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my personal edition > obesity > news
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DGDispatch
Epilepsy Drug Has Weight Loss Effect, But Adverse Events Stop Study: Presented at ECO
By Mark Pownall
HELSINKI, FINLAND -- June 3, 2003 -- The epilepsy drug topiramate has been shown to be an effective weight loss agent for a period of one year to 18 months, but it was associated with side effects that resulted in the study being halted.
Study author Dr. Luc Van Gall, from the University of Antwerp, in Antwerp, Belgium, presented the study's findings here May 30th at the 12th European Congress on Obesity.
Dr. Van Gall and colleagues enrolled 484 patients -- 381 randomised to various doses of topiramate and 103 received placebo treatment.
Patients on two of three higher doses used in the study (192 mg and 256 mg) had a mean weight loss of 12-13 kg when the study was ended. At this time the patients had been taking the drug for between 60 and 76 weeks. By comparison, patients in the placebo arm lost a mean of 2.9 kg. These losses corresponded to a mean decrease of 12% to 13% from baseline for the two highest dose groups.
One unusual trend observed during the study was a consistent decline in weight over the entire study period, said Dr. Van Gall. "Beyond Week 26 to 28, where we usually see a plateau in weight management trials, there continues to be a small gradual fall in weight," he said.
"If further trials also show this [result], topiramate would be the first drug with such a long term weight loss effect," he added.
The proportion of patients who responded to treatment by losing more than 5% of their body weight was high -- 80% to 88% for the two highest topiramate doses. The proportion of patients who lost 10% or more of their body weight was also high -- 59% to 64% for the higher dose patients. Only 27% of placebo patients lost more than 5% of their body weight and only 10% of them lost 5%.
There was a small but significant decrease in blood pressure seen in patients given the higher doses of topiramate, with a mean decrease of 6.8 mm Hg systolic and 3.3 mm Hg diastolic in patients on the 192-mg/day dose of topiramate.
The researchers observed benefits in low-density lipoprotein (LDL) levels, and high-density lipoprotein (HDL), as well as in the LDL-to-HDL ratio with topiramate.
Among benefits seen early in the course of topiramate treatment: two of the 484 patients in the study decreased their body mass index to below 25 by the end of the study, and were no longer judged to be overweight or obese.
However, the study's sponsors, Johnson & Johnson, which manufacturers topiramate, decided to end the study early because of the high incidence of side effect. "I should stress that this decision does not affect any other seizure-control indications for topiramate," Dr. Van Gall said.
During the study, 19% of patients withdrew because of side effects. Mild to moderate paresthesia was the most common. There were 57 reports of paresthesia and 5% of patients withdrew due to this side effect.
Other adverse effects included headache, dizziness, anorexia, depression and problems with concentration and depression.
Dr. Van Gall said the majority of adverse events and discontinuation of the drug occurred early in the course of treatment.
"New trials with a new formulation need to be carried out to look at efficacy in relation to side effects," he said.
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