Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States

TL;DR

This study estimates how many U.S. adults could benefit from inclisiran, a new drug that lowers cholesterol, and how many heart disease events it could prevent.

Contribution

The study provides the first U.S.-specific estimates of inclisiran eligibility and potential cardiovascular event prevention.

Findings

Approximately 20 million U.S. adults may be eligible for inclisiran treatment.

Inclisiran could prevent over 1.6 million atherosclerotic cardiovascular disease events over 10 years.

Most preventable events are projected to occur among males and White patients.

Abstract

Many patients do not reach recommended low-density lipoprotein cholesterol (LDL-C) levels on statins alone. Inclisiran is a small interfering RNA providing ∼50% further reduction in LDL-C.

The authors estimated the number of U.S. adults eligible for inclisiran and the number of preventable atherosclerotic cardiovascular disease (ASCVD) events with inclisiran use.

Using a cross-sectional study of the National Health and Nutrition Examination Survey 2011 to 2020, the authors identified 3 cohorts: high-risk primary prevention (≥20% 10-year ASCVD risk or 7.5% to <20% with ≥2 risk-enhancing factors), diabetes, and secondary prevention. Included adults were ≥18 years with LDL-C ≥70 mg/dL (≥55 mg/dL if very high-risk for ASCVD events) despite statin therapy. The ASCVD Pooled Cohort Equation and SMART2 risk score were used to estimate ASCVD events in 10 years “without inclisiran.” Preventable ASCVD events were calculated “with inclisiran” using inclisiran trial data to estimate LDL-C reduction and Cholesterol Treatment Trialists’ data to estimate reductions in ASCVD events per mmol/L of LDL-C.

Among the high-risk primary prevention, diabetes, and secondary prevention cohorts, the authors estimated 5.4 million, 6.5 million, and 8.0 million U.S. adults, respectively, to be eligible for inclisiran. Based on 34.5%, 29.0%, and 29.0% respective risk reductions, the authors estimated ∼448,600, ∼459,800, and ∼711,000 ASCVD events could be prevented over 10 years with inclisiran. Most preventable ASCVD events occurred among males and White patients.

Approximately 20 million U.S. adults with inadequately controlled LDL-C may be eligible for inclisiran, with the potential to prevent over 1.6 million ASCVD events over 10 years.

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