Losartan and diabetic nephropathy: commentaries on the RENAAL study

<p>Abstract</p> <p>The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) study is a multinational, double-blind, randomized, placebo controlled trial which was recently published. It was aimed to evaluate the effect of the angiotensin receptor blo...

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Main Authors: Tenenbaum Alexander, Fisman Enrique Z, Motro Michael
Format: Article
Language:English
Published: BMC 2002-04-01
Series:Cardiovascular Diabetology
Subjects:
Online Access:http://www.cardiab.com/content/1/1/2
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author Tenenbaum Alexander
Fisman Enrique Z
Motro Michael
author_facet Tenenbaum Alexander
Fisman Enrique Z
Motro Michael
author_sort Tenenbaum Alexander
collection DOAJ
description <p>Abstract</p> <p>The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) study is a multinational, double-blind, randomized, placebo controlled trial which was recently published. It was aimed to evaluate the effect of the angiotensin receptor blocker losartan in patients with diabetic nephropathy. The primary efficacy measure was the time to the first event of the composite end point of a doubling of serum creatinine, end-stage renal disease, or death. The conclusion was that losartan led to significant improvement in renal outcomes, that was beyond that attributable to blood pressure control in patients with type 2 diabetes and nephropathy.</p> <p>The perusal of the report raises concern, regarding to both the patient population as well as the outcome measures. At randomization, the placebo group included more patients with angina, myocardial infarction and lipid disorders than the losartan group. Information on glucose metabolism was disregarded, and data on antihyperglycemic therapy – which may have undesirable influences on cardiac performance – were not included in a multivariate analysis. In addition, only data on first hospitalization were reported, whilst information on total specific-cause hospitalizations was disregarded, thus potentially masking further unfavorable events. Furthermore, creatinine seems not to be a reliable surrogate end point. Based on its mechanism of action, losartan may possess favorable renoprotective properties. However, due to the methodological flaws and the incomplete data in the RENAAL study, the question of the effectiveness and safety of this drug in diabetic nephropathy remains yet unanswered.</p>
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spelling doaj.art-78abe327ee854a3a930f32f9527291852022-12-21T21:19:14ZengBMCCardiovascular Diabetology1475-28402002-04-0111210.1186/1475-2840-1-2Losartan and diabetic nephropathy: commentaries on the RENAAL studyTenenbaum AlexanderFisman Enrique ZMotro Michael<p>Abstract</p> <p>The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) study is a multinational, double-blind, randomized, placebo controlled trial which was recently published. It was aimed to evaluate the effect of the angiotensin receptor blocker losartan in patients with diabetic nephropathy. The primary efficacy measure was the time to the first event of the composite end point of a doubling of serum creatinine, end-stage renal disease, or death. The conclusion was that losartan led to significant improvement in renal outcomes, that was beyond that attributable to blood pressure control in patients with type 2 diabetes and nephropathy.</p> <p>The perusal of the report raises concern, regarding to both the patient population as well as the outcome measures. At randomization, the placebo group included more patients with angina, myocardial infarction and lipid disorders than the losartan group. Information on glucose metabolism was disregarded, and data on antihyperglycemic therapy – which may have undesirable influences on cardiac performance – were not included in a multivariate analysis. In addition, only data on first hospitalization were reported, whilst information on total specific-cause hospitalizations was disregarded, thus potentially masking further unfavorable events. Furthermore, creatinine seems not to be a reliable surrogate end point. Based on its mechanism of action, losartan may possess favorable renoprotective properties. However, due to the methodological flaws and the incomplete data in the RENAAL study, the question of the effectiveness and safety of this drug in diabetic nephropathy remains yet unanswered.</p>http://www.cardiab.com/content/1/1/2Angiotensin receptor blockersClinical trialsDiabetes mellitusLosartanNephropathyRENAAL study
spellingShingle Tenenbaum Alexander
Fisman Enrique Z
Motro Michael
Losartan and diabetic nephropathy: commentaries on the RENAAL study
Cardiovascular Diabetology
Angiotensin receptor blockers
Clinical trials
Diabetes mellitus
Losartan
Nephropathy
RENAAL study
title Losartan and diabetic nephropathy: commentaries on the RENAAL study
title_full Losartan and diabetic nephropathy: commentaries on the RENAAL study
title_fullStr Losartan and diabetic nephropathy: commentaries on the RENAAL study
title_full_unstemmed Losartan and diabetic nephropathy: commentaries on the RENAAL study
title_short Losartan and diabetic nephropathy: commentaries on the RENAAL study
title_sort losartan and diabetic nephropathy commentaries on the renaal study
topic Angiotensin receptor blockers
Clinical trials
Diabetes mellitus
Losartan
Nephropathy
RENAAL study
url http://www.cardiab.com/content/1/1/2
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