Although statins play a pivotal role in the prevention of atherosclerotic cardiovascular disease, many patients fail to achieve recommended lipid levels due to statin-associated muscle symptoms. Bempedoic acid is an oral pro-drug that is activated in the liver and inhibits cholesterol synthesis in hepatocytes, but is not activated in skeletal muscle which has the potential to avoid muscle-related adverse events. Accordingly, this agent effectively lowers atherogenic lipoproteins in patients who experience statin-associated muscle symptoms. However, the effects of bempedoic acid on cardiovascular morbidity and mortality have not been studied. STUDY DESIGN: Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes is a randomized, double-blind, placebo-controlled clinical trial. Included patients must have all of the following: (i) established atherosclerotic cardiovascular disease or have a high risk of developing atherosclerotic cardiovascular disease, (ii) documented statin intolerance, and (iii) an LDL-C ≥100 mg/dL on maximally-tolerated lipid-lowering therapy. The study randomized 14,014 patients to treatment with bempedoic acid 180 mg daily or matching placebo on a background of guideline-directed medical therapy. The primary outcome is a composite of the time to first cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. The trial will continue until 1620 patients experience a primary endpoint, with a minimum of 810 hard ischemic events (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) and minimum treatment duration of 36 months and a projected median treatment exposure of 42 months. CONCLUSIONS: CLEAR Outcomes will determine whether bempedoic acid 180 mg daily reduces the incidence of adverse cardiovascular events in high vascular risk patients with documented statin intolerance and elevated LDL-C levels.
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http://dx.doi.org/10.1016/j.ahj.2020.10.060 | DOI Listing |
Expert Opin Pharmacother
December 2024
Department of Metabolic Medicine/Chemical Pathology Guy's, St Thomas' Hospitals, London, UK.
Introduction: Lipid-lowering therapies are well established for the treatment of cardiovascular disease (CVD). Historically monotherapy studies have been performed, but the introduction of statins has led to these drugs being recognized as baseline therapies and to the investigation of combination therapy of both older and newer medications with them.
Areas Covered: Surrogate marker studies have shown additive effects on LDL-C, triglycerides and HDL-C of combination therapies with statins and these have extended to lipoprotein (a).
Hosp Pharm
December 2024
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore, India.
Lipid-lowering therapy (LLT) includes a diverse group of pharmaceuticals designed to reduce blood levels of cholesterol and triglyceride (TG), helping to prevent cardiovascular diseases like myocardial infarction and stroke. LLT includes treatment with several lipid-lowering drugs (LLD), including hydroxymethylglutaryl (HMG-CoA) reductase inhibitors (statin), PCSK9 Inhibitors, cholesterol-absorbing inhibitors (Ezetimibe), Bile Acid Sequestrants, Fibrates, Niacin (Vitamin B3), Omega-3 Fatty Acids, Bempedoic Acid, and combination therapy. The efficacy and safety of these molecules vary widely.
View Article and Find Full Text PDFJACC Case Rep
December 2024
Cardiology Unit, Policlinico di Modena Hospital, Modena, Italy.
Myotonic dystrophy type 1 (MD1) is the most common form of muscular dystrophy in adults. MD1 is caused by the expansion of CTG repeats in the DMPK gene and affects various organs beyond muscles. We present a case of a patient with MD1 exhibiting features of metabolic syndrome (MetS), including insulin resistance and dyslipidemia.
View Article and Find Full Text PDFJ Clin Med
December 2024
Interventional Cardiology, Sandro Pertini Hospital, 00157 Rome, Italy.
Cardio-cerebral vascular diseases due to atherosclerosis are still the leading cause of death worldwide. Low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B have been identified as the primary factors responsible for the atherosclerotic process, with a causal effect. Many drugs aimed at reducing LDL-C levels are already on the market, acting in different ways in terms of mechanism of action, efficacy, and safety.
View Article and Find Full Text PDFPharmacotherapy
December 2024
Department of Pharmacotherapy & Outcomes Science, Virginia Commonwealth University School of Pharmacy, Richmond, Virginia, USA.
Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of death worldwide. Lowering low-density lipoprotein cholesterol (LDL-C) levels is a primary strategy to reduce ASCVD risk. Although statin therapy remains the initial therapy of choice to reduce LDL-C and ASCVD risk, statin intolerance and suboptimal LDL-C lowering response prompts the need for additional non-statin therapies.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!