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Long-term Maintenance of Response Across Multiple Fibromyalgia Symptom Domains in a Randomized Withdrawal Study of Pregabalin

Pauer, Lynne MS*; Atkinson, Gary MSc; Murphy, T. Kevin PhD; Petersel, Danielle MD; Zeiher, Bernhardt MD*

doi: 10.1097/AJP.0b013e31823dd315
Original Articles
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Objective: To determine the incidence and duration of response of clinically meaningful improvements with pregabalin across several key symptoms of fibromyalgia (FM).

Methods: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled, randomized, withdrawal study, originally designed to evaluate the efficacy of pregabalin monotherapy for durability of effect on FM pain based on pain and Patient Global Impression of Change (PGIC) criteria. Responder criteria for Fibromyalgia Impact Questionnaire total score (≥16-point change), Medical Outcomes Study Sleep Scale Sleep Disturbance subscale (≥15.8-point change), and the 36-item Short-Form Health Survey Vitality scale (≥10-point change) were used to evaluate the incidence and duration of improvements in function, sleep, and fatigue for pregabalin versus placebo among pain and PGIC responders. A composite responder index consisting of pain, PGIC, function, and sleep endpoints was used to explore multidimensional response.

Results: Approximately 80% of patients meeting pain and PGIC improvement criteria at randomization had clinically meaningful improvement in fatigue, sleep, or function. Higher proportions of patients in the pregabalin group maintained a clinically meaningful response, and pregabalin-treated patients had a significantly longer time to loss of therapeutic response compared with the placebo group. Composite responder Kaplan-Meier analysis, performed with patients demonstrating clinically meaningful improvements in pain, PGIC, function, and sleep at randomization showed a significantly longer median time to loss of therapeutic response for pregabalin-treated patients.

Discussion: The results from this post hoc analysis indicate that pregabalin provides long-term effects across multiple domains of FM (ClinicalTrials.gov registry ID: NCT00151489).

*Pfizer Global Research and Development, New London, CT

Pfizer Global Research and Development, Sandwich, Kent, UK

Pfizer Inc., New York, NY

The original study and this post hoc analysis were funded by Pfizer Inc. (New York, NY). Bernhardt Zeiher, MD was an employee of Pfizer Inc. (Pfizer Global Research and Development, New London, CT) at the time the study and this analysis were conducted and the original manuscript was drafted. Gary Atkinson, MD (Pfizer Global Research and Development, Sandwich, Kent, UK), Lynne Pauer, MS (Pfizer Global Research and Development, New London, CT), T. Kevin Murphy, PhD (Pfizer Inc., New York, NY), and Danielle Petersel, MD (Pfizer Inc., New York, NY) are full-time employees of Pfizer Inc. Editorial support was provided by Dr Max Gough, PhD, at Technical Typesetters Inc., Ashford, Kent, TN24 8HL and Dr Alison Gagnon, PhD, of UBC Scientific Solutions, Southport, CT, and was funded by Pfizer Inc. All authors contributed to the editing and revision of the manuscript; and all authors have reviewed, approved, and take responsibility for the content of the manuscript. The authors declare no conflict of interest.

Reprints: Lynne Pauer, MS, Pfizer Inc., 445 Eastern Point Rd., Groton, CT 06340 (e-mail: lynne.pauer@pfizer.com).

Received June 8, 2011

Accepted October 18, 2011

Copyright © 2012 Wolters Kluwer Health, Inc. All rights reserved.