Cited by 820Lipoproteins and Cardiovascular HealthLipid metabolism and disordersCholesterol and Lipid Metabolism

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Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia

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Raal, Frederick J., Kallend, David, Ray, Kausik K., Turner, Traci, Koenig, Wolfgang, Wright, R. Scott, Wijngaard, Peter L.J., Curcio, Danielle, Jaros, Mark J., Leiter, Lawrence A., Kastelein, John J.P.·2020·New England Journal of Medicine

DOI 10.1056/nejmoa1913805

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Abstract

BACKGROUND: Familial hypercholesterolemia is characterized by an elevated level of low-density lipoprotein (LDL) cholesterol and an increased risk of premature atherosclerotic cardiovascular disease. Monoclonal antibodies directed against proprotein convertase subtilisin-kexin type 9 (PCSK9) have been shown to reduce LDL cholesterol levels by more than 50% but require administration every 2 to 4 weeks. In a phase 2 trial, a twice-yearly injection of inclisiran, a small interfering RNA, was shown to inhibit hepatic synthesis of PCSK9 in adults with heterozygous familial hypercholesterolemia. METHODS: In this phase 3, double-blind trial, we randomly assigned, in a 1:1 ratio, 482 adults who had heterozygous familial hypercholesterolemia to receive subcutaneous injections of inclisiran sodium (at a dose of 300 mg) or matching placebo on days 1, 90, 270, and 450. The two primary end points were the percent change from baseline in the LDL cholesterol level on day 510 and the time-adjusted percent change from baseline in the LDL cholesterol level between day 90 and day 540. RESULTS: The median age of the patients was 56 years, and 47% were men; the mean baseline level of LDL cholesterol was 153 mg per deciliter. At day 510, the percent change in the LDL cholesterol level was a reduction of 39.7% (95% confidence interval [CI], -43.7 to -35.7) in the inclisiran group and an increase of 8.2% (95% CI, 4.3 to 12.2) in the placebo group, for a between-group difference of -47.9 percentage points (95% CI, -53.5 to -42.3; P<0.001). The time-averaged percent change in the LDL cholesterol level between day 90 and day 540 was a reduction of 38.1% (95% CI, -41.1 to -35.1) in the inclisiran group and an increase of 6.2% (95% CI, 3.3 to 9.2) in the placebo group, for a between-group difference of -44.3 percentage points (95% CI, -48.5 to -40.1; P<0.001). There were robust reductions in LDL cholesterol levels in all genotypes of familial hypercholesterolemia. Adverse events and serious adverse events were similar in the two groups. CONCLUSIONS: Among adults with heterozygous familial hypercholesterolemia, those who received inclisiran had significantly lower levels of LDL cholesterol than those who received placebo, with an infrequent dosing regimen and an acceptable safety profile. (Funded by the Medicines Company; ORION-9 ClinicalTrials.gov number, NCT03397121.).

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Additional file 2 of Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2)
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Authors: Raal, F. J., Kallend, D., Ray, K. K., Turner, T., Koenig, W., Wright, R. S., Wijngaard, P. L. J., Curcio, D., Jaros, M. J., Leiter, L. A., & Kastelein, J. J. P.
Affiliations: University of the Witwatersrand (ZA)
Medpace (United States) (US)
From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa (F.J.R.); the Medicines Company, Zurich, Switzerland (D.K.); the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College, London (K.K.R.); Medpace Reference Laboratories, Cincinnati (T.T.); Deutsches Herzzentrum München, Technische Universität München, and German Center for Cardiovascular Research, Munich Heart Alliance, Munich (W.K.), and the...
Mayo Clinic (US)
St. Michael's Hospital (CA)
ORCID: Raal, Frederick J.
Kallend, David
Ray, Kausik K.
Turner, Traci
Wright, R. Scott
Curcio, Danielle
Leiter, Lawrence A.
Kastelein, John J.P.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2020-04-16
Volume: 382
Issue: 16
Pages: 1520-1530
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1913805
OpenAlex: W3011005820
Semantic Scholar: cd7f15bcb062953bf710c34645a08f7b4818c4d9
Cited by: 818
References: 52
Citations by year: 2026: 88 · 2025: 126 · 2024: 142 · 2023: 154 · 2022: 140 · 2021: 111 · 2020: 56
FWCI: 105.56
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Pure Amsterdam UMC (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
Data Archiving and Networked Services (DANS) (submittedVersion)
mediaTUM (Technical University of Munich) (submittedVersion)
Spiral (Imperial College London) (submittedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
Keywords: inclisiran, heterozygous familial hypercholesterolemia, PCSK9 inhibition, siRNA, LDL cholesterol lowering, atherosclerotic cardiovascular disease prevention, hypercholesterolemia treatment, lipid-lowering therapy, PCSK9 monoclonal antibodies
MeSH terms: Proprotein Convertase 9, PCSK9 Inhibitors, Adult, Anticholesteremic Agents, Double-Blind Method, Female, Humans, Hyperlipoproteinemia Type II, Injections, Subcutaneous, Cholesterol, LDL, Male, Middle Aged, Treatment Outcome, RNA, Small Interfering

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Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia

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