European Heart Journal

New REDUCE-IT® Analyses Show VASCEPA® (icosapent ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome, but Without Diabetes at Baseline

Retrieved on: 
Sunday, November 12, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 12, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced results from new REDUCE-IT analyses showing that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition of VASCEPA/VAZKEPA (icosapent ethyl) significantly reduced the risk of first and total cardiovascular events. This subgroup was almost exclusively comprised of patients with established cardiovascular disease. The results were presented today at the American Heart Association (AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open.

Key Points: 
  • This subgroup was almost exclusively comprised of patients with established cardiovascular disease.
  • The results were presented today at the American Heart Association (AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open.
  • The large relative and absolute risk reductions observed supports IPE as an important therapeutic option for patients with metabolic syndrome at high cardiovascular risk, despite lacking robust effects on any metabolic syndrome component.
  • In addition, variation in subjective measures (e.g., waist circumference) may have affected classification of metabolic syndrome.

New Study Published in Cardiovascular Digital Health Journal Shows Implicity's Algorithm Significantly Reduces AF Alert Burden in Remote Cardiac Monitoring

Retrieved on: 
Tuesday, October 24, 2023

CAMBRIDGE, Mass., Oct. 24, 2023 /PRNewswire/ -- Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, today announced the results of a clinical study published in the Cardiovascular Digital Health Journal.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 24, 2023 /PRNewswire/ -- Implicity , a leader in remote patient monitoring (RPM) and cardiac data management solutions, today announced the results of a clinical study published in the Cardiovascular Digital Health Journal.
  • "For a patient with AF who is already anticoagulated, a single AF episode isn't as important as established patterns or occurrences associated with arrhythmia progression and patient outcomes.
  • Results showed the algorithm broke down 67,883 AF burden-related alerts into 9,728 (14.3%) clinically relevant AF events, according to the European Society of Cardiology classification.
  • Implicity's algorithm works with any device that collects atrial burden trends data and can classify the following scenarios in line with ESC recommendations:

CytoSorbents Highlights Upcoming Presentations at EACTS 2023: Focus on Antithrombotic Removal including the 2nd Analysis of the International STAR Registry

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Wednesday, September 27, 2023

The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting.

Key Points: 
  • The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting.
  • The STAR Registry, not to be confused with the completed U.S. and Canada STAR-T pivotal trial, is enrolling ahead of internal projections with plans for ongoing presentations at large, international conferences.
  • The first registry analysis entitled, “ Insights from the International Safe and Timely Antithrombotic Removal (STAR) Registry ” was presented at the EuroPCR conference in May 2023, the largest interventional cardiology conference in the E.U., attracting 11,500+ participants this year.
  • It also includes, for the first time, data on patients being treated with CytoSorb to reduce seven different antithrombotic medications.

CorVista Health Announces FDA Clearance of the Novel CorVista System to Detect the Presence of Cardiac Disease

Retrieved on: 
Tuesday, September 12, 2023

CorVista Health, Inc ., a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the FDA clearance of the CorVista System® with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.

Key Points: 
  • CorVista Health, Inc ., a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the FDA clearance of the CorVista System® with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.
  • The CAD Add-On is the first of the company’s anticipated suite of cardiac detection algorithms to receive market clearance.
  • “From all of us at CorVista Health, we are thrilled to announce we have obtained FDA clearance of the CorVista System,” said Don Crawford, President and CEO of CorVista Health.
  • “CorVista Health’s innovative solution has the potential to make a tremendous impact to our healthcare system and enable more equitable care.”
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LIB Therapeutics Announces Positive Results from the Phase 3 Long-term Efficacy and Safety of Lerodalcibep in Heterozygous Familial Hypercholesterolemia (LIBerate-HeFH) Trial

Retrieved on: 
Monday, August 28, 2023

The results from the large global Phase 3 randomized, placebo-controlled trial, of lerodalcibep, the company’s monthly small binding protein PCSK9 inhibitor, in patients with heterozygous familial hypercholesterolemia (HeFH) were presented today at the European Society of Cardiology and simultaneously published in the European Heart Journal.

Key Points: 
  • The results from the large global Phase 3 randomized, placebo-controlled trial, of lerodalcibep, the company’s monthly small binding protein PCSK9 inhibitor, in patients with heterozygous familial hypercholesterolemia (HeFH) were presented today at the European Society of Cardiology and simultaneously published in the European Heart Journal.
  • The trial enrolled 478 adult participants, who were randomized 2:1 to receive lerodalcibep or placebo for a 24-week treatment period.
  • The mean reduction in Apolipoprotein B of 45.6% and median reduction in Lp(a) of 24% compared to patients treated with placebo were statistically significant (p
  • Lerodalcibep was well-tolerated, with a safety profile generally comparable to placebo with only mild injection site adverse events being observed more frequently than placebo.

EQS-News: SYNLAB AG: SYNLAB plays key role in the largest ever multinational study on cholesterol

Retrieved on: 
Monday, July 17, 2023

SYNLAB (FSE: SYAB), the leader in medical diagnostic services and specialty testing in Europe, provided significant support for the largest ever multi-national study on circulating cholesterol concentrations.

