199 Safety considerations in the treatment with anti-CGRP antibodies 9 Table 2. Characteristics of patients with a moderate to severe cardiovascular event during 18 months follow-up Sex Age (years) BMI (kg/m2) Diagnosis CGRP-mAb SCORE2 (10-year CVD risk) CVD history Baseline 3 months 6 months 9 months 12-18 months Conclusion 1 F 34 20.1 MA Erenumab <2.5% None Normal Normal ECG Normal ECG SCAD needing PCI ¶ Discontinuation of treatment 2 F 42 29.1 MA Fremanezumab <2.5% None Normal Pericarditis ¶ ¶ ¶ Discontinuation of treatment 3 F 43 22.1 MO Fremanezumab <2.5% None Normal Normal ECG Normal ECG Normal ECG Normal ECG, cerebellar stroke (18m) Discontinuation of treatment CVD = cardiovascular disease, CGRP-Mab = Calcitonin Gene Related Peptide - Monoclonal antibody, F = female, MA = migraine with aura, MO = migraine without aura, PCI = percutaneous coronary intervention, SCAD = spontaneous coronary artery dissection. SCORE2 = risk assessment model to estimate the 10-year risk of cardiovascular disease in individuals without previous CVD or diabetes aged 40-69 years in Europe25, factors included in this prediction model are sex, age, systolic blood pressure, smoking status and non-HDL cholesterol. * = (random) missing data, ¶ = missing due to discontinuation of treatment. Table 3. Characteristics of patients that had a normal ECG at baseline and developed ECG abnormalities without physical complaints during 12 months follow-up. Sex Age (years) BMI (kg/m2) Diagnosis CGRP-(R-) Mab SCORE2 (10 year CVD risk) CVD history Baseline 3 months 6 months 9 months 12 months Conclusion 4 F 40-44 17.3 MO Erenumab <2.5% None Normal Normal ECG Normal ECG Normal ECG Negative ST-segments V1-V3 Discontinuation of treatment. Cardiologist: by absence of physical complaints no further analysis 5 F 68 22.5 MO Fremanezumab 5 to <10% None Normal PVC, mild hypertension PVC, moderate hypertension Normal ECG, severe hypertension RBBB, mild hypertension Cardiologist: no objection to continuing CGRP-Mab 6 F 49 23.2 MO Fremanezumab <2.5% None Normal PVC, mild hypertension Normal ECG PVC Normal ECG No intervention CVD = cardiovascular disease, CGRP-Mab = Calcitonin Gene Related Peptide - Monoclonal antibody, F = female, LVH = left ventricular hypertrophy, M = male, MA = migraine with aura, MO = migraine without aura, PVC = premature ventricular complex, RBBB = right bundle branch block. SCORE2 = risk assessment model to estimate the 10-year risk of cardiovascular disease in individuals without previous CVD or diabetes aged 40-69 years in Europe25, factors included in this prediction model are sex, age, systolic blood pressure, smoking status and non-HDL cholesterol. * = (random) missing data, ¶ = missing due to discontinuation of treatment.
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