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Review: Orlistat and Sibutramine Are Modestly Effective for Weight Loss at 1 Year

Posted on: Tuesday, 25 January 2005, 03:00 CST

Padwal R, Li SK, Lau DC. Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev. 2004;(3):CD004094.

QUESTION

What is the effectiveness of antiobesity medications in trials with ≥ 1-year follow-up?

METHODS

Data sources: MEDLINE (1966 to December 2002), EMBASE/ ExcerptaMedica (1980 to December 2002), the Cochrane Controlled Trials Register (Issue 3, 2002), the Current Controlled Trials metaRegister of Controlled Trials (December 2002), bibliographies of relevant studies, and contact with experts and manufacturers.

Study selection and assessment: Studies in any language were selected if they were randomized controlled trials (RCTs) of approved antiobesity agents for weight loss or weight maintenance in adults (age ≥ 18 y) with body mass index (BMI) ≥ 30 kg/ m^sup 2^ or > 27 kg/m^sup 2^ plus ≥ 1 obesity-related comorbid condition (e.g., coronary artery disease, stroke, type 2 diabetes, heart failure, dyslipidemia, hypertension, reproductive or gastrointestinal cancer, gallstones, fatty liver disease, osteoarthrkis, and sleep apnea), had blinding of patients and health care providers, included a placebo group or compared ≥ 2 antiobesity drugs, used an intention-to-treat analysis, and had ≥ 1 year follow-up. Studies of off-label therapy; drugs with high addiction potential that preclude long-term use; or investigational, herbal, or alternative compounds were excluded. Study quality assessment included method of randomization, allocation concealment, blinding, intention-to treat analysis, and attrition. Outcome: Weight loss at 1 year.

MAIN RESULTS

Only trials of orlistat and sibutramine met the selection criteria. 16 RCTs (11 of orlistat and 5 of sibutramine) were included. 14 RCTs (11 of orlistat and 3 of sibutramine) were weight loss trials in which drug therapy was used in conjunction with a weight loss diet for 1 year. 2 RCTs of sibutramine were weight maintenance trials with 12- to 18-month follow-up.

11 weight loss trials (n = 6021, mean age 49 y, 71% women, mean BMI 35.7 kg/m^sup 2^) used standard doses of orlistat (120 mg, 3 times/d). 3 weight loss trials (n = 929, mean age 47 y, 80% women, mean BMI 33.4 kg/m^sup 2^) used sibutramine, 10 to 20 mg/d. Patients who received orlistat had a 2.7-kg (95% CI 2.3 to 3.1 kg; 11 RCTs) greater weight loss (2.9%, CI 2.3 to 3.4; 10 RCTs) than patients who received placebo, and sibutramine-group patients had a 4.3-kg (CI 3.6 to 4.9 kg; 3 RCTs) greater weight loss (4.6%, CI 3.8 to 5.4; 3 RCTs) than placebo-group patients. More orlistat- and sibutramine- group patients achieved a 5% and 10% weight loss than did placebo- group patients (Table).

Orlistat (OrI) or sibutramine (Sib) vs placebo for weight loss at 1 year*

2 sibutramine weight maintenance trials (n = 627, mean age 49 y, 83% women, mean BMI 37 kg/m^sup 2^) used a 10-mg/d dose of sibutramine. Results from these 2 trials were not pooled, but both showed greater weight loss in participants who received sibutramine than in those who received placebo.

CONCLUSION

Orlistat and sibutramine are modestly effective for weight loss at 1 year.

Source of funding: No external funding.

For correspondence: Dr. R. Padwal, University of Alberta and Walter C. Mackenzie Health Sciences Centre, Edmonton, Alberta, Canada. E-mail rpadwal@ualberta.ca.

Copyright American College of Physicians Jan/Feb 2005

Source: ACP Journal Club

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