• N. Engl. J. Med. · Dec 2022

    Randomized Controlled Trial Multicenter Study

    Renin-Angiotensin System Inhibition in Advanced Chronic Kidney Disease.

    • Sunil Bhandari, Samir Mehta, Arif Khwaja, ClelandJohn G FJGFFrom the Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, and Hull York Medical School, Hull (S.B.), the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I., E.B., M.C.), and the I, Natalie Ives, Elizabeth Brettell, Marie Chadburn, Paul Cockwell, and STOP ACEi Trial Investigators.
    • From the Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, and Hull York Medical School, Hull (S.B.), the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I., E.B., M.C.), and the Institute of Inflammation and Aging (P.C.), University of Birmingham, and the Department of Renal Medicine, Queen Elizabeth Hospital, University Hospitals Birmingham (P.C.), Birmingham, the Sheffield Kidney Institute, Sheffield (A.K.), and the British Heart Foundation Centre for Research Excellence, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow (J.G.F.C.) - all in the United Kingdom.
    • N. Engl. J. Med. 2022 Dec 1; 387 (22): 202120322021-2032.

    BackgroundRenin-angiotensin system (RAS) inhibitors - including angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) - slow the progression of mild or moderate chronic kidney disease. However, the results of some studies have suggested that the discontinuation of RAS inhibitors in patients with advanced chronic kidney disease may increase the estimated glomerular filtration rate (eGFR) or slow its decline.MethodsIn this multicenter, open-label trial, we randomly assigned patients with advanced and progressive chronic kidney disease (eGFR, <30 ml per minute per 1.73 m2 of body-surface area) either to discontinue or to continue therapy with RAS inhibitors. The primary outcome was the eGFR at 3 years; eGFR values that were obtained after the initiation of renal-replacement therapy were excluded. Secondary outcomes included the development of end-stage kidney disease (ESKD); a composite of a decrease of more than 50% in the eGFR or the initiation of renal-replacement therapy, including ESKD; hospitalization; blood pressure; exercise capacity; and quality of life. Prespecified subgroups were defined according to age, eGFR, type of diabetes, mean arterial pressure, and proteinuria.ResultsAt 3 years, among the 411 patients who were enrolled, the least-squares mean (±SE) eGFR was 12.6±0.7 ml per minute per 1.73 m2 in the discontinuation group and 13.3±0.6 ml per minute per 1.73 m2 in the continuation group (difference, -0.7; 95% confidence interval [CI], -2.5 to 1.0; P = 0.42), with a negative value favoring the outcome in the continuation group. No heterogeneity in outcome according to the prespecified subgroups was observed. ESKD or the initiation of renal-replacement therapy occurred in 128 patients (62%) in the discontinuation group and in 115 patients (56%) in the continuation group (hazard ratio, 1.28; 95% CI, 0.99 to 1.65). Adverse events were similar in the discontinuation group and continuation group with respect to cardiovascular events (108 vs. 88) and deaths (20 vs. 22).ConclusionsAmong patients with advanced and progressive chronic kidney disease, the discontinuation of RAS inhibitors was not associated with a significant between-group difference in the long-term rate of decrease in the eGFR. (Funded by the National Institute for Health Research and the Medical Research Council; STOP ACEi EudraCT number, 2013-003798-82; ISRCTN number, 62869767.).Copyright © 2022 Massachusetts Medical Society.

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