A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia

• Published in: The Clinical journal of pain Vol. 25; no. 5; p. 365
• Main Authors: Chappell, Amy S, Littlejohn, Geoffrey, Kajdasz, Daniel K, Scheinberg, Morton, D'Souza, Deborah N, Moldofsky, Harvey
• Format: Journal Article
• Language: English
• Published: United States 01.06.2009
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Comorbidity; Dopamine Uptake Inhibitors - administration & dosage; Dose-Response Relationship, Drug; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions - epidemiology; Duloxetine Hydrochloride; Female; Fibromyalgia - diagnosis; Fibromyalgia - drug therapy; Fibromyalgia - epidemiology; Humans; Internationality; Male; Middle Aged; Pain - diagnosis; Pain - epidemiology; Pain - prevention & control; Pain Measurement - drug effects; Thiophenes - administration & dosage; Treatment Outcome; Young Adult
• DOI: 10.1097/AJP.0b013e31819be587

Evaluate the efficacy and safety of duloxetine at doses up to 120 mg once daily in patients with fibromyalgia. This was a phase 3, 60-week study, which included an 8-week open-label period followed by a 52-week, randomized, double-blind period. Patients received duloxetine 30 mg daily for 1 week and duloxetine 60 mg daily for 7 weeks and were then randomized to receive either 60 or 120 mg daily (1:2 ratio). Enrolled patients (N=350, 95.7% female) exhibited moderate disease symptoms at study entry (Brief Pain Inventory average pain=6.7, Clinical Global Impression of Severity=4.1, and Patient's Global Impression of Severity=4.1). Significant pain reduction in patients was observed during the open-label study phase. This pain reduction continued during the 52-week double-blind study phase, as demonstrated by additional mean decreases in the Brief Pain Inventory average pain score within both duloxetine groups. The most common (> or =15%) treatment-emergent adverse events (overall phase) were nausea, headache, insomnia, dizziness, constipation, and dry mouth. Seventy-four (21.1%) patients reported adverse events as a reason for discontinuation [most common (>1%) were insomnia, vomiting, diarrhea, dizziness, and nausea]. The mean change (SD) in sitting systolic blood pressure (mm Hg) was -0.1 (14.4), in sitting diastolic blood pressure was -0.2 (9.6), in sitting pulse rate was 1.9 (10.4) bpm, and in weight was 0.7 (4.3) kg. The profile of duloxetine for the long-term treatment of fibromyalgia was consistent with that seen in other indications for which the drug is currently marketed.