Amgen (NASDAQ:AMGN) today announced that new data from its cardiovascular portfolio will be presented at the American Heart Association (AHA) Scientific Sessions 2019 in Philadelphia, Nov. 16-18. This includes new clinical and real-world studies that provide further evidence of the benefits of intensive lipid-lowering therapy with Repatha® (evolocumab) as well as new data for omecamtiv mecarbil, a novel selective cardiac myosin activator being developed for the treatment of heart failure with reduced ejection fraction (HFrEF).
“The Amgen clinical and real-world data being presented at AHA highlights our ongoing commitment to further the cardiovascular community’s understanding of Repatha’s role in lowering high LDL-C, one of the most important modifiable risk factors associated with an increased risk of heart attack,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “In addition, we look forward to presenting data that showcases the potential of omecamtiv mecarbil for the treatment of heart failure. Despite advances in care over the years, 50% of people diagnosed with heart failure will die within five years of initial hospitalization so continued advancements are needed in this area.”2
Notable data from the Company’s cardiovascular (CV) portfolio include two new analyses from the Repatha cardiovascular outcomes (FOURIER) study evaluating the efficacy and safety of Repatha in patients with a recent heart attack, and the impact of low-density lipoprotein cholesterol (LDL-C) lowering with Repatha on cognitive function. In addition, a new post-hoc analysis from the Phase 2 clinical trial, COSMIC-HF, evaluated the effects of omecamtiv mecarbil on diastolic function.
Real-world Evidence Shows Need for More Intensive Treatment in High-Risk Patients
Amgen is presenting the results of nine real-world data analyses, including results from the GOULD (Getting to an imprOved Understanding of Low-Density lipoprotein cholesterol and dyslipidemia management) registry, a prospective cohort of approximately 5,000 atherosclerotic cardiovascular disease (ASCVD) patients with LDL-C above 70 mg/dL across 119 sites in the U.S. These results demonstrate that a large proportion of patients with a prior myocardial infarction (MI) do not receive optimal secondary prevention therapy. Results from GOULD also highlight gender differences in the use of high-intensity statins as well as limited intensification of lipid lowering therapy over one year of follow up in this ASCVD population with elevated LDL-C.
A list of Amgen-sponsored abstracts at AHA 2019 can be found below:
Omecamtiv Mecarbil clinical data
- The Effect of the Cardiac Myosin Activator, Omecamtiv Mecarbil, on Diastolic Filling and Function in Chronic Systolic Heart Failure (COSMIC-HF)
Monday, Nov. 18, 2:45-2.50 p.m. ET
Repatha clinical data
- Impact of Lowering LDL-C With Evolocumab on Everyday Cognition in Participants From the FOURIER Trial
Saturday, Nov. 16, 4:30-5 p.m. ET - Effect of Evolocumab on Non-high-density Lipoprotein Cholesterol and Apolipoprotein B Levels: An Analysis of Double-blind and Open-label Extension Studies
Saturday, Nov. 16, 4:30-5 p.m. ET - Use of a Genetic Risk Score to Predict Coronary and Vascular Events and Benefit From Evolocumab Therapy in Patients With Atherosclerotic Disease From the FOURIER Trial
Sunday, Nov. 17, 9:19-9:25 a.m. ET - Evolocumab and Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: Analysis From FOURIER
Monday, Nov. 18, 11:30 a.m.-12 p.m. ET
Real world treatment patterns
- Patient Perspectives on Cholesterol Lowering Therapies Among Those Who Report Statin-associated Adverse Events. Results From a National Survey in the Getting to an Improved Understanding of Low-density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry
Sunday, Nov. 17, 3-3:30 p.m. ET - Utilization of Cholesterol-lowering Therapies in Patients With Chronic Kidney Disease and Atherosclerotic Cardiovascular Disease (ASCVD). Results From a National Survey in the Getting to an Improved Understanding of Low-density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry
Sunday, Nov. 17, 3-3:30 p.m. ET - Does the Intensity of Lipid-Lowering Therapy Vary by Sex in the United States? Insights From Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD): A Registry of High Cardiovascular Risk Patients in the United States
Sunday, Nov. 17, 3-3:30 p.m. ET - Use of Guideline-Recommended Risk-Reduction Strategies Among Patients With Prior MI: Insights From Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD)
Sunday, Nov. 17, 3-3:30 p.m. ET - Is Lipid-Lowering Therapy Being Intensified in the United States?: Primary, One-year Results of the Getting to an Improved Understanding of Low-density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry of Patients With Atherosclerotic Cardiovascular Disease (ASCVD)
Sunday, Nov. 17, 3-3:30 p.m. ET - LDL-C Values and Lipid-Lowering Therapy Utilization Among Medicare Beneficiaries With a Recent Myocardial Infarction
Monday, Nov. 18, 1:30-2 p.m. ET
Identification of high-risk subpopulations
- Agreement Among Four Methods For Identifying Patients With FH In A Large Healthcare System
Saturday, Nov. 16, 4:30-5 p.m. ET
Real-world LDL measurement and goal achievement
- Low-Density Lipoprotein-Cholesterol Lowering in Real-World Patients Treated With Evolocumab
Sunday, Nov. 17, 3-3:30 p.m. ET - Lipid testing trends in the U.S. before and after the release of the 2013 ACC/AHA Cholesterol Guidelines
Monday, Nov. 18, 1:30-2 p.m. ET
