PMID- 22271298
OWN - NLM
STAT- MEDLINE
DCOM- 20120914
LR  - 20230120
IS  - 1432-1041 (Electronic)
IS  - 0031-6970 (Linking)
VI  - 68
IP  - 6
DP  - 2012 Jun
TI  - The adverse event profile of pregabalin across different disorders: a 
      meta-analysis.
PG  - 903-12
LID - 10.1007/s00228-012-1213-x [doi]
AB  - PURPOSE: In a recent meta-analysis of 38 double-blind randomized controlled 
      trials (RCTs) comparing pregabalin (PGB) to placebo, we found 20 adverse events 
      (AEs) to be significantly associated with PGB treatment. In the present study, we 
      evaluated whether the incidence of these 20 AEs differs across distinct disorders 
      in which PGB was investigated. METHODS: Among the 38 previously identified RCTs 
      of PGB, we selected only those including a PGB 600 mg/day arm and subsequently 
      classified them into four distinct groups according to the disorder in which PGB 
      was investigated: (1) drug-resistant partial epilepsy, (2) psychiatric disorders, 
      (3) fibromyalgia, and (4) neuropathic pain. We used risk differences (RDs) to 
      quantify the placebo-corrected proportion of subjects discontinuing PGB due to 
      intolerable AEs and to determine the placebo-corrected incidence of each of the 
      20 PGB AEs across the four disorders. RESULTS: Twenty-two RCTs were included in 
      this study. Neither the proportion of subjects discontinuing PGB due to 
      intolerable AEs nor the incidence of PGB AEs (with the exception of ataxia) 
      differed significantly across the four disorders. Ataxia was more common in 
      drug-resistant partial epilepsy compared to fibromyalgia. When limiting analyses 
      to subjects on placebo, most vestibulo-cerebellar AEs (ataxia, diplopia, and 
      blurred vision) were found to be more common in drug-resistant partial epilepsy 
      compared to all other disorders. Diplopia and blurred vision were more common in 
      epilepsy than in neuropathic pain; and ataxia had a higher incidence in epilepsy 
      than in anxiety disorder and fibromyalgia. Among other CNS AEs, somnolence was 
      more common in epilepsy compared to neuropathic pain and in anxiety disorders 
      alone compared to neuropathic pain and fibromyalgia. Asthenia was also more 
      common in epilepsy than in neuropathic pain and fibromyalgia. CONCLUSIONS: 
      Although drug-resistant partial epilepsy is associated with a higher probability 
      of developing vestibulo-cerebellar AEs, the risk for PGB toxicity does not differ 
      across distinct disorders.
FAU - Zaccara, Gaetano
AU  - Zaccara G
AD  - U.O. Neurologia, Azienda Sanitaria di Firenze, Florence, Italy. 
      gaetano.zaccara@asf.toscana.it
FAU - Perucca, Piero
AU  - Perucca P
FAU - Gangemi, Pier Franco
AU  - Gangemi PF
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20120121
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
RN  - 0 (Analgesics)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adolescent
MH  - Analgesics/*adverse effects
MH  - Anxiety Disorders/drug therapy
MH  - Double-Blind Method
MH  - Epilepsies, Partial/drug therapy
MH  - Fibromyalgia/drug therapy
MH  - Humans
MH  - Neuralgia/drug therapy
MH  - Pregabalin
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives
EDAT- 2012/01/25 06:00
MHDA- 2012/09/15 06:00
CRDT- 2012/01/25 06:00
PHST- 2011/10/18 00:00 [received]
PHST- 2012/01/04 00:00 [accepted]
PHST- 2012/01/25 06:00 [entrez]
PHST- 2012/01/25 06:00 [pubmed]
PHST- 2012/09/15 06:00 [medline]
AID - 10.1007/s00228-012-1213-x [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2012 Jun;68(6):903-12. doi: 10.1007/s00228-012-1213-x. Epub 
      2012 Jan 21.