Cardiology Letters 2019, 28(2):94-98

Alirocumab reduces total non-fatal and fatal cardiovascular events - from the ODYSSEY OUTCOMES study

Murín J¹, Bulas J¹, Wawruch M²

¹ I. interná klinika LFUK a UNB, Nemocnica Staré Mesto, Bratislava

² Ústav farmakológie a klinickej farmakológie LF UK, Bratislava, Slovenská republika

The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes after an Acute Coronary Syndrome during Treatment with Alirocumab) study compared alirocumab with placebo in 18 924 patients after acute coronary syndrome, where all patients had excellent secondary preventive treatment (maximum-tolerated statin treatment included). Alirocumab reduced the first occurrence of the primary composite endpoint [first cardiovascular (CV) events/mortality]. In this analysis the benefit of alirocumab treatment was evaluated on all CV events/mortality. These events were included: nonfatal myocardial infarction, non-fatal stroke, unstable angina pectoris with hospitalization, heart failure with hospitalization, ischemia-driven coronary revasculatization. The joint semiparametric model was used for analysis, as it allows us to evaluate the occurrence of many non-fatal CV events in a given patient, while simultaneously adjusting for possible informative censoring of the non-fatal event process by death.

Results: a) There were 3064 "first" CV events/deaths and in the alirocumab treatment arm these were 190 less than in the placebo arm. b) There were 5425 "total" CV events/deaths and in the alirocumab treatment arm there were 385 events less. c) Alirocumab reduced total non-fatal CV events by the relative risk (RR) of 0.87 (CI: 0.82 - 0.93) and d) deaths by RR 0.83 (CI: 0.71 - 0.97). e) There was a strong association between non-fatal and fatal risk events. In the ODYSSEY OUTCOMES study there was a total occurrence of CV events/deaths twice as frequent as the occurrence of first events/deaths. The benefit of alirocumab treatment is better evaluated here when we focus more on total CV events/deaths.

Keywords: ODYSSEY OUTCOMES study; acute coronary syndrome; alirocumab; cardiovascular events; mortality

Published: February 1, 2019  Show citation