Sibutramine (Meridia)

While behavioral interventions demonstrate successful weight loss in the short term, the effects are difficult to maintain. Pharmacological treatment has yielded positive results in weight loss and weight loss maintenance. Sibutramine, a beta-phenethylamine that inhibits the reuptake of norepinephrine, serotonin, and dopamine to a very limited degree, was approved by the U.S. Food and Drug Administration (FDA) for long-term weight loss for patients 16 years and older.

Substantial evidence based on clinical trials lasting six months up to 24 months has shown that doses of 10 to 15 mg/d (i.e., the recommended dose) produced average weight losses of 8 to 10 percent of initial weight, as compared to reductions of only 1 to 2 percent for placebo-treated patients. Clinical trials have documented these losses in the first six months and showed that they were maintained at 12 months if patients remained on medication.

One of the most notable clinical trials, Sibutramine Trial of Obesity Reduction and Maintenance (STORM), was conducted by W. P. James and colleagues. This multisite randomized trial investigated the efficacy of sibutramine in adults over an 18-month period. Findings from this study revealed that 77 percent of the patients treated with sibutramine lost weight, while 43 percent of the individuals in the sibutramine group maintained at least 80 percent of their weight loss compared to 16 percent of those in the placebo group at the end of 18 months.

Behavioral and Pharmacological Treatment Combined

More recently, research supports a combination of behavioral and pharmacological treatment in achieving weight loss. Thomas Wadden and colleagues examined this among adult women who were randomized to one of three groups (drug alone, drug plus lifestyle modification, or combined drug, lifestyle modification, and portion controlled diet). The researchers found significantly greater reductions in weight in the drug plus lifestyle modification group as well as in the combined group at 12 months.

Robert Berkowitz and colleagues examined the combination of pharmacotherapy and behavioral intervention among adolescents in a single-center, six-month controlled trial combining sibutramine with a comprehensive behavioral program that induced a statistically significant weight loss in obese adolescents compared to a behavioral program alone. Following month six, all subjects were treated with sibutramine plus a behavioral program for an additional six months. At month 12, those adolescents originally treated with placebo in the initial six months lost further weight and those initially treated with sibutramine for six months maintained their weight loss at month 12. Adolescents in both groups lost similar amounts of weight by month 12, [Page 690]suggesting that sibutramine may be used following six months of behavioral treatment and that sibutramine may also induce a stable weight loss following 12 months of treatment.

Two more studies were recently released supporting the use of sibutramine in the induction of weight loss for adolescents. Amelio Godoy-Matos and colleagues conducted a randomized, double-blind, placebo-controlled trial in which adolescents were randomized to placebo or sibutramine for six months, along with a hypocaloric diet. Adolescents randomized to the sibutramine group lost 22 pounds on average compared to 5 pounds in the placebo group. The change in mean BMI was also significantly greater among the sibutramine group, replicating the earlier results of Berkowitz.

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