Abstract: FR-OR18
Benefits of Icosapent Ethyl Across a Range of Baseline Renal Function in Patients with Established Cardiovascular Disease or Diabetes: Results of REDUCE-IT RENAL
Session Information
- Clinical Trials and Related Studies to Improve CKD Outcomes
October 23, 2020 | Location: Simulive
Abstract Time: 05:00 PM - 07:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Majithia, Arjun, Brigham and Women's Hospital, Boston, Massachusetts, United States
- Bhatt, Deepak L., Brigham and Women's Hospital, Boston, Massachusetts, United States
- Friedman, Allon N., Indiana University School of Medicine, Indianapolis, Indiana, United States
- Miller, Michael, University of Maryland School of Medicine, Baltimore, Maryland, United States
- Steg, Philippe Gabriel, Hopital Bichat - Claude-Bernard, Paris, Île-de-France, France
- Brinton, Eliot A., Utah Lipid Center, Salt Lake City, Utah, United States
- Jacobson, Terry A., Emory University School of Medicine, Atlanta, Georgia, United States
- Ketchum, Steven B., Amarin Pharma Inc, Bridgewater, New Jersey, United States
- Juliano, Rebecca A., Amarin Pharma Inc, Bridgewater, New Jersey, United States
- Jiao, Lixia, Amarin Pharma Inc, Bridgewater, New Jersey, United States
- Doyle, Ralph T., Amarin Pharma Inc, Bridgewater, New Jersey, United States
- Granowitz, Craig B., Amarin Pharma Inc, Bridgewater, New Jersey, United States
- Budoff, Matthew Jay, University of California Los Angeles, Los Angeles, California, United States
- Mason, Preston, Brigham and Women's Hospital, Boston, Massachusetts, United States
- Tardif, Jean-Claude, Institut De Cardiologie de Montreal, Montreal, Quebec, Canada
- Boden, William E., VA Boston Healthcare System, West Roxbury, Massachusetts, United States
- Ballantyne, Christie, Baylor College of Medicine, Houston, Texas, United States
Group or Team Name
- REDUCE-IT Investigators
Background
Chronic kidney disease is associated with adverse outcomes among patients with established cardiovascular disease (CVD) or diabetes. Medications for treatment of CVD among patients with low estimated glomerular filtration rate (eGFR) may be ineffective.
Methods
The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) randomized patients with CVD or diabetes and one additional risk factor to treatment with icosapent ethyl or placebo. Patients from REDUCE-IT were categorized by prespecified eGFR categories for analysis of the effect of icosapent ethyl (IPE) on the primary endpoint (composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina) and key secondary endpoint (a composite of CV death, nonfatal MI, or nonfatal stroke). In post hoc analysis, patients were categorized by additional eGFR cutoffs consistent with current medical guidelines.
Results
Among the 8179 REDUCE-IT patients, median baseline eGFR was 75 mL/min/1.73m2 (range: 17 to 123 mL/min/1.73m2). There were no meaningful changes in median eGFR for IPE versus placebo across study visits. IPE benefit was consistent across baseline eGFR for the primary (Figure) and key secondary endpoints. The numerical reduction in CV death was greatest in the eGFR <60 mL/min/1.73m2 group (IPE: 7.6%; placebo: 10.6%; HR 0.70, 95%CI 0.51, 0.95, p=0.02). The rate of microalbuminuria in adverse event reporting was lower among IPE-treated patients (0.1% versus 0.3%, p=0.01).
Conclusion
In REDUCE-IT, icosapent ethyl reduced fatal and nonfatal ischemic events across the broad range of baseline eGFR categories.
Funding
- Commercial Support – Amarin