Update on the cardiovascular profile of fingolimod in the therapy of relapsing-remitting multiple sclerosis (MS)

The safety analyses on file gave no indication of any increased cardiovascular risk. The 2-3 mmHg increase in blood pressure observed after the first dose of fingolimod has no therapeutic consequences. The first dose of 0.5 mg fingolimod resulted in an average decrease in heart rate of 7-8 beats/min. The onset of effect occurred approximately 1-2 h after the first dose and the nadir was reached after approximately 4-5 h. This negative chronotropic effect returned to normal after internalisation of the S1P1 receptors on maintenance therapy. There were no indications that patients with cardiac risk factors required closer observation beyond the monitoring recommended by the EMA following the first dose of fingolimod. Case study observations from the routine clinical setting show that patients accept this method of monitoring, which they assess as being a positive aspect of attentive medical care and concern.