{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T06:30:17Z","timestamp":1790231417509,"version":"4.1.0"},"reference-count":45,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2022,2,28]],"date-time":"2022-02-28T00:00:00Z","timestamp":1646006400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2022,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Approach and Results<\/jats:title>\n                    <jats:p>\n                      The Nonalcoholic Steatohepatitis Clinical Research Network conducted a multicenter, double\u2010masked, placebo\u2010controlled, randomized clinical trial in children with histologically confirmed NAFLD at 10 sites (September 2018 to April 2020). Inclusion criteria were age 8\u201317 years, histologic NAFLD activity score \u2265 3, and serum alanine aminotransferase (ALT) \u2265 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                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u00a0=\u00a0110. Treatment effects were assessed using linear regression of change in treatment group adjusted for baseline value. Eighty\u2010three participants (81% male, 80% Hispanic) were randomized to losartan (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u00a0=\u00a043) or placebo (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u00a0=\u00a040). 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.\n                    <\/jats:p>\n                    <jats:p>\n                      Baseline characteristics were similar between groups. The 24\u2010week change in ALT did not differ significantly between losartan versus placebo groups (adjusted mean difference: 1.1 U\/l; 95% CI = \u221230.6, 32.7;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u00a0=\u00a00.95), although alkaline phosphatase decreased significantly in the losartan group (adjusted mean difference: \u221223.4 U\/l; 95% CI = \u221241.5, \u22125.3;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u00a0=\u00a00.01). Systolic blood pressure decreased in the losartan group but increased in placebo (adjusted mean difference: \u22127.5 mm Hg; 95% CI = \u221212.2, \u22122.8;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u00a0=\u00a00.002). Compliance by pill counts and numbers and types of adverse events did not differ by group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Losartan did not significantly reduce ALT in children with NAFLD when compared with placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/hep.32403","type":"journal-article","created":{"date-parts":[[2022,2,8]],"date-time":"2022-02-08T08:43:25Z","timestamp":1644309805000},"page":"429-444","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":35,"title":["Randomized placebo\u2010controlled trial of losartan for pediatric NAFLD"],"prefix":"10.1097","volume":"76","author":[{"given":"Miriam B.","family":"Vos","sequence":"first","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hepatology and Nutrition,Department of Pediatrics,Emory 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School of Northwestern University,Chicago,Illinois,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Hertel","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Nutrition,Texas Children\u2019s Hospital,Baylor College of Medicine,Houston,Texas,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay K.","family":"Jain","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Nutrition,Department of Pediatrics,St. Louis University,St. Louis,Missouri,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3379-7592","authenticated-orcid":false,"given":"Saul\u00a0J.","family":"Karpen","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hepatology and Nutrition,Department of Pediatrics,Emory University School of Medicine,Children\u2019s Healthcare of 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