Topiramate’s Side Effects
Stops Weight Loss Study
Patients had a mean weight loss of 26 pounds when
the study was ended.
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 randomized 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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