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 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