Bupropion SR shows dual benefits in obese, depressed patients: 50-week study

OB/GYN News, August 15, 2003 by Bruce Jancin

SAN FRANCISCO -- Twenty-four percent of 140 obese patients with depression lost 10% or more of their initial body weight during up to 50 weeks on slow-release bupropion, Dr. Paul S. Bradley reported at the annual meeting of the American Psychiatric Association.

Fifty-one percent of patients lost 5% or more of their baseline body weight.

These findings underscore bupropion SR's dual utility as an antidepressant and weight loss agent. That's a highly desirable one-two punch, given that roughly two-thirds of Americans are now overweight or obese, and that 10% of adults experience an episode of major depression in any given year, said Dr. Bradley, who is in group practice in Savannah, Ga.

He reported on 231 obese depressed patients who completed a double-blind 26-week clinical trial involving randomization to either 300-400 mg/day of bupropion SR or placebo. Of those patients, 211 elected to continue on in a 24-week open-label phase. The participants had a baseline score of 10-30 on the Beck Depression Inventory-Second Edition (BDI-II), but they did not meet diagnostic criteria for major depression. Of the 140 patients who completed all 50 weeks of the study, 76 had been on bupropion SR the whole time, while 64 spent 26 weeks on placebo followed by 24 weeks on the antidepressant.

Mean weight loss in the 140 patients who completed the study was 5.9 kg, or 6.3% of their initial body weight. Total cholesterol decreased by a mean 11.4 mg/dL, LDL by 7.8 mg/dL, and hemoglobin [A.sub.1c] by 0.20%, while HDL cholesterol rose by 2.6 mg/dL.

Of note, only 5% of patients achieved a 10% or greater weight loss after 26 weeks on diet-plus-placebo, compared with 32% following the switch from placebo to bupropion.

Depressive symptoms continued to improve over time in response to bupropion. Among patients randomized to the drug in the double-blind phase of the study, 47% showed a significant response after 26 weeks as defined by at least a 50% reduction from baseline in BDI-II scores. By week 50, this figure had climbed to 62%. Forty-two percent of patients showed a significant response to placebo in the double-blind phase, inching up to 45% at week 50 after 24 weeks on bupropion.

A significant correlation was observed between weight loss and antidepressant efficacy. Patients who lost at least 5% of their body weight during the 50-week study were 2.6-fold more likely to experience a 50% or greater reduction in BDI-II scores.

Bupropion SR is approved for treatment of depression and for smoking cessation. Use of the drug for weight control is off label.

The study was funded by Glaxo-SmithKline.