGOC, and with the INTEGRATE IIa study, regorafenib has been added to this evolving landscape.READ MORE...The phase 3, randomized, controlled trial, conducted from October 2016 to September 2021, enrolled 251 patients with AGOC whose disease had progressed after two previous therapies. Patients were randomized to receive either regorafenib 160 mg on days 1 to 21 of a 28-day cycle, or placebo. The trial showed that regorafenib considerably extends OS (19%) for patients with refractory AGOC versus placebo (6%). It also demonstrated a 32% reduction in the risk of death when regorafenib was added to best supportive care.Additionally, patients receiving regorafenib experienced a longer time to deterioration in quality of life, as measured by the European Organisation for Research and Treatment of Cancer QLQ-C30 and STO22 modules (hazard ratio = 0.68). This suggests that regorafenib not only improves survival but also maintains a better quality of life for patients facing advanced cancer.These important findings of INTEGRATE IIa underscore the potential benefits of regorafenib as a treatment option in AGOC for a patient population with limited alternatives. (Pavlakis, N. [2024]. INTEGRATE IIa phase III study: Regorafenib for refractory advanced gastric cancer. Journal of Clinical Oncology. Advance online publication. Retrieved October 2024 from https://ascopubs.org/doi/10.1200/JCO.24.00055?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed; Stenger, M. [2024]. Regorafenib in refractory advanced gastric cancer. The ASCO Post. Retrieved October 2024 from https://ascopost.com/news/october-2024/regorafenib-in-refractory-advanced-gastric-cancer/)Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerTenecteplase Versus Alteplase for Stroke in Patients with Diabetes and Hyperglycemia on AdmissionDiabetes is prevalent among stroke patients and is associated with poorer neurologic outcomes, increased risk of symptomatic intracerebral hemorrhage (sICH), and generally unfavorable clinical results post-stroke. Although thrombolytic therapy can be beneficial, elevated admission glucose levels are common and complicate treatment, leading to worse outcomes and longer hospital stays.READ MORE...Alteplase is the only approved fibrinolytic for acute ischemic stroke (AIS), while tenecteplase, a modified variant of alteplase, has advantages like a longer half-life and faster administration. The TRACE-2 trial, a phase 3 multicenter study, which ran from June 2021 to May 2022, aimed to assess the efficacy and safety of tenecteplase against alteplase in AIS patients, especially considering their diabetic status and admission glucose levels.TRACE-2 included adult AIS patients eligible for thrombolysis but not for thrombectomy, enrolling participants with varying histories of diabetes and hyperglycemia. The study compared the functional outcomes at 90 days and the incidence of adverse events between patients receiving tenecteplase (0.25 mg/kg IV) and those receiving alteplase (0.9 mg/kg IV).Results indicated that although patients with a history of diabetes had significantly lower rates of excellent functional outcomes compared to those without diabetes, the efficacy of tenecteplase was comparable to alteplase in both diabetic and nondiabetic groups. The safety profiles were also similar, though patients with diabetes exhibited a higher incidence of sICH and other serious adverse events overall. Interestingly, tenecteplase was associated with shorter door-to-needle times in patients with diabetes, suggesting potential operational benefits.The study concluded that tenecteplase could be a viable alternative to alteplase for AIS patients, including those with diabetes and hyperglycemia, while also emphasizing the need for further research to confirm these findings across diverse patient groups. (Liu, H., et al. [2024]. Efficacy and safety of intravenous tenecteplase versus alteplase in treating acute ischemic stroke with diabetes and admission hyperglycemia. Journal of the American Heart Association, 13[20], Article e036393. Retrieved October 2024 from https://www.ahajournals.org/doi/full/10.1161/JAHA.124.036393)Released: November 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - October 2024
Ziresovir for Respiratory Syncytial Virus in Young ChildrenRespiratory syncytial virus (RSV) poses a serious health threat, particularly to young children, leading to millions of hospitalizations and significant mortality each year. Although some vaccines exist for adults and pregnant women, there is currently no approved vaccine for children.READ MORE...AIRFLO, a phase 3 trial, assessed the selective oral RSV F protein inhibitor, ziresovir, for its effictiveness and safety in children ages 1 to 24 months hospitalized with RSV. The study ran from September 2020 to January 2022 and was conducted across multiple centers in China. Participants, most age 6 months or younger, were randomly assigned to receive either ziresovir or placebo, focusing on clinically relevant cases of RSV infection.The trial comprised two parts: the first assessed safety and pharmacokinetics, while the second evaluated efficacy. Participants received doses of ziresovir every 12 hours for 5 days, tailored to their body weight. The primary efficacy endpoint was the Wang bronchiolitis clinical score, which measures the severity of respiratory symptoms, while secondary endpoints included viral load reductions and symptom-based assessments.Results showed that ziresovir improved clinical scores compared to placebo. Specifically, ziresovir produced notable reductions in the Wang score (−3.4 points versus −2.7 points for placebo), with reductions observed as early as 48 hours after treatment initiation. Furthermore, ziresovir achieved a decrease in RSV viral load, affirming its antiviral effectiveness. Improvements were consistent across various patient subgroups, including those at higher risk for severe outcomes.In terms of safety, adverse events were similar between the ziresovir and placebo groups and were predominantly mild to moderate in severity. Overall, the trial's encouraging clinical and virological results highlight the need for further international trials to explore ziresovir's potential as a treatment for RSV in young children worldwide. (Zhao, S., et al. (2024). Ziresovir in hospitalized infants with respiratory syncytial virus infection. NEJM, 391, 1096–1107. Retrieved September 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2313551)Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerLiraglutide Effective for Weight Loss in Children with ObesityMany children with severe obesity