Amarin Announces Publication of REDUCE-IT Cardiovascular Outcomes Study Rationale and Design in Clinical Cardiology
REDUCE-IT is a landmark global study of approximately 8,000 patients to evaluate whether treatment with prescription pure EPA Vascepa® (icosapent ethyl) at four grams per day reduces cardiovascular events in patients, who despite having their LDL-cholesterol (LDL-C) controlled with statin therapy, have elevated triglyceride levels and demonstrate other risk factors, such as diabetes and previous cardiovascular events.
"Controlling LDL-C is critically important but only one aspect of overall good cardiovascular health," said
The publication notes that,
while clinical and epidemiological studies have demonstrated patients with elevated triglycerides remain at high cardiovascular risk despite controlling LDL-C, to date no study has prospectively examined this population. For this population, high dose prescription pure EPA may prove beneficial. EPA has been shown to improve relevant lipid, lipoprotein and inflammatory parameters without raising LDL-C and may have pleiotropic benefits. An open label, blinded endpoint outcomes study in
"Despite significant advances in the diagnosis, management, and understanding of cardiovascular disease, it remains the leading killer in this country," said
Residual Cardiovascular Risk in Statin-Treated Patients
Cardiovascular disease remains the leading cause of death in
REDUCE-IT is a global Phase 3, randomized, multicenter, double-blind,
placebo-controlled study designed to evaluate whether treatment with Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors. The primary endpoint of the study is the time to the first occurrence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. Secondary endpoints include time to event analyses of components of the primary endpoint. The study is being conducted under a special protocol assessment agreement with the
Additional information on the REDUCE-IT trial and Amarin's other 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
- 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 FDA at 1‑800‑FDA‑1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin's clinical program includes a commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa, visit www.vascepa.com. For more information about Amarin, visit www.amarincorp.com.
This press release contains forward-looking statements such as expectations regarding the ability of REDUCE-IT to provide important answers on whether the addition of Vascepa to statin therapy would confer a meaningful reduction in the occurrence of major cardiovascular events in the patient population studied. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. For example, statements related to the potential efficacy and therapeutic benefits of Vascepa have been subject to different
interpretations on matters such as the potential clinical importance of lowering triglyceride levels in studied patients. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with complex clinical trials like REDUCE-IT and research and development and clinical trial risk generally; differing views on interpretation of clinical trial results including the results of the cited Japanese study and other relevant studies; and reliance on third parties. Due to these risks and other uncertainties, REDUCE-IT may not generate positive or useful results. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the
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