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Study Finds Oral Drug to Be Effective in Multiple Sclerosis

Last Updated: January 20, 2010.

In patients with relapsing-remitting multiple sclerosis, once-daily oral fingolimod is more effective than once-weekly intramuscular interferon injection at preventing relapses, according to a study published online Jan. 20 in the New England Journal of Medicine.

WEDNESDAY, Jan. 20 (HealthDay News) -- In patients with relapsing-remitting multiple sclerosis, once-daily oral fingolimod is more effective than once-weekly intramuscular interferon injection at preventing relapses, according to a study published online Jan. 20 in the New England Journal of Medicine.

Jeffrey A. Cohen, M.D., of the Cleveland Clinic, and colleagues randomly assigned 1,292 patients to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg, or intramuscular interferon beta-1a at a weekly dose of 30 µg, both for one year.

The researchers found that fingolimod at a dosage of 1.25 and 0.5 mg was associated with a significantly lower annualized relapse rate (0.20 and 0.16, respectively) than interferon (0.33). They observed two infection-related deaths in the 1.25 mg fingolimod group, one from disseminated primary varicella zoster and the other from herpes simplex encephalitis, and also found that fingolimod was associated with adverse events such as nonfatal herpes virus infections, bradycardia and atrioventricular block, hypertension, macular edema, skin cancer, and elevated liver-enzyme levels.

"Fingolimod was associated with clearly identified adverse events, some of which may be dose-related," the authors conclude. "The absence of dose-related differences in efficacy in this study requires further evaluation in the two-year, placebo-controlled phase 3 trials."

This study was supported by Novartis Pharma; several authors reported financial relationships with the company.

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