Introduction :
Sibutramine is a tertiary amine originally developed as a potential antidepressant, but with weight-loss-inducing properties. These properties are induced by a dual mechanism involving the inhibition of neuronal reuptake of norepinephrine and serotonin at the receptor sites that affect food intake, and the prevention of the decline in energy expenditure during weight loss. This drug induces dose-dependant weight loss and, over a year's treatement, can amplify the effects of a very low-calorie diet. The current study, recently published in The Lancet, was a randomized, placebo-controlled, double,blind, parallel-group trial with an open run-in designed to assess sibutramine's ability to maintain longer-term weight loss.
During the weight maintenance phase, subjects on sibutramine showed a more consistent weight change than the placebo group. Patients in the sibutramine group on average maintained their weight for another year, with slight upward incline in weight thereafter. Of the 204 sibutramine-treated individuals who completed the trial, 43% maintained 80% or more of their original 6-month weight loss compared with 16% of the 57 patients in the placebo group. Of those who entered the weight maintenance phase on sibutramine, 69% maintained at least 5% weight loss 18 months later, 46% maintained 10% weight loss, and 27% maintained their full weight loss. Of the patients that maintained their full weight loss, 40 remained on 15 mg sibutramine, eight were on 15 mg, and a further eight were on the maximum dose of 20 mg. There were substantial decreases in concentrations of serum triglycerides, VLDL cholesterol, insulin, C-peptide, and uric acid, but not in concentrations of LDL cholesterol. These changes were maintained for up to 2 years and were proportional to weight loss. HDL cholesterol concentrations increased substantially after month 6 when body weights in general had stabilized.
The overall long-term benefit of sibutramine now needs to be assessed not only in obese patients, but also in those with lipid disorders where the impact of sibutramine on HDL cholesterol would be particularly interesting. It is prudent to monitor the blood pressure of patients receiving sibutramine so any unusual cardiovascular response can be identified.
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