A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain

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...

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Bibliographic Details
Published in:Pain practice 2015-01, Vol.15 (1), p.47-57
Main Authors: Freynhagen, Rainer, Serpell, Michael, Emir, Birol, Whalen, Ed, Parsons, Bruce, Clair, Andrew, Latymer, Mark
Format: Article
Language:English
Subjects:
Adolescent
Adult
adverse events
Aged
Aged, 80 and over
Analgesics - adverse effects
Case-Control Studies
Constipation - chemically induced
diabetic
Disorders of Excessive Somnolence - chemically induced
Dizziness - chemically induced
Edema - chemically induced
Female
Humans
Male
Middle Aged
Mood Disorders - chemically induced
neuralgia
Neuralgia - drug therapy
Original
pain
peripheral neuropathic pain
postherpetic neuralgia
Postural Balance
pregabalin
Pregabalin - adverse effects
safety
Sensation Disorders - chemically induced
Vision Disorders - chemically induced
Weight Gain
Young Adult
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Summary: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.
ISSN:1530-7085
1533-2500
DOI:10.1111/papr.12146