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Cited by 47Fibromyalgia and Chronic Fatigue Syndrome ResearchPharmacovigilance and Adverse Drug ReactionsPain Mechanisms and Treatments

Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: pooled analysis of data from five clinical trials

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Choy, Ernest H. S., Mease, Philip J., Kajdasz, Daniel K., Wohlreich, Madelaine M., Crits-Christoph, Paul, Walker, Daniel J., Chappell, Amy S.·2009·Clinical Rheumatology
DOI 10.1007/s10067-009-1203-2PMC PMC2721139
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Abstract

The purpose of this report is to describe the overall safety profile of both short- and longer-term duloxetine treatment of fibromyalgia. Data from four double-blind, randomized, placebo-controlled studies (two with 6-month open-label extension phases) and a 1-year, open-label safety study were included. Safety measures included treatment-emergent adverse events (TEAEs), adverse events leading to discontinuation, serious adverse events (SAEs), clinical laboratory tests, vital signs, and electrocardiograms. The most common TEAEs for short-term treatment with duloxetine were nausea (29.3%), headache (20.0%), dry mouth (18.2%), insomnia (14.5%), fatigue (13.5%), constipation (14.5%), diarrhea (11.6%), and dizziness (11.0%; all p < 0.05 vs. placebo). Most TEAEs emerged early and were mild to moderate in severity. The profile of adverse events in patients enrolled at least 6 months, and for patients in the 1-year study, was similar to that found in the short-term treatment studies, with no new adverse events emerging at a notable rate. About 20% of patients discontinued due to adverse events in the short-term treatment studies and in the 1-year study. SAEs were uncommon, and none occurred at a significantly higher frequency for duloxetine compared with placebo. Mean changes in vital signs and weight were small. Rates of treatment-emergent potentially clinically significant (PCS) vital sign, laboratory, and electrocardiogram measures were low, with only PCS rates of alanine aminotransferase being significantly higher for duloxetine compared with placebo in the placebo-controlled treatment studies. In the 1-year study, four patients (1.1%) had suicide-related behavior. The data provided here summarize short- and long-term safety from five clinical studies in patients treated with duloxetine for fibromyalgia. In addition, postmarketing surveillance continues for adverse events reported with duloxetine in fibromyalgia, as in other indications.

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Cited by

Sorted by citations

Authors
Choy, E. H. S., Mease, P. J., Kajdasz, D. K., Wohlreich, M. M., Crits-Christoph, P., Walker, D. J., & Chappell, A. S.
Affiliations
  • King's College London (GB)
  • University of Washington (US)
  • Eli Lilly (United States) (US)
  • University of Pennsylvania (US)
Corresponding author
Choy, Ernest H. S.
ORCID
Venue
Clinical Rheumatology
Publisher
Springer Science and Business Media LLC
Published
2009-06-18
Volume
28
Issue
9
Pages
1035-1044
ISSN
  • 0770-3198 (ISSN-L)
  • 1434-9949
DOI
10.1007/s10067-009-1203-2
PMC
PMC2721139
OpenAlex
W2017997790
Cited by
47
References
2
Citations by year
2026: 1 · 2025: 2 · 2024: 1 · 2022: 2 · 2021: 1 · 2019: 1 · 2018: 2 · 2017: 1 · 2016: 4 · 2015: 2 · 2014: 3 · 2013: 2 · 2012: 7
FWCI
5.15
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • Clinical Rheumatology (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Research Portal (King's College London) (submittedVersion)
Funders
  • Eli Lilly and Company
  • Pfizer
  • Allergan
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
Keywords
duloxetine, fibromyalgia, drug safety, tolerability, adverse events, long-term treatment, treatment-emergent adverse events, serious adverse events, discontinuation, vital signs, alanine aminotransferase, suicide-related behaviors, antidepressants
MeSH terms
Duloxetine Hydrochloride, Antidepressive Agents, Fibromyalgia, Humans, Thiophenes, Randomized Controlled Trials as Topic, Treatment Outcome

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