Summary

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• Alirocumab (Praluent) is indicated for reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. This medication is also used in combination with a diet or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH). It is additionally recommended in combination with diet and other LDL-C-lowering therapies for pediatric patients aged 8 years and older with HeFH.
• The study involved a total of 32 systematic reviews/meta-analyses related to Praluent.
• In terms of efficacy among patients with Familial Hypercholesterolemia, both alirocumab and evolocumab demonstrated substantial effectiveness in reducing LDL-C levels by up to approximately 49.59% compared to placebo.
• For patients with established cardiovascular disease, alirocumab has been noted specifically for its ability to reduce all-cause mortality risk, which wasn't significantly demonstrated by evolocumab. Both medications, however, significantly reduced the risks associated with myocardial infarction, coronary revascularization, and ischemic stroke.
• Among diabetic patient subgroups, PCSK9 inhibitors like alirocumab or evolocumab resulted in a reduction of major adverse cardiovascular events by about 18%, while substantially improving lipid profiles.
• The overall safety profile shows that PCSK9 inhibitors such as alirocumab are well-tolerated without any significant association towards increased risk factors such as sepsis, onset diabetes, or neurocognitive events across the studies reviewed providing reassurance on their safety usage.
• Injection site reactions were more frequent with the administration of these drugs, but potential adverse effects like liver enzyme elevations, myopathy, or neurocognitive disorders did not significantly differ from control groups.
• The efficacy and safety profiles of PCSK9 inhibitors were consistent across various subgroups, including those with different genetic backgrounds of FH and diabetic status. No significant differential response in LDL-C reduction efficacy was observed across races or specific genetic variants within the FH population, suggesting a broad applicability for these treatments.