Key Points: 
  • SYNLAB (FSE: SYAB), the leader in medical diagnostic services and specialty testing in Europe, provided significant support for the largest ever multi-national study on circulating cholesterol concentrations.
  • It posits that geographical location and sex as well as cultural and genetic differences influence cholesterol levels.
  • The research, moreover, includes medically recognised laboratory markers of cardiovascular disease risk, including levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides.
  • Of these, the highest mean total cholesterol levels were in Austria (5.40 mmol/L, 208.8 mg/dL) and Germany (5.35 mmol/L, 206.9 mg/dL).

Analysis of Half a Billion Lipid Tests from Five Continents Reveals Wide Variation of Heart Disease Lipid Risk by Country and Sex

Retrieved on: 
Monday, July 10, 2023

Published in European Heart Journal , the analysis includes globally recognized laboratory markers of cardiovascular disease risk, including levels of total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, and triglyceride.

Key Points: 
  • Published in European Heart Journal , the analysis includes globally recognized laboratory markers of cardiovascular disease risk, including levels of total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, and triglyceride.
  • The World Health Organization (WHO) and clinical practice guidelines in different countries recognize lipid testing’s clinical value.
  • Of these, the highest mean total cholesterol levels were in Austria (5.40 mmol/L, 208.8 mg/dL) and Germany (5.35 mmol/L, 206.9 mg/dL).
  • While the laboratories involved in the analysis are leaders in their respective countries, their laboratory data may not fully represent any particular country or geography.

Windtree Therapeutics to Host Virtual R&D and Investor Day Focusing on the Cardiogenic Shock Market, Istaroxime, Company Strategy and Planned Near-Term Milestones

Retrieved on: 
Monday, June 5, 2023

WARRINGTON, Pa., June 05, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced it will host a virtual R&D and Investor Day on Wednesday, June 14, 2023 at 1:00 PM ET. The program will feature the Company’s lead drug candidate, istaroxime, a first in class, dual-acting agent, being developed to treat cardiogenic shock and acute decompensated heart failure. Istaroxime is designed to improve systolic contraction and diastolic relaxation of the heart.

Key Points: 
  • The program will feature the Company’s lead drug candidate, istaroxime, a first in class, dual-acting agent, being developed to treat cardiogenic shock and acute decompensated heart failure.
  • Istaroxime is designed to improve systolic contraction and diastolic relaxation of the heart.
  • Members of Windtree’s leadership team will present istaroxime early cardiogenic shock study data and provide insight into the istaroxime expanded development strategy and planned near-term milestones.
  • Additionally, strategy related to acute heart failure, the follow-on oral, SERCA2a activators and business development will be discussed.

Amarin Highlights New Data Providing Potential Mechanistic Insight into Vascepa®/Vazkepa® (Icosapent Ethyl) Reduction of Cardiovascular Events

Retrieved on: 
Friday, May 12, 2023

DUBLIN, Ireland and BRIDGEWATER, N.J., May 12, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted new data describing the benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) on coronary physiology, which was published in the European Heart Journal - Cardiovascular Imaging, and plaque progression, which was presented at the American Heart Association’s Vascular Discovery 2023 meeting in Boston, MA, May 10-13.

Key Points: 
  • EVAPORATE demonstrated that in statin-treated patients, VASCEPA/VAZKEPA significantly reduced plaque burden measured by serial coronary computed tomography angiography (CTA) compared with placebo.
  • VASCEPA/VAZKEPA improved mean distal segment FFRCT at 9- and 18-months follow-up compared with placebo (P = 0.02, P = 0.03 respectively).
  • “These new findings from two different studies provide important mechanistic information about VASCEPA/VAZKEPA and further elucidate its value in reducing cardiovascular events in at-risk patients,” said Nabil Abadir, MB.
  • We are proud to add to the body of research that further demonstrates the benefit of VASCEPA/VAZKEPA."

Hanmi Pharmaceutical's Combination Drug for Dyslipidemia Treatment, 'Rosuzet': Confirmed Non-inferiority Efficacy and Safety Compared to Monotherapy in 'The Lancet' & 'European Heart Journal'

Retrieved on: 
Friday, March 17, 2023

R&D-oriented pharmaceutical company, Hanmi Pharmaceutical's Rosuzet is a dyslipidemia medicine, is a single-pill combination of two different active ingredients: rosuvastatin and ezetimibe, and is a blockbuster product that records prescription sales in Korea of more than one hundred million dollars.

Key Points: 
  • R&D-oriented pharmaceutical company, Hanmi Pharmaceutical's Rosuzet is a dyslipidemia medicine, is a single-pill combination of two different active ingredients: rosuvastatin and ezetimibe, and is a blockbuster product that records prescription sales in Korea of more than one hundred million dollars.
  • The result of a large randomized trial comparing Rosuzet and rosuvastatin monotherapy in 3,780 patients with arteriosclerotic cardiovascular disease (ASCVD) was published in The Lancet(IF 202.731) in August, 2022.
  • A sub-analysis of the diabetes mellitus (DM) cohort of the RACING study was published in the European Heart Journal(IF 35.855) in December, 2022.
  • This study evaluated the effect of moderate-intensity statin with ezetimibe combination therapy(Rosuzet) versus high-intensity statin monotherapy among 1398 patients with DM and ASCVD.