Real-World Data Supports Association Between Elevated Triglyceride Levels and Increased Cardiovascular Events and Healthcare Costs
The poster was titled "Triglycerides ≥ 150 mg/dL Associated With Greater Risk of Cardiovascular Events, Costs, and Resource Utilization in High-Risk Statin-Treated Patients With Controlled Low-Density Lipoprotein Cholesterol: A Real-World Analysis." 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.
Patients with diabetes mellitus and/or established atherosclerotic cardiovascular disease were followed longitudinally for up to five years. Those patients with elevated TG levels, defined as TG ³ 150 mg/dL, as compared with the normal TG group defined as TG < 150 mg/dL and HDL-C > 40 mg/dL, were at increased risk of adverse CV outcomes after multivariable adjustment as follows:
- 26% increased risk for the composite initial major adverse CV event (MACE) (95% confidence interval [CI] 1.19-1.34)
• The increase in composite MACE in the elevated TG group was driven by a 32% (95% CI 1.20-1.45) increased risk of non-fatal myocardial infarction and a 46% (95% CI 1.33-1.61) increased risk of coronary revascularization
- 12% higher average total healthcare cost (95% CI 1.08-1.16)
- 13% higher rate of occurrence of initial inpatient hospital stay (95% CI 1.10-1.17)
This study, in concert with real-world evidence posters presented previously from two separate studies of patients with different demographics and health care options, support previous findings that patients with elevated TGs have increased risk of future cardiovascular events, even when LDL-C is controlled with statins. This analysis was not based on specific treatment groups; these studies were based on patients with elevated/high and normal TGs while controlling for other factors. Along with genetic and epidemiologic studies, these real-world data further affirm the association of elevated TGs in patients with residual risk that remains after statin control of LDL-C.
The authors of this study were
"Research continues to show the association of elevated and high triglycerides with cardiovascular risk and healthcare costs," said
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 (150-499 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. As reported previously, Amarin expects to announce top-line results of this important study before the end of Q3 2018. The REDUCE-IT trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
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 data. 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
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