Cited by 54Fibromyalgia and Chronic Fatigue Syndrome ResearchPain Mechanisms and TreatmentsMusculoskeletal pain and rehabilitation

Long-Term Safety, Tolerability, and Efficacy of Duloxetine in the Treatment of Fibromyalgia

Mease, Philip J., Russell, I. Jon, Kajdasz, Daniel K., Wiltse, Curtis G., Detke, Michael J., Wohlreich, Madelaine M., Walker, Daniel J., Chappell, Amy S.·2010·Seminars in Arthritis and Rheumatism

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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Crossref · 10.1016/j.semarthrit.2008.11.001

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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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