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Cited by 277Fibromyalgia and Chronic Fatigue Syndrome ResearchPain Mechanisms and TreatmentsMusculoskeletal pain and rehabilitation

The DOI matches its Crossref record; 35 of the 38 references it cites were found in a registry or an index.

A 14-week, Randomized, Double-Blinded, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia

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Arnold, Lesley M., Russell, I. Jon, Diri, E.W., Duan, W. Rachel, Young, James P., Sharma, Uma, Martin, Susan A., Barrett, Jeannette A., Haig, George·2008·The Journal of Pain
DOI 10.1016/j.jpain.2008.03.013
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Abstract

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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Metadata

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.
ORCID
Venue
The Journal of Pain
Publisher
Elsevier BV
Published
2008-09
Volume
9
Issue
9
Pages
792-805
ISSN
1526-5900 (ISSN-L)
DOI
10.1016/j.jpain.2008.03.013
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
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 (medical) › Pain Mechanisms and Treatments
  • Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › 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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