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Table 5 Treatment-Emergent Cardiovascular Adverse Events in Patients with Cardiovascular Risk Factors at Baseline

From: Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies

 

Eptinezumab 100 mg

Eptinezumab 300 mg

Eptinezumab 1000 mg

Placebo

Patients with at least 1 cardiovascular risk factor, n (%)

N = 350

N = 316

N = 41

N = 382

Any TEAE

196 (56.0)

187 (59.2)

22 (53.7)

220 (57.6)

Cardiac or Vascular TEAEs

13 (3.7)

14 (4.4)

4 (9.8)

19 (5.0)

 Increased blood pressure

5 (1.4)

3 (0.9)

0

2 (0.5)

 Hypertension

2 (0.6)

1 (0.3)

0

5 (1.3)

 Hot flush

0

3 (0.9)

0

0

 Palpitations

1 (0.3)

1 (0.3)

0

3 (0.8)

 Syncope

2 (0.6)

2 (0.6)

0

3 (0.8)

 Tachycardia

0

2 (0.6)

0

1 (0.3)

 Chest pain

0

0

1 (2.4)

1 (0.3)

 ECG QT prolongation

0

0

2 (4.9)

1 (0.3)

 Flushing

0

1 (0.3)

0

1 (0.3)

 Sinus tachycardia

1 (0.3)

0

0

0

 Increased systolic blood pressure

1 (0.3)

0

0

0

 Abnormal ECG Q wave

0

0

1 (2.4)

0

 Increased heart rate

0

1 (0.3)

0

0

 Hypotension

1 (0.3)

0

0

0

 Atrial fibrillation

0

0

0

1 (0.3)

 Prehypertension

0

0

0

1 (0.3)

Patients with at least 2 cardiovascular risk factors, n (%)

N = 97

N = 83

N = 7

N = 112

Any TEAE

54 (55.7)

51 (61.4)

4 (57.1)

69 (61.6)

Cardiac or Vascular TEAEs

8 (8.2)

4 (4.8)

0

8 (7.1)

 Increased blood pressure

2 (2.1)

1 (1.2)

0

1 (0.9)

 Hypertension

2 (2.1)

1 (1.2)

0

4 (3.6)

 Syncope

2 (2.1)

1 (1.2)

0

2 (1.8)

 Palpitations

1 (1.0)

0

0

0

 Hot flush

0

1 (1.2)

0

0

 Sinus tachycardia

1 (1.0)

0

0

0

 Atrial fibrillation

0

0

0

1 (0.9)

  1. ECG Electrocardiogram, TEAE Treatment-emergent adverse event