Aims: To conduct a systematic review with meta-analysis to determine the efficacy and safety of topiramate as monotherapy for weight reduction in patients with type 2 diabetes mellitus.
Methods: We searched MEDLINE, Embase, and International Pharmaceutical Abstracts from inception to June 2015. We included randomized controlled trials that evaluated topiramate monotherapy versus control agents or placebo for weight loss in obese type 2 diabetes patients.
Results: Of the 284 studies identified, 5 studies fulfilled the inclusion criteria. Topiramate decreased weight by a mean difference of 3.4kg (95% CI, -3.79 to -3.04) compared to placebo. Mean HbA1c reduction of -0.4% (95% CI, -0.58 to -0.32) and mean BMI reduction of -1.43kg/m(2) (95% CI, -1.83 to -1.03) were both significantly observed with topiramate (p<0.00001). Serious and total adverse events occurred more commonly among topiramate users, with a risk ratio for serious adverse events of 1.69 (95% CI, 1.00-2.87). All but one study had high risk of bias.
Conclusions: Topiramate monotherapy reduced weight in obese type 2 diabetes patients, but increased adverse events including serious adverse events. Given these safety concerns and the absence of data on clinically meaningful efficacy endpoints, clinicians should generally avoid use of topiramate alone for this indication.
Keywords: Obesity; Topiramate; Type 2 diabetes mellitus; Weight loss.
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