Safety of the Lipid-Modifying Treatment Alirocumab

Alirocumab is an injectable monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9) that reduces the level of low-density lipoprotein-cholesterol and other atherogenic lipoproteins. The ODYSSEY OUTCOMES trial demonstrated that in patients with a recent acute coronary syndrome who were receiving high-intensity statins, alirocumab reduced the risk of recurrent ischemic cardiovascular events and lowered the rate of death from all causes. In a recently published report in the European Heart Journal: Cardiovascular PharmacotherapyCVC Co-director Dr. Shaun Goodman and his fellow authors analyzed safety data from over 47,000 patients-years of placebo-controlled observation in order to expand upon the findings of the ODYSSEY OUTCOMES trial.

Alirocumab and placebo had a nearly identical safety profile, with the exception of an approximately 1.7% absolute increase in local injection site reactions, which were typically mild and resulted in the discontinuation of the study drug in only 26 (of 9,462) patients. Alirocumab was confirmed to be safe for vulnerable populations identified before randomization, including the elderly and those with diabetes mellitus, previous ischemic stroke, or chronic kidney disease. Additionally, the rate of adverse events and laboratory abnormalities was similar in both the alirocumab and placebo groups.

Based on these findings, alirocumab appears to be a safe and effective lipid-modifying treatment for a period of at least 5 years. While it is encouraging that the drug has been on the market for close to 8 years and no serious adverse events have been reported, the researchers emphasize the importance of continued monitoring of long-term safety, particularly in older and more vulnerable populations.