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Meta ‐analysis of clinical outcomes of PCSK9 modulators in patients with established ASCVD
AbstractThe advent of monoclonal antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) ushered in a new era of dyslipidemia pharmacotherapy. The first two antibodies targeting PCSK9 (evolocumab, alirocumab) approved by the United States Food and Drug Administration (FDA) provided significant and sustained reductions in atherogenic lipids and a reduced risk of atherosclerotic cardiovascular disease (ASCVD) events. More recently, phase 3 trials of inclisiran —a small interfering RNA-based agent targeting PCSK9—reported similar lipid-lowering effects and preliminary evidence of ASCVD risk reduction, a...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - October 30, 2021 Category: Drugs & Pharmacology Authors: Azita H. Talasaz, Ai ‐Chen (Jane) Ho, Fawzia Bhatty, Rachel A. Koenig, Dave L. Dixon, William L. Baker, Benjamin W. Van Tassell Tags: TI ON ADVANCES IN CARDIOVASCULAR PHARMACOTHERAPY Source Type: research

Usefulness of alirocumab and evolocumab for the treatment of patients with diabetic dyslipidemia.
Abstract In 2015, the US Food and Drug Administration (FDA) approved the anti-proprotein convertase subtilsin/kexin type 9 (PCSK9) monoclonal antibodies, alirocumab and evolocumab, to treat patients with hypercholesterolemia and mixed dyslipidemia. Since then, considerable attention has been paid to the use of these monoclonal antibodies for the treatment of diabetic dyslipidemia with a goal of reducing the risk for cardiovascular disease. Recently, consensus statements on the clinical use of PCSK9 inhibitors in patients with type 2 diabetes mellitus, who are unable to achieve the goal of low-density lipoprotein c...
Source: Baylor University Medical Center Proceedings - April 1, 2018 Category: Universities & Medical Training Authors: Zhang J, Tecson KM, Rocha NA, McCullough PA Tags: Proc (Bayl Univ Med Cent) Source Type: research

The case for adding eicosapentaenoic acid (icosapent ethyl) to the ABCs of cardiovascular disease prevention.
Authors: Trivedi K, Le V, Nelson JR Abstract The high-purity eicosapentaenoic acid (EPA) prescription fish oil-derived omega-3 fatty acid (omega-3), icosapent ethyl (IPE), was recently approved by the United States Food and Drug Administration (FDA) for cardiovascular disease (CVD) prevention in high-risk patients. This approval is based on the 25% CVD event risk reduction observed with IPE in the pre-specified primary composite endpoint (cardiovascular [CV] death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) in the landmark Reduction of Cardio...
Source: Postgraduate Medicine - August 13, 2020 Category: Internal Medicine Tags: Postgrad Med Source Type: research

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA ™(6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.1 The FDA approval of INVEGA ...
Source: Johnson and Johnson - September 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New ERLEADA ® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
SAN FRANCISCO, Feb. 14, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new real-world evidence data showing the initiation of ERLEADA® (apalutamide) results in high rates of rapid and deep prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC). In a separate post-hoc analysis of the registrational Phase 3 SPARTAN and TITAN studies, rapid and deep PSA responses with ERLEADA® were associated with improvement in patient-reported outcomes (PROs) related to quality of life, physical wellbeing, pain, and fatigue intensity. The...
Source: Johnson and Johnson - February 14, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Straight from the heart: Mysterious lipids may predict cardiac problems better than cholesterol
Stephanie Blendermann, 65, had good reason to worry about heart disease. Three of her sisters died in their 40s or early 50s from heart attacks, and her father needed surgery to bypass clogged arteries. She also suffered from an autoimmune disorder that results in chronic inflammation and boosts the odds of developing cardiovascular illnesses. “I have an interesting medical chart,” says Blendermann, a real estate agent in Prior Lake, Minnesota. Yet Blendermann’s routine lab results weren’t alarming. At checkups, her low-density lipoprotein (LDL), or “bad,” cholesterol hovered around the 100 milligrams-per-...
Source: Science of Aging Knowledge Environment - March 16, 2023 Category: Geriatrics Source Type: research

Plain language summary of results from ORION-10 and ORION-11: Two studies to learn how well inclisiran works in people with high cholesterol
Future Cardiol. 2023 Jun 6. doi: 10.2217/fca-2022-0133. Online ahead of print.ABSTRACTWHAT IS THIS PLAIN LANGUAGE SUMMARY ABOUT?: This is a summary of the article describing the results of the ORION-10 and ORION-11 studies, which was published in the New England Journal of Medicine in April 2020. The studies included adult participants with atherosclerotic cardiovascular disease (ASCVD). ASCVD happens when the blood vessels that carry blood from the heart to other areas of the body are blocked by fatty build-up (plaque) causing a heart attack, stroke, or other problems. High levels of low-density lipoprotein cholesterol (L...
Source: Atherosclerosis - June 7, 2023 Category: Cardiology Authors: Kausik K Ray R Scott Wright Source Type: research