Abstract | OBJECTIVES: 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 <or= 0.01) and the placebo/ duloxetine 60 mg group in Study 2 (4.8 [SD = 10.2], P <or= 0.001). Most treatment groups showed small mean change improvements in the Brief Pain Inventory average pain severity score. CONCLUSIONS: These findings support a positive risk/benefit profile for duloxetine in the long-term treatment of fibromyalgia.
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Authors | Philip J Mease, I Jon Russell, Daniel K Kajdasz, Curtis G Wiltse, Michael J Detke, Madelaine M Wohlreich, Daniel J Walker, Amy S Chappell |
Journal | Seminars in arthritis and rheumatism
(Semin Arthritis Rheum)
Vol. 39
Issue 6
Pg. 454-64
(Jun 2010)
ISSN: 1532-866X [Electronic] United States |
PMID | 19152958
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2010 Elsevier Inc. All rights reserved. |
Chemical References |
- Antidepressive Agents
- Thiophenes
- Duloxetine Hydrochloride
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Topics |
- Antidepressive Agents
(therapeutic use)
- Depression
(drug therapy, psychology)
- Disability Evaluation
- Double-Blind Method
- Duloxetine Hydrochloride
- Female
- Fibromyalgia
(drug therapy, physiopathology, psychology)
- Health Status
- Humans
- Male
- Middle Aged
- Pain
(drug therapy, physiopathology)
- Pain Measurement
- Thiophenes
(therapeutic use)
- Treatment Outcome
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