An evidence-based review of pregabalin for the treatment of fibromyalgia

Arnold, Lesley M., Choy, Ernest ORCID: https://orcid.org/0000-0003-4459-8609, Clauw, Daniel J., Oka, Hiroshi, Whalen, Ed, Semel, David, Pauer, Lynne and Knapp, Lloyd 2018. An evidence-based review of pregabalin for the treatment of fibromyalgia. Current Medical Research and Opinion 34 (8) , pp. 1397-1409. 10.1080/03007995.2018.1450743

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Abstract

Objectives: Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies, and post-hoc analyses of clinical study data. Methods: PubMed was searched using the term ‘pregabalin AND fibromyalgia’ and the Cochrane Library with the term ‘pregabalin’. Both searches were conducted on 2 March 2017 with no other date limits set. Results: Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, 2-way crossover, and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality, and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1–2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Conclusions: Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine
Publisher:	Taylor & Francis: STM, Behavioural Science and Public Health Titles
ISSN:	0300-7995
Date of First Compliant Deposit:	23 April 2018
Date of Acceptance:	9 March 2018
Last Modified:	25 Nov 2024 05:15
URI:	https://orca.cardiff.ac.uk/id/eprint/110869

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