struggle to achieve weight loss through standard lifestyle therapies alone, creating a need for more effective treatments. The SCALE Kids trial evaluated liraglutide for weight loss in children with obesity and found it an encouraging treatment option when paired with lifestyle changes. As there are currently no approved medications for obesity treatment in children under age 12, this trial is a potential breakthrough for addressing pediatric obesity.READ MORE...SCALE Kids, a phase 3 trial, involved 82 participants ages 6 to less than 12 with a BMI of 95% or higher, randomized to receive liraglutide or placebo, alongside lifestyle interventions. Results showed a major reduction in BMI and body weight for the liraglutide group. After 56 weeks, the liraglutide group had a BMI reduction of −5.8% compared to +1.6% in the placebo group, marking a substantial difference of −7.4% favoring liraglutide.Secondary endpoints, including blood pressure and glycated hemoglobin levels, also supported liraglutide. However, waist circumference changes were not significantly different between groups, and GI side effects were more common with the treatment. In addition, the study doesn't discuss how body composition changes with treatment and whether the weight loss comes from fat mass or lean mass.Although liraglutide shows promise for treating severe obesity in children who don't respond to lifestyle changes, it's important to consider a careful, individualized approach. The goal should not be to prescribe medication broadly for all children with elevated BMI but rather to identify those who truly need additional help because of severe obesity and related health complications. (Neale, T. (2024). Liraglutide helps shed weight in young children with obesity. TCTMD. Retrieved September 2024 from https://www.tctmd.com/news/liraglutide-helps-shed-weight-young-children-obesity; Fox, C. K., et al. (2024). Liraglutide for children 6 to < 12 years of age with obesity — a randomized trial. NEJM. Advance online publication. Retrieved September 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2407379)Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerErenumab Provides Relief for Medication-Overuse Headache in Chronic MigraineMedication-overuse headache (MOH) is a concern for patients with chronic migraine, often resulting from the excessive use of headache medications, such as analgesics, triptans, and opioids. MOH is linked to increased health care utilization, psychiatric comorbidities, and a decline in quality of life, making effective management crucial.READ MORE...Management strategies emphasize the withdrawal of overused medications; however, this withdrawal process can lead to high relapse rates. Recent studies have focused instead on targeting the calcitonin gene-related peptide (CGRP) pathway, which is implicated in migraine pathogenesis. Erenumab, a monoclonal antibody that inhibits CGRP receptors, is a promising candidate for helping patients with MOH revert to nonmedication overuse status.A recent study investigated the efficacy and safety of erenumab in adults diagnosed with chronic migraine and concomitant MOH. The phase 4, randomized, controlled trial, which ran from October 2019 to November 2022, enrolled 584 participants who had a history of preventive treatment failure. Participants received either erenumab (140 mg or 70 mg) or placebo for 24 weeks, with a primary endpoint focused on the absence of MOH by month 6.Results indicated that a significant proportion of participants receiving erenumab achieved MOH remission (69.1% with 140-mg dose; 60.3% with 70-mg dose) compared to those on placebo (52.6%), with improvements in acute medication use and overall functionality. Additionally, participants reported a reduction in average monthly headache days and improvements in physical impairment and quality-of-life metrics, reinforcing the benefits of effective preventive therapies for managing MOH.These findings support the use of erenumab as an effective treatment option for patients suffering from MOH due to chronic migraine. The study's outcomes support the importance of preventive treatment strategies that not only alleviate headache frequency but also enhance the overall quality of life for these patients. (Tepper, S. J., et al. (2024). Efficacy and safety of erenumab for nonopioid medication overuse headache in chronic migraine: A phase 4, randomized, placebo-controlled trial. JAMA Neurology. Advance online publication. Retrieved September 2024 from https://jamanetwork.com/journals/jamaneurology/fullarticle/2823594)Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerCabozantinib for Advanced Neuroendocrine TumorsNeuroendocrine tumors (NETs) are diverse malignancies primarily found in the GI tract, lungs, and pancreas. Treatment for advanced NETs depends on multiple factors, such as tumor location, differentiation grade, symptoms, and somatostatin-receptor expression. Options, including somatostatin analogues, everolimus, and sunitinib are available; however, most patients experience disease progression despite these treatments.READ MORE...In a phase 2 trial, cabozantinib, a tyrosine kinase inhibitor, showed potential in treating advanced NETs. This prompted the CABINET trial: a phase 3, double-blind, randomized, controlled study, designed to assess cabozantinib's efficacy in patients with previously treated, progressive extrapancreatic or pancreatic NETs. This trial was critical for evaluating new treatment avenues after standard therapies.The CABINET trial ran from October 2018 to August 2023 and enrolled 203 adults with extrapancreatic NETs and 95 with pancreatic NETs across multiple U.S. sites. It included patients with well- or moderately- differentiated NETs of grades 1 to 3. The study randomly assigned patients to receive either cabozantinib (60 mg) or a placebo. The primary endpoint was progression-free survival, defined as the time from randomization to disease progression or death.The results indicated a significant advantage for cabozantinib in delaying disease progression. In the extrapancreatic cohort, those receiving cabozantinib experienced a median progression-free survival of 8.4 months, compared to 3.9 months for placebo. Similarly, in the pancreatic cohort, cabozantinib led to a median progression-free survival of 13.8 months versus 4.4 months for placebo, demonstrating its potential as an effective treatment option.Although cabozantinib showed improved progression-free survival rates, overall survival results were not statistically significant, likely due to subsequent therapies received by patients. The trial did report adverse events consistent with the known safety profile of cabozantinib, with many patients requiring dose adjustments. Despite this, the CABINET trial supports cabozantinib as a promising therapy for advanced NETs. (Chan, J. A., et al. (2024). Phase 3 trial of cabozantinib to treat advanced neuroendocrine tumors. NEJM. Advance online publication. Retrieved September 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2403991)Released: October 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - September 2024
