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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