Ramseier SP, Roth S, Czaplinski A. A Swiss real world best practice experience in three different clinical settings of the 6 hour fingolimod first dose observation procedure.BMC Pharmacol Toxicol. 2015;16(1):7. [Epub ahead of print]
BACKGROUND:The Swiss label of oral fingolimod (0.5 mg once daily) requires a 6-hour first dose observation (FDO) including an ECG prior to and 6 hours after the first intake but in comparison to other countries such as Austria, Australia and Canada there are no restrictions regarding the clinical settings of the FDO procedure in Switzerland. We present here our real-world experience of the 6 hour FDO procedure in three different clinical settings, following fingolimod treatment initiation. This is the first report on the FDO of fingolimod in these real-world clinical settings in Swiss patients with multiple sclerosis (MS).
METHODS:This was a retrospective, multi-clinic, observational study of 136 patients with relapsing-remitting multiple sclerosis. Summary statistics have been used to present the data.
RESULTS:Only two patients (<1.5% [2/136]) experienced symptoms after the first dose of fingolimod. Atrioventricular conduction abnormalities were reported in 3% (4/136) of patients, which resolved spontaneously within 24 hours of treatment initiation. During the average 6.8 months follow-up, 96% (131/136) of the patients remained on therapy
CONCLUSIONS: These findings support the safety and feasibility of FDO and tolerability of fingolimod in real-world clinical settings.
Switzerland is the home of Fingolimod. One of its side-effects are heart issues on first dosing this study in the real word indicates that this issue is apparent but thankfully at a low level