Extended-release naltrexone/bupropion and liver health: Pooled,post hoc analysis from four randomized controlled trials |
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Authors: | Harpreet S. Bajaj MD MPH Melonie Burrows PhD Jessica Blavignac PhD Emilia Paron PhD Fernando Camacho PhD Errol Gould PhD Maxime Barakat MD |
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Affiliation: | 1. LMC Diabetes and Endocrinology, Brampton, Ontario, Canada;2. Bausch Health, Laval, Quebec, Canada;3. Department of Statistics and Actuarial Sciences, University of Waterloo, Waterloo, Ontario, Canada;4. Currax Pharmaceuticals LLC, Morristown, New Jersey, USA |
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Abstract: | Sustained weight loss improves liver histology in non-alcoholic fatty liver disease. This post hoc analysis of four phase III, 56-week, randomized controlled trials investigated if extended-release naltrexone and bupropion (NB) affects alanine aminotransferase (ALT) and Fibrosis-4 (FIB-4) index in adults with overweight or obesity. Two thousand and seventy-three subjects (NB = 1310; placebo = 763; 79.0% female; 81.6% Caucasian) had baseline mean weight 101 kg, body mass index 36.2 kg/m2, ALT 26.9 IU/L and FIB-4 0.79. At 56 weeks, NB-treated subjects experienced more weight loss than placebo (8.7 vs. 3.2 kg, respectively, P < .0001). Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (P < .0001). There was a significant independent effect of NB on change from baseline for FIB-4 (P < .0001), but not for ALT (P = .54). Categorical ALT response (from above to within normal ranges: 10-40 IU/L for men; 7-35 IU/L for women) and achievement of 25% and 50% reduction in ALT were greater for NB versus placebo, and independently affected by weight loss (P < .0001), but not treatment. NB-associated weight loss may improve liver health by normalizing ALT values for those with high baseline levels. |
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Keywords: | antiobesity drug clinical trial fatty liver disease obesity therapy phase III study randomized trial |
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