Long-Term Safety, Tolerability, and Efficacy of Duloxetine in the Treatment of Fibromyalgia
Abstract
Objectives To assess the long-term safety, tolerability, and efficacy of duloxetine in patients with fibromyalgia. Methods We report results from the 6-month extension phases of 2 randomized, double-blind, placebo-controlled clinical trials having 6-month placebo-controlled phases. In Study 1, all patients received duloxetine 120 mg/d after 28 weeks on placebo or duloxetine 60 or 120 mg/d. In Study 2, patients taking placebo were titrated to duloxetine 60 mg/d after 27 weeks on treatment, while duloxetine-treated patients remained on their dosages of 60 or 120 mg/d. Safety and tolerability were assessed via discontinuation rates, treatment-emergent adverse events (TEAEs), and changes in vital signs and laboratory measures. The primary efficacy measure was the Brief Pain Inventory average pain severity score. Results The percentage of patients entering and completing the extension phase was 56% (156/278) for Study 1 and 69% (140/204) for Study 2. Groups titrating from placebo to duloxetine showed the highest discontinuation rates due to an adverse event (Study 1, 25%; Study 2, 19%) and TEAE rates (Study 1, 82%; Study 2, 77%). The most common TEAEs were nausea and dry mouth. No significant within-group changes in blood pressure occurred in any group. Significant within-group mean increases in pulse (bpm) were observed in the placebo/duloxetine 120 mg group in Study 1 (3.7 [SD = 11.2], P Conclusions These findings support a positive risk/benefit profile for duloxetine in the lon…
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In the 1-year study, 1.1% of patients on DLX had suicide-related behavior.
“In the 1-year study, 1.1% of the patients on DLX had suicide-related behavior.”
From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [46]
The placebo/DLX subgroups showed a significant within-group improvement in only 1 study (NCT00233025).
“The placebo/DLX subgroups showed a significant within-group improvement in only 1 study (NCT00233025).”
From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [46]
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- Authors
- Mease, P. J., Russell, I. J., Kajdasz, D. K., Wiltse, C. G., Detke, M. J., Wohlreich, M. M., Walker, D. J., & Chappell, A. S.
- Affiliations
- University of Washington (US)
- The University of Texas at San Antonio Health Science Center (US)
- Harvard University (US)
- Eli Lilly (United States) (US)
- Corresponding author
- Chappell, Amy S.
- Venue
- Seminars in Arthritis and Rheumatism
- Publisher
- Elsevier BV
- Published
- 2010-06
- Volume
- 39
- Issue
- 6
- Pages
- 454-464
- ISSN
- 0049-0172 (ISSN-L)
- OpenAlex
- W2113214053
- Cited by
- 54
- References
- 58
- Citations by year
- 2022: 1 · 2021: 1 · 2020: 1 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 1 · 2014: 5 · 2013: 12 · 2012: 4
- FWCI
- 5.36
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Seminars in Arthritis and Rheumatism (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, long-term safety, tolerability, efficacy, treatment-emergent adverse events, discontinuation rate, pain intensity, pulse rate, blood pressure, dose titration, antidepressant treatment
- MeSH terms
- Duloxetine Hydrochloride, Antidepressive Agents, Depression, Disability Evaluation, Double-Blind Method, Female, Fibromyalgia, Health Status, Humans, Male, Middle Aged, Pain, Pain Measurement, Thiophenes, Treatment Outcome
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