☆ 3.8 Review

Inclisiran: A New Strategy for LDL-C Lowering and Prevention of Atherosclerotic Cardiovascular Disease

VASCULAR HEALTH AND RISK MANAGEMENT (2023)

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Inclisiran and cardiovascular events: a patient-level analysis of phase III trials

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Summary: Exploratory findings from the ORION trials suggest that treatment with inclisiran is associated with reductions in major cardiovascular events, providing potential cardiovascular benefits.

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Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial

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Summary: This study aimed to assess the long-term effect of inclisiran on patients with high cardiovascular risk and elevated LDL cholesterol. The results showed that twice-yearly treatment with inclisiran resulted in sustained reductions in LDL cholesterol and was well tolerated over 4 years.

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Inclisiran creates unique opportunities and challenges for patient access to therapy: early experience in a United States Lipid Clinic

Tommy T. Chiou et al.

Summary: We presented an early experience with inclisiran in an academic lipid clinic, administered by healthcare professionals. The study showed variations in approval rates among different insurance types, with Medicare beneficiaries having higher approval rates compared to non-Medicare insurance holders. The findings suggest the need for increased accessibility of inclisiran, particularly for younger patients with non-Medicare insurance.

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Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association

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Review Cardiac & Cardiovascular Systems

Efficacy and safety for the achievement of guideline-recommended lower low-density lipoprotein cholesterol levels: a systematic review and meta-analysis

Safi U. Khan et al.

Summary: This meta-analysis found that intensive lipid-lowering therapy to achieve LDL-C levels below 70 mg/dL can safely reduce the risk of mortality and major adverse cardiovascular events (MACE).

EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY (2022)

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Small interfering ribonucleic acid for cholesterol lowering - Inclisiran

Daniel Soffer et al.

Summary: Despite the development of new therapies, the trend of reductions in cardiovascular disease (CVD) mortality has reversed. Lowering low-density lipoprotein cholesterol (LDL-C) is important for preventing and managing atherosclerotic CVD (ASCVD), but many patients with established ASCVD fail to achieve guideline-recommended LDL-C targets.

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New Strategies for Lowering Low-Density Lipoprotein Cholesterol for Cardiovascular Disease Prevention

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Summary: This review focuses on the recent FDA-approved medications for reducing LDL-C and ASCVD risk, including PCSK9 inhibitors, ATP citrate lyase inhibitors, and siRNA molecules.

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Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease

Michelle L. O'Donoghue et al.

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2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk

Donald M. Lloyd -Jones et al.

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Review Cardiac & Cardiovascular Systems

Inclisiran: A New Pharmacological Approach for Hypercholesterolemia

Stefania Angela Di Fusco et al.

Summary: Therapeutic approaches based on gene silencing technologies, such as inclisiran, have shown promise in managing hypercholesterolemia. Inclisiran effectively reduces LDL-C levels and is safe and well-tolerated. A meta-analysis of phase 3 trials demonstrated a significant reduction in LDL-C levels with inclisiran compared to placebo. Although patients receiving inclisiran may experience more reactions at the injection site, overall adverse event incidence is comparable to placebo.

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Article Cardiac & Cardiovascular Systems

Lipid treatment status and goal attainment among patients with atherosclerotic cardiovascular disease in the United States: A 2019 update

Jing Gu et al.

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AMERICAN JOURNAL OF PREVENTIVE CARDIOLOGY (2022)

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Review Cardiac & Cardiovascular Systems

How low is safe? The frontier of very low (<30 mg/dL) LDL cholesterol

Angelos D. Karagiannis et al.

Summary: LDL-C is a causative factor for atherosclerotic cardiovascular disease, and pharmacological interventions can lower LDL-C levels. More patients are achieving very low LDL-C levels, with cardiovascular event reduction increasing log linearly in association with lowering LDL-C.

EUROPEAN HEART JOURNAL (2021)

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Treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe: baseline demographics from the multinational observational SANTORINI study

K K Ray et al.

EUROPEAN HEART JOURNAL (2021)

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Article Cardiac & Cardiovascular Systems

Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis

R. Scott Wright et al.

Summary: Inclisiran, a double-stranded small interfering RNA, was shown to effectively lower LDL-C levels in adults with heterozygous familial hypercholesterolemia, ASCVD, or ASCVD risk equivalents, with a good safety profile in a patient-level pooled analysis from three phase 3 studies.

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Review Chemistry, Medicinal

Bempedoic Acid for Heterozygous Familial Hypercholesterolemia: From Bench to Bedside

Anandita Agarwala et al.

Summary: Bempedoic acid is a first-in-class oral inhibitor of cholesterol biosynthesis approved for use in patients with ASCVD and HeFH, with promising results in lowering LDL-C levels. The ongoing CLEAR Outcomes trial will provide further insights into its placement among non-statin lipid-lowering therapy options.

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Walhan Alshaer et al.

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Use of Lipid-Lowering Therapies Over 2 Years in GOULD, a Registry of Patients With Atherosclerotic Cardiovascular Disease in the US

Christopher P. Cannon et al.

Summary: This study tracked LDL-C treatment patterns in US patients with atherosclerotic cardiovascular disease over 2 years and found that only 17.1% of patients had lipid-lowering therapy intensification after 2 years, with most patients still having LDL-C levels greater than 70 mg/dL. Efforts are needed to achieve optimal LDL-C management in patients with ASCVD.

JAMA CARDIOLOGY (2021)

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How low is safe? The frontier of very low (<30 mg/dL) LDL cholesterol

Angelos D. Karagiannis et al.

Summary: Low-density lipoprotein cholesterol is a proven causative factor for atherosclerotic cardiovascular disease, and pharmacological interventions can significantly lower it to very low levels. However, there is still controversy surrounding potential adverse effects and further long-term studies are needed for safety concerns.

EUROPEAN HEART JOURNAL (2021)

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2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS)

Francois Mach et al.

EUROPEAN HEART JOURNAL (2020)

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Small Interfering RNA Therapeutic Inclisiran: A New Approach to Targeting PCSK9

Charles A. German et al.

BIODRUGS (2020)

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Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies

R. Scott Wright et al.

MAYO CLINIC PROCEEDINGS (2020)

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Article Medicine, General & Internal

Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol

Kausik K. Ray et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia

Frederick J. Raal et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Review Cardiac & Cardiovascular Systems

Targeting RNA With Antisense Oligonucleotides and Small Interfering RNA JACC State-of-the-Art Review

Julius L. Katzmann et al.

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2020)

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Editorial Material Cardiac & Cardiovascular Systems

Cholesterol-Years for ASCVD Risk Prediction and Treatment

Michael D. Shapiro et al.

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2020)

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Article Cardiac & Cardiovascular Systems

Effect of 1 or 2 Doses of Inclisiran on Low-Density Lipoprotein Cholesterol Levels: One-Year Follow-up of the ORION-1 Randomized Clinical Trial

Kausik K. Ray et al.

JAMA CARDIOLOGY (2019)

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Review Medicine, General & Internal

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Erin D. Michos et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

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Conceptual Framework for Addressing Residual Atherosclerotic Cardiovascular Disease Risk in the Era of Precision Medicine

Kershaw V. Patel et al.

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY (2018)

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