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