Statin

NewAmsterdam Pharma Reports Positive Results from Phase 2 Study of Oral Obicetrapib Demonstrating Over 50% LDL-Lowering as an Adjunct to High-Intensity Statins

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Cardiology, Medical specialties, Clinical medicine, Drugs, Organofluorides, Cardiology, TIMI, Statin, Low-density lipoprotein, Ezetimibe, Cholesteryl ester transfer protein, Bempedoic acid/ezetimibe, Gemigliptin

NAP is developing obicetrapib as an adjunct to maximally tolerated lipid-lowering therapy as a monotherapy and a fixed-dose combination with ezetimibe.

Key Points: 
  • NAP is developing obicetrapib as an adjunct to maximally tolerated lipid-lowering therapy as a monotherapy and a fixed-dose combination with ezetimibe.
  • Top-line results of the ROSE study show unprecedented effects of CETP inhibition on LDL-c reduction and HDL-c increase attributed to orally administered obicetrapib.
  • ROSE (NCT04753606) was designed as a placebo-controlled, double-blind, randomized, Phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
  • A total of 120 patients were randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period.

Centrient Pharmaceuticals boosting statins API manufacturing capacity

Retrieved on: 
Monday, June 21, 2021
Health sciences, Health care, Health, Hepatotoxins, Pharmaceutical industry, Statin, Pharmaceuticals policy, Beta-lactam, β-lactam antibiotic, Pharmaceutical industry in China, Medication

Centrient Pharmaceuticals has started production at its newly built statins API manufacturing unit in Toansa, India.

Key Points: 
  • Centrient Pharmaceuticals has started production at its newly built statins API manufacturing unit in Toansa, India.
  • Using backward integrated manufacturing methods, and dedicated production facilities, Centrient Pharmaceuticals is able to offer its customers security of supply.
  • Centrient Pharmaceuticals (Centrient), the global leader in sustainable antibiotics, next-generation statins and anti-fungals, announced today to have started production at its new statins manufacturing unit.
  • Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and antifungals.

TARGET-NASH Study Finds Statins Underutilized in Patients with NAFLD and At-Risk of Heart Disease

Retrieved on: 
Tuesday, June 15, 2021
Medical specialties, Hepatitis, Non-alcoholic fatty liver disease, Hepatotoxins, Clinical medicine, Comorbidity, Anatomy, Statin, Cardiovascular disease

"...Guideline-recommended statins remain underutilized and were not prescribed in 40% of NAFLD patients..." Anna Lok, MD

Key Points: 
  • "...Guideline-recommended statins remain underutilized and were not prescribed in 40% of NAFLD patients..." Anna Lok, MD
    Global prevalence of NAFLD is estimated at 25%, and diagnoses have increased over the past two decades.
  • 1 This increasing prevalence, paired with high risk of heart disease that NAFLD patients face, sets the stage for a growing public health concern.
  • Statins are a class of medications commonly prescribed to reduce the risk of heart disease.
  • 5 , 6
    "Providers are grappling with an aging population, paired with serious and comorbid chronic conditions like heart disease and NAFLD.

Simulation Model based on Pooled Phase 3 Data Demonstrating NEXLETOL® (bempedoic acid) Tablet’s Potential to Lower Absolute Cardiovascular Event Risk Presented at ACC.21

Retrieved on: 
Saturday, May 15, 2021
Medical specialties, Circulatory system, Cardiovascular system, Cardiology, Lipoproteins, Bempedoic acid, Statin, Low-density lipoprotein, Cardiovascular disease, Lipid-lowering agent

Using observed changes in LDL-C at week 12, researchers applied the CTT coefficient to calculate an estimated 10-year cardiovascular event relative risk reduction rate.

Key Points: 
  • Using observed changes in LDL-C at week 12, researchers applied the CTT coefficient to calculate an estimated 10-year cardiovascular event relative risk reduction rate.
  • In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering at week 12 when used with moderate or high-intensity statins.
  • The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.\nElevations in serum uric acid have occurred.
  • \xe2\x80\x9cRationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance.\xe2\x80\x9d American Heart Journal.

Prime Therapeutics proactive prescriber outreach significantly improves statin use in Medicare members with diabetes

Retrieved on: 
Tuesday, May 11, 2021
Pharmacy benefit management, Statin, Medicare, Health

b'EAGAN, Minn., May 11, 2021 /PRNewswire/ -- Using a proactive prescriber outreach program, Prime Therapeutics LLC (Prime), a pharmacy benefit manager (PBM) serving nearly 33 million members nationally, saw increased statin use in Medicare members with diabetes.

Key Points: 
  • b'EAGAN, Minn., May 11, 2021 /PRNewswire/ -- Using a proactive prescriber outreach program, Prime Therapeutics LLC (Prime), a pharmacy benefit manager (PBM) serving nearly 33 million members nationally, saw increased statin use in Medicare members with diabetes.
  • This program identified members with diabetes who did not have a statin claim and sent a fax to the members\' prescriber(s) recommending statin medication therapy.\nPrime has a total Medicare member population of 1.4 million members.
  • Increasing SUPD also contributed to higher health plan Star Ratings.\nPrime offers a variety of other programs to help health plans and employers manage members with diabetes.
  • Additionally, we were encouraged to see that when multiple Prime clinical programs are working together, even better results can be realized.

