Table 3. Safety Outcomes of Evolocumab Treatment vs Placebo Stratified by Potency of a Background Statina .
| Outcome | Maximal Potency Background Statin (n = 7524) |
Submaximal Potency Background Statin (n = 20 001) |
||
|---|---|---|---|---|
| Evolocumab (n = 3754) |
Placebo (n = 3770) |
Evolocumab (n = 10 015) |
Placebo (n = 9986) |
|
| Serious adverse event | 979 (26.1) | 1010 (26.8) | 2431 (24.3) | 2394 (24.0) |
| Adverse event related to study drug and leading to drug discontinuation | 53 (1.4) | 53 (1.4) | 173 (1.7) | 148 (1.5) |
| Injection site reaction | 84 (2.2) | 68 (1.8) | 212 (2.1)b | 151 (1.5) |
| Muscle-related event | 207 (5.5) | 194 (5.1) | 475 (4.7) | 462 (4.6) |
| Cataract | 53 (1.4) | 64 (1.7) | 175 (1.7) | 178 (1.8) |
| New-onset diabetes (CEC adjudicated)c | 214/2385 (9.0)b | 176/2383 (7.4) | 463/5952 (7.8) | 468/5956 (7.9) |
| Neurocognitive event | 64 (1.7) | 63 (1.7) | 153 (1.5) | 139 (1.4) |
| AST or ALT level >3 times normald | 84 (2.3) | 81 (2.2) | 156 (1.6) | 161 (1.6) |
| Creatine kinase level >5 times normald | 28 (0.8) | 33 (0.9) | 67 (0.7) | 66 (0.7) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CEC, Clinical End Point Committee; LDL-C, low-density lipoprotein cholesterol.
a
Unless otherwise indicated, data are expressed as number (percentage) of patients in the safety cohort. No significant treatment × subgroup interaction was found.
b
Nominal P < .05 vs placebo.
c
Patients with prevalent diabetes were excluded.
d
Owing to missing patient data, denominators may be less than column headings.