Kidney Week

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

Arjun Majithia, MD

• Bhatt, Deepak L., Brigham and Women's Hospital, Boston, Massachusetts, United States

Deepak L. Bhatt,

• Friedman, Allon N., Indiana University School of Medicine, Indianapolis, Indiana, United States

Allon N. Friedman,

• Miller, Michael, University of Maryland School of Medicine, Baltimore, Maryland, United States

Michael Miller,

• Steg, Philippe Gabriel, Hopital Bichat - Claude-Bernard, Paris, Île-de-France, France

Philippe Gabriel Steg,

• Brinton, Eliot A., Utah Lipid Center, Salt Lake City, Utah, United States

Eliot A. Brinton,

• Jacobson, Terry A., Emory University School of Medicine, Atlanta, Georgia, United States

Terry A. Jacobson,

• Ketchum, Steven B., Amarin Pharma Inc, Bridgewater, New Jersey, United States

Steven B. Ketchum,

• Juliano, Rebecca A., Amarin Pharma Inc, Bridgewater, New Jersey, United States

Rebecca A. Juliano,

• Jiao, Lixia, Amarin Pharma Inc, Bridgewater, New Jersey, United States

Lixia Jiao,

• Doyle, Ralph T., Amarin Pharma Inc, Bridgewater, New Jersey, United States

Ralph T. Doyle,

• Granowitz, Craig B., Amarin Pharma Inc, Bridgewater, New Jersey, United States

Craig B. Granowitz,

• Budoff, Matthew Jay, University of California Los Angeles, Los Angeles, California, United States

Matthew Jay Budoff,

• Mason, Preston, Brigham and Women's Hospital, Boston, Massachusetts, United States

Preston Mason,

• Tardif, Jean-Claude, Institut De Cardiologie de Montreal, Montreal, Quebec, Canada

Jean-Claude Tardif,

• Boden, William E., VA Boston Healthcare System, West Roxbury, Massachusetts, United States

William E. Boden,

• Ballantyne, Christie, Baylor College of Medicine, Houston, Texas, United States

Christie Ballantyne,

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 –