PMID- 24279736
OWN - NLM
STAT- MEDLINE
DCOM- 20160505
LR  - 20211021
IS  - 1533-2500 (Electronic)
IS  - 1530-7085 (Print)
IS  - 1530-7085 (Linking)
VI  - 15
IP  - 1
DP  - 2015 Jan
TI  - A comprehensive drug safety evaluation of pregabalin in peripheral neuropathic 
      pain.
PG  - 47-57
LID - 10.1111/papr.12146 [doi]
AB  - Pregabalin is a commonly used therapy currently recommended as first-line 
      treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a 
      number of clinical trials of pregabalin in different NeP conditions have been 
      completed from which additional data on safety and tolerability can be drawn. In 
      this analysis, patient-level data from 31 randomized clinical trials of 
      pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for 
      incidence of adverse events (AEs). Incidence by age, disease condition, and race, 
      together with risk differences and time to onset and resolution of AEs, was 
      assessed. In total, 7,510 patients were included: 4,884 on pregabalin 
      (representing 805 patient-years treatment) and 2,626 on placebo. Pregabalin vs. 
      placebo risk analysis identified 9 AEs with a risk difference, for which the 
      lower limit of the 95% confidence interval (CI) was > 1%: dizziness (risk 
      difference [95% CI]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), 
      peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry 
      mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 
      [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 
      to 2.0]). The most common AEs, dizziness and somnolence, typically emerged within 
      the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without 
      resulting in cessation of treatment. The data from this review provide 
      information, indicating which AEs may be expected in patients treated with 
      pregabalin, and suggest that careful dose titration to the highest tolerable dose 
      is the most appropriate approach in clinical practice.
CI  - (c) 2013 Pfizer Inc. Pain Practice published by Wiley Periodicals, Inc. on behalf 
      of World Institute of Pain.
FAU - Freynhagen, Rainer
AU  - Freynhagen R
AD  - Zentrum fur Anasthesiologie, Intensivmedizin, Schmerztherapie & Palliativmedizin, 
      Benedictus Krankenhaus, Tutzing and Klinik fur Anasthesiologie, Technische 
      Universitat Munchen, Munchen, Germany.
FAU - Serpell, Michael
AU  - Serpell M
FAU - Emir, Birol
AU  - Emir B
FAU - Whalen, Ed
AU  - Whalen E
FAU - Parsons, Bruce
AU  - Parsons B
FAU - Clair, Andrew
AU  - Clair A
FAU - Latymer, Mark
AU  - Latymer M
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20131127
PL  - United States
TA  - Pain Pract
JT  - Pain practice : the official journal of World Institute of Pain
JID - 101130835
RN  - 0 (Analgesics)
RN  - 55JG375S6M (Pregabalin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics/*adverse effects
MH  - Case-Control Studies
MH  - Constipation/chemically induced
MH  - Disorders of Excessive Somnolence/chemically induced
MH  - Dizziness/chemically induced
MH  - Edema/chemically induced
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mood Disorders/chemically induced
MH  - Neuralgia/*drug therapy
MH  - Postural Balance
MH  - Pregabalin/*adverse effects
MH  - Sensation Disorders/chemically induced
MH  - Vision Disorders/chemically induced
MH  - Weight Gain
MH  - Young Adult
PMC - PMC4320770
OTO - NOTNLM
OT  - adverse events
OT  - diabetic
OT  - neuralgia
OT  - pain
OT  - peripheral neuropathic pain
OT  - postherpetic neuralgia
OT  - pregabalin
OT  - safety
EDAT- 2013/11/28 06:00
MHDA- 2016/05/06 06:00
CRDT- 2013/11/28 06:00
PHST- 2013/09/17 00:00 [received]
PHST- 2013/10/07 00:00 [accepted]
PHST- 2013/11/28 06:00 [entrez]
PHST- 2013/11/28 06:00 [pubmed]
PHST- 2016/05/06 06:00 [medline]
AID - 10.1111/papr.12146 [doi]
PST - ppublish
SO  - Pain Pract. 2015 Jan;15(1):47-57. doi: 10.1111/papr.12146. Epub 2013 Nov 27.