Real-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
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
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
Amarin's clinical development program for Vascepa includes a trial known as the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride-lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (150 mg/dL to 499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study are anticipated to also be diagnosed with type 2 diabetes. Amarin expects that the onset of the target final primary cardiovascular event will be reached before the end of Q1 2018, with results announced before the end of Q3 2018.
Additional information on clinical studies of Vascepa can be found at www.clinicaltrials.gov.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and
product complaints may be reported by calling 1-855-VASCEPA or the
FDAat 1-800- FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
This press release contains statements related to scientific presentations from real-world evidence and other studies.These statements are not promises or
guarantees related to the potential for favorable outcomes from the ongoing REDUCE-IT cardiovascular outcomes trial. As disclosed in filings with the
Availability of other Information about Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (http://investor.amarincorp.com), including but not limited to investor presentations and investor FAQs,
Amarin Contact Information
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
In U.S.: +1 (646) 378-2992
In U.S.: +1 (312) 329-3911
News Provided by Acquire Media