Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial ☆
Abstract
The primary objectives of this study were to assess the efficacy and safety of duloxetine for reducing pain severity in fibromyalgia patients with or without current major depressive disorder. This was a 6-month, multicenter, randomized, double-blind, placebo-controlled study. In total, 520 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to duloxetine (20 mg/day, 60 mg/day, or 120 mg/day) or placebo, administered once daily, for 6 months (after 3 months, the duloxetine 20-mg/day group titrated to 60 mg/day). The co-primary outcome measures were the Brief Pain Inventory (BPI) average pain severity score and Patient Global Impressions of Improvement (PGI-I) score. Safety was assessed via treatment-emergent adverse events, and changes in vital sign, laboratory, and ECG measures. Compared with placebo-treated patients, those patients treated with duloxetine 120 mg/day improved significantly more on the co-primary outcome measures at 3 months (change in BPI score [-2.31 vs -1.39, P<0.001] and PGI-I [2.89 vs 3.39, P=0.004]) and at 6 months (change in BPI [-2.26 vs -1.43, P=0.003] and PGI-I [2.93 vs 3.37, P=0.012]). Compared with placebo, treatment with duloxetine 60 mg/day also significantly improved the co-primary measures at 3 months and BPI at 6 months. Duloxetine was efficacious in patients both with and without major depressive disorder. There were no clinically significant differences between treatment groups in changes in vi…
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Which dose of duloxetine is optimal for fibromyalgia remains controversial.
“however, which dose is optimal for fibromyalgia remains controversial.”
From Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis (2023) · cites this paper as [25]
The DLX studies demonstrated that the effects of DLX on pain did not differ between patients with and without major depression.
“The DLX studies demonstrated that the effects of DLX on pain did not differ between patients with and without major depression.”
From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [56]
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- Authors
- Russell, J. I., Mease, P. J., Smith, T. R., Kajdasz, D. K., Wohlreich, M. M., Detke, M. J., Walker, D. J., Chappell, A. S., & Arnold, L. M.
- Affiliations
- The University of Texas at San Antonio Health Science Center (US)
- University of Washington (US)
- Eli Lilly (United States) (US)
- Harvard University (US)
- University of Cincinnati (US)
- Corresponding author
- Chappell, Amy S.
- Venue
- Pain
- Published
- 2008-06
- Volume
- 136
- Issue
- 3
- Pages
- 432-444
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W2128447164
- Cited by
- 367
- References
- 2
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 10 · 2023: 6 · 2022: 7 · 2021: 12 · 2020: 6 · 2019: 8 · 2018: 4 · 2017: 15 · 2016: 8 · 2015: 14 · 2014: 25 · 2013: 29 · 2012: 25
- FWCI
- 44.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- 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
- duloxetine, fibromyalgia, major depressive disorder, pain intensity, antidepressant efficacy, drug safety, dose titration, Brief Pain Inventory
- MeSH terms
- Duloxetine Hydrochloride, Analgesics, Clinical Protocols, Clinical Trials as Topic, Double-Blind Method, Female, Fibromyalgia, Humans, Longitudinal Studies, Male, Middle Aged, Thiophenes, Placebo Effect, Treatment Outcome, Outcome Assessment, Health Care, Adrenergic Uptake Inhibitors
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