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Table 3 Adverse event rates at 12-week follow-up following different dosages of evolocumab treatments

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

Safety endpoints 420 mg Q4W (12 Week) 140 mg Q2W (12 Week) 420 mg Q4W versus 140 mg Q2W (12 Week)
  Pooled event rate (95 % CI) Event/Total Pooled event rate (95 % CI) Event/Total RR (95 % CI) P value
TEAE (Any) 52.1 (42.9, 61.3) 565/1228 52.0 (43.1, 60.9) 496/1095 1.01 (0.92, 1.10) 0.873
TEAE (Serious) 1.4 (0.8, 1.9) 23/1228 2.5 (1.6, 3.3) 30/1095 0.69 (0.39, 1.23) 0.214
Leading to discontinuation 1.4 (0.6, 2.2) 26/1228 1.8 (0.8, 2.9) 26/1095 0.94 (0.54, 1.64) 0.835
Death NA 0/1228 NA 1/1095 NA NA
CK >5 ULN 0.5 (0.1, 0.9) 8/1183 0.1 (0, 0.3) 2/1050 1.58 (0.44, 5.75) 0.484
ALT or AST >3 ULN 0.4 (0.2, 0.7) 5/1183 0.5 (0.1, 0.8) 5/1050 0.70 (0.20, 2.44) 0.573
Adjudicated cardiovascular events 1.1 (0.2, 2.0) 3/288 1.5 (0.3, 2.6) 6/285 0.56 (0.17, 1.92) 0.36
Musculoskeletal and connective-tissue disorders 3.9 (1.0, 6.9) 21/421 8.0 (3.4, 12.5) 30/386 0.63 (0.29, 1.34) 0.227
Back pain 3.6 (1.0, 6.3) 20/830 2.4 (1.4, 3.5) 20/788 1.09 (0.42, 2.87) 0.86
Arthralgia 1.8 (0.9, 2.7) 13/687 1.5 (0.6, 2.3) 10/678 1.27 (0.56, 2.87) 0.568
Muscle spasms 2.0 (0.5, 3.5) 18/823 1.4 (0.4, 2.5) 15/780 1.10 (0.56, 2.20) 0.776
Myalgia 1.3 (0, 2.7) 11/414 2.3 (0.4, 4.2) 12/378 0.91 (0.40, 2.06) 0.82
Headache 3.1 (1.7, 4.4) 40/1142 2.7 (1.3, 4.2) 26/1043 1.40 (0.84, 2.33) 0.202
Injection-site reactions 2.0 (0.9, 3.1) 18/577 2.4 (0.8, 4.0) 19/540 0.94 (0.50, 1.78) 0.853
Gastrointestinal disorders 4.9 (2.3, 7.5) 35/580 5.4 (2.5, 8.2) 28/488 1.13 (0.68, 1.87) 0.637
Nasopharyngitis 4.9 (2.5, 7.4) 36/613 4.1 (1.7, 6.6) 24/488 1.10 (0.63, 1.89) 0.744
Influenza 1.2 (0.1, 2.4) 9/350 2.5 (0.4, 5.4) 8/225 0.19 (0.03, 1.10) 0.064
Upper respiratory tract infection 4.6 (2.2, 6.9) 14/247 4.8 (1.2, 8.4) 6/123 1.30 (0.46, 3.70) 0.621
  1. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; CK, creatine kinase; NA, not applicable; RR, relative risk; TEAE, treatment emergent adverse event; ULN, upper limit of normal