Delayed Alteplase for Posterior Circulation Ischemic Stroke
A randomized clinical trial conducted in China evaluated the safety and effectiveness of administering intravenous alteplase between 4.5 and 24 hours after the onset of posterior circulation ischemic stroke. The safety and potential benefits of giving intravenous thrombolysis beyond the traditional treatment window for posterior circulation ischemic stroke are not well understood.
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To investigate this, the study enrolled adults with posterior circulation strokes who showed no extensive early damage on CT imaging and had no plan for thrombectomy. Participants were randomly assigned (1:1) to receive either alteplase at a dose of 0.9 mg/kg (maximum 90 mg) or standard medical care 4.5 to 24 hours after the onset of symptoms. The primary outcome was functional independence, defined as a score of 0 to 2 on the modified Rankin scale (where lower scores indicate better recovery), at 90 days.
A total of 234 adults were enrolled, and most patients had relatively mild strokes, with a median National Institutes of Health Stroke Scale score of 3. The key safety outcomes assessed were symptomatic intracranial hemorrhage and mortality. At 90 days, 89.6% of patients in the alteplase group achieved functional independence, compared with 72.6% in the standard care group. The incidence of symptomatic intracranial hemorrhage within 36 hours was rare, occurring in 1.7% of the alteplase group and in 0.9% in the standard treatment group. Mortality at 90 days was 5.2% in the alteplase group and 8.5% in the standard treatment group.
Findings from this study suggest that for select patients with mild posterior circulation stroke and no indication for thrombectomy, intravenous alteplase given beyond the standard 4.5-hour window can improve long-term functional outcomes with a low risk of serious complications. (Yan, S., et al. [2025]. Alteplase for posterior circulation ischemic stroke at 4.5 to 24 hours. N Engl J Med, 392, 1288–1296. Retrieved May 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2413344)
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Oral vs Extended-Release Naltrexone for Alcohol Use Disorder in Hospitalized Patients
A randomized clinical trial investigated the effectiveness of starting oral versus extended-release injectable naltrexone for patients with alcohol use disorder (AUD) at the time of hospital discharge. The study, known as the Alcohol Disorder Hospital Treatment (ADOPT) trial, was conducted at a U.S. urban teaching hospital and enrolled participants between June 2016 and March 2020.
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The study included medical inpatients with AUD and recent heavy drinking, defined as consuming 5 or more alcoholic drinks per day for men or 4 or more for women. Participants were randomized at hospital discharge to receive either daily oral naltrexone or monthly extended-release injectable naltrexone. All participants received additional medical management from a research nurse trained in addiction care.
Researchers measured changes in heavy drinking behavior by evaluating the percentage of heavy drinking days (HDDs) over the past 30 days, from hospital discharge to a 3-month follow-up. They also assessed acute healthcare use, specifically emergency department visits and hospital readmissions, at the 3-month follow-up over the prior 90 days.
Of the 248 study participants, most were male (80.2%), with a mean age of 49.4 years. At enrollment, the median percentage of heavy drinking days (HDDs) in the past month was 80%. At the 3-month follow-up, both groups demonstrated significant reductions in alcohol use. Those who received oral naltrexone saw HDDs drop from 66.7% to 27.4%, while those given the extended-release injection saw a reduction from 70.7% to 23.8%. However, the differences between the two groups were not statistically significant. Similarly, no significant differences were seen in rates of acute healthcare use in the prior 3 months (oral naltrexone: 54.1% vs injectable naltrexone: 61.1%).
The findings support that initiating either form of naltrexone during hospitalization can lead to meaningful reductions in heavy drinking among patients with AUD. Furthermore, since both forms of naltrexone were similarly effective, treatment choice may depend on individual factors such as adherence likelihood, patient preference, and insurance coverage. (Magane, K.M., et al. [2025]. Oral vs extended-release injectable naltrexone for hospitalized patients with alcohol use disorder: a randomized clinical trial. JAMA Intern Med, 185(6), 635–645. Retrieved May 2025 from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832702)
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Semaglutide Improves Liver Health in Patients with MASH and Fibrosis
A phase 3 randomized, double-blind, placebo-controlled trial investigated the effects of semaglutide in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. MASH is a progressive liver disease that can lead to cirrhosis and liver failure. Semaglutide is a glucagon-like peptide-1 receptor agonist approved for type 2 diabetes and obesity that lowers blood glucose, curbs appetite, and promotes weight loss, effects that could potentially benefit patients with MASH.
