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A randomized, controlled, crossover pilot study of losartan for pediatric nonalcoholic fatty liver disease
Miriam B Vos1,2, Ran Jin1, Juna V Konomi1
11Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, School of Medicine, Emory University, Room W-450, 1760 Haygood Dr NE, Atlanta, GA 30322 USA.
Insights
Losartan is a safe potential treatment for pediatric nonalcoholic fatty liver disease (NAFLD), showing promising trends in improving liver enzymes and insulin resistance. Further research is warranted to confirm its efficacy in children with NAFLD.
Area of Science:
- Pediatric Hepatology
- Clinical Pharmacology
- Metabolic Disorders
Background:
- Nonalcoholic fatty liver disease (NAFLD) is the most prevalent liver condition in children, lacking FDA-approved treatments.
- Elevated plasminogen activator inhibitor-1 (PAI-1) levels in pediatric NAFLD correlate with increased disease severity.
- Losartan potassium (losartan), an angiotensin II receptor blocker, reduces PAI-1 and enhances insulin sensitivity, making it a potential therapeutic candidate for pediatric NAFLD.
Purpose of the Study:
- To evaluate the safety and preliminary efficacy of losartan in treating biopsy-proven nonalcoholic steatohepatitis (NASH) in children.
- To assess the impact of losartan on liver enzymes, insulin resistance, and blood pressure in pediatric NASH patients.
Main Methods:
- An 8-week, randomized, double-blind, placebo-controlled, crossover Phase 2a study.
- 12 normotensive children with biopsy-proven NASH received oral losartan 50 mg daily.
- A 6-week washout period was implemented between treatment conditions.
Main Results:
- Nine out of twelve participants completed the study.
- No significant changes in blood pressure or serious adverse events were observed.
- Trends toward improvement in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and homeostatic model assessment insulin resistance (HOMA-IR) were noted with losartan compared to placebo.
- A higher percentage of participants showed decreased ALT levels during losartan treatment (89%) versus placebo (56%).
Conclusions:
- Losartan treatment demonstrated an 8-week safety profile in children with NAFLD.
- Preliminary data suggest potential efficacy, supporting further investigation in larger clinical trials.
- Losartan warrants consideration as a therapeutic option for pediatric NAFLD.
Background:
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in children, and currently, there are no FDA-approved therapies. Plasminogen activator inhibitor-1 (PAI-1) is elevated in children with NAFLD and associated with increased disease severity. Losartan potassium (losartan) is an angiotensin II receptor blocker (ARB) that reduces PAI-1 production and improves insulin sensitivity that has been proposed as a treatment for pediatric NAFLD but has not previously been tested.
Methods:
This was an 8-week randomized, double-blind, placebo-controlled, phase 2a, crossover study (with a 6-week washout between conditions) for safety and preliminary efficacy of losartan 50 mg a day taken orally in 12 normotensive children with biopsy proven nonalcoholic steatohepatitis (NASH).
Results:
Twelve children enrolled in the study, and nine completed all visits. No changes in blood pressure or serious adverse events occurred during the study. Trends in improvement in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and homeostatic model assessment insulin resistance (HOMA-IR) were seen with losartan treatment compared to the placebo time-period. More participants decreased ALT on losartan as compared to placebo (89% [8 out 9] vs. 56% [5 out of 9], respectively).
Conclusions:
This data provides preliminary evidence that losartan treatment is safe over 8 weeks in children with NAFLD and supports consideration of larger studies to test its efficacy.
Trial Registration:
URL and trial identification number: https://clinicaltrials.gov/show/NCT01913470, NCT01913470.Date registered: August 1, 2013.
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