Ziresovir for Respiratory Syncytial Virus in Young Children
Respiratory 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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Liraglutide Effective for Weight Loss in Children with Obesity
Many 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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Erenumab Provides Relief for Medication-Overuse Headache in Chronic Migraine
Medication-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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Cabozantinib for Advanced Neuroendocrine Tumors
Neuroendocrine 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.
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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 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer