التفاصيل البيبلوغرافية
| العنوان: |
Randomized placebo‐controlled trial of losartan for pediatric NAFLD |
| المؤلفون: |
Vos, Miriam B, Van Natta, Mark L, Blondet, Niviann M, Dasarathy, Srinivasan, Fishbein, Mark, Hertel, Paula, Jain, Ajay K, Karpen, Saul J, Lavine, Joel E, Mohammad, Saeed, Miriel, Laura A, Molleston, Jean P, Mouzaki, Marialena, Sanyal, Arun, Sharkey, Emily P, Schwimmer, Jeffrey B, Tonascia, James, Wilson, Laura A, Xanthakos, Stavra A, Network, NASH Clinical Research |
| المصدر: |
Hepatology, vol 76, iss 2 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2022 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Biomedical and Clinical Sciences, Clinical Sciences, Pediatric, Digestive Diseases, Clinical Research, Prevention, Hepatitis, Liver Disease, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Angiotensin Receptor Antagonists, Blood Pressure, Child, Double-Blind Method, Female, Humans, Hypertension, Losartan, Male, Non-alcoholic Fatty Liver Disease, Treatment Outcome, NASH Clinical Research Network, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology |
| جغرافية الموضوع: |
429 - 444 |
| الوصف: |
Background and aimsTo date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due to its antifibrotic effects.Approach and resultsThe Nonalcoholic Steatohepatitis Clinical Research Network conducted a multicenter, double-masked, placebo-controlled, randomized clinical trial in children with histologically confirmed NAFLD at 10 sites (September 2018 to April 2020). Inclusion criteria were age 8-17 years, histologic NAFLD activity score ≥ 3, and serum alanine aminotransferase (ALT) ≥ 50 U/l. Children received 100 mg of losartan or placebo orally once daily for 24 weeks. The primary outcome was change in ALT levels from baseline to 24 weeks, and the preset sample size was n=110. Treatment effects were assessed using linear regression of change in treatment group adjusted for baseline value. Eighty-three participants (81% male, 80% Hispanic) were randomized to losartan (n=43) or placebo (n=40). During an enrollment pause, necessitated by the 2019 coronavirus pandemic, an unplanned interim analysis showed low probability (7%) of significant group difference. The Data and Safety Monitoring Board recommended early study termination. Baseline characteristics were similar between groups. The 24-week change in ALT did not differ significantly between losartan versus placebo groups (adjusted mean difference: 1.1 U/l; 95% CI = -30.6, 32.7; p=0.95), although alkaline phosphatase decreased significantly in the losartan group (adjusted mean difference: -23.4 U/l; 95% CI = -41.5, -5.3; p=0.01). Systolic blood pressure decreased in the losartan group but increased in placebo (adjusted mean difference: -7.5 mm Hg; 95% CI = -12.2, -2.8; p=0.002). Compliance by pill counts and numbers and types of adverse events did not differ by group.ConclusionsLosartan did not significantly reduce ALT in children with NAFLD when compared with placebo. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt4zr8572g; https://escholarship.org/uc/item/4zr8572gTest |
| الإتاحة: |
https://escholarship.org/uc/item/4zr8572gTest |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.64A5B080 |
| قاعدة البيانات: |
BASE |
