Table 4.
Summary of Naltrexone (NTX) Efficacy and Safety in Adult Trials for Obesity and Eating Disorders
| Reference | Sample Size (Study Design) | Drug: Dosing and Duration | Outcomes |
|---|---|---|---|
| Overweight and/or obesity | |||
| Apovian141 | 1496 (PCT) | NTX: 32 mg/day + bupropion 360 mg/day up to 56 wk | Weight: NB: −6.4%, PLB: −1.2% 5% weight loss: NB: 50.5% (CV = 124%); PLB: 17.1% SAE: NB: 2.1% (1 myocardial infarction, 1 seizure), PLB: 1.4% |
| Kolotkin142 | 3362 (PCT) | NTX: 32 mg/day + bupropion 360 mg/day for 56 wk | Weight: NB: −7.0% (CV = 129%); PLB: −2.3% Weight-loss associated QoL score: NB: +11.9, PLB: +8.2 SAE: none |
| Hollander143 | 505 (PCT) | Overweight/obese with type 2 diabetes. NTX: 32 mg/day + bupropion 360 mg/day for 56 wk | Weight: NB: −5.0% (CV = 98%), PLB: −1.8% 5% weight loss: NB: 44.5%; PLB: 18.9% SAE: 3.9% NB vs 4.7% PLB (similar profile to non-diabetic patients) |
| Wadden144 | 793 (PCT) | NTX: 32 mg/day + bupropion 360 mg/day for 56 wk + behavioral modification | Weight: NB: −9.3% (CV 94%), PLB: −5.1% 5% weight loss: NB: 66.4%, PLB: 42.5% (CV = 94%) SAE: none |
| Greenway145 | 1742 (PCT) | NTX: 16 or 32 mg/day + bupropion 360 mg/day for 56 wk | Weight: NB16: −4.9% (CV = 133%); NB32: −6.1% (CV = 107%); PLB: −1.4% 5% weight loss: NB16: 39%; NB32: 48%; PLB: 16% (CV = 133%) SAE: none |
| Malcolm151 | N = 41 (PCT) | Obesity – NTX: 200 mg/day × 8 wk | Weight loss, kg: NTX: 1.8 (CV = 200%), PLB: 1.5 Female: NTX 1.5, PLB 1.5 Male: NTX: 2.6, PLB: 1.4 SAE: NTX: 3 patients had liver transaminases 2 × ULN |
| Mason152 | N = 44 (PCT with crossover) | Obese females – Day 1: PLB; Day 4: NTX 25 mg; Day 7: PLB; Day 10: NTX 50 mg; Day 38: NTX 50 mg | NTX blunted association between reward-based eating drive and food craving (50 mg vs PLB) SAE: none |
| Eating disorders | |||
| Mitchell146 | 16 (PCT with crossover) | BN with normal weight – NTX: 50 mg/day for 3 wk | Binge days/wk: NTX: 4.9 (CV = 106%); PLB: 5.7 Vomit days/wk: NTX: 7.0 (CV = 143%), PLB: 7.6 SAE: none |
| Alger147 | Obese BED: 4; NL weight BN: 28 (PCT) | NTX: Titrate up to 50 mg thrice daily for 6 wk | Bingeing: Obese BED: −70% (SIQR: 21.4%) BN: −30% (SIQR: 15.6%) SAE: none |
| Marrazzi148 | N = 19 (PCT with crossover) | AN and BN – NTX: 100 mg twice daily for 6 wk | Binge and purge symptoms: Reduction in 95% of participants SAE: none |
| Jonas149 | N = 10 (open-label) | Antidepressant-resistant BN – NTX: 300 mg/day for 6 wk | Bulimic symptoms: Reduction of ≥75% in 70% of participants |
| SAE: none | |||
| Jonas150 | N = 16 (Open- label, randomized dosing scheme) | BN – NTX: ≤100 mg/day vs ≥200 mg/day for 6 wk | Binge days: High dose: −5.1 (CV = 150%); low dose: −1.9 (CV = 35%) Purge days: High dose: −3.9; low dose: −1.5 SAE: none |
AN, anorexia nervosa; BED, binge eating disorder; BN, bulimia nervosa; CV, coefficient of variation; NB, NTX/bupropion; NB16, NB + 16 mg of NTX; NB32, NB + 32 mg of NTX; NL, normal PCT, placebo-controlled trial; QoL, quality of life; SIQR, semi-interquartile range; ULN, upper limits of normal