Topiramate Weight Loss Anti-Obesity Drug
A 6-Month Randomized, Placebo-Controlled,
Dose-Ranging Trial of Topiramate for Weight Loss in Obesity
The aim was to evaluate the efficacy and
safety of topiramate (TPM) for weight loss in healthy obese subjects.
Topiramate Weight Loss Drug Study
A randomized, double-blind, placebo-controlled, dose-ranging trial was
conducted. Three hundred eighty-five subjects, 18 and 75 years of age,
were randomized to receive either placebo or TPM at 64, 96, 192, or 384
mg daily. Dosing began at 16 mg once daily. In week 2, the dose was increased
to 16 mg twice daily. Thereafter, the dose was raised every week by 32
mg/d (16 mg twice daily) until subjects reached their target dose. Twenty-four
weeks after beginning treatment, all subjects were tapered off treatment
by a dose reduction of 50 percent per week. All participants received
the same lifestyle program.
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Topiramate Weight Loss Drug Results
Mean percent weight loss from baseline to week 24 was -2.6 percent
in placebo-treated patients vs. -5.0 percent, -4.8 percent, -6.3
percent, and -6.3 percent in the 64, 96, 192, and 384 mg/d TPM groups,
respectively. Greater percentages of TPM-treated patients lost at
least 5 percent or 10 percent of body weight compared with placebo.
The most frequent adverse events were related to the central or
peripheral nervous system, including paresthesia, somnolence, and
difficulty with memory, concentration, and attention. Most events
were dose-related,
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occurred early in treatment, and usually
resolved spontaneously; only 21 percent receiving TPM withdrew due to adverse
events compared with 11 percent on placebo.
Topiramate TPM produced significantly greater
weight loss than placebo at all doses.
Source: Pennington Biomedical Research
Center, Baton Rouge, Louisiana 2003.
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