Efficacy and safety of pregabalin for treating painful diabetic peripheral neuropathy: a meta-analysis

Pregabalin is considered to be an effective treatment for painful diabetic peripheral neuropathy (DPN), but controversy exists about its efficacy and safety. We performed a meta-analysis to systematically assess the efficacy and safety of pregabalin for managing pain associated with DPN.

Medline, EMBASE, and the Cochrane Central Register were searched in July 2014 for randomized, double-blind, placebo-controlled trials published in English on the use of pregabalin to treat DPN-associated pain. Principal outcomes were mean pain score after pregabalin treatment and the proportions of patients showing a pain reduction of at least 50%.

Nine trials involving a total of 2056 participants were identified. Pooled analysis showed that pregabalin was significantly superior to placebo for improving mean pain scores [mean difference (MD) = -0.79, P < 0.001]. Pregabalin reduced pain below baseline by at least 50% in a significantly greater proportion of patients than placebo did [relative risk = 1.54, P < 0.001]. Patients were more likely to self-report their status as 'improved' after taking pregabalin than placebo (relative risk = 1.38, P < 0.001). Pregabalin also improved sleep quality more than placebo (MD = -0.88, P < 0.001). On the other hand, patients receiving pregabalin were more likely to experience mild side effects than were patients receiving placebo.

Our meta-analysis indicates that pregabalin is more effective than placebo for managing DPN-associated pain and other symptoms that reduce quality of life. The drug is also reasonably well tolerated.