Sibutramine Produces Dose‐Related Weight Loss

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Abstract
BRAY, GEORGE A., GEORGE L. BLACKBURN, JAMES M. FERGUSON, FRANK L. GREENWAY, ADESH K. JAIN, CARL M. MENDEL, JOSEPH MEN‐DELS, DONNA H. RYAN, SHERWYN L. SCHWARTZ, MONTE L. SCHEINBAUM, AND TIMOTHY B. SEATON. Sibutramine produces dose‐related weight loss.Obes Res.ObjectiveSibutramine is a weight control drug that inhibits the reuptake of both serotonin and norepinephrine. In animals, it reduces food intake and increases thermogenesis and preliminary data in human beings showed weight loss. This paper reports a 24‐week dose‐ranging study to determine the effect of sibutramine on body weight of patients with obesity.Research Methods and ProceduresSeven clinical centers screened 1463 patients with obesity and randomized 1047 to 24 weeks of treatment with 1 of 6 doses of sibutramine (1, 5, 10, 15, 20, or 30 mg) or placebo once daily. Six hundred eighty‐three patients completed the study. A two‐week placebo run‐in period was used to initiate a standardized program of diet, physical activity, and lifestyle changes.ResultsWeight loss was dose‐related and statistically significant vs. placebo (pDiscussionSibutramine administered once daily for 24 weeks in the weight loss phase of treatment for uncomplicated obesity produced dose‐related weight loss and was well tolerated. Improvements in serum lipids and uric acid accompany sibutramine‐induced weight loss. Most of the adverse events observed on sibutramine are related to its pharmacology, including small mean increases in blood pressure and heart rate.