Extended-release naltrexone/bupropion and liver health: Pooled, post hoc analysis from four randomized controlled trials.
Harpreet S BajajMelonie BurrowsJessica BlavignacEmilia ParonFernando CamachoErrol GouldMaxime BarakatPublished in: Diabetes, obesity & metabolism (2021)
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.
Keyphrases
- weight loss
- phase iii
- bariatric surgery
- roux en y gastric bypass
- liver fibrosis
- gastric bypass
- weight gain
- body mass index
- randomized controlled trial
- open label
- double blind
- healthcare
- clinical trial
- placebo controlled
- public health
- mental health
- obese patients
- glycemic control
- phase ii
- physical activity
- insulin resistance
- systematic review
- combination therapy
- metabolic syndrome
- atomic force microscopy
- middle aged
- study protocol
- high resolution
- high speed
- smoking cessation