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Zonisamide Plus Hypocaloric Diet Produces Weight Loss In Obese Adults
Journal of the American Medical Association (JAMA)
04/09/2003
By Elda Hauschildt
A preliminary, randomised trial in the United States demonstrates zonisamide therapy plus a hypocaloric diet produces significantly higher weight loss in obese adults than does dietary intervention alone.
Patients using zonisamide for 16 weeks lost 6% of body weight, compared with a 1% loss in those assigned to the hypocaloric diet alone. "The difference in the weight loss efficacy between active treatment and placebo was evident by four weeks and increased as the study progressed," say researchers from Duke University Medical Centre in Durham, North Carolina.
They explain that weight loss has been seen as an adverse effect in clinical epilepsy trials of zonisamide, an antiepileptic drug with serotonergic and dopaminergic activity that also blocks sodium and calcium channels.
Sixty adults (55 men, 5 women) participated in a 2-phase trial, conducted between March 2001 and March 2002, to evaluate the drug's efficacy for weight loss in obese adults. Mean age was 37 years.
Participants were randomised to either zonisamide or placebo, with 30 patients in each group. All participants followed a balanced, hypocaloric diet. Compliance was monitored through self-rated food diaries.
Seventeen participants (57%) taking zonisamide had lost at least 5% of their body weight at week 16. Similar weight loss was seen in only 3 participants (10%) in the diet- only group.
The researchers note 51 participants completed the first phase and 39 participants were enrolled in the 16-week extension phase. A total of 36 patients completed it. Mean weight loss for the 19 zonisamide participants in the second phase was 9.4%. Mean weight loss for the 17 placebo participants was 1.8%.
Zonisamide was tolerated well, and few adverse effects were seen.
"In addition to weight loss, zonisamide therapy led to improvement of some risk factors associated with obesity," the investigators report. These included decreased waist circumference, reduced systolic blood pressure and significant improvement in quality of life measures such as mobility, general health, occupational functioning and activities of daily living.
JAMA 2003;289:14:1820-1825.
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