Table 2. Safety Outcomes of Evolocumab Treatment vs Placebo Stratified by Baseline LDL-C Levelsa.
| Outcome | Baseline LDL-C Level | |||
|---|---|---|---|---|
| <70 mg/dL (n = 2033)b |
≥70 mg/dL (n = 25 491) |
|||
| Evolocumab (n = 1030) |
Placebo (n = 1003) |
Evolocumab (n = 12 739) |
Placebo (n = 12 752) |
|
| Serious adverse event | 268 (26.0) | 274 (27.3) | 3142 (24.7) | 3130 (24.5) |
| Adverse event related to study drug and leading to therapy discontinuation | 19 (1.8) | 19 (1.9) | 207 (1.6) | 182 (1.4) |
| Injection site reaction | 30 (2.9)c | 16 (1.6) | 266 (2.1)c | 203 (1.6) |
| Muscle-related event | 49 (4.8) | 60 (6.0) | 633 (5.0) | 596 (4.7) |
| Cataract | 19 (1.8) | 16 (1.6) | 209 (1.6) | 226 (1.8) |
| New-onset diabetes (CEC adjudicated)d | 45/509 (8.8) | 53/475 (11.2) | 632/7828 (8.1) | 591/7864 (7.5) |
| Neurocognitive event | 17 (1.7) | 12 (1.2) | 200 (1.6) | 190 (1.5) |
| AST or ALT level >3 times normale | 27 (2.7) | 23 (2.3) | 213 (1.7) | 219 (1.7) |
| Creatine kinase level >5 times normal | 9 (0.9) | 9 (0.9) | 86 (0.7) | 90 (0.7) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CEC, Clinical End Point Committee; LDL-C, low-density lipoprotein cholesterol.
SI conversion factor: To convert LDL-C to millimoles per liter, multiply by 0.0259.
Baseline LDL-C level was not available for 1 patient, and 39 patients who did not receive the study drug were excluded. Unless otherwise indicated, data are expressed as number (percentage) of patients. No significant treatment × subgroup interaction was found.
These patients either had a final screening LDL-C of at least 70 mg/dL or a final screening non–high-density lipoprotein cholesterol level of at least 100 mg/dL.
Nominal P < .05 vs placebo.
Patients with prevalent diabetes were excluded.
Owing to missing patient data, denominators may be less than column headings.