EPA Therapy Added to Statin Therapy Showed Coronary Plaque Regression at Approximately Twice the Prevalence Compared to Statin Therapy Alone in Japanese Clinical Study

Amarin Corporation plc

today commented on new data from the CHERRY study that supports the hypothesis under investigation in Amarin's cardiovascular outcomes study of Vascepa® (icosapent ethyl) capsules, the REDUCE-IT trial: that highly purified EPA drug therapy may reduce residual risk in coronary heart disease (CHD) patients already on lipid-lowering statin therapy. The CHERRY study was a randomized, non-blinded, parallel group, multicenter study designed to investigate whether coronary plaque regression and stabilization are reinforced by additional administration of EPA to pitavastatin (PTV 4 mg/day) therapy in patients. Approximately 200 adult Japanese CHD patients who underwent percutaneous coronary intervention were randomly allocated to either the statin only group (n=96) or to the statin/EPA (1.8 g/day) group (n=97), prospectively followed for 6 to 8 months, and included in the primary analysis. Coronary plaque volume and composition in non-stenting lesions were analyzed by integrated backscatter-intravascular ultrasonography (IB-IVUS) at baseline and follow up. The primary endpoint was the change in coronary tissue characteristics as evaluated by IB-IVUS. Secondary end points included changes in the volume of target coronary plaques and major cardiovascular events. Baseline low-density lipoprotein cholesterol levels for the statin and statin/EPA groups were 99 and 107 mg/dL, respectively, and total cholesterol levels were 166 and 175 mg/dL, respectively. Triglyceride levels were in the normal range at baseline in both arms [1]. After 6-8 months the CHERRY study showed a statistically significant reduction in coronary plaque volume (from 74.5 to 61.4 mm3; p<0.001), lipid volume (from 39.2 to 34.8 mm3; p<0.05), and fibrous volume (from 28.9 to 22.8 mm3; p<0.05) of the lesions in the statin plus EPA group, but in each case no statistically significant difference was observed in the statin-only group. The prevalence of clinically significant plaque regression, defined as percent change in plaque volume more than -15%, was significantly greater in the statin plus EPA group than in the statin group alone (48% vs. 25%; p<0.001). Patient safety was evaluated by regular medical examinations and laboratory tests at 1, 3, and 6-8 months after enrollment. An assessment committee evaluated major adverse cardiovascular events (MACE) and any other adverse events. In this short-term study of <100 patients per arm, there were no statistically significant differences between groups in MACE or adverse events. MACE was defined as cardiac death, myocardial infarction, PCI and coronary artery bypass graft. CHERRY is the first known study to use IB-IVUS to investigate the effects of combination therapy with statin and EPA on plaque regression. Coronary atherosclerosis progression/regression evaluation by IVUS is reported to be a feasible means to predict future cardiovascular events [2,3], and IB-IVUS analysis of specific tissue components (calcification, dense fibrosis, fibrosis, lipid pool) of coronary plaques in vivo [4,5] has been considered a useful tool for assessing risk of experiencing a coronary event in patients with coronary atherosclerosis [6-8]. The CHERRY study was not sponsored by or affiliated with Amarin. The study was presented by Dr. Kaoru Ando (Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan) and his colleagues at the American Heart Association Scientific Sessions in Orlando, Florida on November 8 and the abstract has been published in Circulation. 2015; 132: A12007. Information in this press release is based on publicly presented data. Amarin disclaims responsibility for inaccuracies of third-party publicly presented data. Amarin looks forward to publication of complete results from the CHERRY study to more fully assess the strengths and limitations of the study and the resulting data. The CHERRY investigators concluded from their study that additional administration of EPA to high dose statin treatment significantly reduced coronary plaque volume and suggested from their study results that EPA therapy may reduce the residual risk that remains in secondary prevention patients being treated with statin therapy [9-10].