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OBESITY DRUG COULD SUSTAIN WEIGHT LOSS (p 2119)
December 21, 2000Results of a clinical trial published in this week's issue of THE LANCET suggest that the drug sibutramine is effective in sustaining weight loss in obese patients. However, questions remain about the drug's long-term safety.
Sibutramine is a tertiary amine, originally developed as a potential antidepressant. It has been shown to induce dose-dependent weight loss and to enhance the effects of a low-calorie diet for up to a year. The Sibutramine Trial of Obesity Reduction and Maintenance (STORM) was a randomised trial to assess the usefulness of sibutramine in maintaining substantial weight loss over 2 years.
605 obese patients were recruited from eight European centres for a 6-month period of weight loss with sibutramine (10 mg per day) and an individualised dietary programme based on measured resting metabolic rates. 467 (77%) of these patients achieved more than 5% weight loss; they were eligible for the second phase of the trial and were randomly assigned either 10 mg per day sibutramine (352 patients) or placebo (115 patients) for a further 18 months. Sibutramine was increased up to 20 mg per day if weight regain occurred. The primary outcome measure was the number of patients at the end of the trial who maintained at least 80% of the weight loss achieved in the first phase of the trial. Other outcome measures included changes in uric acid concentrations and glycaemic and lipid variables.
148 (42%) individuals in the sibutramine group and 58 (50%) in the placebo group dropped out of the trial for reasons ranging from voluntary withdrawal to varied side-effects. Of the 204 sibutramine-treated individuals who completed the trial, 89 (43%) maintained 80% or more of their original weight loss, compared with nine (16%) of the 57 individuals in the placebo group. Patients had substantial decreases over the first 6 months with respect to triglycerides, VLDL cholesterol, insulin, C peptide, and uric acid; these changes were sustained in the second phase of the trial in the sibutramine group but not the placebo group. However, HDL cholesterol concentrations (regarded as beneficial in protecting against heart disease) rose substantially in the second year, and were greater in the sibutramine group (20.7% compared with 11.7%). 20 (3%) of patients were withdrawn because of increases in blood pressure; in the sibutramine group, systolic blood pressure rose throughout the trial by 0.1 mm Hg, diastolic blood pressure by 2.3 mm Hg, and pulse rate increased by 4.1 beats per minute.
The investigators comment that the benefits of weight loss associated with sibutramine could be moderated by an increased risk of raised blood pressure. They conclude that the overall long-term benefit of sibutramine needs to be assessed, and that patients should regularly have their blood pressure monitored to identify any unusual cardiovascular effects.
Contact: Professor W Philip T James, c/o International Obesity Task Force, 231 North Gower Street, London NW1 2NS, UK; T) +44 (0)20 7691 1900; F) +44 (0)20 7387 6033; E) jeanhjames@aol.com
Lancet
148 (42%) individuals in the sibutramine group and 58 (50%) in the placebo group dropped out of the trial for reasons ranging from voluntary withdrawal to varied side-effects. Of the 204 sibutramine-treated individuals who completed the trial, 89 (43%) maintained 80% or more of their original weight loss, compared with nine (16%) of the 57 individuals in the placebo group. Patients had substantial decreases over the first 6 months with respect to triglycerides, VLDL cholesterol, insulin, C peptide, and uric acid; these changes were sustained in the second phase of the trial in the sibutramine group but not the placebo group. However, HDL cholesterol concentrations (regarded as beneficial in protecting against heart disease) rose substantially in the second year, and were greater in the sibutramine group (20.7% compared with 11.7%). 20 (3%) of patients were withdrawn because of increases in blood pressure; in the sibutramine group, systolic blood pressure rose throughout the trial by 0.1 mm Hg, diastolic blood pressure by 2.3 mm Hg, and pulse rate increased by 4.1 beats per minute.
The investigators comment that the benefits of weight loss associated with sibutramine could be moderated by an increased risk of raised blood pressure. They conclude that the overall long-term benefit of sibutramine needs to be assessed, and that patients should regularly have their blood pressure monitored to identify any unusual cardiovascular effects.
Contact: Professor W Philip T James, c/o International Obesity Task Force, 231 North Gower Street, London NW1 2NS, UK; T) +44 (0)20 7691 1900; F) +44 (0)20 7387 6033; E) jeanhjames@aol.com
Lancet
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