The addition of alirocumab to maximally tolerated high-intensity statins significantly improved outcomes in patients after recent acute coronary syndrome (ACS) regardless of age and without major safety issues in elderly patients, according to findings from an ODYSSEY OUTCOMES trial analysis published in the European Heart Journal. The treatment only increased absolute benefit with advancing age, suggesting that "lipid lowering therapy beyond statins may be an important secondary preventive intervention" for older patients after ACS, researchers said. 

Peter R. Sinnaeve, MD, FACC, et al., assessed 18,294 patients (aged >_40 years; mean age 59) with recent ACS who were randomized to either 75 mg of alirocumab or matching placebo. All doses were given via subcutaneous injection every two weeks. The goal: to assess "the impact of age on recurrent ischemic cardiovascular events and the impact of age on the effect of treatment with alirocumab on LDL-C levels and recurrent ischemic cardiovascular events in post-ACS patients with elevated atherogenic lipoproteins despite maximally tolerated intensive statin therapy." The primary endpoint was a combination of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, or unstable angina requiring hospitalization. Secondary endpoints included all-cause death, and the combined secondary endpoint of all-cause death, myocardial infarction or ischemic stroke.  

Results found relative risk reductions were consistent for MACE and all-cause death in patients under 65 years of age, as well as those older than 65 years of age. Although adverse events were more frequent in older patients, the researchers noted no differences between alirocumab and placebo. LDL-C levels with alirocumab were also similar in patients both under the age of 65 and those older than 65 at one, four and eight months after randomization. Additionally, while there appeared to be diminishing benefit with age in primary prevention, researchers noted "no trend towards smaller proportional reductions in death with increasing age in patients with established vascular disease." 

Study limitations included a small number of very elderly patients, which lead to less precise estimates of efficacy and insufficient data to define safety in octogenarians. Older participants were also largely tolerant to intensive statin therapy at baseline and less likely to be frail, due to the study's need for them to be on stable maximally tolerated high-intensity statin therapy after their ACS. However, Sinnaeve and colleagues note "the current findings are analogous to previous studies that have indicated a consistent benefit of statin treatment in the elderly, particularly for secondary prevention of cardiovascular events." They suggest that the findings potentially be considered in future guideline recommendations for lipid lowering therapies in older patients.

Clinical Topics: Acute Coronary Syndromes, Cardiovascular Care Team, Dyslipidemia, Geriatric Cardiology, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors, Acute Coronary Syndrome, Cholesterol, LDL, Secondary Prevention, Brain Ischemia, Frail Elderly, Random Allocation, Stroke, Angina, Unstable, Antibodies, Monoclonal, Myocardial Infarction, Atherosclerosis, Atherosclerosis

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