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NDT Advance Access published online on May 1, 2008
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfn230
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© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Antiproteinuric effects of angiotensin receptor blockers: telmisartan versus valsartan in hypertensive patients with type 2 diabetes mellitus and overt nephropathy

Jan Galle1, Edzard Schwedhelm2, Sabine Pinnetti3, Rainer H. Böger2, Christoph Wanner2 and on behalf of the VIVALDI investigators

1 Department of Internal Medicine, University Hospital, Würzburg 2 Institute for Experimental and Clinical Pharmacology, University Hospital Hamburg-Eppendorf, Würzburg 3 Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach (SP), Germany

Correspondence and offprint requests to: Jan Galle, Abteilung für Nephrologie und Dialyseverfahren, Klinikum Lüdenscheid, Paulmannshöher Strasse 14, Lüdenscheid D-58515, Germany. E-mail: J.Galle{at}klinikum-luedenscheid.de



  Abstract

Background. Renin–angiotensin system blockade reduces proteinuria and prevents nephropathy progression in patients with type 2 diabetes mellitus (T2D). Experimental evidence demonstrates that angiotensin receptor blockers (ARBs) possess anti-inflammatory potential, which might contribute to reducing proteinuria and providing renoprotection.

Methods. We conducted a multicentre, double-blind, prospective, parallel-group non-inferiority study of 885 hypertensive [systolic blood pressure/diastolic blood pressure (SBP/DBP) >130/80 mmHg] patients with T2D, proteinuria (≥900 mg/24 h) and serum creatinine (≤3.0 mg/dl) who were randomized to once-daily telmisartan 80 mg or valsartan 160 mg; additional antihypertensive therapy was permitted. The primary endpoint was the change from baseline in the 24-h proteinuria after 12 months. Secondary endpoints included changes in 24-h albuminuria, estimated glomerular filtration rate (eGFR) and inflammatory parameters asymmetrical dimethylarginine (ADMA), high-sensitivity C-reactive protein (CRP) and urinary 8-iso-prostaglandin F2{alpha} (8-iso-PGF2{alpha}).

Results. Telmisartan and valsartan produced comparable reductions in 24-h urinary protein excretion rates: geometric mean reduction (95% confidence interval) [telmisartan, 33% (27–39%); valsartan, 33% (27–38%)]. No significant differences between treatments were seen in changes from baseline in 24-h urinary albumin excretion rate and eGFR at 12 months. With both treatments, greater renoprotection was seen among patients with better blood pressure control. No significant changes in ADMA or CRP were noted in either group after 12 months, but urinary 8-iso-PGF2{alpha} levels decreased by 14% with telmisartan and by 7% with valsartan (P = 0.040).

Conclusions. In patients with T2D, hypertension and overt nephropathy, the renoprotection afforded by telmisartan and valsartan appears similar, and the study was unable to show any effect beyond that due to blood pressure control. At doses used to treat hypertension, there is no evidence of inflammatory parameters being modified by ARBs in patients with more advanced kidney disease due to T2D.

Keywords: angiotensin receptor blockers; diabetic nephropathy; proteinuria; telmisartan; valsartan

Received for publication: 21. 1.08
Accepted in revised form: 3. 4.08


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