D A Simpson1. 1. From the Michigan Institute for Neurological Disorders, Farmington Hills, Michigan.
Abstract
OBJECTIVE: To evaluate the safety and efficacy of gabapentin and venlafaxine in the treatment of painful diabetic neuropathy in patients whose pain did not improve with gabapentin monotherapy. METHODS: (1) A randomized, double-blind, placebo-controlled, 8-week clinical trial comparing gabapentin versus placebo to define a patient population whose pain did not improve with monotherapy; (2) a second 8-week trial comparing gabapentin plus venlafaxine with gabapentin plus placebo; (3) a third uncontrolled 8-week trial of patients who did not improve on gabapentin monotherapy and then receivedvenlafaxine in addition to gabapentin. RESULTS: (1) Gabapentin-treated patients showed statistically significant improvement in pain reduction as well as improvement in quality of life and mood disturbance when compared with placebo-treated patients; (2) patients who received gabapentin plus venlafaxine showed significant improvement in pain reduction, mood disturbance, and quality of life when compared with patients treated with gabapentin plus placebo; (3) patients who received gabapentin plus venlafaxine showed significant improvement in pain reduction, mood disturbance, and quality of life. CONCLUSIONS: (1) Gabapentin is efficacious in the treatment of painful diabetic neuropathy; (2) and (3) in patients who do not respond to gabapentin monotherapy, the addition of venlafaxine is also efficacious.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of gabapentin and venlafaxine in the treatment of painful diabetic neuropathy in patients whose pain did not improve with gabapentin monotherapy. METHODS: (1) A randomized, double-blind, placebo-controlled, 8-week clinical trial comparing gabapentin versus placebo to define a patient population whose pain did not improve with monotherapy; (2) a second 8-week trial comparing gabapentin plus venlafaxine with gabapentin plus placebo; (3) a third uncontrolled 8-week trial of patients who did not improve on gabapentin monotherapy and then received venlafaxine in addition to gabapentin. RESULTS: (1) Gabapentin-treated patients showed statistically significant improvement in pain reduction as well as improvement in quality of life and mood disturbance when compared with placebo-treated patients; (2) patients who received gabapentin plus venlafaxine showed significant improvement in pain reduction, mood disturbance, and quality of life when compared with patients treated with gabapentin plus placebo; (3) patients who received gabapentin plus venlafaxine showed significant improvement in pain reduction, mood disturbance, and quality of life. CONCLUSIONS: (1) Gabapentin is efficacious in the treatment of painful diabetic neuropathy; (2) and (3) in patients who do not respond to gabapentin monotherapy, the addition of venlafaxine is also efficacious.
Authors: V Bril; J England; G M Franklin; M Backonja; J Cohen; D Del Toro; E Feldman; D J Iverson; B Perkins; J W Russell; D Zochodne Journal: Neurology Date: 2011-04-11 Impact factor: 9.910