PMID- 16466610
OWN - NLM
STAT- MEDLINE
DCOM- 20060417
LR  - 20220408
IS  - 0300-7995 (Print)
IS  - 0300-7995 (Linking)
VI  - 22
IP  - 2
DP  - 2006 Feb
TI  - Efficacy and tolerability of twice-daily pregabalin for treating pain and related 
      sleep interference in postherpetic neuralgia: a 13-week, randomized trial.
PG  - 375-84
AB  - OBJECTIVE: This trial evaluated the efficacy and safety of pregabalin dosed twice 
      daily (BID) for relief of neuro-pathic pain associated with postherpetic 
      neuralgia (PHN). RESEARCH DESIGN AND METHODS: The 13-week, 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, 12-lead 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 13-week study.
FAU - van Seventer, Robert
AU  - van Seventer R
AD  - Amphia Ziekenhuis, Department of Anaesthesiology, The Netherlands. 
      7ster@planet.nl
FAU - Feister, Hilary A
AU  - Feister HA
FAU - Young, James P Jr
AU  - Young JP Jr
FAU - Stoker, Malcolm
AU  - Stoker M
FAU - Versavel, Mark
AU  - Versavel M
FAU - Rigaudy, Laurence
AU  - Rigaudy L
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Placebos)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/*drug therapy
MH  - Placebos
MH  - Pregabalin
MH  - Sleep Wake Disorders/*drug therapy/etiology
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
EDAT- 2006/02/10 09:00
MHDA- 2006/04/18 09:00
CRDT- 2006/02/10 09:00
PHST- 2006/02/10 09:00 [pubmed]
PHST- 2006/04/18 09:00 [medline]
PHST- 2006/02/10 09:00 [entrez]
AID - 10.1185/030079906x80404 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2006 Feb;22(2):375-84. doi: 10.1185/030079906x80404.