Hypertension

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Henry Schein Cares Foundation Launches ‘Prevention is Power’ Public Health Awareness Campaign

Retrieved on: 
Wednesday, February 14, 2024

Henry Schein, Inc. (Nasdaq: HSIC) today announced the launch of Prevention is Power™, a multi-year public health awareness campaign from the Henry Schein Cares Foundation, Inc. (HSCF) to help improve health literacy and strengthen patient utilization of integrated, preventive care, with the goal of reducing incidences of chronic diseases as well as overall health care spending.

Key Points: 
  • Henry Schein, Inc. (Nasdaq: HSIC) today announced the launch of Prevention is Power™, a multi-year public health awareness campaign from the Henry Schein Cares Foundation, Inc. (HSCF) to help improve health literacy and strengthen patient utilization of integrated, preventive care, with the goal of reducing incidences of chronic diseases as well as overall health care spending.
  • Chan School of Public Health, the Commonwealth Fund, and others, despite spending more on health care than any other high-income country, overall health outcomes in the U.S. trail those in its peer countries.
  • It is well established that patient utilization of routine preventive health care leads to better population health outcomes as well as lower overall health care costs.
  • The Gold Foundation, which champions the human connection in health care, is proud to partner with the Henry Schein Cares Foundation to expand access and address health inequities.”
    Dr. Ayman El-Mohandes, Dean of CUNY SPH: “We are thrilled to partner with two impactful organizations, the Henry Schein Cares Foundation and NACHC, in this important work aimed at improving patient outcomes through education and engagement.

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Tuesday, February 13, 2024

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

The Inner Circle Acknowledges, Pedro P. Ylisastigui, as a Pinnacle Lifetime Member

Retrieved on: 
Monday, February 12, 2024

LEHIGH ACRES, Fla., Feb. 12, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Pedro P. Ylisastigui, MD is acknowledged as a Pinnacle Lifetime Member for his contributions to the Medical field.

Key Points: 
  • LEHIGH ACRES, Fla., Feb. 12, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Pedro P. Ylisastigui, MD is acknowledged as a Pinnacle Lifetime Member for his contributions to the Medical field.
  • Dr. Pedro P. Ylisastigui, MD, a highly respected primary care physician in Lehigh Acres, Florida, has been recognized for his outstanding contributions to healthcare.
  • Dr. Pedro P. Ylisastigui earned his MD from the Higher Institute of Medical Sciences in Havana, Cuba.
  • Beyond his medical practice, Dr. Pedro P. Ylisastigui actively engages with the community and demonstrates a commitment to charitable work.

It’s time for a heart-to-heart about women’s cardiovascular health, unique risk factors and symptoms

Retrieved on: 
Sunday, February 11, 2024

Cardiovascular disease — also called heart disease — is a condition affecting the heart and blood vessels, and is the leading cause of death among women worldwide.

Key Points: 
  • Cardiovascular disease — also called heart disease — is a condition affecting the heart and blood vessels, and is the leading cause of death among women worldwide.
  • In fact, a women dies of heart disease every 20 minutes in Canada.
  • Although cardiovascular disease is often considered a disease of men, women are more likely to die from a heart attack when compared with men.

Women’s hearts are different

  • From the outside, women’s hearts may look the same as men’s, but there are important differences.
  • Specifically, women experience unique events over the course of their lifespan which may impact their cardiovascular health.
  • Pregnancy complications, such as hypertensive disorders of pregnancy and gestational diabetes, can also play a role in cardiovascular health.

Heart attack symptoms

  • Early heart attack symptoms are missed in up to 78 per cent of women, in part related to the fact that women may present with different symptoms than men.
  • An awareness of the differences in heart attack symptoms may lead to improved recognition and timely care for women.

Reducing heart risks

  • There are many steps that you can take to reduce your risk of heart disease.
  • Living free from commercial tobacco and vaping, reducing alcohol intake and managing stress are also key ways to reduce your risk.

Wear red and learn more

  • On Feb. 13, we invite you to celebrate Wear Red Canada to raise awareness for women’s cardiovascular health, hosted by the Canadian Women’s Heart Health Alliance and the Canadian Women’s Heart Health Centre.
  • Attend free presentations and webinars by Canadian experts, join the Wear Red Canada Movement Challenge and take part in local events.


Nabilah Gulamhusein has received funding from the Canadian Institutes of Health Research through the Canada Graduate Scholarship - Master’s. Sandi Dumanski receives funding from the Canadian Fertility and Andrology Society and the Kidney Foundation.

Kaiser Foundation Health Plan and Hospitals report 2023 financial results

Retrieved on: 
Friday, February 9, 2024

OAKLAND, Calif., Feb. 9, 2024 /PRNewswire/ -- Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported 2023 annual financial results that reflect a commitment to deliver on its mission to provide high-quality, affordable care and services amid ongoing industrywide challenges of high medical costs and a competitive labor environment.

