From: Safety and efficacy of anti-PCSK9 antibodies: a meta-analysis of 25 randomized, controlled trials
Safety endpoint | Alirocumab | Placebo | Alirocumab versus Placebo | Ezetimibe | Alirocumab versus Ezetimibe | |||||
---|---|---|---|---|---|---|---|---|---|---|
 | Pooled event rate (95 % CI) | Event/Total | Pooled event rate (95 % CI) | Event/Total | RR (95 % CI) | P value | Pooled event rate (95 % CI) | Event/Total | RR (95 % CI) | P value |
TEAE (Any) | 71.7 (67.7, 75.6) | 2561/3425 | 68.4 (58.7, 78.2) | 783/1007 | 1.00 (0.92, 1.10) | 0.938 | 70.1 (62.9, 77.4) | 605/862 | 1.01 (0.96, 1.07) | 0.615 |
TEAE (Serious) | 8.6 (4.5, 12.8) | 455/3363 | 9.3 (1.2, 17.4) | 158/992 | 0.94 (0.79, 1.12) | 0.47 | 8.5 (4.1, 12.8) | 91/862 | 1.03 (0.81, 1.31) | 0.815 |
Leading to discontinuation | 4.8 (2.7, 6.9) | 187/3363 | 4.6 (2.1, 7.1) | 56/992 | 1.07 (0.78, 1.47) | 0.667 | 7.9 (3.9, 12.0) | 69/862 | 0.83 (0.38, 1.83) | 0.645 |
Death | 0.5 (0.3, 0.7) | 15/3363 | 1.2 (0.5, 1.8) | 11/992 | 0.43 (0.19, 0.96) | 0.04 | 0.5 (0.1, 1.0) | 7/862 | 0.48 (0.16, 1.45) | 0.192 |
CK >3 ULN | 2.0 (1.0, 3.1) | 114/3415 | 3.9 (2.0, 5.8) | 54/1003 | 0.72 (0.52, 1.01) | 0.059 | 2.4 (1.1, 3.7) | 28/855 | 0.75 (0.46, 1.24) | 0.261 |
ALT or AST >3 ULN | 0.9 (0.5, 1.3) | 25/1869 | 1.3 (0.2, 2.4) | 2/218 | 0.95 (0.26, 3.47) | 0.94 | 0.5 (0.2, 0.9) | 4/858 | 1.91 (0.75, 4.88) | 0.176 |
Musculoskeletal and connective-tissue disorders | 16.7 (5.9, 27.6) | 536/2450 | 17.3 (3.8, 30.7) | 235/865 | 1.00 (0.87, 1.14) | 0.967 | 22.3 (0, 46.5) | 74/416 | 0.80 (0.60, 1.05) | 0.108 |
Injection-site reactions | 6.0 (3.8, 8.2) | 225/3425 | 3.7 (2.5, 4.8) | 42/1007 | 1.48 (1.05, 2.09) | 0.024 | 3.0 (1.1, 4.9) | 35/862 | 1.30 (0.88, 1.92) | 0.194 |
Adjudicated cardiovascular events | 2.6 (1.3, 3.9) | 109/3130 | 3.2 (1.3, 5.0) | 38/930 | 0.94 (0.64, 1.39) | 0.768 | 1.2 (0.5, 1.9) | 15/811 | 1.29 (0.71, 2.36) | 0.405 |
Nervous system disorders | 9.3 (4.2, 14.5) | 338/2813 | 6.6 (0.0, 15.9) | 145/865 | 0.97 (0.81, 1.17) | 0.776 | 6.2 (4.2, 8.2) | 34/536 | 0.85 (0.56, 1.30) | 0.461 |
Gastrointestinal disorders | 16.4 (9.4, 23.4) | 332/1845 | 13.3 (5.1, 21.5) | 158/865 | 1.01 (0.57, 1.80) | 0.964 | 9.8 (1.6, 8.0) | 5/51 | 1.77 (0.63, 4.91) | 0.276 |
Neurocognitive disorders | 0.6 (0.2, 1.1) | 27/2923 | 0.6 (0.1, 1.0) | 6/930 | 1.03 (0.23, 4.60) | 0.97 | 1.3 (0.5, 2.1) | 8/609 | 0.65 (0.22, 1.91) | 0.431 |