Table 2.
Overall frequencies of adverse events for both PCSK9 inhibitors with gender differences
| ERASMUS MC | Total (n = 68a) | OR (95% CI) male vs. female | Lareb | Total (n = 149) | OR (95% CI) male vs. female | VigiLyze | Total (n = 15,554) | OR (95% CI) male vs. female |
|---|---|---|---|---|---|---|---|---|
| Any TEAE, n (%) | 68 (100.0) | 0.58 (0.31–1.09)b | Any TEAE, n (%) | 149 (100.0) | Any TEAE, n (%) | 15,554 (100.0) | ||
| 1 event | 37 (54.4) | 1 event | 51 (34.2) | |||||
| 2 events | 21 (30.9) | 2 events | 41 (27.5) | |||||
| ≥3 events | 10 (14.7) | ≥ 3 events | 61 (38.3) | |||||
| Events, median (IQR) | 1.0 (1.0–2.0) | Events, median (IQR) | 2.0 (1.0–3.0) | |||||
| Total no. of TEAEs reported | 116 | Total no. of TEAEs reported | 375 | Total no. of TEAEs reported | 29,956 | |||
| TEAEs leading to discontinuation | 11 (16.2) | TEAEs leading to discontinuation | 60 (40.3) | TEAEs leading to discontinuation | N/A | |||
| TEAEs leading to death | 0 (0.0) | TEAEs leading to death | 1 (0.7) | TEAEs leading to death | N/A | |||
| Most common (≥4%) TEAEs, n (%) | Most common (≥4%) TEAEs, n (%) | Most common (≥4%) TEAEs, n (%) | ||||||
| Influenza‐like illness | 19 (27.9) | 0.56 (0.19–1.66) | Myalgia | 19 (12.8) | 1.63 (0.62–4.32) | Myalgia | 1,287 (8.3) | 1.11 (0.99–1.25) |
| Injection‐site hematoma | 13 (19.1) | 0.43 (0.12–1.56) | Influenza like illness | 14 (9.4) | 2.15 (0.69–6.77) | Drug dose omission | 1,151 (7.4) | 0.87 (0.77–0.99) |
| Nasopharyngitis | 11 (16.2) | 0.52 (0.16–2.25) | Fatigue | 12 (8.1) | 1.13 (0.35–3.67) | Injection‐site pain | 959 (6.2) | 0.55 (0.48–0.65) |
| Abdominal discomfort | 8 (11.8) | 2.04 (0.45–9.31) | Headache | 12 (8.1) | 0.20 (0.04–0.95) | Influenza like illness | 818 (5.3) | 1.06 (0.91–1.23) |
| Myalgia | 7 (10.3) | 0.41 (0.07–2.30) | Arthralgia | 10 (6.7) | 1.73 (0.47–6.42) | Back pain | 816 (5.2) | 0.95 (0.82–1.09) |
| Cognitive disorder | 6 (8.8) | 2.43 (0.41–14.25) | Dyspnea | 9 (6.0) | 0.13 (0.02–1.04) | Arthralgia | 789 (5.1) | 1.01 (0.87–1.17) |
| Fatigue | 6 (8.8) | 2.43 (0.41–14.25) | Nausea | 9 (6.0) | 0.54 (0.13–2.24) | Fatigue | 764 (4.9) | 0.92 (0.79–1.06) |
| Headache | 6 (8.8) | 0.53 (0.09–3.13) | Malaise | 8 (5.4) | 0.35 (0.07–1.81) | Pain in extremity | 755 (4.9) | 0.77 (0.66–0.90) |
| Injection‐site pain | 6 (8.8) | 1.14 (0.21–6.08) | Muscle spasms | 8 (5.4) | 0.65 (0.15–2.84) | Muscle spasms | 719 (4.6) | 0.81 (0.69–0.95) |
| Injection‐site swelling | 6 (8.8) | 2.43 (0.41–14.25) | Pain in extremity | 8 (5.4) | 0.35 (0.07–1.81) | Pain | 703 (4.5) | 0.66 (0.56–0.78) |
| Rash | 4 (5.9) | 0.36 (0.04–3.60) | Diarrhea | 6 (4.0) | 0.54 (0.10–3.07) | Headache | 651 (4.2) | 0.72 (0.61–0.86) |
| Dizziness | 6 (4.0) | 0.54 (0.10–3.07) | ||||||
| Injection‐site reactions, n (%) | 23(33.8) | 0.62 (0.22–1.71) | Injection‐site reactions, n (%) | 3 (2.0) | 2.27 (0.20–25.53) | Injection‐site reactions (≥ 1.0%), n (%) | 3,291 (21.2) | 0.55 (0.50–0.60) |
| Injection‐site hematoma | 13 (19.1) | 0.43 (0.12–1.56) | Injection‐site hematoma | 1 (0.7) | Injection‐site pain | 959 (6.2) | 0.55 (0.48–0.65) | |
| Injection‐site pain | 6 (8.8) | 1.14 (0.21–6.08) | Injection‐site hemorrhage | 1 (0.7) | Injection‐site bruising | 526 (3.4) | 0.56 (0.46–0.67) | |
| Injection‐site swelling | 6 (8.8) | 2.43 (0.41–14.25) | Injection‐site swelling | 1 (0.7) | Injection‐site hemorrhage | 373 (2.4) | 0.72 (0.58–0.89) | |
| Injection‐site erythema | 2 (2.9) | 1.13 (0.07–18.8) | Injection‐site erythema | 268 (1.7) | 0.49 (0.37–0.65) | |||
| Injection‐site infection | 1 (1.5) | Injection‐site swelling | 229 (1.5) | 0.61 (0.45–0.81) | ||||
| Injection‐site pruritus | 152 (1.0) | 0.42 (0.29–0.62) |
95% CI, confidence interval; IQR, interquartile range; N/A, not applicable; OR, odds ratio; PCSK9, proprotein convertase subtilisin/kexin 9; TEAE, treatment‐emergent adverse event.
Significant results are set in bold.
aOnly patients with adverse events at follow‐up 1. Total patients n = 164. bORs calculated on total population of men and women with and without adverse events.