Preventive cardiologyEicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Patients With Very High Triglyceride Levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] Trial)
Section snippets
Methods
The Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension (MARINE) was a Phase III study conducted in the United States, South Africa, India, Russia, Ukraine, Finland, Germany, Italy, and The Netherlands. The study was conducted under guidelines set forth by Good Clinical Practice, the Declaration of Helsinki, and all local and/or national regulations and directives. The protocol was approved by the appropriate institutional review boards, and
Results
The baseline demographics of the patients are listed in Table 1 and were comparable across the treatment groups. In general, most patients were overweight (mean body mass index 30.8 kg/m2), white (88%), and male (76%), with a mean age of 52.9 years. Of the randomized patients, 24.9% received background statin therapy, 27.5% had diabetes mellitus, and 55.0% were at a high risk of coronary heart disease according to the patients' medical histories. For the randomized population, the median TG
Discussion
AMR101 is a novel lipid-altering agent that contains ≥96% EPA ethyl ester and no DHA. The MARINE study (to our knowledge, the largest reported clinical trial of its kind) was a Phase III, 12-week, multicenter, placebo-controlled, randomized, double-blind study evaluating 229 patients with fasting TGs ≥500 mg/dl and ≤2,000 mg/dl (with or without statin therapy), who were randomized to AMR101 4 g/day, AMR101 2 g/day, or placebo. AMR101 4 g/day significantly reduced the placebo-corrected median TG
Acknowledgment
The authors wish to thank the MARINE study investigators and the patients who participated in this study.
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The MARINE study was sponsored and designed by Amarin Pharma Inc., Mystic, Connecticut, and conducted by Medpace, Inc., Cincinnati, Ohio, with funding from Amarin Pharma Inc. Editorial assistance was provided by Peloton Advantage, LLC, Parsippany, New Jersey, and funded by Amarin Pharma Inc.
Dr. Bays has received research grants and served as an advisor to Amarin Pharma Inc., and has also received research grants and served as a consultant and speaker for numerous other pharmaceutical companies.
A complete list of the study investigators can be found in the Appendix.