Two antidepressants show promise for fibromyalgia.
Neither drug is approved in the United States for fibromyalgia, but the Food and Drug Administration is considering a New Drug Application for milnacipran jointly submitted by Forest Laboratories Inc. and Cypress Bioscience, Anne Cazorla said at the annual congress of the European College of Neuropsychopharmacology.
"If this is approved, as we expect, then U.S. physicians will have a third approved choice for treating patients with fibromyalgia," said Ms. Cazorla, a manager with Pierre-Fabre Medicament, Boulogne, France, developer of the drug.
The results of the large European randomized, controlled trial were presented in a poster. The mean age of the 884 patients was 49 years; 94% were female. They were randomized to placebo or 200 mg/day milnacipran.
Patients taking milnacipran reported significant improvements in pain, quality of life, fatigue, sleep quality, and cognition.
"For all parameters, the efficacy of milnacipran vs. placebo was observed as soon as the first on--treatment assessment visit at week 4 and was maintained up to the end of treatment," wrote principal investigator Dr. Jaime C. Branco, chief of rheumatology at the Hospital Egas Moniz, Lisbon.
Trazodone, a drug fibromyalgia patients usually receive to improve sleep, also appears to have an impact on a wide range of fibromyalgia symptoms, Rocio Molina-Barea concluded in another poster. But the drug's side effects made the researcher question its clinical usefulness in fibromyalgia.
Patients who received the drug had an "unusually high frequency of palpitations," wrote Mr. Molina-Barea, a researcher at the University of Granada, Spain. "Globally, our data do seem to support the use of trazodone in fibromyalgia management."
The 12-week open-label study included 44 patients with a mean age of 50 years. Patients were started on 25 mg trazodone given at bedtime; the final dose ranged from 50 to 300 mg/day.
By the study's end, patients experienced significant improvements in sleep, pain, and global pain interference with daily activities. Both depression and anxiety showed significant improvements.
At the end of the study, 51% of patients reported mild improvement and 15% reported much or very much improvement.
Mr. Molina-Barea reported that he had no conflicts to declare.
BY MICHELE G.SULLIVAN
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|Author:||Sullivan, Michele G.|
|Publication:||Internal Medicine News|
|Date:||Jan 1, 2009|
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