Amarin's REDUCE-IT Cardiovascular Outcomes Study Reaches 100% Mark for Estimated Onset of Target Primary Major Adverse Cardiovascular Events
The estimated onset of the targeted number of cardiovascular events in REDUCE-IT is based on documented events having exceeded 90% of target as reported in
As previously reported, completion of the REDUCE-IT study does not require reaching exactly 1,612 MACE. The actual number of events is likely to differ from this study design target. The powering assumptions for the study were based on 1,612 MACE with 90% power to detect a 15% relative risk reduction. A final cumulative MACE tally from inception date of the study which is slightly above or below 1,612 MACE is not anticipated to have a significant impact on the overall powering of the study results.
Amarin maintains its guidance to report top-line results from the study before the end of Q3 2018.
"We are excited to be nearing conclusion of this potentially landmark cardiovascular outcomes study," commented Dr. Steven Ketchum, president of R&D and chief scientific officer of Amarin. "We appreciate the continued dedication of patients participating in this important study and the continued commitment and hard work at the clinical sites and by the many professionals involved in study conduct and completion. We will work diligently to rapidly roll-up and report the results of the study in the hope that such results can lead to better informed preventative care of patients at high cardiovascular risk."
Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked. Final patient visits will be followed by adjudication of newly reported cardiovascular events in the study, completing data entry for the greater than 33,000 patient years of study in REDUCE-IT, and typical database quality control measures, known as cleaning. This will be followed by the database lock and final efficacy and safety analyses, including analysis of the trial's primary endpoint of first MACE events in the study, and the analyses of more than thirty pre-defined secondary and
tertiary endpoints. Publication of the study design can be found at https://doi.org/10.1002/clc.22692. The lead author of this paper, published in Clinical Cardiology, is Deepak L. Bhatt, M.D., M.P.H., executive director of the Interventional Cardiovascular Programs at Brigham and
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
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease. 3, 4, 5, 6
Leading clinical investigations seeking to address cardiovascular risk reduction beyond lowering LDL-C focus on interrupting the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting other lipid, lipoprotein and inflammation biomarkers and cellular functions thought to be related to atherosclerosis and cardiovascular events.
This press release contains forward-looking statements, including expectations regarding anticipated MACE onset in the REDUCE-IT study, the timing of clinical trial event adjudication, clinical trial results and
related announcement timing associated with Amarin's REDUCE-IT cardiovascular outcomes study; and expectations related to the successful completion of REDUCE-IT. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in its previous 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 (http://www.amarincorp.com/), the investor relations website (http://investor.amarincorp.com/), including but not limited to investor presentations and investor FAQs,
3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
4 Toth PP, Granowitz C, Hull M, et al. 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 [abstract]. Circulation. 2017;136(suppl 1):A15187.
5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease.
Amarin Contact Information
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