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Table 4 Adverse event rates following alirocumab, placebo or ezetimibe treatments

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
  1. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; CK, creatine kinase; RR, relative risk; TEAE, treatment emergent adverse event; ULN, upper limit of normal