New RSV Vaccination Recommendations for Older AdultsRespiratory syncytial virus (RSV) poses a major risk to older adults, especially during the fall and winter months. In response, the Advisory Committee on Immunization Practices (ACIP) initially recommended RSV vaccination for U.S. adults age 60 and older in June 2023. However, due to new evidence and postlicensure data, the ACIP updated its guidance on June 26, 2024. The revised recommendation advises a single dose of any FDA-approved RSV vaccine for all adults age 75 and older and for those ages 60 to 74 who are at higher risk for severe RSV disease. This update aims to improve vaccination coverage and target those who would benefit most.READ MORE...As of spring 2024, RSV vaccination uptake among adults 60 and older was about 20% to 25%. The updated recommendations were informed by new clinical trial data and postlicensure studies, including those for Moderna's mResvia, which showed an efficacy of about 78.7% initially, though it waned over time. Safety data indicated more severe reactions compared to placebo but didn't show a significant increase in serious adverse events. For other vaccines like GlaxoSmithKline's Arexvy and Pfizer's Abrysvo, effectiveness ranged from 75% to 82% in preventing RSV-related hospitalizations, with some safety concerns about Guillain-Barré syndrome, though not conclusively linked to the vaccines.The ACIP's updated recommendations aim to simplify vaccination guidelines based on age and risk. The committee will continue to assess and update recommendations as new evidence emerges and will consider the need for additional doses in the future. (Britton, A., et al. (2024). Use of respiratory syncytial virus vaccines in adults aged ≥60 years: Updated recommendations of the Advisory Committee on Immunization Practices: United States, 2024. MMWR Weekly, 73(32), 696–702. Retrieved August 2024 from https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm?s_cid=mm7332e1_w)Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerOsimertinib Improves Progression-Free Survival in EGFR-Mutated NSCLCPatients with epidermal growth factor receptor (EGFR) mutations tend to experience shorter progression-free survival and higher incidence of distant metastases compared to those without mutations. For patients with unresectable stage III non-small-cell lung cancer (NSCLC) with EGFR mutations, the current standard treatment involves concurrent chemoradiotherapy followed by consolidation with durvalumab. However, targeted treatments are lacking, and previous studies suggest poorer outcomes for these patients.READ MORE...LAURA, an international, phase 3, double-blind, placebo-controlled trial, evaluated the efficacy and safety of osimertinib, an EGFR tyrosine-kinase inhibitor, in EGFR-mutated unresectable stage III NSCLC. The study ran from August 2018 through July 2022 and enrolled 216 patients. Eligible participants had completed chemoradiotherapy and showed no progression. They were randomized to receive either osimertinib (80 mg once per day) or placebo. The primary endpoint was progression-free survival.Results showed that osimertinib significantly improved progression-free survival compared to placebo, with a median of 39.1 months versus 5.6 months, respectively, and demonstrated a substantial reduction in the risk of disease progression or death (hazard ratio, 0.16). The treatment also showed lower rates of local progression, distant metastases, and new lesions, particularly brain lesions, compared to placebo.Adverse events with osimertinib included radiation pneumonitis and diarrhea. Although the incidence of interstitial lung disease was higher with osimertinib compared to placebo, most cases were mild. Despite the higher incidence of some adverse effects, osimertinib's overall safety profile was manageable.The results of the LAURA trial indicate that osimertinib may be a promising postchemoradiotherapy option for patients with unresectable stage III EGFR-mutated NSCLC compared to placebo, suggesting a shift in treatment strategies for this specific patient group. (Lu, S., et al. (2024). Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. NEJM, 391, 585–597. Retrieved August 2024 from https://www.nejm.org/doi/10.1056/NEJMoa2402614?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed)Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerOlanzapine for Nausea and Vomiting in Moderately Emetogenic ChemotherapyChemotherapy-induced nausea and vomiting (CINV) remain significant challenges for cancer patients undergoing treatment, impacting their quality of life (QOL). Guidelines for antiemetic prophylaxis (AEP) have evolved to address these issues, but clinical studies indicate that breakthrough CINV remains a problem, prompting further research.READ MORE...Olanzapine, an atypical antipsychotic, has shown promise in controlling nausea and vomiting in highly emetogenic chemotherapy regimens. A recent phase 3 trial aimed to determine if incorporating olanzapine into standard AEP protocols could enhance complete response (CR) rates in patients receiving moderately emetogenic chemotherapy (MEC) regimens, including oxaliplatin, carboplatin, or irinotecan, and to assess its impact on patient-reported outcomes.Conducted from March 2019 to August 2023, this multicenter trial involved 560 chemotherapy-naïve patients receiving MEC regimens. Participants were randomized to receive either standard AEP or the same regimen with the addition of olanzapine. The study included randomization and blinding of medical professionals and statisticians to ensure accurate results. Patients recorded their symptoms and treatment responses, and QOL was measured using the Functional Living Index - Emesis questionnaire.The trial found that adding olanzapine significantly improved CR rates compared to standard AEP alone, with a notable benefit in the delayed phase of CINV. Specifically, 91% of patients in the olanzapine group achieved CR compared to 82% in the observation group, and this improvement was maintained during the later assessment period. The olanzapine group