Gallstone

First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

Retrieved on: 
Mittwoch, Mai 22, 2024

ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.

Key Points: 
  • Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further.
  • Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo.
  • “Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sonntag, April 7, 2024

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Freitag, März 22, 2024

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Freitag, März 22, 2024

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Herbal medicinal product: Boldi foliumArray, C: ongoing call for scientific data

Retrieved on: 
Dienstag, März 12, 2024

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of boldo leaf.
  • The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing boldo leaf.
  • Herbal medicines containing these boldo leaf preparations are usually available as herbal tea to be drunk and in solid forms to be taken by mouth.
  • Boldo leaf preparations may also be found in combination with other herbal substances in some herbal medicines.

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

Retrieved on: 
Freitag, März 8, 2024

"This patient population has a higher risk of cardiovascular death, heart attack and stroke.

Key Points: 
  • "This patient population has a higher risk of cardiovascular death, heart attack and stroke.
  • Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."
  • Obesity or overweight affect approximately 70% of American adults.
  • Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke.

Including race in clinical algorithms can both reduce and increase health inequities – it depends on what doctors use them for

Retrieved on: 
Samstag, Mai 27, 2023

Health practitioners are increasingly concerned that because race is a social construct, and the biological mechanisms of how race affects clinical outcomes are often unknown, including race in predictive algorithms for clinical decision-making may worsen inequities.

Key Points: 
  • Health practitioners are increasingly concerned that because race is a social construct, and the biological mechanisms of how race affects clinical outcomes are often unknown, including race in predictive algorithms for clinical decision-making may worsen inequities.
  • A higher eGFR value means better kidney health.
  • My recently published research suggests that excluding race from certain diagnostic algorithms could worsen health inequities.

Different approaches to fairness

    • Researchers use different economic frameworks to understand how society allocates resources.
    • This approach allocates resources to those with the most opportunities to generate positive outcomes or mitigate negative ones.
    • Although utilitarian approaches do not take fairness into account, an approach that does would ask two questions: How do we define fairness?
    • Are there conditions when maximizing an algorithm’s prediction power and accuracy would not conflict with fairness?

Equality of opportunity

    • There are two fundamental principles in equality of opportunity.
    • However, differences in individual effort that occur because of circumstances, such as living in an area with limited access to healthy food, are not addressed under equality of opportunity.
    • Equality of opportunity implies that if algorithms were to be used for clinical decision-making, then it is necessary to understand what causes variation in the predictions they make.

Evaluating clinical algorithms for fairness

    • To hold machine learning and other artificial intelligence algorithms accountable to a standard of equity, I applied the principles of equality of opportunity to
      evaluate whether race should be included in clinical algorithms.
    • The first, diagnostic algorithms, makes predictions based on outcomes that have already occurred at the time of decision-making.
    • The second, prognostic algorithms, predicts future outcomes that have not yet occurred at the time of decision-making.
    • For example, prognostic algorithms are used to predict whether a patient will live if they do or do not obtain a kidney transplant.

Unanswered questions and future work

    • My colleagues and I are exploring many of these unanswered questions to reduce algorithmic discrimination.
    • We believe our work will readily extend to other areas outside of health, including education, crime and labor markets.

Sickle Cell Disease Association of America to promote clinical trials

Retrieved on: 
Freitag, März 17, 2023

HANOVER, Md., March 17, 2023 /PRNewswire-PRWeb/ -- The Sickle Cell Disease Association of America, a national nonprofit membership organization that advocates for people affected by sickle cell, formed the Sickle Cell Disease C.A.R.E.S. Consortium, an initiative of pharmaceutical companies united to promote clinical trial participation and education.

Key Points: 
  • The Sickle Cell Disease Association of America, a national nonprofit membership organization that advocates for people affected by sickle cell, formed the Sickle Cell Disease C.A.R.E.S.
  • HANOVER, Md., March 17, 2023 /PRNewswire-PRWeb/ -- The Sickle Cell Disease Association of America, a national nonprofit membership organization that advocates for people affected by sickle cell, formed the Sickle Cell Disease C.A.R.E.S.
  • "We have an opportunity and a responsibility to change the perception of clinical trials and increase the participation of sickle cell patients in clinical trials," said Regina Hartfield, president and CEO of the Sickle Cell Disease Association of America.
  • Sickle Cell Disease Association of America advocates for people affected by sickle cell conditions and empowers community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.

Advanced Robotic and Foregut Surgery Expert to Lead NYU Langone's Division of General Surgery

Retrieved on: 
Donnerstag, Februar 23, 2023

NEW YORK, Feb. 23, 2023 /PRNewswire/ -- Tanuja Damani, MD , a nationally renowned expert in the fields of advanced robotic and foregut surgery, has been named the new chief of the Division of General Surgery at NYU Langone Health.

Key Points: 
  • NEW YORK, Feb. 23, 2023 /PRNewswire/ -- Tanuja Damani, MD , a nationally renowned expert in the fields of advanced robotic and foregut surgery, has been named the new chief of the Division of General Surgery at NYU Langone Health.
  • Dr. Damani currently serves as the section chief of esophageal and foregut surgery and recently launched the institution's inaugural minimally invasive and robotic surgery fellowship.
  • "I am humbled to work alongside and lead the incredibly talented faculty within the Division of General Surgery.
  • Dr. Damani travels nationally to train surgeons in robotic and foregut surgery and regularly presents at major national society meetings.

Reducing Childhood Obesity by Using Virtual Role-Players to Train Healthcare Providers

Retrieved on: 
Montag, Januar 23, 2023

The CDC funded SIMmersion to help pediatricians and other healthcare providers, learn how to help families make healthier choices.

Key Points: 
  • The CDC funded SIMmersion to help pediatricians and other healthcare providers, learn how to help families make healthier choices.
  • Obesity rates among children in the U.S. have doubled since 1980 and have tripled for teens.… The likelihood of childhood obesity persisting into adulthood increases as the child ages.
  • ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2692353/ )
    To address the issue of childhood obesity, the CDC funded SIMmersion (Grant # R44 DP005954) to develop a training system for pediatricians and other healthcare providers.
  • Free training on how to have a conversation with a parent about childhood obesity is available at https://www.training.simmersion.com .