Skip to main content

Table 4 Cardiovascular effects experienced by patients following first dose of fingolimod 0.5 mg

From: Analysis of cardiac monitoring and safety data in patients initiating fingolimod treatment in the home or in clinic

Event

Gilenya@ Home (N = 5573)

Gilenya Assessment Network (N = 15,025)

Pooled RCTs [17] (n = 1212)

FIRST [18] (N = 2415)

EPOC [19] (N = 976)

START [20] (N = 3951)a

Italian open-label trial [21] (N = 906)

No PCCs (n = 2120)

PCCs (n = 295)

Heart rate

 Maximum reduction, mean (SD), bpm

10.6 (12.0)

6.3 (9.6)

8.1 (8.1)

6.5 (NR)

7.4 (NR)

8.1 (8.3)

11.8 (8.5)

NR

 Monitoring for more than 6 h

557 (10.0)

398 (2.6)

157 (13.0)

25 (2.6)b

15 (5.5)b

13 (1.3)

333 (8.4)

34 (3.8)

New-onset conduction abnormalities

 First-degree AV block

132 (2.4)

74 (0.5)

56 (4.7)c

0

0

16 (8.8)d

206 (5.8)

1 (0.1)

 Second-degree AV block

4 (0.07)

9 (0.1)

2 (0.2)c

25 (1.2)

18 (6.1)

2 (0.2)d

78 (2.0)

2 (0.2)

  Wenckebach (Mobitz type I) second-degree AV block

3 (0.05)

NR

2 (0.2)c

18 (0.9)

12 (4.1)

2 (0.2)d

60 (1.5)

2 (0.2)

  2:1 s-degree AV block

0

NR

0c

7 (0.3)

6 (2.0)

NR

18 (0.5)

NR

  Mobitz type II second-degree AV block

1 (0.02)

NR

0c

0

0

0d

0

NR

  1. Data are n (%) unless stated otherwise. aInterim data [20]. bEvents in the subgroup of patients monitored on site (N = 1219): no PCC, n = 948; PCC, n = 271. In total, 40 patients on site underwent extended monitoring, of whom 15 had PCCs [18]. cPatients with electrocardiogram recordings, n = 1182; includes patients from the phase 3 RCTs of fingolimod [14,15,16,17]. dNew abnormalities among individuals receiving an electrocardiogram recording after more than 6 h of first-dose observation, n = 181 [19]. AV atrioventricular, NR not reported, PCC pre-existing cardiac condition, RCT randomized controlled trial, SD standard deviation