also experienced better nausea and CINV control and used fewer rescue medications.QOL assessments confirmed these results, with fewer patients in the olanzapine group experiencing deterioration in QOL related to CINV. Although the addition of olanzapine didn't significantly change nausea control compared to the observation group, it did improve overall control of nausea and vomiting combined.Study limitations include the absence of a placebo control and the lack of evaluation for lower doses of olanzapine. Also, the predominance of GI cancer patients receiving oxaliplatin could influence the findings. Nonetheless, the trial supports the incorporation of olanzapine into AEP protocols for MEC regimens, suggesting that it could become a standard part of antiemetic therapy. (Ostwal, V., et al. (2024). Olanzapine as antiemetic prophylaxis in moderately emetogenic chemotherapy: A phase 3 randomized clinical trial. JAMA Network Open, 7(8), Article e2426076. Retrieved August 2024 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822027)Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerEnfortumab Vedotin Plus Pembrolizumab for Urothelial CancerEnfortumab vedotin, an antibody-drug conjugate targeting nectin-4, combined with pembrolizumab, a programmed death-1 inhibitor, has shown promise in treating advanced urothelial carcinoma. Based on positive phase 1b/2 trial results showing high response rates and durable outcomes, the FDA granted accelerated approval for this combination for patients who are ineligible for cisplatin-based chemotherapy.READ MORE...The EV-302 trial, a global phase 3 study, aimed to compare the effectiveness and safety of enfortumab vedotin plus pembrolizumab versus platinum-based chemotherapy in patients with previously untreated advanced urothelial carcinoma. The trial included 886 patients, median age 69 years, with a range of histologic types. Patients were randomly assigned to either the combination therapy or the chemotherapy group and treated accordingly.Results from the trial showed that enfortumab vedotin and pembrolizumab significantly improved progression-free survival compared to chemotherapy, with a median of 12.5 months versus 6.3 months, respectively. Overall survival was longer in the combination group as well, with a median of 31.5 months compared to 16.1 months in the chemotherapy group.Adverse events associated with enfortumab vedotin and pembrolizumab, such as skin reactions and peripheral neuropathy, were still present, but manageable. The combination therapy also resulted in fewer severe adverse events compared to chemotherapy, despite the longer duration of treatment.The EV-302 trial demonstrated that enfortumab vedotin and pembrolizumab offer significant benefits over platinum-based chemotherapy for untreated advanced or metastatic urothelial carcinoma. The improved survival and response rates make this combination a compelling alternative, potentially changing the standard treatment paradigm for this challenging cancer. (Levitan, D. (2024). Enfortumab vedotin plus pembrolizumab offer improved survival without detriment to quality of life. American Society of Clinical Oncology, Daily News. Retrieved August 2024 from https://dailynews.ascopubs.org/do/enfortumab-vedotin-plus-pembrolizumab-offer-improved-survival-without-detriment-quality; Powles, T., et al. (2024). Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. NEJM, 390, 875–888. Retrieved August 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2312117)Released: September 2024Nursing Drug Handbook© 2024 Wolters Kluwer
News Capsules - August 2024
Comparing Safety and Efficacy of Chemotherapy Regimens for Hodgkin LymphomaSurvival outcomes for advanced-stage classical Hodgkin lymphoma were poor before the advent of modern chemotherapy. The high-intensity regimen, eBEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), has been standard but is associated with serious toxicities. BrECADD, which incorporates the antibody-drug conjugate brentuximab vedotin, was developed to potentially offer comparable effectiveness with fewer toxic side effects. A study comparing the two chemotherapy regimens aimed to balance treatment efficacy with reduced toxicity, particularly focusing on long-term health impacts like organ dysfunction and infertility in young adults with Hodgkin lymphoma.READ MORE...The phase 3 randomized, multicenter, parallel, intergroup clinical trial was conducted between July 2016 and August 2020, and enrolled 1,500 patients (age 60 and younger) across multiple countries. Patients received cycles of either eBEACOPP or BrECADD (both initiated at full-dose level 4) administered in 21-day intervals. Positron emission tomography (PET) guided treatment adaptation to tailor therapy based on early response assessment.Researchers sought to compare treatment-related morbidity and progression-free survival between the two regimens. BrECADD demonstrated significantly lower treatment-related morbidity rates, with 42% of patients experiencing at least one treatment-morbidity event compared to 59% of patients receiving eBEACOPP. Both groups achieved similar rates of complete remission post-chemotherapy, with a substantial proportion of patients benefiting from PET-guided treatment adjustments.Regarding efficacy, BrECADD showed noninferiority and, in a subsequent analysis, superiority in progression-free survival compared to eBEACOPP (4-year progression-free survival for BrECADD was 94.3% versus 90.9% for eBEACOPP). Safety assessments included resolution of toxicities within a year posttreatment, showing generally manageable long-term impacts on patients' health. Additionally, BrECADD was associated with better preservation of gonadal function and fewer second primary malignancies compared to eBEACOPP.Overall, the study supports BrECADD as a promising alternative to eBEACOPP for treating advanced-stage Hodgkin lymphoma, offering comparable efficacy with significantly reduced treatment-related toxicity. These findings are likely to influence future treatment guidelines and improve outcomes for young adults facing this challenging cancer diagnosis. (Borchmann, P., et al. (2024). Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): A randomised, multicentre, parallel, open-label, phase 3 trial. The Lancet. Advance online publication. Retrieved July 2024 from https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01315-1/fulltext)Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerCendakimab Improves Skin Symptoms in Severe Atopic DermatitisAtopic dermatitis, a chronic inflammatory skin condition, causes substantial patient burden including severe itching, sleep disturbances, and impacts on daily activities. When topical treatments are inadequate for moderate to severe atopic dermatitis, systemic therapies like biologics become necessary. Biologics approved for atopic dermatitis target interleukin (IL)-4 or IL-13 pathways due to their involvement in atopic dermatitis pathogenesis.READ MORE...Cendakimab, a monoclonal antibody targeting IL-13, was evaluated in a phase 2 randomized, double-blind, placebo-controlled clinical trial for its efficacy and safety in adults with moderate to severe atopic dermatitis. The study, which ran from May 2021 to November 2022, randomized 221 patients to receive varying doses of cendakimab (720 mg, once weekly; 720 mg, every 2 weeks; or 360 mg, every 2 weeks) or placebo for 16 weeks. Primary endpoints included improvement in Eczema Area and Severity Index (EASI) scores, with secondary endpoints focusing on skin clearance and pruritus reduction.Overall, a larger proportion of cendakimab patients achieved a 75% or greater reduction in EASI (720 mg, once weekly: 50.0%; 720 mg, every 2 weeks: 48.2%; 360 mg, every 2 weeks: 52.7%) compared to placebo (26.3%). There was also a noticeable improvement in skin clearance in patients receiving 720-mg weekly cendakimab, with 33.3% of patients achieving a score of 0 (clear) or 1 (almost clear) than with placebo (9.4%). Safety assessments indicated manageable adverse events, with conjunctivitis being the most notable, consistent with other IL-13 inhibitors.This study supports cendakimab as a potential therapeutic option for treating moderate to severe atopic dermatitis, particularly in reducing inflammation and improving skin symptoms. Further research could explore its long-term efficacy and broader applicability in diverse patient populations. (Blauvelt, A., et al. (2024). Cendakimab in patients with moderate to severe atopic dermatitis: A randomized clinical trial. JAMA Dermatology. Published online. Retrieved July 2024 from https://jamanetwork.com/journals/jamadermatology/fullarticle/2821285)Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerEfanesoctocog Alfa Manages Bleeding in Children with Severe Hemophilia AHemophilia A is characterized by deficiency in factor VIII, leading to recurrent bleeding episodes, particularly into joints, despite current therapies. Standard treatments require frequent injections due to their limited duration of action, which poses challenges for adherence, especially in children. XTEND-Kids, a phase 3 open-label, international, single-group study, evaluated efanesoctocog alfa, a new factor VIII replacement therapy, in previously treated children with severe hemophilia A. Efanesoctocog alfa is designed to extend factor VIII half-life, which allows for weekly dosing, potentially improving treatment adherence.READ MORE...The study enrolled 74 patients (younger than age 12) who received prophylactic intravenous efanesoctocog alfa (50 IU/kg) once per week for 52 weeks. For bleeding episodes, one dose of efanesoctocog alfa (50 IU/kg) was given, with additional 30 or 50 IU/kg doses every 2 or 3 days, as needed. The primary endpoint was the development of inhibitors to factor VIII, which did not occur in any patient. Adverse events were mostly nonserious, and no treatment discontinuations due to adverse effects were reported.Efanesoctocog provided effective bleeding prevention, with a median annualized bleeding rate of 0.00 and a mean rate of 0.89. Bleeding episodes were likewise managed efficiently, with most resolved using a single injection. Joint health showed overall improvement, indicating potential long-term benefits in joint preservation. In addition, sustained factor VIII levels above therapeutic thresholds were observed for up to 7 days, supporting the weekly prophylactic dosing.Demonstrating promising safety and efficacy profiles in children with severe hemophilia A, efanesoctocog alpha offers a convenient weekly prophylactic option that may enhance treatment outcomes and patient quality of life compared to current therapies. Future studies will further explore its long-term safety and efficacy, including for previously untreated patients and different age groups. (Malec, L., et al. (2024). Efanesoctocog alfa prophylaxis for children with severe hemophilia A. N Engl J Med, 391, 235—246. Retrieved July 2024 from https://www.nejm.org/doi/abs/10.1056/NEJMoa2312611)Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerLowering LDL Cholesterol with Lerodalcibep in Patients with or at Risk for Cardiovascular DiseaseRecent updates to lipid guidelines suggest more aggressive treatment for lowering LDL cholesterol to prevent cardiovascular (CV) events, advocating for additional medications and stricter targets if statins alone are insufficient. However, lerodalcibep, a third-generation PCSK9 inhibitor, appears effective in achieving these lower targets.READ MORE...Lerodalcibep works by blocking proprotein convertase subtilisin/kexin type 9 (PCSK9) from binding to LDL cholesterol, thereby enhancing cholesterol clearance without significant safety concerns. The drug combines adnectin, an anti-PCSK9 binding protein, with human serum albumin, allowing for a smaller injection volume compared to existing monoclonal antibodies.The phase 3 LIBerate-HR study aimed to evaluate the effectiveness of lerodalcibep in lowering LDL cholesterol in patients at risk for CV disease. The study included 922 patients, with or at high risk for CV disease, randomized to receive monthly subcutaneous injections of lerodalcibep (300 mg) or placebo for 52 weeks. Results showed that lerodalcibep achieved a profound reduction in LDL cholesterol, with 94% of treated patients achieving at least a 50% reduction compared to placebo (19%). The drug also lowered non-HDL cholesterol (−47.3%), apolipoprotein B (−43%), lipoprotein(a) (−33.4%), and triglycerides (−16.5%) while increasing HDL cholesterol by 6.5%. Safety profiles were similar to placebo, with manageable injection-site reactions and no immunogenicity issues reported.Lerodalcibep may be a versatile option for patients needing PCSK9 inhibitors, with the advantage of monthly injections over bi-weekly injections required by current monoclonal antibodies. However, concerns remain regarding long-term safety and immunogenicity, given past issues with other PCSK9 inhibitors like bococizumab.Results of this study show lerodalcibep to be an effective and well-tolerated PCSK9 inhibitor, potentially enhancing treatment options for patients with or at high risk for CV disease, pending further regulatory and safety evaluations. (Maxwell, Y. L. (2024). LIBerate-HR: Lerodalcibep lowers LDL more sharply than placebo over 1 year. TCTMD. Retrieved July 2024 from https://www.tctmd.com/news/now-published-liberate-hr-lerodalcibep-lowers-ldl-more-sharply-placebo-over-1-year; Klug, E. Q., et al. (2024). Efficacy and safety of lerodalcibep in patients with or at high risk of cardiovascular disease: A randomized clinical trial. JAMA Cardiol. Advance online publication. Retrieved July 2024 from https://jamanetwork.com/journals/jamacardiology/article-abstract/2820248)Released: August 2024Nursing Drug Handbook© 2024 Wolters Kluwer
