Drug updated on 3/28/2024
| Dosage Form | Injection (subcutaneous; 140 mg/mL, 420 mg/3.5 mL) |
| Drug Class | PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD).
- 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 .
- As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C.
- As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C.
Summary
- Evolocumab (Repatha) is indicated for reducing the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease; as an adjunct to diet alone or combined with other low-density lipoprotein cholesterol-lowering therapies in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia; and as an adjunct to diet and other LDL-C lowering therapies in pediatric patients aged 10 years and older.
- A total of 24 systematic reviews/meta-analyses were reviewed which focused on evaluating evolocumab (Repatha), comparing it primarily against alirocumab and inclisiran among others.
- Both evolocumab (Repatha) and alirocumab significantly reduce LDL-C levels across various patient populations such as those suffering from familial hypercholesterolemia, primary hyperlipidemia, or established cardiovascular disease.
- The safety profile of evolocumab (Repatha) was found comparable to that of alirocumab and inclisiran without any significant increase in adverse events like neurocognitive effects or injection site reactions compared to control groups using placebo or ezetimibe.
- In terms of major adverse cardiovascular events reduction benefits were observed for both evolocumab (Repatha) and alirocumabin certain trials while less specific information was available about inclisiran's impact on MACEs from the studys reviewed.
- Beyond just LDL-C reduction PCSK9 inhibitors like evolucamob (Repatha) and Alirocumb have also shown significant reductions in atherogenic lipids such as triglycerides, Lipoprotein along with improvements HDL-C.
- Evolucamob (Repatha) has been effective across a broad spectrum including Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease and in primary as well as secondary prevention settings.
- The studys reviewed suggest that the efficacy of evolocumab (Repatha) might vary based on genetic background of familial hypercholesterolemia patients indicating a potentially tailored approach to therapy could be beneficial.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Repatha (evolocumab) Prescribing Information. | 2021 | Amgen Inc., Thousand Oaks, CA |