Outcome and safety data of evolocumab and alirocumab trials
| Pooled OSLER-1, OSLER-250 evolocumab | ODYSSEY LONG TERM51 alirocumab | |
|---|---|---|
| No. patients | 4,465 | 2,341 |
| Follow-up | 11.1 months | 78 weeks |
| Study type | Open-label, randomized evolocumab and standard care (n = 2,976) vs standard care (n = 1,489) | Randomized, alirocumab (n = 1,553) vs placebo (n = 788) (post hoc events) |
| % Reduction LDL-C (median mg/dL) | 61 (120 to 48) | 61.9 (122 to 48) |
| CV events | CV death, MI, CVA, UA revascularization, CHF | CV death, MI, CVA, UA |
| Rate CV events (HR) | 0.95% vs 2.18% (0.47) | 1.7% vs 3.3% (0.52) |
| Other adverse events, % of patients | ||
| Severe adverse events | 7.5 vs 7.5 | 18.7 vs 19.5 |
| Liver function tests | 1.0 vs 1.2 | 1.8 vs 2.1 |
| Creatine phosphokinase | 0.6 vs 1.1 | 3.7 vs 4.9 |
| Musculoskeletal | 6.4 vs 6.0 | 5.4 vs 2.9 |
| Neurocognitive | 0.9 vs 0.6 | 1.2 vs 0.5 |
CHF = congestive heart failure; CV = cardiovascular; CVA = cerebral vascular accident; HR = hazard ratio; LDL-C = low-density-lipoprotein cholesterol; MI = myocardial infarction; OSLER-1, OSLER-2 = Open-Label Study of Long-Term Evaluation Against LDL-Cholesterol 1, 2; ODYSSEY LONG TERM = Long-term Safety and Tolerability of Alirocumab in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy; UA = unstable angina