Key Points: 
  • OAKLAND, Calif., Feb. 9, 2024 /PRNewswire/ -- Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported 2023 annual financial results that reflect a commitment to deliver on its mission to provide high-quality, affordable care and services amid ongoing industrywide challenges of high medical costs and a competitive labor environment.
  • Kaiser Permanente met these challenges by reducing administrative costs and pursuing efficiencies while expanding access to its high-quality care.
  • In 2023, Kaiser Permanente supported a wide range of community health programs with an investment of $3.1 billion, compared to $2.8 billion the year prior.
  • As of December 31, 2023, Kaiser Permanente had 618 medical offices, 40 owned hospitals, and 43 retail and employee clinics.

Organizations Unite to Improve Brain Health

Retrieved on: 
Thursday, February 8, 2024

This initiative brings together leaders from some of the biggest organizations in America to create environments that promote brain health for employees, communities, and consumers as brain health conditions rise, including Alzheimer’s and dementia.

Key Points: 
  • This initiative brings together leaders from some of the biggest organizations in America to create environments that promote brain health for employees, communities, and consumers as brain health conditions rise, including Alzheimer’s and dementia.
  • Among other action items, the Collaborative is working with HERO Health and Mercer to develop a Brain Health Best Practices Scorecard.
  • “We are excited to be working alongside so many innovative organizations in the Collaborative to advance practices and programs in the workplace and throughout communities at large to help optimize brain health,” said Sarah Lenz Lock, Senior Vice President for Policy and Brain Health and Executive Director of the Global Council on Brain Health.
  • For more information about the Business Collaborative for Brain Health and the Brain Health Best Practices Scorecard, click here .

Lightbeam Health Solutions Ranks #1 Best in KLAS® 2024 for its Remote Patient Monitoring Solution, CareSignal

Retrieved on: 
Thursday, February 8, 2024

Lightbeam Health Solutions, the leader in population health enablement technology and services, ranked #1 Best in KLAS® in Remote Patient Monitoring (RPM), achieving a 91.1% satisfaction score for its Deviceless RPM® solution, CareSignal.

Key Points: 
  • Lightbeam Health Solutions, the leader in population health enablement technology and services, ranked #1 Best in KLAS® in Remote Patient Monitoring (RPM), achieving a 91.1% satisfaction score for its Deviceless RPM® solution, CareSignal.
  • View the full release here: https://www.businesswire.com/news/home/20240208362723/en/
    Lightbeam Health Solutions, the leader in population health enablement technology and services, ranked #1 Best in KLAS® in Remote Patient Monitoring (RPM), achieving a 91.1% satisfaction score for its Deviceless RPM® solution, CareSignal.
  • “This success is the result of deep collaboration among our innovative client-partners and our talented, passionate team,” says Jerry Shultz, President of Lightbeam Health Solutions.
  • The 2024 Best in KLAS: Software and Services report is now available for download .

Amerigroup Georgia Earns NCQA Health Equity Accreditation Plus

Retrieved on: 
Thursday, February 8, 2024

Amerigroup Georgia recently earned the National Committee for Quality Assurance (NCQA) Health Equity Accreditation Plus, a recognition of Amerigroup’s leadership in developing solutions to enhance access equitable, high-quality healthcare.

Key Points: 
  • Amerigroup Georgia recently earned the National Committee for Quality Assurance (NCQA) Health Equity Accreditation Plus, a recognition of Amerigroup’s leadership in developing solutions to enhance access equitable, high-quality healthcare.
  • “NCQA’s Health Equity Accreditation Plus recognizes our unwavering dedication to eliminating health disparities and ensuring access to high-quality care for everyone,” said Mel Lindsey, President, Amerigroup Georgia.
  • “This milestone positions Amerigroup at the forefront of advancing health equity through our innovative and impactful programs and personalized care to improve the whole health of our members.”
    NCQA Health Equity Accreditation Plus builds upon the Health Equity Accreditation designation Amerigroup received last year, when it was recognized among the first Medicaid plans in the nation to create a strategic framework that prioritizes health equity based on race, ethnicity, language, sexual orientation, and gender identity.
  • “Organizations earning the Health Equity Accreditation Plus like Amerigroup Georgia are leading the way in bridging this gap, and NCQA salutes their commitment.”

Mineralys Therapeutics Announces $120 Million Private Placement Financing

Retrieved on: 
Thursday, February 8, 2024

In the PIPE, Mineralys is selling an aggregate of approximately 8.9 million shares of its common stock (or pre-funded warrants in lieu thereof) at a price of $13.50 per share (or $13.499 per pre-funded warrant).

Key Points: 
  • In the PIPE, Mineralys is selling an aggregate of approximately 8.9 million shares of its common stock (or pre-funded warrants in lieu thereof) at a price of $13.50 per share (or $13.499 per pre-funded warrant).
  • The pre-funded warrants will have an exercise price of $0.001 per share of common stock, will be immediately exercisable and will not expire.
  • Mineralys expects to use the net proceeds from the PIPE to fund the research and development of lorundrostat, and for working capital and general corporate purposes.
  • BofA Securities and Evercore are acting as placement agents to the Company in connection with the PIPE.