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A randomized, double-blind, placebo-controlled, multicenter trial of pregabalin vs placebo in the treatment of neuropathic pain associated with HIV neuropathy
Presented by David Simpson, United States.
D.M. Simpson1, T.K. Murphy2, E. Durso-De Cruz2, P. Glue2, E. Whalen2
1Mount Sinai Medical Center, New York, United States, 2Pfizer Global Pharmaceuticals, New York, United States
Objective: Pregabalin has shown efficacy in several neuropathic pain syndromes. This trial is the first to evaluate its efficacy, safety, and tolerability as treatment of pain associated with HIV sensory neuropathy.
Methods: This was a randomized, double-blind, placebo-controlled, parallel-group trial. There were 4 phases: 1-2 week screening, 2-week double-blind dose-adjustment (150-600 mg/d BID), 12-week double-blind maintenance, 1-week taper. The primary efficacy measure was endpoint mean pain score (MPS) on 11-point numeric rating scale completed daily by patients; weekly MPS was a supplemental analysis. Secondary measures included Patient Global Impression of Change (PGIC).
Results: 151 patients were randomized to pregabalin, 151 to placebo. Baseline MPS was 6.93 for pregabalin and 6.72 for placebo. Overall average daily dosage (SD) of pregabalin was 385.7 (160.3) mg/d (placebo dosage was 448.9 [163.9]). At endpoint, pregabalin and placebo showed substantial reductions in MPS from baseline: 2.88 (42%) vs -2.72 (40%), P=.3941. At Weeks 1 and 2, pregabalin had significantly greater improvements in MPS relative to placebo (W1, 1.14 vs -0.69, P=.0131; W2, -1.92 vs 1.43, P=.0393). At subsequent timepoints, differences between groups were not significant. In an analysis of PGIC scores, 82.8% of pregabalin and 66.7% of placebo patients rated themselves in one of the 3 “Improved” categories; 13.3% and 25.4% experienced “No Change”; 3.9% and 7.9% rated a “Worsened” category by study end (P=.0077). Somnolence (pregabalin, 23.2%; placebo, 8.6%) and dizziness (pregabalin, 19.2%; placebo, 10.6%) were the most common AEs among pregabalin patients; no other AEs were reported by ³10% of pregabalin patients. Seven patients (4.6%) in the pregabalin group and 2 patients (1.3%) in the placebo group discontinued because of treatment-related AEs.
Conclusions: Pregabalin and placebo were associated with substantial improvements in pain and PGIC, with no significant difference in endpoint MPS. AEs were consistent with the tolerability profile of pregabalin in other neuropathic pain clinical trials.