Abstract | OBJECTIVE: DESIGN: This was a pooled exploratory analysis of three randomized placebo-controlled clinical trials of pregabalin in FM patients to assess the impact of comorbid OA on the response to pregabalin. METHODS: Patients were divided into those with and without comorbid OA. Difference in change in least squares (LS) mean pain score at endpoint (assessed by 0-10 numeric rating scale, controlled for baseline pain score) with pregabalin (300 mg/day and 450 mg/day) vs placebo was assessed. Changes in Patient Global Impression of Change (PGIC) responders and Fibromyalgia Impact Questionnaire (FIQ) total score were also assessed. RESULTS: There were 1665 patients in the analysis set (558, placebo; 552, pregabalin 300 mg/day; 555, pregabalin 450 mg/day), including 296 with comorbid OA. Pregabalin 450 mg/day significantly improved the LS mean (95% confidence interval) difference in pain score vs placebo in patients with (0.99 [0.44, 1.55], P < 0.001), and without (0.64 [0.39, 0.89], P < 0.001) OA. Improvements with pregabalin 300 mg/day with (0.31 [-0.25, 0.86], P = 0.276) and without (0.51 [0.25, 0.76], P < 0.001) OA were not consistently significant. Improvements in PGIC and FIQ total score were observed in patients with and without comorbid OA. CONCLUSIONS: FM patients with or without comorbid OA respond to treatment with pregabalin 450mg/day with significant improvements in pain intensity scores. These data could provide guidance to healthcare professionals treating these patients.
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Authors | Charles E Argoff, Birol Emir, Ed Whalen, Marie Ortiz, Lynne Pauer, Andrew Clair |
Journal | Pain medicine (Malden, Mass.)
(Pain Med)
Vol. 17
Issue 11
Pg. 2100-2108
(11 2016)
ISSN: 1526-4637 [Electronic] England |
PMID | 27257288
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: [email protected]. |
Chemical References |
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Topics |
- Adolescent
- Adult
- Aged
- Analgesics
(pharmacology, therapeutic use)
- Comorbidity
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Fibromyalgia
(diagnosis, drug therapy, epidemiology)
- Humans
- Male
- Middle Aged
- Osteoarthritis
(diagnosis, drug therapy, epidemiology)
- Pain
(diagnosis, drug therapy, epidemiology)
- Pain Measurement
(drug effects, methods)
- Pregabalin
(pharmacology, therapeutic use)
- Treatment Outcome
- Young Adult
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