Back to Journals » Journal of Pain Research » Volume 8

Temporal analysis of pain responders and common adverse events: when do these first appear following treatment with pregabalin

Authors Parsons B, Emir B, Clair A, Fink J

Received 13 February 2015

Accepted for publication 1 May 2015

Published 29 June 2015 Volume 2015:8 Pages 303—309


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Michael E Schatman

Bruce Parsons, Birol Emir, Andrew Clair

Pfizer, New York, NY, USA

Background: Pregabalin is an α2δ ligand indicated in the USA for treatment of a number of chronic pain conditions, including diabetic peripheral neuropathy, postherpetic neuralgia, pain associated with spinal cord injury, and fibromyalgia. A greater understanding of when patients first respond to treatment with pregabalin and when adverse events emerge, or worsen, could aid design of new proof-of-concept studies and help guide treatment of patients.
Methods: This was an analysis of five randomized, placebo-controlled, double-blind trials (between 8 and 16 weeks in duration) of flexible-dose pregabalin (150–600 mg/day). Individual patient data were pooled into three groups by disease condition: diabetic peripheral neuro-pathy or postherpetic neuralgia (n=514), spinal cord injury (n=356), and fibromyalgia (n=498). Responders were classified as having a ≥30% and/or ≥50% reduction in mean pain score from baseline; once a patient responded, they were not scored subsequently (and were excluded from the responder analysis). The emergence of adverse events at each week was also recorded.
Results: The majority of the 30% and 50% responders emerged within the first 3–4 weeks with pregabalin, but were more uniformly distributed across the 6 weeks of the analysis with placebo. The majority of common adverse events also emerged within the first 3–4 weeks of pregabalin treatment.
Conclusion: These data suggest that the majority of pain responders and common adverse events emerge within 3–4 weeks of treatment with pregabalin. These data could advise new proof-of-concept studies and guide clinical management.

Keywords: neuropathic pain, fibromyalgia, clinical trial design

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]