Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients with Post Herpetic Neuralgia

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SCIENCE
Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients with Post Herpetic Neuralgia
Key Take-Away: 

The effectiveness of controlled-release Pregabalin in post herpetic neuralgia has not been explored in the previous studies. The investigators of the present comparative analysis study were successful in assessing the efficacy and safety profile of controlled and immediate release formulation of pregabalin in nerve pain management.

To assess efficacy and safety of once-daily controlled-release (CR) formulation of pregabalin in patients with postherpetic neuralgia.

ABSTRACT: 
Background: 

To assess efficacy and safety of once-daily controlled-release (CR) formulation of pregabalin in patients with postherpetic neuralgia.

Methods: 

An enriched enrollment, randomized withdrawal trial, with 6-week single-blind pregabalin treatment phase and 13-week double-blind phase, where patients with ≥50% decrease in mean pain score at single-blind endpoint from baseline were randomized (1:1) to pregabalin CR (82.5 to 660 mg/d) or placebo.

Primary efficacy outcome was time to loss of therapeutic response (LTR) (<30% decrease in weekly mean pain score from single-blind baseline or discontinuation due to an adverse event or lack of efficacy). Secondary efficacy outcomes included a change in weekly mean pain score (1-wk recall period) at the double-blind endpoint.

Results: 

In total, 801 patients were randomized and treated in the single-blind phase, and 413 in the double-blind phase (208, pregabalin CR; 205, placebo).

Pregabalin CR significantly increased the time to LTR versus placebo (Kaplan-Meier analysis) with significantly fewer LTR events with pregabalin CR than with placebo (29 [13.9%] vs. 63 [30.7%]; P<0.0001). Median time to LTR was not estimable. Pregabalin CR significantly improved weekly mean pain score versus placebo: LS mean difference (95% CI) of −1.11 (−1.47, −0.75) and −1.00 (−1.34, −0.65) (P<0.0001) from single-blind baseline and double-blind baseline, respectively. Most commonly reported adverse events in the single-blind phase were dizziness, somnolence, and peripheral edema. Pregabalin CR was well tolerated.

Conclusion: 

Time to loss of therapeutic response (LTR) was significantly longer with pregabalin CR than with placebo.

The safety profile of pregabalin CR was comparable to that reported for the immediate-release formulation in patients with postherpetic neuralgia

The Clinical Journal of Pain
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