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Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: Pooled analysis of data from five clinical trials
Clinical Rheumatology, 06/24/09

Choy EHS et al. - Data summarizes the 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.

Methods

Study describes the overall safety profile of both short- and longer-term duloxetine treatment of fibromyalgia
Data from 4 studies: 2 with 6-mo open-label extension phases and a 1-yr, open-label safety study
Safety measures included:
- Treatment-emergent adverse events (TEAEs)
- Adverse events leading to discontinuation
- Serious adverse events (SAEs)
- Clinical laboratory tests, vital signs, and electrocardiograms

Results

Most common TEAEs for short-term treatment: nausea, headache, dry mouth, insomnia, fatigue, constipation, diarrhea, and dizziness
Most TEAEs emerged early and were mild to moderate in severity
Profile of AEs in pts enrolled at least 6 mo, and in the 1-yr study, was similar to that found in the short-term treatment studies
20% of pts discontinued due to AEs in short-term treatment studies and in 1-yr study
SAEs were uncommon, and none occurred at a higher frequency vs 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
Only PCS rates of alanine aminotransferase were higher for duloxetine vs placebo
In the 1-yr study, 4 pts (1.1%) had suicide-related behavior

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