PMID- 18090504
OWN - NLM
STAT- MEDLINE
DCOM- 20080214
LR  - 20151119
IS  - 0268-1315 (Print)
IS  - 0268-1315 (Linking)
VI  - 23
IP  - 1
DP  - 2008 Jan
TI  - Long-term efficacy of pregabalin in generalized anxiety disorder.
PG  - 18-28
AB  - A multicenter, randomized, placebo-controlled, double-blind study was conducted 
      to evaluate the efficacy of pregabalin in preventing relapse of generalized 
      anxiety disorder (GAD) after response to short-term treatment. Outpatients 
      (n=624) with GAD for > or =1 year received open-label pregabalin (450 mg/day) for 
      8 weeks and, if a clinical response was observed, were randomized to receive 
      either pregabalin (450 mg/day; n=168) or placebo (n=170) for 24 weeks. The 
      primary efficacy parameter was time to relapse. Among responders to open-label 
      acute treatment with pregabalin, time to relapse of GAD was significantly longer 
      for patients treated with pregabalin compared with placebo (P<0.0001). Fifty per 
      cent of the placebo group had relapsed by day 23, and at study endpoint, 65% had 
      relapsed. In the pregabalin group, only 42% had relapsed by study end. Total 
      attrition during double-blind treatment was somewhat higher on pregabalin 
      compared with placebo (21.4 vs. 15.3%); attrition owing to adverse events (AEs) 
      was also somewhat higher on pregabalin (6.0 vs. 2.4%). AEs were relatively low in 
      the double-blind phase; only three AEs occurred with an incidence of more than 5% 
      on pregabalin and placebo, respectively: infection (14.9 vs. 11.2%), headache 
      (10.1 vs. 11.2%), and somnolence (6.0 vs. 0%). No safety concerns were identified 
      with long-term treatment. The study indicates that pregabalin is an effective 
      treatment for the prevention of relapse in patients with GAD.
FAU - Feltner, Douglas
AU  - Feltner D
AD  - Pfizer Global Research and Development, Ann Arbor, Missouri, USA. 
      Douglas.feltner@pfizer.com
FAU - Wittchen, Hans-Ulrich
AU  - Wittchen HU
FAU - Kavoussi, Richard
AU  - Kavoussi R
FAU - Brock, Jerri
AU  - Brock J
FAU - Baldinetti, Francesca
AU  - Baldinetti F
FAU - Pande, Atul C
AU  - Pande AC
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Int Clin Psychopharmacol
JT  - International clinical psychopharmacology
JID - 8609061
RN  - 0 (Anti-Anxiety Agents)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Anxiety Agents/adverse effects/*therapeutic use
MH  - Anxiety Disorders/*drug therapy/psychology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pregabalin
MH  - Psychiatric Status Rating Scales
MH  - Sample Size
MH  - Secondary Prevention
MH  - gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives/therapeutic use
EDAT- 2007/12/20 09:00
MHDA- 2008/02/15 09:00
CRDT- 2007/12/20 09:00
PHST- 2007/12/20 09:00 [pubmed]
PHST- 2008/02/15 09:00 [medline]
PHST- 2007/12/20 09:00 [entrez]
AID - 00004850-200801000-00003 [pii]
AID - 10.1097/YIC.0b013e3282f0f0d7 [doi]
PST - ppublish
SO  - Int Clin Psychopharmacol. 2008 Jan;23(1):18-28. doi: 
      10.1097/YIC.0b013e3282f0f0d7.