Drug News Abstracts - July 2024
Neoadjuvant Immunotherapy for Mismatch Repair Deficient Colon Cancer: Redefining TreatmentLocally advanced DNA mismatch repair-deficient (dMMR) colon cancer accounts for up to 15% of nonmetastatic colon cancers. These tumors are typically managed similarly to mismatch repair-proficient tumors, with surgery followed by adjuvant chemotherapy. However, recent studies, including the NICHE-2 trial, suggest potential benefits of immunotherapy over chemotherapy in this patient population.READ MORE...The NICHE-2, a phase 2, multicenter, single-group study, conducted by the Netherlands Cancer Institute, aimed to evaluate the safety and efficacy of neoadjuvant therapy using a combination of nivolumab (a programmed cell death 1 [PD-1] inhibitor) and ipilimumab (a cytotoxic T-lymphocyte antigen 4 [CTLA-4] inhibitor) in patients with unresected, locally advanced dMMR colon cancer. The study, which ran from July 2017 to July 2022, enrolled 115 patients (median age, 60 years; 58% women) with stage II or III disease, confirmed as resectable with no distant metastases. Patients received 4-weeks of neoadjuvant treatment (2-week cycles, with treatment at the start of each cycle) prior to surgery. Primary end points of the study were timely surgery (delay of no more than 2 weeks) and 3-year disease-free survival.Key findings from NICHE-2 included a high pathologic response rate: 98% of patients showed some degree of pathologic response to the immunotherapy regimen, affording them a timely surgery, with 68% achieving a pathologic complete response (no residual viable tumor in the tumor bed or lymph nodes). Importantly, no disease recurrences were observed during the study's follow-up period (median, 26.2 months), suggesting promising long-term disease control outcomes. This contrasts with historic recurrence rates seen in dMMR colon cancer despite adjuvant chemotherapy.The safety profile of the regimen was also assessed, with most adverse events being manageable grade 1 or 2 immune-related adverse events. Grade 3 or 4 adverse events occurred in a small percentage of patients and were generally reversible.The NICHE-2 trial contributes significant evidence supporting the use of neoadjuvant PD-1 and CTLA-4 inhibitors in locally advanced dMMR colon cancer, potentially redefining standard treatment for this subset of patients. (Chalabi, M., et al. (2024). Neoadjuvant immunotherapy in locally advanced mismatch repair-deficient colon cancer. N Engl J Med, 390, 1949-1958. Retrieved June 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2400634)Released: July 2024Nursing Drug Handbook© 2024 Wolters KluwerPeceleganan Spray for Skin Wound InfectionsSkin wound infections are typically treated with antibiotics, but frequent use of these drugs can cause antibiotic resistance. As a result, antimicrobial peptides (AMPs), like peceleganan (PL-5), have been considered as an alternative treatment option for skin wound infections. AMPs work via nonspecific mechanisms of disrupting bacterial cells, which reduces the likelihood of antibiotic resistance.READ MORE...In a phase 3 clinical trial conducted across 37 hospitals in China, PL-5 spray was evaluated for its efficacy and safety in treating skin wound infections compared to silver sulfadiazine (SSD) cream, a conventional topical antibiotic. The trial enrolled 570 patients, ages 18 to 75, with secondary open wound infections randomized to receive either 2% peceleganan spray (n = 381) or 1% SSD cream (n = 189). The primary endpoint, clinical efficacy rate on day 8, showed that 90.4% of patients treated with PL-5 achieved clinical efficacy compared to 78.7% in the SSD group, a statistically significant difference. Although SSD showed higher rates of bacterial clearance (46.0%) compared to PL-5 (24.0%), PL-5 still exhibited substantial effectiveness against common wound pathogens like Staphylococcus aureus and Pseudomonas aeruginosa.Safety evaluations indicated that PL-5 spray had a comparable incidence of adverse events to SSD cream, with no unexpected safety issues reported. Both treatments were well-tolerated among the study population, which included diverse wound types, such as burns, physical injuries, and diabetic foot ulcers.Overall, PL-5 spray demonstrated promising clinical efficacy and safety in treating skin wound infections, likely due to its unique antimicrobial action against a broad spectrum of bacteria, including drug-resistant strains. Further research is recommended to explore its mechanism of action and optimize its clinical applications, possibly expanding its role in wound care management. (Wei, Y., et al. (2024). Peceleganan spray for the treatment of skin wound infections: A randomized clinical trial. JAMA Netw Open, 7(6), Article e2415310. Retrieved June 2024 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2819836) Released: July 2024Nursing Drug Handbook© 2024 Wolters KluwerLinvoseltamab: A Different Approach to Treating Relapsed and Refractory Multiple MyelomaMultiple myeloma remains incurable despite advances in therapies, and there is a need for treatments that produce deep and long-lasting remissions, especially in patients who are resistant to current standard therapies. Linvoseltamab, a B-cell maturation antigen (BCMA)xCD3 bispecific antibody, which has shown antitumor activity in previous studies, has been suggested as a possible treatment option for relapsed and refractory multiple myeloma (RRMM).READ MORE...LINKER-MM1, an open-label, phase 1/2 clinical trial, sought to evaluate the efficacy of linvoseltamab in treating RRMM. The trial was conducted at 23 centers in multiple countries between January 2019 and October 2022 and included 282 patients (median age, 70) with triple-class refractory multiple myeloma. Phase 1 and 2 of the trial treated patients with varying doses of linvoseltamab (ranging from 3 mg to 800 mg) for a minimum of 24 weeks, and evaluated overall response rate, duration of response, and progression-free survival.Results showed that the optimal dose of