Table 4.
Recent randomised controlled trials of weight loss therapies with 6-month followup.
| Drug | No. subjects | Outcomes | Serious adverse events | Reference | |||
|---|---|---|---|---|---|---|---|
| Absolute weight loss (kg) (95% CI) | ≥5% weight loss | ≥10% weight loss | Change in WC (cm) | ||||
| Bupropion (400 mg) plus Naltrexone | Placebo-85 | 0.9 ± 0.5 | 15% | 2% | −0.9 ± 0.9 | Nausea: 3.5% P, 28.1% BN16, 39.7% BN32, 41% BN48 | [22] |
| N 48 mg-56 B-60 | 1.1 ± 0.7 | 10% | 2% | −3.8 ± 1.2 | |||
| BN16 mg-64 | 2.6 ± 0.6 | 26% | 7% | −2.9 ± 1.1 | |||
| 5.1 ± 0.6P < .05 | 52%, P < .05 | 17%, P < .05 | −3.7 ± 1.1, P < .05 | ||||
| BN 32 mg-63 | 5.1 ± 0.6P < .05 | 51%, P < .05 | 19%, P < .05 | −4.6 ± 1.0, P < .05 | |||
| BN 48 mg-61 | 4.0 ± 0.6P < .05 | 39%, P < .05 | 15%, P < .05 | −4.7 ± 1.2, P < .05 | |||
| Bupropion (120 mg/360 mg) + Zonisamide (360 mg/360 mg) | 729 (total) | 1.4∧ P | 15%∧ P | 4%∧ P | NA | NA | [97] |
| 3.2∧ Z120 5.3∧ Z360 |
27%∧ Z120 44%∧ Z360 | 9%∧ Z120 18%∧ Z360 |
|||||
| 2.3∧ B360 | 21%∧ B360 | 11%∧ B360 | |||||
| 6.1∧ ZB120 P < .001 7.5∧ ZB360 P < .001 |
47%∧ ZB120 (P < .05) 60%∧ ZB360 (P < .05) | 25%∧ ZB120 P < .05 32%∧ ZB360 P < .05 |
|||||
| Rimonabant | P-417 | 0.5 (0.3, 1.3) | NR | NR | 1.0 (−0.2, 1.9) | Psychiatric: 28.4% P, 43.4% R, P < .001 | [98] |
| R-422 | 4.3 (3.5, 5.1) P < .001 | 4.5 (−3.7, −5.4), P < .001 | Severe psychiatric: 3.5% P, 4.8% R, P = .52 | ||||
| Rimonabant* | 3165 (total) | Placebo 1.6 R 6.5 |
19.7% 50.8%, P < .001 |
7.8% 27%, P < .001 |
6.4 2.5 |
Depression: 0.8% P, 1.9% R, NS Anxiety: 0.3 P, 1.0% R, NS | [96] |
| Tesofensine | Placebo-52 | 2.2 (0.9, 3.5) | 13 (29%) | 3 (7%) | −2.4 (0.7, 4.2) | Anger and hostility: 4% P, 14.3% T 1 mg, P = .018 | [99] |
| T 0.25 mg-52 | 6.7 (5.4, 8.0), P < .0001 | 29 (59%) | 17 (35%) | −5.9 (4.0, 7.8), P = .007 | Increased confusion: P-NA, | ||
| T 0.5 mg-50 | 11.3 (9.9, 12.7), P < .0001 | 41 (87%) | 25 (53%) | –9·4 (7.7, 11.0), P < .0001 | T 0.5 mg P = .015, | ||
| T 1.0 mg-49 | 12·8 (11.6, 14.1), P < .0001 | 42 (91%) | 34 (74%) | –9·3 (7.6, 11.0), P < .0001 | T 1 mg P = .0003 | ||
Absolute weight loss: weight loss from baseline; NS: not significant; NR: not recorded; WC: waist circumference; P: placebo; B: bupropion; N: naltrexone; Z: zonisamide; R: rimonabant; T: tesofensine; NA: not available; *pooled non-diabetic patients; #mean ± standard deviation; ∧estimated absolute weight based on mean baseline weight of 100 kg.