Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients With Postherpetic Neuralgia: A Double-Blind, Enriched Enrollment Randomized Withdrawal, Placebo-Controlled Trial. Issue 7 (July 2017)

• Record Type: Journal Article
• Authors: Huffman, Cynthia L.; Goldenberg, James N.; Weintraub, James; Sanin, Luis; Driscoll, Joseph; Yang, Ruoyong; Chew, Marci L.; Scavone, Joseph M.
• Is Part Of: Clinical journal of pain. Volume 33:Issue 7(2017)
• Publication Date: 2017-07
• Subjects: postherpetic neuralgia -- pregabalin controlled-release -- pain -- enriched enrollment randomized withdrawal; Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesia -- Periodicals; 616.047205
• DOI: 10.1097/AJP.0000000000000445
• Languages: English
• ISSNs: 0749-8047

Abstract

Abstract : Objectives: 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 end point 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 adverse event or lack of efficacy). Secondary efficacy outcomes included change in weekly mean pain score (1-wk recall period) at double-blind end point. 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 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. Discussion: Time to LTR was significantly longer with pregabalin CR than with placebo. Safety profile of pregabalin CR was comparable to that reported for the immediate-release formulation in patients with postherpetic neuralgia.