linvoseltamab was 200 mg, which provided an overall response rate of 70.9%, with 63.2% of patients achieving very good partial response or better, and 49.6% achieving complete response. Responses were rapid and long-lasting, with a median time of response of 29.4 months and a progression-free survival not reached at the data cutoff. Safety profiles indicated mild to moderate adverse events. Infections were common but decreased over time, especially among patients achieving deep responses.The outcomes of this study support linvoseltamab as a valuable addition to the treatment landscape for multiple myeloma, offering deep and durable responses with a manageable safety profile compared to other BCMA-targeted therapies. (Bumma, N., et al. (2024). Linvoseltamab for treatment of relapsed/refractory multiple myeloma. Journal of Clinical Oncology. Advanced online publication. Retrieved June 2024 from https://ascopubs.org/doi/10.1200/JCO.24.01008)Released: July 2024Nursing Drug Handbook© 2024 Wolters KluwerTirzepatide Shows Promise in Managing Obstructive Sleep ApneaObstructive sleep apnea (OSA), characterized by disrupted breathing during sleep, is linked to cardiovascular complications, often exacerbated by excess weight. Traditional treatments, like positive airway pressure (PAP), have limitations in adherence and long-term effectiveness, prompting exploration of pharmaceutical interventions, like the GLP-1 receptor agonist, tirzepatide.READ MORE...SURMOUNT-OSA, comprised of two 52-week, phase 3 clinical trials, was conducted from June 2022 to March 2024 at 60 sites in multiple countries to assess tirzepatide as a treatment option for moderate-to-severe sleep apnea in those who are obese. The trials enrolled 469 participants either not using PAP (trial 1, 234 participants) or currently using PAP (trial 2, 235 participants) and randomized them to receive either tirzepatide (2.5 mg once weekly, then 2.5-mg dose increase every 4 weeks until week 20) or placebo for 52 weeks. The primary endpoint was the change in apnea-hypopnea index (AHI), with secondary endpoints including changes in body weight, hypoxic burden, inflammatory markers, and blood pressure. Baseline characteristics showed high AHI levels (average 51.5 to 49.5 events per hour) and severe obesity (average BMI 39.1 to 38.7).Results demonstrated significant reductions in AHI with tirzepatide compared to placebo in both trials: −20.0 to −23.8 events per hour. Secondary endpoints, such as body weight, high-sensitivity C-reactive protein concentration, and systolic blood pressure also showed improvements with tirzepatide. Adverse events, predominantly gastrointestinal, were mostly mild to moderate and occurred more frequently during dose escalation.These findings support further research of GLP-1 receptor agonists, such as tirzepatide, as a treatment option for OSA in individuals with obesity, addressing both sleep-related and cardiovascular risks associated with the condition. (Malhotra, A., et al. (2024). Tirzepatide for the treatment of obstructive sleep apnea and obesity. NEJM. Advanced online publication. Retrieved June 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2404881)Released: July 2024Nursing Drug Handbook© 2024 Wolters Kluwer
Drug News Abstracts - June 2024
Analysis of Self-Administered Aspirin Post-Chest Pain to Prevent Cardiovascular MortalityAccording to the American Heart Association, someone experiences an acute myocardial infarction (AMI) in the United States every 40 seconds, making it a leading cause of mortality. However, a significant number of AMI deaths occur outside the hospital, with delayed access to medical care being a contributing factor. The International Study of Infarct Survival sought to analyze the potential benefits and risks of self-administering aspirin within 4 hours of experiencing severe chest pain to reduce mortality post-AMI.READ MORE...The analysis used a population simulation model with data pooled from the 2019 U.S. Census. It included adults age 40 and older who self-administered 325 mg of aspirin within 4 hours after chest-pain onset (with or without AMI) and continued aspirin treatment for 28 days after AMI diagnosis (standard care). This data was compared to the results of patients who received aspirin therapy more than 4 hours after symptoms began. The primary outcome was estimating the potential number of deaths delayed post-AMI and the increased risk of bleeding associated with aspirin use.The study found that self-administration of aspirin within 4 hours of chest pain onset resulted in 13,016 deaths delayed in the United States in 2019 among adults age 40 and older. The bleeding deaths due to aspirin use in the same population was 963. Despite the bleeding risk, the researchers suggest that the benefits of aspirin self-administration should be promoted as a simple and cost-effective intervention for reducing AMI mortality.The findings highlight the need for further research and efforts to scale up aspirin self-administration initiatives to reach more individuals at risk for AMI. (Russo, R. G., et al. (2024). Self‐administration of aspirin after chest pain for the prevention of premature cardiovascular mortality in the United States: A population‐based analysis. Journal of the American Heart Association. Advance online publication. Retrieved May 2024 from https://www.ahajournals.org/doi/10.1161/JAHA.123.032778)Released: June 2024Nursing Drug Handbook© 2024 Wolters KluwerDequalinium as Potential Treatment for Bacterial VaginosisBacterial vaginosis (BV), a common and recurrent vaginal infection in females of reproductive age, is typically treated with antibiotics, like metronidazole and clindamycin. However, their adverse effects and risk of antibiotic resistance necessitate alternative treatments. A recent study evaluated the efficacy of dequalinium chloride, an antiseptic with broad-spectrum activity against various microorganisms, as a potential nonantibiotic treatment for BV.READ MORE...The phase 4, multicenter, triple-blind, parallel clinical trial aimed to compare the safety and efficacy of dequalinium to oral metronidazole, as first-line treatment for BV. The study, which ran from July 2021 to August 2022, recruited 151 premenopausal females (age 18 and older) with BV from Poland, the Czech Republic, and Slovakia. The participants were randomized into two groups receiving either dequalinium or placebo (10-mg intravaginal tablets used once a day for 6 days), or metronidazole or placebo (500-mg oral tablets taken twice a day for 7 days). Patients were asked to keep track of symptoms, tolerability, efficacy, and adverse