Drug updated on 9/5/2024
| Dosage Form | Injection (subcutaneous; 140 mg/mL, 420 mg/3.5 mL) |
| Drug Class | Proprotein convertase subtilisin kexin type 9 inhibitors (PCSK9) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicate in adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD).
- 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 diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C.
- Indicated 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.
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Summary
- Repatha (evolocumab) is indicated in adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization; 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; and 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.
- This summary is based on the review of 31 systematic review(s)/meta-analysis(es). [1-31]
- Reduction in LDL-C: Evolocumab reduced LDL-C by -61.09% (95% CI: -64.81, -57.38), alirocumab by -46.35% (95% CI: -51.75, -41.13), and inclisiran by -54.83% (95% CI: -59.04, -50.62) at 284mg and -43.11% (95% CI: -52.42, -33.80) at 300mg, compared to placebo.
- Impact on Major Adverse Cardiac Events (MACE): Evolocumab reduced MACE risk by 15% (OR 0.85, 95% CI: 0.80, 0.89), and alirocumab by 65% (OR 0.35, 95% CI: 0.16, 0.77), with a combined reduction in diabetic patients (OR 0.82; 95% CI: 0.74-0.90).
- Reduction in Cardiovascular and All-Cause Mortality: Alirocumab reduced cardiovascular mortality (OR 0.35, 95% CI: 0.16, 0.77) and all-cause mortality (OR 0.60, 95% CI: 0.43, 0.84), with no significant mortality reduction observed for evolocumab.
- Other Lipid Parameters: Evolocumab and alirocumab significantly reduced lipoprotein(a), triglycerides, total cholesterol, non-HDL-C, and apolipoprotein B, while increasing HDL-C and apolipoprotein A1.
- Treatment-Emergent Adverse Events (TEAEs): PCSK9 inhibitors did not significantly alter the risk of TEAEs compared to placebo (RR 0.92, 95% CI 0.75, 1.13).
- Severe Adverse Events (SAEs): No significant increase in SAEs was observed with PCSK9 inhibitors overall (RR 1.04, 95% CI 0.99, 1.08), though alirocumab specifically was associated with a reduced risk of SAEs compared to controls (RR 0.94, 95% CI 0.90-0.99).
- Injection Site Reactions: An increased risk of injection site reactions was noted with alirocumab compared to evolocumab (RR 1.27).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Repatha (evolocumab) Prescribing Information. | 2021 | Amgen Inc., Thousand Oaks, CA |