In:
Obesity Research, Wiley, Vol. 7, No. 2 ( 1999-03), p. 189-198
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 . Objective Sibutramine 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 Procedures Seven 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. Results Weight loss was dose‐related and statistically significant vs. placebo ( p 〈 0.05) across all time‐points for a 5 mglday to 30 mglday dosage of sibutramine. At week 24, percent weight loss from baseline for completers was: placebo, 1.2%; 1 mg, 2.7%; 5 mg, 3.9%; 10 mg, 6.1%; 15 mg, 7.4%; 20 mg, 8.8%; and 30 mg, 9.4%. Weight loss achieved at week 4 was predictive of weight loss achieved at week 24. Patients losing weight demonstrated an increase in serum high density lipoprotein cholesterol and reductions in serum triglycerides, total cholesterol, low density lipoprotein cholesterol, and uric acid. Small mean increases in blood pressure and pulse rate (with considerable individual variability) were observed in patients treated with sibutramine. The most frequent adverse events were dry mouth, anorexia, and insomnia. Discussion Sibutramine 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.
Type of Medium:
Online Resource
ISSN:
1071-7323
,
1550-8528
DOI:
10.1002/oby.1999.7.issue-2
DOI:
10.1002/j.1550-8528.1999.tb00701.x
Language:
English
Publisher:
Wiley
Publication Date:
1999
detail.hit.zdb_id:
1201744-9
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