Patients with stage 3 chronic kidney disease (CKD) and persistent high triglycerides (TG) despite statin therapy have a high risk of cardiovascular disease (CVD). The presentation of additional data from the phase 3 ANCHOR study of Vascepa® (icosapent ethyl) showed, in a post hoc analysis, that consistent with overall study results, Vascepa® 4 g/day (n=18) reduced potentially atherogenic lipid and inflammatory markers without raising LDL-C, and with a safety profile similar to placebo (n=35) in patients with CKD. These hypothesis-generating data warrant further prospective study to determine the clinical benefit of Vascepa, if any, as an adjunct to statin therapy in patients with CKD. The ongoing CVD outcomes trial with prescription, high-dose (4 grams/day) of icosapent ethyl in addition to statin therapy, REDUCE-IT, while not designed specifically to evaluate CVD outcomes in CKD patients, is expected to include some patients with CKD.
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As is typical with subgroup analyses, a limitation of this ANCHOR dataset analysis includes the post-hoc sub-analysis and relatively small sample sizes. Nonetheless, the results show potentially important changes in triglyceride levels and other potentially atherogenic lipid and inflammatory markers with Vascepa compared with placebo. The efficacy and safety of Vascepa 4 g/day in patients with Stage 3 CKD and persistent high triglycerides were consistent with the overall ANCHOR study results.
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 previously reported, Amarin expects that the onset of the target final primary cardiovascular event will be reached in Q1 2018, with results announced in Q2 or 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
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
This press release contains forward-looking statements, including statements about the potential efficacy and therapeutic benefits of Vascepa and EPA, including implications about the potential clinical importance of the findings presented as well as statements concerning the REDUCE-IT cardiovascular outcomes study such as the anticipated inclusion of certain patient populations, related timing and announcements with respect to the onset of the target final primary cardiovascular event and final outcomes and the anticipated successful completion of the REDUCE-IT study. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with retrospective subset
analyses, research on biomarkers thought to be relevant in the treatment of cardiovascular disease, research and development and clinical trial risk generally, including the risk that study results in small sample sizes may not be predictive of future results in larger studies, that studied parameters may not have clinically meaningful effect and the risk that patents may not adequately protect Vascepa against competition. 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
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
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