A 1-year Safety and Efficacy Study of Duloxetine in Patients With Fibromyalgia

Objectives: Evaluate the efficacy and safety of duloxetine at (loses Lip to 120mg once daily in patients with fibromyalgia. Methods: This was a phase 3, 60-week study, which included all 8-week open-label period followed by a 52-week, randomized, double-blind period. Patients received duloxetine 30 mg daily for I week and duloxetine Wing daily For 7 weeks and were then randomized to receive either 60 or 120mg daily (1:2 ratio). Results: 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 (>= 15%) treatment-emergent adverse events (overall phase) were nausea, headache, insomnia, dizziness, constipation, and dry Mouth. Seventy-four (21.1%) patients reported adverse events is a reason for discontinuation [most common ( > 1%) were insomnia, vomiting, diarrhea, dizziness, and nausea]. The mean change (SD) in sitting systolic blood pressure (runt 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. Discussion: 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.