From the Guidelines
Repatha (evolocumab) is indicated for adults with established cardiovascular disease to reduce the risk of heart attack, stroke, and coronary revascularization, and for patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL cholesterol, as evidenced by the most recent guidelines 1. The primary use of Repatha is as an adjunctive therapy for patients with ASCVD or familial hypercholesterolemia who are receiving maximally tolerated statin therapy but require additional lowering of LDL cholesterol 1. Key points to consider when prescribing Repatha include:
- The standard dose is 140 mg every two weeks or 420 mg once monthly, administered as a subcutaneous injection 1.
- Patients can self-administer using either a prefilled autoinjector or syringe.
- Repatha works by inhibiting PCSK9, a protein that regulates LDL receptor recycling, thereby increasing LDL receptor availability on liver cells and enhancing clearance of LDL cholesterol from the bloodstream 1.
- This mechanism allows for substantial LDL reduction, typically 50-60% beyond what statins alone can achieve, as demonstrated in the FOURIER trial 1. The most recent guidelines from 2022 support the use of Repatha for these indications, highlighting its efficacy in reducing LDL cholesterol and improving cardiovascular outcomes 1.
From the Research
Indication for Repatha (Evolocumab)
The indication for Repatha (Evolocumab) can be summarized as follows:
- Primary hypercholesterolemia or mixed dyslipidemia, particularly in patients unable to reach LDL-C goals despite treatment with statins with or without other lipid-lowering therapies and in patients who do not tolerate or are not able to receive statins 2
- Heterozygous familial hypercholesterolemia, especially when added to statin therapy 2, 3, 4
- Homozygous familial hypercholesterolemia, when added to statins with or without other lipid-lowering therapies 2, 3, 5
- Clinical atherosclerotic cardiovascular disease where LDL-C lowering is insufficient 3, 5
Patient Eligibility
Eligibility criteria for Repatha (Evolocumab) treatment include:
- Patients with LDL-C ≥70 mg/dL despite maximal-tolerated LDL-cholesterol-lowering therapy 3
- Patients with heterozygous familial hypercholesterolemia and LDL-C >100 mg/dL despite maximal-tolerated dose of standard-of-care LDL cholesterol-lowering therapy 3
- Patients with statin intolerance, without heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease 3
Efficacy of Evolocumab
The efficacy of Evolocumab in reducing LDL-C levels has been demonstrated in several studies:
- A 12-week phase III trial showed that Evolocumab significantly lowered LDL-C levels by approximately 54.8-76.3% compared to placebo 2
- A clinical practice experience study found that Evolocumab reduced LDL-C levels by 58% in patients with heterozygous familial hypercholesterolemia 4
- A network meta-analysis compared the efficacy of Evolocumab with other non-statin lipid-lowering therapies and found that Evolocumab provided superior efficacy in reducing LDL-C levels 6