Drug updated on 3/28/2024
| Dosage Form | Injection (subcutaneous; 75 mg/mL, 150 mg/mL) |
| Drug Class | PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
- Indicated 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.
- Indicated as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
Summary
- Alirocumab (Praluent) 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 for adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH).
- A total of 22 systematic reviews/meta-analyses were reviewed which provided insights into alirocumab's safety, effectiveness, and comparative performance against other drugs within different population types and subgroups.
- The drug has shown substantial efficacy in reducing LDL-C across general populations as well as specific subgroups such as patients with FH, diabetes mellitus, and established CVD; it was effective both when used alone or combined with statins.
- In terms of safety profile among various patient populations studied PCSK9 inhibitors like alirocumab exhibited a favorable outcome; incidence of serious adverse events did not significantly differ from control groups indicating long term tolerance.
- When compared to ezetimibe and statins PCSK9 inhibitors outperformed these therapies in reducing LDL-C levels making them a superior option for individuals who cannot achieve target LDL-C levels using only statins.
- Indirect comparisons between alirocumab vs evolocumab showed mixed evidence on superiority regarding LDL-C reduction but shared similar safety profiles though differences exist warranting further direct head-to-head comparisons especially concerning all-cause mortality outcomes where some evidence suggests that alirocumab may reduce death rates more than controls do.
- For high-risk cardiovascular patients including those suffering from diabetes mellitus PCSK9 inhibitors like Praluent show significant promise by improving lipid profiles and reducing the incidence of major adverse cardiovascular events (MACE).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Praluent (alirocumab) Prescribing Information. | 2021 | Regeneron Pharmaceuticals, Inc. Tarrytown, NY |