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Table 2 Patient characteristics with potential relevance for cardiac events and frequency of symptoms by subgroup

From: Electrocardiographic assessments and cardiac events after fingolimod first dose – a comprehensive monitoring study

 

Overall population

Patients with bradycardia

Patients with second-degree AV block

Patients with AE

Patients with symptoms suggestive of cardiac events at visit 2

Patients who discontinued study drug due to AE

N = 3951

N = 31

N = 62a

N = 1350

N = 120

N = 38

Demographics

 Age (years), mean ± SD

39.3 ± 10.4

42.1 ± 10.9

40.4 ± 11.7

39.3 ± 10.4

39.6 ± 10.4

42.3 ± 12.4

 Female, n (%)

2779 (70.3)

14 (45.2)

57 (91.9)

1023 (75.8)

96 (80.0)

29 (76.3)

Concomitant medication known to prolong QT interval:

 SSRI n (%)

339 (10.1)

1 (3.2)

4 (6.5)

152 (11.3)

17 (14.2)

6 (15.8)

 TCA n (%)

92 (2.3)

0

0

38 (2.8)

2 (1.7)

1 (2.6)

 Amantadin n (%)

42 (1.1)

0

0

18 (1.3)

2 (1.7)

0

 Carbamazepin n (%)

29 (0.7)

0

1 (1.6)

14 (1.0)

3 (2.5)

1 (2.6)

 Fampridine n (%)

299 (7.6)

3 (9.7)

5 (8.1)

81 (6.0)

8 (6.7)

1 (2.6)

Heart rate at visit 2 pre-dose

 Heart rate (bpm), mean ± SD

73.9 ± 10.4

59.5 ± 8.0

75.0 ± 8.5

73.4 ± 10.4

73.3 ± 11.6

75.8 ± 10.6

Blood pressure at visit 2 pre-dose

 Systolic (mmHg), mean ± SD

121.8 ± 14.0

125.7 ± 20.3

117.5 ± 13.7

122.0 ± 14.1

123.9 ± 14.5

120.4 ± 15.4

 Diastolic (mmHg), mean ± SD

78.5 ± 9.7

78.1 ± 13.1

75.7 ± 9.0

78.7 ± 9.8

79.9 ± 10.0

76.1 ± 11.1

Potassium levels at visit 2

  < 3.5 mmol/L

13 (0.3)

0

0

5 (0.4)

0

0

  ≥ 3.5–5.5 mmol/L

3853 (98.3)

31 (100)

61 (98.4)

1320 (98.5)

119 (99.2)

38 (100.0)

  > 5.5 mmol/L

54 (1.4)

0

1 (1.6)

15 (1.1)

1 (0.8)

0

Symptoms suggestive of cardiac eventsb during 6 h first-dose observation

 Patients with symptoms, n (%)

120 (3.0)

1 (3.2)c

1 (1.6)d

120 (8.9)

120 (100.0)

1 (2.6)

  1. aOne of the patients had both, bradycardia and second-degree AV block and is therefore included in both groups
  2. bCardiac symptoms are defined as the following MedDRA preferred terms: Angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoe exertional, fatigue, palpitations, syncope, vertigo, vertigo positional, blurred vision
  3. cFatigue and chest discomfort
  4. dPalpitations