PHOENIX — Sibutramine helped people who had lost substantial amounts of weight maintain much of their weight loss for 2 years in a multicenter, double-blind, randomized trial. By 3 years, however, they had regained about as much as a control group on placebo.
In all, 466 participants started the maintenance study after losing an average of 30 kg in nonpharmacologic weight-loss programs. Although everyone had begun to put the pounds back on before entering the trial, they had to have maintained at least half of their peak weight loss for 6 months, said Dr. James W. Anderson, the lead investigator, reported in an analysis at the annual meeting of The Obesity Society.
Indeed, the net weight gain for the two groups was significantly less with sibutramine (Meridia) for the first 2 years—0.6% vs. 3.1% at 6 months, 2.8% vs. 5.6% at 1 year, and 7.1% vs. 9.8% at 24 months. At 3 years, the sibutramine group still had less net weight gain (9.6% vs. 11.7%), but the difference was no longer significant, and both groups appeared to plateau, said Dr. Anderson of the University of Kentucky, Lexington.
Abbott Laboratories became the study sponsor after acquiring sibutramine and decided to curtail follow-up at 36 months, according to Dr. Anderson, who emphasized that he has not received support from Abbott for more than 5 years.
The trial randomized 236 subjects to 15 mg of sibutramine per day and 230 to placebo at 26 sites. Of these, 150 placebo patients and 144 sibutramine patients completed 36 months. Blood pressure and pulse rate were significantly higher with sibutramine. Serious adverse events were more common with placebo (19% vs. 17%), but more people discontinued because of adverse events on sibutramine (15% vs. 7%).