198 Chapter 9 A total of 193 patients with migraine started treatment with either erenumab (n=101) or fremanezumab (n=92). Among the patients treated with erenumab, 82/101 (81%) were female, the average age was 43 years and 43/101 (43%) patients had migraine with aura. Among the patients treated with fremanezumab, 76/92 (83%) were women, the average age was 43 years and 32/92 (35%) patients had migraine with aura. None of the patients had hypertension or were smoking at baseline. Baseline characteristics for both treatment groups are presented in Table 1. Table 1. Patient characteristics for patients treated with erenumab or fremanezumab Total (n=193) Erenumab (n=101) Fremanezumab (n=92) Women, n (%) 158 (81.9) 82 (80.8) 76 (82.6) Age, mean ± SD (years) 43 ± 13.2 43 ± 12.7 43 ± 13.7 Chronic migraine, n (%) 106 (54.9) 53 (52.5) 53 (57.6) Migraine with aura, n (%) 75 (38.9) 43 (42.6) 32 (34.8) MMD baseline, mean ± SD 13.9 ± 5.9 14.1 ± 5.8 13.8 ± 6.1 MHD baseline, mean ± SD 17.5 ± 6.6 17.3 ± 6.3 17.8 ± 7.0 BMI, mean ± SD (kg/m2) 24.5 ± 4.4 24.4 ± 4.4 24.7 ± 4.5 History of smoking, n (%) 7 (3.6) 4 (4.0) 3 (3.3) Systolic BP, mean ± SD (mmHg)* 120 ± 9.8 119 ± 10.0 121 ± 9.5 Diastolic BP, mean ± SD (mmHg)* 78 ± 7.2 76 ± 7.8 80 ± 5.9 BP = blood pressure, MMD = monthly migraine days, MHD = monthly headache days. A month is defined as 28 days. Baseline = 28 days before starting treatment. *At baseline, 31 blood pressure measurements were missing (17 for erenumab, 14 for fremanezumab). Cerebro- and cardiovascular adverse events Of all patients, 3.11% (6/193) developed an abnormal ECG or CV adverse events during treatment with either erenumab (n=3) or fremanezumab (n=3). At baseline, all these patients had normal SCORE2 risks and BP measurements (eTable 1). Three of these six patients (1.55%) discontinued their treatment due to a moderate to severe CV events including a cerebellar stroke (n=1), a spontaneous coronary artery dissection (SCAD) (n=1), and pericarditis (n=1)) (Table 2). Additionally, the other three (1.55%) patients developed ECG abnormalities without physical complaints during follow-up (Table 3). All six patients had normal ECG readings and did not report any (history of) CV symptoms prior to the start of the study. Furthermore, a distinct subset of 13/193 (6.74%) patients had baseline ECG abnormalities without physical complaints that remained stable throughout the entire study period. None of these patients discontinued treatment due to these abnormalities, as presented in Table 4. An overview of all percentages of CV adverse events is displayed in Figure 2.
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