Topiramate safely decreases body mass hypertension

Topiramate safely decreases body mass, hypertension. Topiramate reduces body weight and blood pressure with generally mild-to-moderate adverse effects, according to a randomized, placebo-controlled trial involving obese subjects with hypertension.

The study, published in the American Journal of Cardiology, involved 531 individuals with established hypertension and body mass indices between 27 kg/m² and 50 kg/m² . Following a 4-week placebo run-in period, patients were randomly assigned to placebo or 1 of 2 doses of topiramate: 96 mg/d or 192 mg/d. Each subject received a standardized diet, exercise advice, and behavioral modification from run-in through study end.

The placebo and 96- and 192-mg groups had respective weight losses of 1.9% (±3.37%), 5.9% (±5.21%), and 6.5% (±4.85%) from baseline (P<.001 for each comparison with placebo) and decreases in diastolic blood pressure of 2.1 (±6.86%), 5.5 (±8.42%), and 6.3 (±7.70%) mmHg (P<.015 vs placebo). Systolic blood pressure was decreased by 8.6 (±12.26%) and 9.7 (±10.61%) mmHg in the 96- and 192-mg groups, respectively, and 4.9 (±11.32%) mmHg in the placebo group (P=NS).

Adverse events included paresthesia, fatigue, taste perversion, loss of appetite, and difficulty with concentration and attention. Initially scheduled for 60 weeks on medication, the sponsor ended the study early to develop a new controlled-release formulation. As a consequence, efficacy was assessed within a predefined modified intent-to-treat population-subjects who had enrolled early enough to potentially complete 28 weeks on medication.

Tonstad S, Tykarski A, Weissgarten J, et al. Efficacy and safety of topiramate in the treatment of obese subjects with essential hypertension. Am J Cardiol. 2005;96:243–251.