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

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, two-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.

Keywords:

• Pregabalin
• fibromyalgia
• pain
• sleep

Transparency

Declaration of funding

This manuscript was not funded.

Author contributions: All authors were involved in the conception of this article; in the drafting of the article and for critically revising it for intellectual content; approved the final version to be published; and agree to be accountable for all aspects of the work.

Declaration of financial/other relationships

L.M.A. has disclosed that she has performed consulting services for Pfizer Inc., Daiichi Sankyo, Prismic, Zynerba Pharmaceuticals Inc., Eli Lilly & Company, CinRx and Astellas; participated on speaker bureau for Pfizer Inc.; and received research support from Eli Lilly & Company, Cefaly, Daiichi Sankyo, Allergan, Tonix and Pfizer Inc. E.C. has disclosed that he has served as a member of advisory boards and on speaker bureau for Pfizer. D.J.C. has disclosed that he has performed consulting services for Pfizer Inc., Eli Lilly & Company, Pierre Fabre Laboratories, Aptinyx Inc., Cerephex Corporation, IMC Pharma, Zynerba Pharmaceuticals Inc. and Samumed LLC; and received research support from Pfizer Inc., Forest Laboratories and Cerephex Corporation. E.W., D.S., L.P. and L.K. have disclosed that they are employees of Pfizer, and have stocks or stock options in Pfizer. H.O. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

We thank Andrew Clair of Pfizer for initial discussions on potential topics for review. Medical writing support was provided by David Cope PhD of Engage Scientific Solutions, and funded by Pfizer.