Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, was compared with a placebo in patients with ACS and persistent dyslipidemia, in addition to receiving treatment with high-intensity or maximum tolerated statin therapy.
A study published by the American Heart Association indicates that patients who have already experienced an acute coronary syndrome (ACS) and are now taking alirocumab experienced a reduction in total hospitalizations, as well as an increase in the number of days alive and out of the hospital (DAOH).
Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, was compared with a placebo in patients with ACS and persistent dyslipidemia, in addition to receiving treatment with high-intensity or maximum tolerated statin therapy. The researchers compared primary composite endpoints between the 2 groups, as well as days alive and out of the hospital (DAOH) and the percent DAOH (PDAOH).
The patients were followed for a median of 2.8 years, consisting of 27,014 patient-years for the group receiving alirocumab and 26,915 patient-years for the placebo group.
Among 18,924 patients, alirocumab reduced the first occurrence of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina—all of which were the primary composite end point. The drug also reduced the total nonfatal cardiovascular events and all-cause deaths compared with patients receiving the placebo.
Approximately 40% of the total patients experienced at least 1 hospitalization during the study, whereas roughly 1% died before experiencing a hospitalization. Of 16,629 total hospitalizations, 30.2% were attributed to protocol-defined efficacy endpoints, 61.7% were attributed to other adverse events, and 8.1% were for elective reasons.
There were 389 fewer total hospitalizations or deaths in patients receiving alirocumab (8872 events for those receiving the placebo vs 8483 events for those receiving alirocumab). These numbers include 331 fewer hospitalizations and 58 fewer deaths for patients receiving alirocumab.
In total, the study authors found that alirocumab resulted in avoiding 13.4 total hospitalizations and 15.6 total hospitalizations or deaths per 1000 patient-years of assigned treatment.
Although many similar studies have analyzed their results using the number of total events, these study authors noted that the more patient-centric outcomes, such as DAOH and PDAOH, showed a favorable result when patients received alirocumab in addition to statin therapy. DAOH and PDAOH are measurements that do not require adjudication such as analyses that account only for total nonfatal and fatal events, and offer an alternative metric of the effect of an intervention on the burden of disease.
Szarek M, Steg G, DiCenso D, Bhatt D, et al. Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial. American Heart Association; Dallas, TX. https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.119.005858, Accessed Nov. 13, 2019.