Esperion Announces Publication of Rationale and Design of Landmark CLEAR Cardiovascular Outcomes Trial Evaluating NEXLETOL® (bempedoic acid) Tablet in American Heart Journal

Retrieved on: 
Tuesday, April 27, 2021
PCSK9, Bempedoic acid, Statin, Esperion Therapeutics, Medical specialties, Cardiovascular disease, Drugs, Organ systems, JUPITER trial, PCSK9, Bempedoic acid, Statin, Esperion Therapeutics, Medical specialties, Cardiovascular disease, Drugs, Organ systems, JUPITER trial

Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance.

Key Points: 
  • Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance.
  • Rationale and design of the Further cardiovascular Outcomes Research with PCSK9 Inhibition in subjects with Elevated Risk trial.
  • ESPERION Therapeutics, Inc. Sept-Oct 2018.\nTweet Copy: #News: CLEAR Outcomes study rationale and design in patients with documented statin-intolerance was highlighted in the latest issue of @AmericanHeartJ.
  • Despite this, these patients have never been the focus of a cardiovascular outcomes study.\nThe rationale and design of our landmark CLEAR Outcomes study in patients with documented statin-intolerance was featured in the May issue of the American Heart Journal.

Amarin Receives European Commission (EC) Approval for VAZKEPA to Reduce Cardiovascular Risk

Retrieved on: 
Tuesday, March 30, 2021
Amarin Corporation, Drugs, Cardiovascular disease, Statin, Organ systems

The approval of VAZKEPA marks a significant milestone for high-risk cardiovascular patients in Europe as it offers the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients who have elevated triglycerides, said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin.

Key Points: 
  • The approval of VAZKEPA marks a significant milestone for high-risk cardiovascular patients in Europe as it offers the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients who have elevated triglycerides, said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin.
  • We are especially pleased to receive the ECs approval of VAZKEPA to reduce cardiovascular risk as cardiovascular disease remains the number one cause of death in the European Union and its economic burden exceeds 210 billion per year3, stated John F. Thero, president and chief executive officer.
  • Importantly, this EC approval provides ten years of market protection for VAZKEPA in the European Union.
  • In Europe, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.

Fifteen Medical Societies Now Recommend Icosapent Ethyl to Reduce Cardiovascular Risk, Further Supporting that VASCEPA® is Rapidly Becoming a New Standard of Care

Retrieved on: 
Monday, March 29, 2021
Fish products, Organic compounds, Chemistry, Fatty acids, Cardiovascular diseases, Medical specialties, Biochemistry, Ethyl eicosapentaenoic acid, Polyolefins, Cardiovascular disease, Statin, Eicosapentaenoic acid

These recommendations increase to 15 the number of global organizations or medical societies that recommend icosapent ethyl for cardiovascular risk reduction following its previously reported favorable outcomes study results.

Key Points: 
  • These recommendations increase to 15 the number of global organizations or medical societies that recommend icosapent ethyl for cardiovascular risk reduction following its previously reported favorable outcomes study results.
  • Patients with HTG and at high risk must receive a statin as a first-line treatment to reduce cardiovascular disease (CVD) risk.
  • The recommendation from the CCS was classified as Strong Recommendation; High-Quality Evidence and supported by the results of the REDUCE-IT cardiovascular outcomes study.
  • VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid.

Cymbiotika Combats LDL Cholesterol with New Red Yeast Rice

Retrieved on: 
Tuesday, February 2, 2021
Cardiology, Alternative medicine, General Health, Health, Food, Beverage, Fitness & Nutrition, Retail, Other Health, Articles, Health, Branches of biology, GABAA receptor positive allosteric modulators, Dietary Supplements, Cardiology, Lipoproteins, Red yeast rice, Traditional Chinese medicine, Cholesterol, Statin, Low-density lipoprotein

Cymbiotika , a leading nutritional supplement brand known for creating pure, clinically backed supplements, has launched Red Yeast Rice.

Key Points: 
  • Cymbiotika , a leading nutritional supplement brand known for creating pure, clinically backed supplements, has launched Red Yeast Rice.
  • In the United states, Red Yeast Rice has been used as a natural alternative to statin therapy in treating people with mild to moderate hypercholesterolemia by significantly lowering LDL (bad) cholesterol levels, as well as total cholesterol.
  • Cymbiotika Red Yeast Rice has zero synthetic ingredients and is gluten-free, vegan, keto, and sugar-free.
  • It is also available in the Cholesterol and Healthy Heart Bundle (Red Yeast Rice, D3K2, Omega and Adrenal Super Tonic).

InVixa announces licensing deal with University of California, Davis for the commercialization of novel inhaled statins for the treatment of COVID-19

Retrieved on: 
Tuesday, January 19, 2021
Health sciences, Health, Hepatotoxins, Statin, Coronavirus disease, Medication, Pharmaceutical industry

DAVIS, Calif., Jan. 19, 2021 /PRNewswire/ -- InVixa Inc ('InVixa'), a biopharmaceutical start-up developing inhaled statins to treat COVID-19, announced today an exclusive licensing deal with the University of California, Davis, a leading US academic and medical institution.

Key Points: 
  • DAVIS, Calif., Jan. 19, 2021 /PRNewswire/ -- InVixa Inc ('InVixa'), a biopharmaceutical start-up developing inhaled statins to treat COVID-19, announced today an exclusive licensing deal with the University of California, Davis, a leading US academic and medical institution.
  • This deal provides InVixa with the rights to the intellectual property in order to commercialize inhaled statins for the treatment of COVID-19 and other viral-based respiratory diseases.
  • Our initial focus will be to treat hospitalized patients to prevent progression to respiratory failure using our novel inhaled statin formulation.
  • InVixa is planning to progress its novel drug candidates through preclinical studies in early 2021.