The rise in blood pressure on fingolimod was small, but sustained and statistically significant, starting within 2–6 months of treatment initiation. Systolic and diastolic blood pressure increases averaged 1–2 mm Hg on 0.5 mg/day fingolimod and 1–3 mm Hg on 1.25 mg/day fingolimod, compared with placebo.
Rates of hypertension adverse events were higher in the fingolimod groups − 4% on the lower dose and 5% on the higher dose – compared with the placebo group (3%) or the interferon group (2%). The proportions of patients who needed antihypertensive therapy, however, were similar between groups: 5% on low-dose fingolimod, 6% on high-dose fingolimod, 6% on placebo, and 4% on interferon.
Patients who were treated responded to standard antihypertensive therapy.
Data for the analysis came from the Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis (FREEDOMS) trial and from the Trial Assessing Injectable Interferon vs. FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Both were international, multicenter, randomized double-blind trials.