If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Duloxetine Safety in Fibromyalgia Sustained Up to 60 Weeks and Comparable to Other Uses of the Drug: Presented at EULAR By Bruce Sylvester PARIS -- June 16, 2008 -- The safety profile of long-term treatment of fibromyalgia with duloxetine is similar and consistent with other approved uses of the drug, researchers reported here at EULAR 2008, the Annual Congress of the European League Against Rheumatism. "We found that safety and tolerability of duloxetine for up to 120 mg/day for up to 60 weeks was similar to other indications of the drug for which long-term safety has been studied, and we saw no new safety issues emerge in this particular patient population," said lead researcher Amy Chappell, MD, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana. The phase 3, 60-week safety study, presented on June 12, included an 8-week open-label phase followed by a 52-week, randomised, double-blind phase. Subjects were treated with duloxetine 30 mg/day for 1 week and duloxetine 60 mg/day for the next 7 weeks. Then, 104 patients were randomised to receive 60 mg/day of the drug and 203 were randomised to receive a 120-mg/day dose. At baseline, patients had a mean average pain score on the Brief Pain Inventory of 6.7, the mean Clinical Global Impression of Severity score was 4.1, and mean Patient's Global Impression of Severity score was 4.1. The most common treatment-emergent adverse events 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 adverse events as their reason for dropping out of the trial; the most common events cited for withdrawal were insomnia (2.6%), vomiting (2.0%), diarrhoea (1.4%), dizziness (1.4%), and nausea (1.4%). For the overall 60 weeks, the researchers reported that mean change in sitting systolic blood pressure was -0.1 mm Hg, in sitting diastolic blood pressure -0.2 mm Hg, 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 fibromyalgia was consistent with that seen in other indications for which the drug is currently marketed," the authors concluded. Funding for this study was provided by Eli Lilly and Company and Boehringer Ingelheim GmbH. [Presentation title: A 1-Year Safety and Efficacy Study of Duloxetine in Patients With Fibromyalgia. Abstract THU0370]
|
