In a randomized, placebo-controlled trial, topiramate was demonstrated to be an effective add-on treatment to lifestyle changes in obese patients with type 2 diabetes.
In a randomized, placebo-controlled trial published in the journal Diabetes, Obesity, and Metabolism, topiramate was demonstrated to be an effective add-on treatment to lifestyle changes in obese patients with type 2 diabetes.
In this study, 229 previously untreated, obese patients with type 2 diabetes were randomized to receive topiramate 96 mg/d (n=74), topiramate 192 mg/d (n=77), or placebo (n=78) in addition to formal dietary counseling. The planned follow-up was 72 weeks, but the sponsor terminated the study after 40 weeks so a new formulation of the drug could be implemented to reduce adverse effects experienced in this trial.
At Week 40, topiramate was associated with significant decreases in HbA1c compared with placebo (topiramate 96 mg/d, –0.6%; topiramate 192 mg/d, –0.7%: and placebo, –0.2%; P<.001 for both comparisons).
"Taken together, the observed improvement in these surrogate markers indicates a significant overall improvement in the cardiovascular risk profile for this population," the authors stated.
The most common adverse events associated with topiramate use were related to the central nervous system, peripheral nervous system, or were psychiatric in nature; 46% of all patients treated with topiramate experienced paresthesia compared with 12% of patients treated with placebo. According to the authors, these adverse events occurred most frequently during titration and resolved during treatment or after patients discontinued use of the drug. They stated that the risk of adverse events should be weighed against the benefits of treatment with topiramate.
Stenlöf K, Rössner, Vercruysse F, Kumar A, Fitchet M, Sjöström L; for the OBDM-003 Study Group. Topiramate in the treatment of obese subjects with drug-naïve type 2 diabetes. Diabetes Obes Metab. 2007; 9:360–368.