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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, fgomezp{at}prodigy.net.mx

Armando Perez-Monteverde

Centro Medico Docente La Trinidad, Caracas, Venezuela

Osvaldo Nascimento

Fluminense Federal University, Rio de Janeiro, Brazil

Pablo Aschner

Colombian Diabetes Association, Bogotá, Colombia

Marino Tagle

Teodoro Maldonado Hospital, Guayaquil, Ecuador

Klaus Fichtner

Latin American CRO Mmatiss, Mexico City, Mexico

Ponni Subbiah

Pfizer Inc., New York, NY, USA

Elizabeth M Mutisya

Pfizer Inc., New York, NY, USA

For The Latin American Diabetic Neuropathy Study Group

Bruce Parsons

Pfizer Inc., New York, NY, USA

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

Key Words: neuropathic pain • gabapentin • dose titration.

The British Journal of Diabetes & Vascular Disease, Vol. 4, No. 3, 173-178 (2004)
DOI: 10.1177/14746514040040030601


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