Objective
This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuropathic pain associated with postherpetic neuralgia (PHN).
Research design and methods
The 13week, double blind, placebo-controlled study randomized 370 patients with PHN to pregabalin (150, 300, or 600 mg/day BID) or placebo.
Main outcome measures
Primary efficacy measure was endpoint mean pain score from daily pain diaries. Secondary efficacy measures included endpoint mean sleep-interference score from daily sleep diaries and Patient Global Impression of Change (PGIC). Safety evaluations included adverse events (AEs), physical and neurologic examinations, 12lead ECG, vital signs, and laboratory testing.
Results
Pregabalin provided significant, dose proportional pain relief at endpoint: difference from placebo in mean pain score, 150 mg/day, –0.88, p = 0.0077; 300 mg/day, –1.07, p = 0.0016; 600 mg/day, –1.79, p = 0.0003. Weekly mean pain scores significantly improved as early as week 1. Sleep interference in all pregabalin groups was also significantly improved at endpoint, compared with placebo ( p < 0.001), beginning at week 1 ( p < 0.01). At study termination, patients in the 150 (p = 0.02) and 600 mg/day (p = 0.003) groups were more likely to report global improvement than were those in the placebo group. Most AEs were mild or moderate. Among pregabalin treated patients, 13.5% withdrew due to AEs, most commonly for dizziness (16 patients, 5.8%), somnolence (8, 2.9%), or ataxia (7, 2.5%).
Conclusions
Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated. It also reduced the extent to which pain interfered with sleep. Pregabalin’s effects were seen as early as week 1 and were sustained throughout the 13week study.
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