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 <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.

• 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)
• Copyright: Copyright 2010 Elsevier Inc. All rights reserved.

Chemical References

• Antidepressive Agents
• Thiophenes
• Duloxetine Hydrochloride

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