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In this ongoing multicenter trial, 1197 adults with biopsy-confirmed MASH and stage 2 or 3 fibrosis were randomized 2:1 to receive weekly subcutaneous semaglutide (2.4 mg) or placebo for up to 240 weeks. An interim analysis was conducted at week 72 based on the first 800 study participants. The primary endpoints of this analysis were resolution of steatohepatitis without worsening liver fibrosis and reduction in liver fibrosis without worsening steatohepatitis. Pre-specified secondary outcomes, adjusted for multiple testing, included combined resolution of steatohepatitis and fibrosis improvement, change in body weight, and change in bodily pain scores.
At 72 weeks, 62.9% of patients receiving semaglutide achieved resolution of steatohepatitis without worsening fibrosis, compared with 34.3% in the placebo group. A reduction in liver fibrosis without worsening of steatohepatitis was reported in 36.8% of the semaglutide group versus 22.4% of the placebo group. Both resolution of MASH and fibrosis improvement occurred in 32.7% of semaglutide-treated patients, compared with 16.1% of those receiving placebo. Patients on semaglutide also experienced a significantly greater average weight loss of 10.5%, compared with 2.0% in the placebo group. There was no significant difference between groups in bodily pain scores. Gastrointestinal adverse events were more frequent in those treated with semaglutide.
These results suggest that semaglutide can improve liver histology in patients with MASH and moderate to advanced fibrosis. Therefore, this pharmacologic therapy may offer a new treatment option for this challenging condition. (Sanyal, A.J., et al. [2025]. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis. N Engl J Med, 392, 2089–2099. Retrieved May 2025 from https://www.nejm.org/doi/full/10.1056/NEJMoa2413258)
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Stapokibart Add-On Therapy in Moderate-to-Severe Seasonal Allergic Rhinitis
A phase 3 multicenter, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of stapokibart in adults with moderate-to-severe seasonal allergic rhinitis (SAR) who remained symptomatic despite standard therapy. SAR is common during pollen season and can greatly impact quality of life, particularly in those with persistent or severe symptoms unresponsive to standard treatments. Stapokibart is a humanized monoclonal antibody that targets the interleukin-4 receptor subunit alpha, thereby blocking its interaction with both interleukin-4 (IL-4) and interleukin-13 (IL-13), key cytokines in type 2 inflammatory pathways.
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This study enrolled 108 adults with moderate-to-severe SAR and elevated blood eosinophil counts (≥300 cells/μL). Participants were randomly assigned (1:1) to receive stapokibart administered subcutaneously as a 600 mg loading dose followed by 300 mg or placebo every two weeks for a total of four weeks during pollen season. All participants continued their usual allergy medications.
The primary endpoint of the study was the change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) during the first two weeks of treatment. Secondary endpoints included changes in rTNSS over a four-week period and reflective Total Ocular Symptom Scores and scores from the Rhinoconjunctivitis Quality of Life Questionnaire assessed at both two and four weeks.
Patients receiving stapokibart had significantly greater reductions in daily rTNSS scores compared with those receiving placebo. At the two-week point, the least-squares mean difference in rTNSS from baseline was −1.3 (95% CI, −2.0 to −0.6; P = 0.0008), and by week four, the difference increased to −1.7 points (95% CI, −2.5 to −0.8; P = 0.0002). Additionally, stapokibart treatment led to statistically significant improvements in all multiplicity-adjusted secondary endpoints, including relief of ocular symptoms and enhanced quality of life. Treatment-emergent adverse events occurred at similar rates in both groups.
Pharmacodynamic and exploratory analyses suggest that the symptom improvements seen during pollen season were likely due to ability of stapokibart to reduce type 2 inflammation. Overall, the trial showed that seasonal use of stapokibart led to meaningful relief of both nasal and eye symptoms and enhanced quality of life in adults with moderate-to-severe SAR. (Zhang, Y., et al. [2025]. Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial. Nat Med. Advance online publication. Retrieved May 2025 from https://doi.org/10.1038/s41591-025-03651-5)
Released: June 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.