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

Abstract

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 neuropathy 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.

• Authors: Bruce Parsons, Birol Emir, Andrew Clair
• Journal: Journal of pain research (J Pain Res) Vol. 8 Pg. 303-9 ( 2015) ISSN: 1178-7090 [Print] New Zealand
• PMID: 26170712 (Publication Type: Journal Article)