Table 2.
Proportions and RR per 1000 cases of cardiovascular AEs when recorded in ≥ 2 cases by CGRP mAb
| Erenumab (n = 5468 AEs, 116,817 estimated exposed patients) | Fremanezumab (n = 450 AEs, 39,515 estimated exposed patients) | Galcanezumab (n = 990 AEs, 36,760 estimated exposed patients) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AE | n | Proportion of AEs (%) out of all reports | RR (per 1000 exposed patients) |
n | Proportion of AEs (%) out of all reports | RR (per 1000 exposed patients) |
n | Proportion of AEs (%) out of all reports | RR (per 1000 exposed patients) |
| Chest pain | 38 | 0.69 | 0.33 | 9 | 2.00 | 0.23 | 5 | 0.51 | 0.14 |
| Blood pressure increased | 35 | 0.64 | 0.30 | 4 | 0.89 | 0.10 | 8 | 0.81 | 0.22 |
| Heart rate increased | 32 | 0.59 | 0.27 | 1 | 0.22 | 0.03 | 3 | 0.30 | 0.08 |
| Palpitations | 26 | 0.48 | 0.22 | 5 | 1.11 | 0.13 | 4 | 0.40 | 0.11 |
| Chest discomfort | 25 | 0.46 | 0.21 | 4 | 0.89 | 0.10 | 7 | 0.71 | 0.19 |
| Hypertension | 25 | 0.46 | 0.21 | 2 | 0.44 | 0.05 | 3 | 0.30 | 0.08 |
| Hot flush | 20 | 0.37 | 0.17 | 4 | 0.89 | 0.10 | 3 | 0.30 | 0.08 |
| Flushing | 18 | 0.33 | 0.15 | 4 | 0.89 | 0.10 | – | – | – |
| Cerebrovascular accident | 13 | 0.24 | 0.11 | 3 | 0.67 | 0.08 | 2 | 0.20 | 0.05 |
| Hypotension | 10 | 0.18 | 0.09 | 2 | 0.44 | 0.05 | 1 | 0.10 | 0.03 |
| Cardiac disorder | 8 | 0.15 | 0.07 | 1 | 0.22 | 0.03 | – | – | – |
| Blood pressure decreased | 6 | 0.11 | 0.05 | – | – | – | – | – | – |
| Blood pressure abnormal | 5 | 0.09 | 0.04 | – | – | – | – | – | – |
| Myocardial infarction | 5 | 0.09 | 0.04 | – | – | – | 3 | 0.30 | 0.08 |
| Angina pectoris | 3 | 0.05 | 0.03 | – | – | – | – | – | – |
| Cardiac flutter | 3 | 0.05 | 0.03 | – | – | – | – | – | – |
| Heart rate decreased | 3 | 0.05 | 0.03 | – | – | – | 2 | 0.20 | 0.05 |
| Heart rate irregular | 3 | 0.05 | 0.03 | – | – | – | – | – | – |
| Atrial fibrillation | 2 | 0.04 | 0.02 | – | – | – | – | – | – |
| Blood pressure fluctuation | 2 | 0.04 | 0.02 | – | – | – | – | – | – |
| Cardiovascular disorder | 2 | 0.04 | 0.02 | – | – | – | – | – | – |
| Ischemic stroke | 2 | 0.04 | 0.02 | – | – | – | – | – | – |
| Tachycardia | 2 | 0.04 | 0.02 | 2 | 0.44 | 0.05 | 1 | 0.10 | 0.03 |
| Transient ischemic attack | 2 | 0.04 | 0.02 | – | – | – | – | – | – |
| Vasoconstriction | 2 | 0.04 | 0.02 | – | – | – | – | – | – |
AEs are presented as MedDRA PTs
AE adverse event, CGRP mAb calcitonin gene-related peptide pathway–targeting monoclonal antibody, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term, RR reporting rate
The number of events is not mutually exclusive and is counted independently