Gabapentin for the treatment of painful diabetic neuropathy: dosing to achieve optimal clinical response

Abstract

Objective To determine whether gabapentin titrated to achieve clinical effect (≥ 50% reduction in pain; 900—3,600 mg/day) provides superior efficacy to a commonly prescribed fixed-dose (900 mg/day) in subjects with PDN. Methods In Latin America, an open-label trial randomised 339 subjects with PDN to gabapentin, 900 mg/day, for seven weeks (n=170), or to 900—3,600 mg/day titrated over four weeks to achieve clinical effect, followed by three weeks at stable dose (n=169). Results Gabapentin produced a significantly greater reduction in final weekly mean pain scores from baseline when titrated to clinical effect than when administered as a fixed-dose regimen (53.6% vs. 43.3%; p=0.009). Responder rate was significantly increased (64.5% vs. 47.5%; p=0.002), mean VAS scores significantly decreased, final weekly sleep interference scores significantly decreased (57% C vs. 37.2%; p=0.013), and trends favouring improvement in global functioning and QOL were seen in the titration to clinical effect group (p<0.001). Both regimens were well-tolerated. Conclusions Titration to clinical effect offered superior efficacy in treating PDN compared to a low fixed-dose treatment. Br J Diabetes Vasc Dis 2004;4:173—8