Summary

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• Evolocumab (Repatha) is recommended for adults with established cardiovascular disease to minimize the risk of myocardial infarction, stroke, and coronary revascularization. It is also advised as an adjunct to diet alone or combined with other therapies for lowering low-density lipoprotein cholesterol (LDL-C) in cases of primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH). Furthermore, it is suitable for pediatric patients aged 10 years and older.
• Thirty-two studies provided comprehensive information on the efficacy and safety of evolocumab compared to various controls such as placebo, ezetimibe, and statins.
• All PCSK9 inhibitors, including evolocumab, have demonstrated a significant reduction in LDL-C levels in various patient populations, such as those with familial hypercholesterolemia (FH) and ASCVD, in comparison to placebo or other lipid-lowering therapies. This reduction was associated with a decreased incidence of major adverse cardiac events, indicating substantial cardiovascular benefits.
• The safety profile of PCSK9 inhibitors was found to be comparable to placebos or other lipid-lowering agents, although injection site reactions were more frequently reported among users, but this was not significantly different from the control conditions.
• Patients with both heterozygous and homozygous forms of Familial Hypercholesterolemia saw significant reductions in LDL-C from PCSK9 inhibitors, showing substantial benefits regardless of their genetic basis or prior statin use.
• In post-heart transplant patients presenting with elevated LDL levels, these drugs effectively reduced LDL-C levels, indicating a potential role in attenuating coronary allograft vasculopathy and demonstrating utility in this unique patient group.
• No significant variability was observed based on the presence of race or diabetes mellitus, suggesting broad applicability of the findings across diverse patient subgroups.
• Head-to-head comparisons between PCSK9 inhibitors (e.g., evolocumab vs. alirocumab) and against other lipid-lowering strategies suggested comparable or superior efficacy in LDL-C reduction for PCSK9 inhibitors.