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Efficacy of Pharmacotherapy for Weight Loss in Adults With Type 2 Diabetes Mellitus
A Meta-analysis
Susan L. Norris, MD, MPH;
Xuanping Zhang, PhD;
Alison Avenell, MD, MBBS;
Edward Gregg, PhD;
Christopher H. Schmid, PhD;
Curi Kim, MD, MPH;
Joseph Lau, MD
Arch Intern Med. 2004;164:1395-1404.
Background Obesity is closely related to type 2 diabetes mellitus, and weight reduction is an important part of the care delivered to obese persons with diabetes. The objective of this review was to assess the efficacy of pharmacotherapy for weight loss in adults with type 2 diabetes.
Methods A systematic review of the literature was performed, and studies were included if pharmacotherapy was used as the primary strategy for weight loss among adults with type 2 diabetes. Published and unpublished studies with any design were included. A random effects model was used to combine outcomes from randomized controlled trials.
Results Sufficient data for the meta-analysis were available for fluoxetine, orlistat, and sibutramine. Fourteen randomized, placebo-controlled trials were included in the review, with a total of 2231 patients. Pharmacotherapy produced modest reductions in weight for fluoxetine (3.4 kg [95% confidence interval (CI), 1.7-5.2 kg] at 8-16 weeks of follow-up; 5.1 kg [95% CI, 3.3-6.9 kg] at 24-30 weeks; and 5.8 kg [ 95% CI, 0.8-10.8 kg] at 52 weeks); orlistat (2.6 kg [95% CI, 2.1-3.2 kg] [2.6% loss] at 52 weeks); and sibutramine (4.5 kg [95% CI, 1.8-7.2 kg] [3.3% loss] at up to 26 weeks). Glycated hemoglobin was also modestly reduced: fluoxetine (1.0% [95% CI, 0.4%-1.5%] at 8-16 weeks; 1.0% [95% 0.6%-1.4%] at 24-30 weeks; and 1.8% [95% CI, –0.2%-3.8%] at 52 weeks); orlistat (0.4% [95% CI, 0.3%-0.5%]); and sibutramine (0.7% [95% CI, –0.5%-1.9%]). Gastrointestinal adverse effects were common with orlistat; tremor, somnolence, and sweating with fluoxetine; and palpitations with sibutramine.
Conclusions Fluoxetine, orlistat, and sibutramine can achieve statistically significant weight loss over 26 to 52 weeks. However, the magnitude of weight loss was modest, and the long-term health benefits and safety remain unclear. Interventions that combine pharmacologic therapy with intensive behavioral interventions may be more effective but need additional research.
From the Division of Diabetes Translation (Drs Norris, Zhang, Gregg, and Kim), National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Ga; Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, Scotland (Dr Avenell); and Biostatistics Research Center (Dr Schmid) and Center for Clinical Evidence Synthesis (Dr Lau), Division of Clinical Care Research, Tufts–New England Medical Center, Boston, Mass. Dr Kim is now with University of Michigan Health Systems, Ann Arbor. Dr Avenell has received research funding from Roche Products Ltd in 1993-1995 for orlistat trials in patients without diabetes.
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