06/07/2019 | Press release | Distributed by Public on 06/07/2019 05:46
Meeting Coverage of 2019 Updated ADA Standards of Medical Care in Diabetes to Include Role of Icosapent Ethyl as a Management Option for Diabetic Patients with Cardiovascular Risks, Based on Landmark REDUCE-ITTM Trial
Approximately 10 Million People with Diabetes Are at Elevated Risk of Cardiovascular Disease1,2
BEDMINSTER, N.J., and DUBLIN, Ireland, June 07, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that three Amarin-supported posters will be presented at the American Diabetes Association 79th Scientific Sessions in San Francisco, June 7 - 11, 2019. All three posters highlight important findings regarding the challenges of current treatment options for diabetes patients with cardiovascular risks. More than 30 million adults in the United States have diabetes, 10 million of whom are considered at elevated risk for cardiovascular events, despite being on cholesterol-management medicines.1,2
'What we have learned through our landmark clinical trial, REDUCE-ITTM, as well as other research, is that cholesterol and diabetes management is not enough to effectively treat cardiovascular disease in patients with diabetes and other risk factors,' said Craig Granowitz, M.D., Ph.D., chief medical officer of Amarin. 'Cardiovascular disease is the No. 1 cause of death in people with diabetes. We applaud the ADA for highlighting the need to better understand and address increased cardiovascular risk in patients with diabetes.'
Recently, the ADA issued important updates to its Standards of Care recommendations, now including a Level 'A' recommendation to consider icosapent ethyl to reduce cardiovascular (CV) risk in patients with diabetes and atherosclerotic cardiovascular disease (ASCVD) or other cardiac risk factors on a statin with controlled LDL-C (bad cholesterol), but with elevated triglycerides (135-499 mg/dL), based on the outcome of the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT).
In REDUCE-IT, icosapent ethyl capsules provided a 25% relative risk reduction compared to placebo in the first occurrence of a major adverse CV event (MACE) in the intent-to-treat population consisting of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization. For total (first and subsequent) cardiovascular events, icosapent ethyl provided a statistically significant 30% risk reduction compared to placebo in the statin-treated patient population studied in REDUCE-IT.3,4 This total event result reflects that for every 1000 patients treated for 5 years, approximately 159 MACE (major adverse cardiovascular events) could be prevented with icospent ethyl versus placebo, including prevention of approximately 12 cardiovascular deaths, 42 heart attacks (myocardial infarctions), 14 strokes, 76 coronary revascularizations and 16 episodes of hospitalization for unstable angina. Among the patients studied, 59 percent had diabetes.
Adverse events occurring with icosapent ethyl use at greater than 5% and greater than placebo were: peripheral edema (6.5% icosapent ethyl versus 5.0%), although there was no increase in the rate of heart failure in icosapent ethyl patients; constipation (5.4% icosapent ethyl versus 3.6%), although mineral oil, as used as placebo, is known to lower constipation; and atrial fibrillation (5.3% icosapent ethyl versus 3.9%), although there were reductions in rates of cardiac arrest, sudden death and myocardial infarctions observed in icosapent ethyl patients. More information on safety data associated with REDUCE-IT is provided below.
Amarin-Supported Research to be Presented at the ADA Scientific Sessions
Association Between Triglycerides and Residual Cardiovascular (CVD) Risk in Patients with Type 2 Diabetes and Established CVD: An Analysis of the BARI2D Trial, Abstract 1472-P, Embargoed Until Saturday, June 8, 11:30 a.m (Pacific Daylight Time).
Neha J. Pagidipati, M.D., MPH; Ann Marie Navar, M.D., Ph.D.; Hillary Mulder, M.S.; Daniel Wodjyla, M.S.; Sephy Philip, RPh, PharmD; Craig Granowitz, M.D., Ph.D.; Eric D. Peterson, M.D., MPH.
Long-term Statin Persistence is Poor Among High-Risk Patients with Baseline Diabetes: A Real-World Administrative Claims Analysis of the Optum Research Database, Abstract 616-P, Embargoed Until Monday, June 10, noon (Pacific Daylight Time),
Peter P. Toth, M.D., Ph.D., Craig Granowitz, M.D., Ph.D. Michael Hull, MS; Sephy Philip, RPh, PharmD.
Late-Breaking Poster Presentation
Eicosapentaenoic Acid (EPA) Inhibits Human HDL Oxidation in a Concentration-Dependent Manner at a Pharmacologic Dose in Vitro, Abstract 612-P; Embargoed Until Saturday, June 8, 11:30 a.m. (Pacific Daylight Time) (New Concepts in Lipidology); Monday, June 10, noon (Pacific Daylight Time) (General Poster Session)
Samuel, C.R. Sheratt, B.S.; R. Preston Mason Ph.D.