Randomized placebo‐controlled trial of losartan for pediatric NAFLD

Background and Aims To 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 Results The Nonalcoholic Steatohepatitis Clinical Research Network conducted a multicenter, double‐...

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Published inHepatology (Baltimore, Md.) Vol. 76; no. 2; pp. 429 - 444
Main Authors 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.
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.08.2022
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Abstract Background and Aims To 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 Results The 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. Conclusions Losartan did not significantly reduce ALT in children with NAFLD when compared with placebo.
AbstractList 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.
To date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due to its antifibrotic effects. The 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. Losartan did not significantly reduce ALT in children with NAFLD when compared with placebo.
Background and Aims To 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 Results The 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. Conclusions Losartan did not significantly reduce ALT in children with NAFLD when compared with placebo.
Author Tonascia, James
Miriel, Laura A.
Dasarathy, Srinivasan
Lavine, Joel E.
Karpen, Saul J.
Jain, Ajay K.
Wilson, Laura A.
Mohammad, Saeed
Hertel, Paula
Molleston, Jean P.
Schwimmer, Jeffrey B.
Sanyal, Arun
Vos, Miriam B.
Sharkey, Emily P.
Mouzaki, Marialena
Fishbein, Mark
Van Natta, Mark L.
Xanthakos, Stavra A.
Blondet, Niviann M.
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NASH CRN, which is supported by the NIDDK (U01DK061713, U01DK061718, U01DK061728, U01DK061731, U01DK061732, U01DK061734, U01DK061737, U01DK061738, U01DK061730, and U24DK061730); National Center for Advancing Translational Sciences (UL1TR000077, UL1TR000150, UL1TR000424, UL1TR000006, UL1TR000448, UL1TR000040, UL1TR000100, UL1TR000004, UL1TR000423, and UL1TR000454); and the Intramural Research Program of the National Institutes of Health, National Cancer Institute
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  publication-title: Hepatology
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Snippet Background and Aims To date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due...
To date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due to its antifibrotic...
Background and AimsTo date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due...
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SubjectTerms Adolescent
Alanine
Alanine transaminase
Alkaline phosphatase
Angiotensin
Angiotensin II
Angiotensin Receptor Antagonists - therapeutic use
Blood Pressure
Child
Children
Clinical trials
Coronaviruses
Double-Blind Method
Drug therapy
Female
Hepatology
Humans
Hypertension - drug therapy
Losartan - adverse effects
Losartan - therapeutic use
Male
Non-alcoholic Fatty Liver Disease - chemically induced
Non-alcoholic Fatty Liver Disease - drug therapy
Pediatrics
Placebos
Treatment Outcome
Title Randomized placebo‐controlled trial of losartan for pediatric NAFLD
URI https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fhep.32403
https://www.ncbi.nlm.nih.gov/pubmed/35133671
https://www.proquest.com/docview/2690095941
Volume 76
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