The FREEDOMS II trial preliminary trial results have been announced. Gilenya 0.5 mg reduced new relapse by 48% compared to placebo. 1083 patients, including patients from our center, participated in this third large Phase III trial. This result is similar to the earlier FREEDOMS trial that showed a drop of relapses by 54% with once-daily oral Gilenya compared to placebo. More herpes viral infections were noted in this trial on Gilenya but not in the other trials.
Greater than 26,000 people globally have been treated with Gilenya. Gilenya can lower the heart rate especially the first six hours after treatment. One patient recently died within 24 hours of taking the first dose of Gilenya. The patient was also treated with two cardiac medications including a beta blocker and a calcium channel blocker, which can lower the heart rate. However, this patient had completed 6 hours of monitoring after the first dose without problems, but died less than 24 hours after the first dose. The exact cause of death has not been established and an autopsy is pending. Inform your neurologist if you have cardiac disease or take cardiac medications if considering Gilenya.
BY: Barry Singer, MD DATE: January 2, 2012 TOPIC: MS Research News