Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• Praluent (alirocumab) is indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. It is also used as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C. Additionally, it serves as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. Furthermore, it is used as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.
• This summary is based on the review of 35 systematic review(s)/meta-analysis(es). ^[1-35]
• LDL-C Reduction: Alirocumab and evolocumab demonstrated significant reductions in LDL-C levels, ranging from 45.52% to 65.3% compared to placebo. The most effective dosages were 150 mg Q2W for alirocumab and 140 mg Q2W for evolocumab.
• Cardiovascular Outcomes: Both alirocumab and evolocumab reduced the incidence of MACE by 18% (OR: 0.82). Alirocumab significantly reduced the risk of all-cause death, whereas evolocumab did not show a significant effect in this regard. These drugs also significantly reduced the risk of myocardial infarction, stroke, and coronary revascularization.
• Lipoprotein(a) Levels: PCSK9 inhibitors reduced Lp(a) levels by up to 25.1%, with the highest reductions observed with alirocumab 150 mg Q2W and evolocumab 140 mg Q2W.
• Population Considerations: In patients with familial hypercholesterolemia, alirocumab and evolocumab were effective in lowering LDL-C levels and achieving pre-defined targets. In patients with diabetes, these drugs significantly reduced MACE, myocardial infarction, stroke, and coronary revascularization.
• Treatment-Emergent Adverse Events (TEAE): PCSK9 inhibitors did not significantly alter the incidence of TEAEs compared to placebo.
• Serious Adverse Events (SAEs): No significant increase in serious adverse events, including infection, neurocognitive events, liver enzyme elevations, rhabdomyolysis, or new-onset diabetes mellitus. A slight, non-significant increase in injection site reactions was observed with alirocumab compared to evolocumab.
• Neurocognitive and Infection Safety: No significant difference in neurocognitive adverse effects or risk of sepsis and severe infections between PCSK9 inhibitors and control.
• PCSK9 inhibitors (alirocumab and evolocumab) were effective in reducing LDL-C levels and achieving LDL-C goals in patients with familial hypercholesterolemia, improved lipid profiles and reduced major adverse cardiovascular events (MACE) in diabetic patients, and were effective in secondary prevention of cardiovascular events in high-risk patients on statin-background therapy. In heart transplant recipients, PCSK9 inhibitors were associated with stable coronary plaque and calcineurin inhibitor levels. There were no significant safety concerns specifically highlighted for diabetic populations.