events in an electronic diary. Two follow-up visits occurred after the start of treatment (on days 7 to 11 and days 20 to 40) for clinical evaluation.Various measures, including clinical and bacteriologic cure rates, safety profiles, and rate of recurrence, were evaluated over the course of the study. Results showed that dequalinium had similar results to metronidazole in terms of clinical cure rates, with over 90% of patients in both groups showing resolution of symptoms at the first visit (93.1% dequalinium versus 90.6% metronidazole). Furthermore, dequalinium demonstrated better tolerability (60.0% rated dequalinium "very good" versus 38.9% for metronidazole) and fewer adverse events compared to metronidazole (7 versus 11). The rate of BV recurrence, which tends to be high (30% to 70% within 6 months), was the same between the groups.The study's findings suggest that dequalinium chloride could be considered as first-line treatment for BV due to its comparable efficacy to antibiotics, broader spectrum of activity, better tolerability, and lower likelihood of resistance development. However, the high BV recurrence rate was similar to antibiotics, indicating the need for further research into strategies to prevent recurrence, such as probiotic use. (Raba, G., et al. (2024). Efficacy of dequalinium chloride vs metronidazole for the treatment of bacterial vaginosis: A randomized clinical trial. JAMA Network Open, 7(5), Article e248661. Retrieved May 2024 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2818221)Released: June 2024Nursing Drug Handbook© 2024 Wolters Kluwer Progestogen Versus Combined Oral Contraceptive for Endometriosis PainEndometriosis, affecting up to 1-in-10 women of reproductive age, involves the growth of endometrial-like tissue outside the uterus, leading to severe pelvic pain and infertility. Surgical treatment is common, but recurrence rates are high, with many women undergoing multiple operations. Hormonal treatments, like the combined oral contraceptive pill (COCP) and progestogens, are recommended postsurgery, but it's uncertain which is more effective in preventing pain recurrence.READ MORE...PRE-EMPT (Preventing Recurrence of Endometriosis), a multicenter, parallel group, randomized controlled trial, aimed to compare long-acting progestogens (LAPs) with COCP in preventing pain recurrence postsurgery for endometriosis. The study spanned from November 2015 to March 2019 and recruited 405 women ages 16 to 45. Participants underwent laparoscopy for endometriosis, and then were randomized to receive LAP (depot medroxyprogesterone acetate 150 mg IM every 3 months or levonorgestrel-releasing intrauterine system delivering 20 mcg daily for 5 years) or COCP (30-mcg ethinylestradiol and 150-mcg levonorgestrel taken continuously or cyclically each month). The primary outcome was pain recurrence measured via the Endometriosis Health Profile-30 pain domain after 3 years postrandomization.After 3 years, both LAP and COCP groups showed around a 40% reduction in pain scores from preoperative levels. Both treatments also demonstrated improvements in other quality of life measures, and adverse events were similar between groups and not directly related to trial treatments. However, the study showed that LAPs had an 11% lower rate of treatment failure, and fewer women required further interventions with LAPs compared to COCP (73 versus 97).Based on these results, providers can assure patients that either class of hormonal drug can help with pain reduction over the next 3 years after endometriosis surgery, but LAPs may reduce the risk of needing additional treatments and surgeries. Future research should explore newer hormonal treatments and focus on early, noninvasive diagnosis to improve long-term pain management and quality of life for endometriosis patients. (Cooper, K. G., et al. (2024). Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: The PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial. BMJ, 385, Article e079006. Retrieved May 2024 from https://www.bmj.com/content/385/bmj-2023-079006)Released: June 2024Nursing Drug Handbook© 2024 Wolters KluwerPerioperative Nivolumab for Non-Small-Cell Lung CancerNivolumab, an antibody targeting programmed death-1, in combination with chemotherapy is standard neoadjuvant treatment for patients with resectable non-small-cell lung cancer (NSCLC). Studies, including the landmark CheckMate 816 trial, showed significant improvements in event-free survival and pathologic complete response with this combination compared to chemotherapy alone. Based on these results, researchers questioned whether a perioperative approach, combining neoadjuvant therapy with nivolumab, followed by surgery and adjuvant therapy, could reduce disease relapse rates, and enhance clinical outcomes by bolstering antitumor immunity.READ MORE...The CheckMate 77T trial, a phase 3, randomized, double-blind study, compared perioperative nivolumab to chemotherapy alone in resectable NSCLC patients. The trial, between November 2019 and April 2022, randomized 461 patients to nivolumab or chemotherapy. The first group received four cycles of neoadjuvant nivolumab and chemotherapy, followed by definitive surgery, and then 1 year of adjuvant treatment with nivolumab. The second group had four cycles of a placebo and chemotherapy, plus definitive surgery, and adjuvant treatment with a placebo for 1 year.Results showed significantly longer event-free survival at 18 months with perioperative nivolumab (70.2%) compared to chemotherapy alone (50.0%), alongside higher rates of pathologic complete response (25.3% nivolumab versus 4.7% chemotherapy) and major pathologic response (35.4% nivolumab versus 12.1% chemotherapy). Safety profiles were comparable between groups, with no new safety signals observed with perioperative nivolumab. Adverse events, including immune-related ones, were manageable, and surgical outcomes were similar between treatment arms.This trial points to the efficacy of perioperative nivolumab in improving event-free survival, pathologic response, and disease-related symptoms compared to chemotherapy alone in resectable NSCLC patients. These findings support the role of immunotherapy in perioperative treatment strategies for NSCLC, potentially offering long-term clinical benefits as data continue to mature. (Cascone, T., et al. (2024). Perioperative nivolumab in resectable lung cancer. NEJM, 390(19), 1756–769. Retrieved May 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2311926)Released: June 2024Nursing Drug Handbook© 2024 Wolters Kluwer
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