"The significance of these findings is uncertain," he said.
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.
Both trials excluded patients with moderate to severe cardiovascular disease. At baseline, 3%-4% in each treatment group had a cardiovascular disorder and 5%-7% had hypertension.
The current analysis was funded by Novartis, which markets fingolimod. Dr. DiMarco disclosed financial relationships with Novartis, Medtronic, St. Jude Medical, Astellas, Sanofi-Aventis Pharmaceuticals, and Boston Scientific. His associates in the study have been employees of Novartis, have held stock in the company, or disclosed other financial relationships with Novartis and other pharmaceutical companies.