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Today's PR re retrospective analysis of relationship between elevated triglycerides and CV events and medical costsReal-World Data Analysis Shows That High Triglyceride Levels Are Associated With Increased Cardiovascular Events and Medical Costs Higher Rates of Myocardial Infarction (Heart Attack) and Revascularization Procedures in Patients with High Triglycerides Were Drivers of the Composite Outcome MACE Rate 35% Higher in Patients Who, Despite Statin Therapy, Have Elevated Triglyceride Levels Cost of Health Care Nearly 15% Higher in this Higher Risk Patient Population BEDMINSTER, N.J. and DUBLIN, Ireland , Nov. 13, 2017 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular (CV) health, presented a real-world data analysis today revealing that patients with high triglycerides, despite controlled LDL (bad) cholesterol, were at significantly greater risk for major adverse cardiovascular events (MACE). The patients studied also incurred higher healthcare costs than those with normal triglyceride levels. The analysis was presented at the 2017 American Heart Association (AHA) Scientific Sessions in Anaheim, CA. The study, "High Triglycerides Increase Cardiovascular Events, Medical Costs, and Resource Utilization in a Real-World Analysis of Statin-Treated Patients with High Cardiovascular Risk and Well-Controlled Low-Density Lipoprotein Cholesterol," was based on a retrospective analysis of de-identified claims. The database utilized for the analysis had millions of de-identified medical records from patient experience within a leading national information and technology-enabled health services business. The study analyzed two adult cohorts with statin use, controlled LDL-C, and with either established atherosclerotic cardiovascular disease (ASCVD) or with diabetes mellitus and additional CV risk factors: those with high triglycerides (200-499 mg/dL) and those with normal triglycerides ( < 150 mg/dL), N=10,990 per cohort. The majority of patients did not have established atherosclerotic cardiovascular disease (primary prevention). Over an average follow-up of 41 to 42 months, ASCVD patients with high TGs, as compared with the normal TG group, were at increased risk of cardiovascular outcomes after multivariable adjustment as follows: 35% increased risk for myocardial infarction (95% CI 1.19-1.52) 51% increased risk for coronary revascularization (95% CI 1.34-1.69) 35% higher rate of occurrence of a major adverse CV event (MACE) (95% CI 1.23-1.49) Composite outcome = nonfatal MI, nonfatal stroke, coronary revascularization, unstable angina, or CV-related mortality In addition, the high TG cohort had nearly a 15% higher average total health care cost and 17% higher rate of occurrence of an inpatient stay over time. Both study cohorts were predominantly comprised of primary prevention patients as only 29% of subjects had established atherosclerotic cardiovascular disease. This study analyzed health data of real-world patients and was not a prospective analysis of medical intervention. The authors of this study were Peter P. Toth , CGH Medical Center , Sterling, IL ; Craig Granowitz , Amarin Pharma, Inc. , Bedminster, NJ ; Michael Hull , Djibril Liassou , Amy Anderson , Optum , Eden Prairie, MN ; Sephy Philip, Amarin Pharma, Inc. , Bedminster, NJ . Potential limitations of real-world data analysis include the observational, retrospective nature of the study which can add to uncertainty regarding findings as compared to prospectively collected data, the potential for inaccurate recording of health events in the database and missing data which may limit the usefulness of the findings. Without further study, the extent, if any, that a biomarker such as triglyceride levels is causally related to the clinical events cannot be determined. "These data highlight the increased cardiovascular risk and healthcare cost in subjects with high triglyceride levels despite statin use and controlled LDL-C in a real-world setting and a large sample of patient experience over multiple years," expressed Peter Toth , MD, PhD. "The ongoing REDUCE-IT cardiovascular outcomes study will prospectively determine whether treatment with Vascepa® provides benefit for high CV risk patients with persistent high triglycerides despite statin controlled LDL-C. If positive, the results of the REDUCE-IT study could provide a pragmatic care solution for the treatment of many at-risk patients." |
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