Zonegran (zonisamide) plus diet, 11 lbs more weight loss after 4 months, 17 lbs more after 8 months

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Monday, June 27, 2005 2:39 am Email this article
Obese adults given the anti-seziure medicine Zonegran (zonisamide) in addition to a diet lost 11 pounds more than women on the diet alone according to a recent study. Subjects: 55 obese women, 5 obese men

The study included 55 obese women and 5 obese men—half were black and half were white—who were randomly assigned to receive Zonegran (zonisamide) or placebo.

Four month weight loss: 13 lbs vs 2 lbs

After four months, those given Zonegran (zonisamide) lost 13 pounds compared to 2 pounds for those given a placebo.

Eight month weight loss: 20 lbs vs 3 lbs

After eight months, those given Zonegran (zonisamide) lost 20.2 pounds compared to 3.3 pounds for those given a placebo.

Comment: All 5 men were in the Zonegran group which could have affected the numbers

Unfortunately, they did not assign half the men to each group.

Instead, by random chance, all 5 men were assigned to the Zonegran (zonisamide) group.

Therefore, since there were no men in the placebo group, the researchers concluded that Zonegran (zonisamide) works in women, but could not say this in men.

Because of this, they also could not compared side effects of Zonegran (zonisamide) in men compared to taking a placebo.

I written to the researchers who performed this study to find out how much weight the men lost, to try and determine if having all the men in the drug group increased the average weight loss in that group, since men tend to weigh more than women and thus also tend to lose more.

Percent of groups that lost at least 5 percent: 57% vs 10%

Roughly six-out-of-ten subjects (57%) given Zonegran (zonisamide) lost at least 5 percent of their body weight compared to one-out-of-ten in the placebo group (10%).

Percent of groups that lost at least 10 percent: 23% vs 0%

Roughly one-fourth of subjects (23%) given Zonegran (zonisamide) lost at least 10 percent of their body weight compared to none of the patients in the placebo group (0%).

Dose: 100 mg per day gradually increased to 400 mg or 600 mg

Zonegran (zonisamide) was started at a dose of 100 mg per day, gradually increasing it to 400 mg per day, and further increasing it to 600 mg per day for patients who had lost less than 5 percent of body weight after three months.

Side Effects: Fatigue

Fatigue was ten times more common in those given Zonegran (zonisamide)—10 patients taking Zonegran (zonisamide) compared to one patient taking the placebo.

No other side effects there significantly more common in the Zonegran (zonisamide) group than the placebo group.

REFERENCE

Gadde K, Franciscy D, Wagner Hn, Krishnan K. Zonisamide for weight loss in obese adults: a randomized controlled trial. JAMA. 2003 Apr 9, 289(14):1820-25.

AUTHOR’S CONTACT INFORMATION

Kishore M. Gadde, MD
Obesity Clinical Trials Program
Department of Psychiatry
Duke University Medical Center
Durham, NC 27710, USA
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