Internal Medicine News - Sibutramine effective in binge eating disorder; two randomized trials
DENVER — The use of sibutramine as a treatment for binge eating disorder in obese patients is now supported by two “very lovely” randomized double-blind placebo-controlled trials that have moved the appetite suppressant to the head of the list of pharmacotherapies for this most common of all eating disorders, Dr. Susan L. McElroy said at an international conference of the Academy for Eating Disorders.
One of these trials was presented at the conference by Dr. Jose C. Appolinario of the Federal University of Rio de Janeiro, Brazil. In the study, 60 obese patients who met DSM-IV criteria for binge eating disorder (BED) were randomized to 15 mg/day of sibutramine or placebo for 12 weeks at two medical centers; 23 in the sibutramine group and 25 on placebo completed the study.
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The primary study end point was change in binge frequency as expressed in the number of days per week featuring one or more binge eating episodes. From a baseline of 5 days per week, binge frequency declined by 66% with sibutramine and 41% with placebo.
Full remission of binge episodes was attained in 47% of patients on sibutramine and 27% on placebo, he continued.
The only two adverse effects more common in the sibutramine group were dry mouth and constipation, both classified as mild to moderate.
Patients on sibutramine lost a mean of 7.4 kg; those on placebo gained 1.4 kg.
Scores on both the Beck Depression Inventory and the Binge Eating Scale declined with placebo, but dropped by a significantly greater margin in patients on sibutramine.
The Brazilian study was well received at the conference, which was sponsored by the University of New Mexico. There is as yet no approved medication for treatment of BED, which accounts for up to two-thirds of all eating disorder diagnoses.
Dr. James E. Mitchell called Dr. Appolinario’s trial “quite important.”
“The amount of weight loss was substantial, despite the fact that it was a relatively brief study,” noted Dr. Mitchell, president and scientific director of the Neuropsychiatric Research Institute, in Fargo, N.D.
Dr. McElroy characterized sibutramine’s significant benefits in each of the three major domains of BED–binge eating, obesity, and depression–as “winning the Trifecta.”
How could a single agent classified as an appetite suppressant exert significant effects in three such disparate domains? “The appetite suppressants work on neurotransmitters–and we have some preliminary evidence of neurotransmitter dysfunction in eating disorders,” explained Dr. McElroy, professor of psychiatry and codirector of the psychopharmacology research program at the University of Cincinnati.
She presented highlights of the other randomized double-blind sibutramine trial. The details were provided to her by Denise E. Wilfley; Ph.D., principal investigator in the still-to-be-published study, which Dr. McElroy described as “the largest and longest study to date of any medication in BED.”
The trial involved 304 BED patients who were randomized to 15 mg/day of sibutramine or placebo for 6 months. There were 115 dropouts.
“People with eating disorders are impulsive,” Dr. McElroy observed. “I work with bipolar patients, and bingers are way less impulsive than [bipolar patients], but they are impulsive, and it’s hard for them to stick with something. High dropout rates are inherent to the illness, in my personal opinion.”
The mean number of binge days per week dropped from 3.0 to 0.6 in sibutramine-treated patients, which was significantly better than the decline from 2.8 to 1.1 days with placebo. The sibutramine group also had significant weight loss.
The irony for Dr. McElroy is that although these two trials have convinced her that sibutramine is first-line pharmacotherapy in BED on the basis of its efficacy and tolerability, she can’t prescribe the appetite suppressant except with great difficulty because in Ohio it’s a scheduled drug. “We’ve really got to get sibutramine unscheduled in Ohio,” she said.
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