Table 3.
Cardiac monitoring results in the FREEDOMS II study [91].
Fingolimod | Placebo (n = 355) | ||
---|---|---|---|
1.25 mg (n = 370) | 0.5 mg (n = 358) | ||
First dose monitoring events | |||
Bradycardia | 21 (6%) | 5 (1%) | 1 (<0.5%) |
Symptomatic bradycardia | 15 (4%) | 3 (1%) | 1 (<0.5%) |
First-degree atrioventricular (AV) block | 35 (10%) | 17 (5%) | 7 (2%) |
Mobitz I AV block | 6 (2%) | 0 | 0 |
Second-degree AV block | 1 (<0.5%) | 0 | 0 |
24-h Holter monitoring events | |||
First dose | |||
Mobitz I (Wenckebach) second-degree AV block | 24 (7%) | 13 (4%) | 7 (2%) |
Second-degree AV block | 12 (3%) | 7 (2%) | 0 |
3 months | |||
Mobitz I (Wenckebach) second-degree AV block | 0 | 0 | 5 (2%) |
Second-degree AV block | 0 | 0 | 1 (<0.5%) |