title: 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.
abstract: To assess efficacy and safety of once-daily controlled-release (CR) formulation of pregabalin in patients with postherpetic neuralgia.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: *Meridien Research, Tampa †JEM Research Institute, Atlantis, FL ‡Michigan Headache and Neurological Institute, Ann Arbor, MI §Pfizer, New York, NY ∥Pfizer, Groton, CT.
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Huffman
authors.forename: James N
authors.initials: JN
authors.lastname: Goldenberg
authors.forename: James
authors.initials: J
authors.lastname: Weintraub
authors.forename: Luis
authors.initials: L
authors.lastname: Sanin
authors.forename: Joseph
authors.initials: J
authors.lastname: Driscoll
authors.forename: Ruoyong
authors.initials: R
authors.lastname: Yang
authors.forename: Marci L
authors.initials: ML
authors.lastname: Chew
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Scavone
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D051474:Neuralgia, Postherpetic / Q000188:drug therapy*; D010147:Pain Measurement; D010349:Patient Compliance; D000069583:Pregabalin / Q000008:administration & dosage*; D011569:Psychiatric Status Rating Scales; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D000069583:Pregabalin