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December 06, 2022
Inclisiran: A Newly Approved Cholesterol Lowering Medication. The 2018 American Heart Association (AHA)/American College of Cardiology (ACC) Multisociety Guideline on the Management of Blood Cholesterol provides guidance for both statin and nonstatin therapy. Since that guideline’s publication, new nonstatin therapies have been approved for low-density lipoprotein cholesterol (LDL-C) lowering. In December 2021, the U.S. Food and Drug Administration (FDA) approved inclisiran as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional LDL-C lowering. This approval came following LDL-C lowering and safety demonstrated in the ORION 9, 10, and 11 clinical trials. The ongoing ORION-4 trial will provide evidence as to whether inclisiran lowers cardiovascular events in those with established ASCVD not achieving LDL-C goals.
Upon completion of the chapter, the reader will be able to:
Identify the common types of lipid disorders.
Identify the statin-benefit groups and intensity of statin therapy according to the American College of Cardiology/American Heart Association.
Recommend appropriate therapeutic lifestyle changes (TLC) and pharmacotherapy interventions for dyslipidemia.
Determine a patient’s atherosclerotic cardiovascular disease risk and corresponding treatment goals according to the National Lipid Association, American Association of Clinical Endocrinologist/American College of Endocrinology, and American Heart Association/American College of Cardiology.
Identify patients who are indicated for nonstatin therapy according to the American Heart Association/American College of Cardiology.
Describe components of a monitoring plan to assess effectiveness and adverse effects of pharmacotherapy for dyslipidemias.
Educate patients about the disease state, appropriate TLC, and drug therapy required for effective treatment.
Hypercholesterolemia, or dyslipidemia, plays a major role in atherosclerosis and plaque formation leading to coronary heart disease (CHD) as well as other forms of atherosclerotic cardiovascular disease (ASCVD), such as carotid and peripheral artery disease.1 CHD is the leading cause of death in adults in the United States and most industrialized nations. It is also the chief cause of premature, permanent disability in the US workforce.
EPIDEMIOLOGY AND ETIOLOGY
It is estimated that 92.8 million US adults have high cholesterol with a value of 200 mg/dL (5.17 mmol/L) or greater.2 Further, one out of every three US adults has high low-density lipoprotein (LDL) cholesterol (≥ 130 mg/dL [3.36 mmol/L]).2 Elevated cholesterol values are a major risk factor for development of ASCVD. Annually, approximately 805,000 Americans experience a new heart attack or recurrent event.2 Lowering cholesterol reduces atherosclerotic progression and mortality from CHD and stroke. Development of CHD is a lifelong process. Except in rare cases of severely elevated serum cholesterol levels, years of poor dietary habits, sedentary lifestyle, and life-habit risk factors (eg, smoking, overweight/obesity) contribute to the development of atherosclerosis....