A 14-week, Randomized, Double-Blinded, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia
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Unlabelled The purpose of the study was to assess the efficacy and safety of pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in pregabalin-treated patients were significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d, -0.98; 600 mg/d, -1.00). Compared with placebo, significantly more pregabalin-treated patients reported improvement on PGIC (P < .01 for all 3 pregabalin doses) and significant improvements in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d (P = .003) doses. Compared with placebo, all 3 doses of pregabalin were associated with significant improvement in sleep. The most commonly reported pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related.Perspective This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that pregabalin is an important treatment option for patients with fibromyalgia.
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As reported previously, all three doses of pregabalin were associated with statistically significantly greater improvements in sleep quality relative to placebo in both study 1056 and study 1077.
“As reported previously, all three doses of pregabalin were associated with statistically significantly greater improvements in sleep quality relative to placebo in both the 1056 [12] and 1077 [13] studies.”
From Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia (2009) · cites this paper as [13]
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- Authors
- Arnold, L. M., Russell, I. J., Diri, E. W., Duan, W. R., Young, J. P., Sharma, U., Martin, S. A., Barrett, J. A., & Haig, G.
- Affiliations
- University of Cincinnati (US)
- The University of Texas at San Antonio Health Science Center (US)
- Trinity Health (US)
- Pfizer (United States) (US)
- Corresponding author
- Arnold, Lesley M.
- Venue
- The Journal of Pain
- Publisher
- Elsevier BV
- Published
- 2008-09
- Volume
- 9
- Issue
- 9
- Pages
- 792-805
- ISSN
- 1526-5900 (ISSN-L)
- OpenAlex
- W2148029309
- Cited by
- 277
- References
- 38
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 2 · 2023: 4 · 2022: 8 · 2021: 8 · 2020: 7 · 2019: 6 · 2018: 6 · 2017: 16 · 2016: 16 · 2015: 14 · 2014: 20 · 2013: 22 · 2012: 27
- FWCI
- 25.50
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- pregabalin, fibromyalgia, monotherapy, pain intensity, sleep quality, Fibromyalgia Impact Questionnaire, Patient Global Impression of Change, adverse events, dizziness, sleepiness, dose comparison
- MeSH terms
- Pregabalin, Adult, Analgesics, Analysis of Variance, Dizziness, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Fibromyalgia, gamma-Aminobutyric Acid, Humans, Male, Middle Aged, Pain Measurement, Placebos, Severity of Illness Index, Single-Blind Method, Treatment Outcome
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