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Obes Res. 2004 Oct;12(10):1658-69.

Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects.

Author information

  • 1The Department of Human Nutrition and LMC, The Royal Veterinary and Agricultural University, 30 Rolighedsvej, 1958 Frederiksberg C, Copenhagen, Denmark. ast@kvl.dk

Abstract

OBJECTIVE:

To examine the safety and efficacy of topiramate (TPM) for maintaining weight following a low-calorie diet.

RESEARCH METHODS AND PROCEDURES:

Obese subjects (30 < or = BMI < 50 kg/m(2)) 18 to 75 years old received a low-calorie diet for 8 weeks. Those who lost > or =8% of their initial weight received TPM (96 or 192 mg/d) or placebo; all were on a lifestyle modification plan. Sixty weeks of medication were planned. Sponsor ended study early to develop a new controlled-release formulation with the potential to enhance tolerability and simplify dosing in this patient population. Efficacy was analyzed in subjects who completed 44 weeks of treatment before study termination.

RESULTS:

Of the 701 subjects enrolled, 80% lost > or =8% of their initial body weight and were randomized; 293 were analyzed for efficacy. Most withdrawals were due to premature termination of the study. Subjects receiving TPM lost 15.4% (96 mg/d) and 16.5% (192 mg/d) of their enrollment weight by week 44, compared with 8.9% in the placebo group (p < 0.001). Subjects on TPM continued to lose weight after the run-in, whereas those on placebo regained weight. Significantly more TPM subjects lost 5%, 10%, or 15% of their randomization weight than placebo. Most adverse events were related to the central nervous system.

DISCUSSION:

During a treatment period of 44 weeks, TPM was generally well tolerated, and subjects maintained weight loss initially achieved by a low-calorie diet-and produced additional clinically significant weight loss beyond that achieved by a low-calorie diet.

PMID:
15536230
[PubMed - indexed for MEDLINE]
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