ODYSSEY Long Term Study

The Odyssey Long Term Study evaluated the safety and efficacy of alirocumab (mAb anti-PCSK9) in 2341 patients with heterozygous FH or at high risk for cardiovascular events who were receiving a maximally tolerated dose of statin but who had an LDL-cholesterol level >70 mg/dL. Patients were randomized to alirocumab 150 mg every two weeks or to placebo. The primary efficacy end point was the reduction in LDL-cholesterol levels at 24 weeks, but the study will continue to evaluate patients beyond one year.
In the patients treated with alirocumab, the mean LDL-cholesterol reduction was 61.0% from baseline. For those at high risk or very high risk of cardiovascular events, 81% achieved the previously recommended LDL-cholesterol targets of In the Odyssey long-term study, also major cardiovascular events were evaluated at 65 weeks, using the end point of time to first coronary heart disease death, nonfatal MI, fatal
and nonfatal ischemic stroke, or unstable angina requiring hospitalization, there was a robust benefit to treatment with alirocumab. In a post-hoc analysis, the rate of adjudicated major CV events was 1.4% for alirocumab vs. 3.0% for placebo, P=0.0089, HR=0.46 (95% CI: 0.26 to 0.82).
In this double-blind phase 3 study of a PCSK9 inhibitor with the longest follow-up to date, alirocumab demonstrated safety generally comparable with maximally tolerated statin therapy -with or without other lipid lowering therapies- and produced significant reductions in LDL-C, with a majority of alirocumab-treated patients reaching prespecified LDL-C treatment targets at Week 24.
Additionally, the absolute event rate of major cardiovascular events was 1.4% in the alirocumab arm and 3.0% in the placebo arm, a difference that means a promising relative risk reduction of 54%.

Author: Robinson JG, et al
Posted: August 31, 2014.

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