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Table 2 Adverse event rates at 12- and 52-week follow-up following evolocumab, placebo or ezetimibe treatments

From: Safety and efficacy of anti-PCSK9 antibodies: a meta-analysis of 25 randomized, controlled trials

Safety endpoints Evolocumab (12 Week) Placebo (12 Week) Evolocumab versus Placebo (12 Week) Ezetimibe (12 Week) Evolocumab versus Ezetimibe (12 Week) Evolocumab (52 Week)
  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 Event/Total
TEAE (Any) 52.2 (44.8, 59.7) 1472/3068 45.2 (40.6, 49.8) 534/1240 1.07 (0.95, 1.21) 0.260 54.7 (41.3, 68.0) 278/554 0.92 (0.84, 1.01) 0.074 78.4 (1047/1335)
TEAE (Serious) 1.9 (1.4, 2.4) 64/3068 1.2 (0.5, 1.9) 23/1240 0.96 (0.60, 1.55) 0.876 0.9 ( 0.3, 1.6) 7/554 1.35 (0.61, 3.00) 0.458 6.4 (85/1335)
Leading to discontinuation 1.6 (0.9, 2.4) 56/3068 1.1 (0.4, 1.8) 21/1240 0.78 (0.46, 1.32) 0.354 3.5 (1.0, 6.0) 24/554 0.68 (0.42, 1.11) 0.127 3.0 (40/1335)
Death NA 1/3068 NA 1/1240 NA NA NA 0/554 NA NA 0.2 (3/1335)
CK >5 ULN 0.5 (0.1, 0.8) 16/2797 0.5 (0.2, 0.8) 8/1150 0.57 (0.21, 1.51) 0.258 0.5 (0, 0.8) 4/509 0.55 (0.17, 1.81) 0.325 1.0 (14/1335)
ALT or AST > 3 ULN 0.2 (0.1, 0.4) 12/2797 0.8 (0.3, 1.2) 13/1150 0.43 (0.20, 0.93) 0.033 0.7 (0.1, 1.3) 4/509 0.43 (0.14, 1.34) 0.147 1.3 (18/1335)
Adjudicated cardiovascular events 0.6 (0.2, 1.1) 20/2287 0.5 (0.1, 0.9) 7/1014 1.07 (0.41, 2.76) 0.892 0.9 (0, 1.9) 2/266 0.50 (0.12, 2.13) 0.346 1.1 (15/1335)
Musculoskeletal and connective-tissue disorders 9.8 (4.1, 15.4) 144/1397 7.1 (1.6, 12.6) 39/508 1.08 (0.70, 1.67) 0.738 6.1 (0.7, 11.5) 13/231 1.10 (0.61, 2.00) 0.751 9.2 (68/736)
Back pain 2.6 (1.7, 3.4) 56/2208 1.8 (0.7, 2.8) 21/912 1.05 (0.53, 2.11) 0.883 2.5 (0.9, 4.1) 8/298 0.72 (0.34, 1.54) 0.4 6.4 (85/1335)
Arthralgia 1.7 (1.0, 2.5) 35/1862 1.7 (0.9, 2.6) 14/803 1.04 (0.56, 1.93) 0.912 1.5 (0.2, 2.9) 4/266 0.97 (0.35, 2.64) 0.945 5.7 (76/1335)
Muscle spasms 1.9 (0.7, 3.2) 45/2193 1.3 (0.5, 2.0) 11/803 1.02 (0.42, 2.49) 0.963 2.5 (0.7, 4.3) 13/400 0.67 (0.30, 1.50) 0.335 2.3 (14/599)
Myalgia 3.5 (1.5, 5.6) 48/1382 1.0 (0.2, 1.8) 5/399 1.13 (0.37, 3.43) 0.833 5.0 (0.6, 9.4) 23/333 0.68 (0.30, 1.56) 0.364 4.0 (24/599)
Headache 3.4 (2.2, 4.6) 86/2830 2.6 (1.5, 3.7) 34/1122 0.81 (0.53, 1.24) 0.331 2.8 (1.2, 4.4) 20/554 0.94 (0.57, 1.55) 0.798 4.0 (24/599)
Injection-site reactions 2.2 (1.3, 3.1) 64/2831 1.7 (0.9, 2.5) 26/1184 1.06 (0.67, 1.67) 0.816 2.0 (0.4, 3.6) 13/522 1.02 (0.54, 1.93) 0.955 5.4 (72/1335)
Gastrointestinal disorders 5.6 (2.7, 8.4) 118/1620 5.3 (1.9, 8.7) 33/580 1.09 (0.68, 1.75) 0.73 6.8 (0.1, 13.4) 18/301 0.81 (0.47, 1.39) 0.441 6.3 (38/599)
Nasopharyngitis 6.2 (3.6, 8.8) 115/1746 4.2 (2.1, 6.3) 28/580 1.39 (0.93, 2.08) 0.11 4.8 (1.6, 8.0) 18/333 0.54 (0.30, 1.15) 0.113 11.5 (153/1335)
Influenza 1.7 (0.5, 2.8) 27/1220 2.0 (0, 4.3) 9/317 0.89 (0.38, 2.07) 0.792 2.1 (0.1, 4.0) 5/179 0.34 (0.10, 1.18) 0.090 7.3 (97/1335)
Upper respiratory tract infection 4.2 (2.5, 5.9) 43/1015 2.9 (0.3, 5.6) 12/317 1.01 (0.54, 1.90) 0.964 5.3 (0, 14.4) 5/77 0.74 (0.22, 2.50) 0.624 8.5 (113/1335)
  1. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; CK, creatine kinase; NA, not applicable; TEAE, treatment emergent adverse event; ULN, upper limit of normal