• Gema Fernandez Juarez, José Luño, Vicente Barrio, Soledad García de Vinuesa, Manuel Praga, Marian Goicoechea, Victoria Cachofeiro, Javier Nieto, Francisco Fernández Vega, Ana Tato, Eduardo Gutierrez, and PRONEDI Study Group.
• Hospital Fundación de Alcorcón, Madrid, Spain.
• Am. J. Kidney Dis. 2013 Feb 1;61(2):211-8.

BackgroundBlockade of the renin-angiotensin system with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers has been shown to lessen the rate of decrease in glomerular filtration rate in patients with diabetic nephropathy.Study DesignA multicenter open-label randomized controlled trial to compare the efficacy of combining the angiotensin-converting enzyme inhibitor lisinopril and the angiotensin II receptor blocker irbesartan with that of each drug in monotherapy (at both high and equipotent doses) in slowing the progression of type 2 diabetic nephropathy.Setting & Population133 patients with type 2 diabetic nephropathy (age, 66 ± 8 years; 76% men) from 17 centers in Spain.InterventionPatients were randomly assigned (1:1:2) to lisinopril (n = 35), irbesartan (n = 28), or the combination of both (n = 70).OutcomesThe primary composite outcome was a >50% increase in baseline serum creatinine level, end-stage renal disease, or death.ResultsBaseline values for mean estimated glomerular filtration rate and blood pressure were 49 ± 21 mL/min/1.73 m(2) and 153 ± 19/81 ± 11 mm Hg. Mean geometric baseline proteinuria was protein excretion of 1.32 (95% CI, 1.10-1.62) g/g creatinine. After a median follow-up of 32 months, 21 (30%) patients in the combination group, 10 (29%) in the lisinopril group, and 8 (29%) in the irbesartan group reached the primary outcome. HRs were 0.96 (95% CI, 0.44-2.05; P = 0.9) and 0.90 (95% CI, 0.39-2.02; P = 0.8) for the combination versus the lisinopril and irbesartan groups, respectively. There were no significant differences in proteinuria reduction or blood pressure control between groups. The number of adverse events, including hyperkalemia, was similar in all 3 groups.LimitationsThe study was not double blind. The sample size studied was small.ConclusionsWe were unable to show a benefit of the combination of lisinopril and irbesartan compared to either agent alone at optimal high doses on the risk of progression of type 2 diabetic nephropathy.Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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