| cardiovascular prevention | All results are NS for efficacy inferior to placebo in terms of serious psychiatric side-effects in Rio-lipid 20 mg, 2005 inferior to placebo in terms of serious psychiatric side-effects in CRESCENDO, 2010 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RIO europe 20mg, 2005 | vs placebo | weight loss equal to or greater than 10 percent 3.80 [2.49; 5.80] weight loss equal to or greater than 5 percent 2.68 [2.10; 3.42] | | serious psychiatric side-effects 1.24 [0.58; 2.67] serious adverse events 1.15 [0.72; 1.84] | | Rio-lipid 20 mg, 2005 | vs placebo | weight loss equal to or greater than 10 percent 4.47 [2.98; 6.71] | serious psychiatric side-effects 6.92 [1.58; 30.22] | serious adverse events 1.73 [0.74; 4.07] | | RIO-North America 20 mg, 2006 | vs placebo | weight loss equal to or greater than 10 percent 2.94 [2.23; 3.88] weight loss equal to or greater than 5 percent 2.44 [2.06; 2.89] | | serious psychiatric side-effects 1.68 [0.77; 3.68] serious adverse events 1.30 [0.80; 2.14] | | RIO europe 5mg, 2005 | vs placebo | | | | | RIO europe (20 vs 5 mg), 2005 | vs placebo | | | | | CRESCENDO, 2010 | vs placebo | | serious psychiatric side-effects 1.92 [1.54; 2.39] | CV events 0.96 [0.84; 1.11] suicide 3.97 [0.44; 35.53] |
| Trial | Treatments | Patients | Method |
|---|
| RIO europe 20mg, 2005 | rimonabant 20mg daily (n=599) vs. placebo (n=305) | patients with body-mass index 30 kg/m2 or greater, or body-mass index greater than 27 kg/m2 with treated or untreated dyslipidaemia, hypertension, or bothtž-dt | Double blind Parallel groups Sample size: 599/305 Primary endpoint: weight change from baseline after 1 year of treatment FU duration: | | Rio-lipid 20 mg, 2005 | rimonabant 20 mg daily (n=346) vs. placebo (n=342) this was a 3-arms trial testing also rimonabant 5mg daily | overweight or obese patients (body-mass index 27 to 40) with untreated dyslipidemia (triglyceride levels >1.69 to 7.90 mmol per liter, or a ratio of cholesterol to high-density lipoprotein [HDL] cholesterol of >4.5 among women and >5 among men) | Double blind Parallel groups Sample size: 346/342 Primary endpoint: loss of body weight FU duration: 12 months | | RIO-North America 20 mg, 2006 | rimonabant 20mg daily (n=1222) vs. placebo (n=607) | obese (body mass index >=30) or overweight (body mass index >=27 and treated or untreated hypertension or dyslipidemia) adult patients | Double blind Parallel groups Sample size: 1222/607 Primary endpoint: Body weight change over year 1ú FU duration: | | RIO europe 5mg, 2005 | 5 mg rimonabant (n=603) vs. placebo (n=305) 3 arms: placebo, 5 mg rimonabant, or 20 mg rimonabant once daily | patients with body-mass index 30 kg/m2 or greater, or body-mass index greater than 27 kg/m2 with treated or untreated dyslipidaemia, hypertension, or both | double-blind Parallel groups Sample size: 603/305 Primary endpoint: weight FU duration: 1 y | | RIO europe (20 vs 5 mg), 2005 | (n=599) vs. (n=603) | | Sample size: 599/603 Primary endpoint: FU duration: | | CRESCENDO, 2010 | rimonabant 20 mg (n=9381) vs. placebo (n=9314) | patients patients with abdominal obesity and with previously manifest or increased risk of vascular disease | double-blind Parallel groups Sample size: 9381/9314 Primary endpoint: CV death, MI, stroke FU duration: 13.8 months the trial was prematurely discontinued because of concerns by health regulatory authorities in three countries about suicide in individuals receiving rimonabant |
|
