Amarin Announces Expanded Research Relationships and Studies to Help Improve Cardiovascular Care
Two of the studies leverage real-world evidence (RWE):
- A study led by
Peter Toth, M.D., Ph.D., Director, Preventive Cardiology, CGH Medical Center, Sterling, IL, determined that the use of RWE data from medical and pharmacy claims can provide strong insight into medication patterns, cardiovascular events, healthcare costs, and resource utilization in an at-risk population similar to the patients being studied in Amarin's REDUCE-IT outcomes study. This RWE study is presented in a poster (abstract #139) titled, "Baseline Characteristics of a Retrospective Claims Analysis of Cardiovascular Outcomes and Health Care Resource Utilization and Costs in High-Risk Statin-Treated Patients with Hypertriglyceridemia."
In a study led by
Gregory Nichols, Ph.D., from the Kaiser Permanente Center for Health Research, and in collaboration with Sergio Fazio, M.D., Ph.D., Director, Center for Preventive Cardiology, Oregon Health & Science University, Portland, OR, RWE data from a large integrated healthcare system determined that electronic health records (EHRs) may be an efficient tool for identifying and screening high-risk patients, such as those sought for evaluation in outcome studies. This study is presented in a poster (abstract #138) titled "The Potential of Electronic Health Record Data to Optimize Recruitment Efficiency in Cardiovascular Outcome Trials."
Both of these studies utilize large patient databases to better define and understand cardiovascular patient demographics and profiles in the real world, particularly in a population of statin-treated patients with dyslipidemia. Further study is planned using this RWE with emphasis on better understanding the increase in patient treatment costs associated with this at-risk population. These studies are intended to complement Amarin's ongoing REDUCE-IT cardiovascular outcomes study.
A third study will evaluate the reduction of coronary plaque using Vascepa® (icosapent ethyl). This study, titled EVAPORATE ("Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides [200-499 mg/dL] on Statin Therapy"), will be led by
"Amarin is pleased to be working with many leading physicians, academic centers and healthcare systems with a shared vision of finding ways to cost-effectively improve patient care," said
Amarin's commitment to advancing scientific knowledge and patient care is evidenced by the more than 30 scientific publications and abstracts sponsored in 2016. The costs of these new studies are included in the company's previously provided financial guidance for 2017.
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
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
been approved for use by the
This press release contains forward-looking statements, including results from real-world evidence studies, reduction of coronary plaque using Vascepa®, costs of research and development; expectations for the anticipated successful completion of the REDUCE-IT study; and statements regarding the potential and therapeutic benefits of
Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in filings with the
Availability of other Information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://investor.amarincorp.com), including but not limited to investor presentations and investor FAQs,
Amarin Contact Information Investor Relations:
Elisabeth SchwartzInvestor Relations and Corporate Communications Amarin Corporation plcIn U.S.: +1 (908) 719-1315 firstname.lastname@example.org Lee M. Stern Trout GroupIn U.S.: +1 (646) 378-2992 email@example.com Media Inquiries: Ovidio Torres Finn PartnersIn U.S.: +1 (312) 329 3911 firstname.lastname@example.org
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