FM can be treated safely for up to 60 weeks with duloxetine (Cymbalta®, Eli Lilly and Co), researchers reported at EULAR.1 The drug safety profile in FM is consistent with that seen in FDA-approved uses of the drug, according to the report.
“Safety and tolerability of duloxetine up to 120 mg/day for up to 60 weeks was similar to indications for the drug for which long-term safety has been studied. We saw no new safety issues emerge in this particular patient population,” said Amy S. Chappell, MD, of Lilly Research Laboratories, Eli Lilly and Co, Indianapolis. Duloxetine is currently FDA-approved to treat major depression, peripheral neuropathy in diabetics, and to relieve nerve pain.
Dr. Chappell reported data from a phase III that enrolled 350 subjects (95.7% female) and included an 8-week open-label period followed by a 52-week randomized, double-blind period. In the open-label period, subjects received duloxetine 30 mg/day for 1 week and duloxetine 60 mg/day for the next 7 weeks. In the following 52-week period, they were randomized to either 60 mg/day (n = 104) or 120 mg/day (n = 203).
At baseline, the patients had a mean Brief Pain Inventory average pain score of 6.7, Clinical Global Impression of Severity score of 4.1, and Patient’s Global Impression of Severity score of 4.1. The investigators reported that the most common (≥15%) treatment-emergent adverse events (AEs) during the 60 weeks were nausea (40.6%), headache (29.4%), insomnia (19.7%), dizziness (18.9%), constipation (17.4%), and dry mouth (17.1%). Seventy-four (21.1%) subjects reported AEs as their reason for leaving the trial; the most common AEs cited for withdrawal were insomnia (2.6%), vomiting (2.0%), diarrhea (1.4%), dizziness (1.4%), and nausea (1.4%).
The researchers found that during the 60 weeks’ study period, mean change in sitting systolic blood pressure (mm Hg) was -0.1, in sitting diastolic blood pressure -0.2, in sitting pulse rate 1.9 beats-per-minute, and in weight it was - 0.7 kg. Thirteen (3.7%) patients had sustained elevated blood pressure.
“The safety profile of duloxetine for the long-term treatment of FM was consistent with that seen in other indications for which the drug is currently marketed,” the authors concluded.
The study was supported by Eli Lilly and Co and Boehringer Ingelheim GmbH.
Reference
1. Chappell AS, Littlejohn G, Kajdasz D, et al. A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. Presented at: EULAR 2008; June 11-14, 2008; Paris, France. Presentation THU0370.
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