Effect of Telmisartan on Renal Outcomes: A Randomized Trial
Identifieur interne : 001B92 ( Main/Exploration ); précédent : 001B91; suivant : 001B93Effect of Telmisartan on Renal Outcomes: A Randomized Trial
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Abstract
Background: Angiotensin-receptor blockers (ARBs) blunt progression of advanced diabetic nephropathy, but their long-term renal effects in other patients are not clear. Objective: To examine the long-term renal effects of telmisartan versus placebo in adults at high vascular risk. Design: Randomized trial. Patients were randomly assigned by a central automated system between November 2001 and May 2004 and were followed until March 2008. Participants and investigators were blinded to intervention status. Setting: Multicenter, multinational study. Patients: 5927 adults with known cardiovascular disease or diabetes with end-organ damage but without macroalbuminuria or heart failure who cannot tolerate angiotensin-converting enzyme inhibitors. Intervention: Telmisartan, 80 mg/d (n = 2954), or matching placebo (n = 2972) plus standard treatment for a mean of 56 months. Measurements: Composite renal outcome of dialysis or doubling of serum creatinine, changes in estimated glomerular filtration rate (GFR), and changes in albuminuria. Results: No important difference was found in the composite renal outcome with telmisartan (58 patients [1.96%]) versus placebo (46 patients [1.55%]) (hazard ratio, 1.29 [95% CI, 0.87 to 1.89]; P = 0.20). Among the telmisartan and placebo groups, 7 and 10 patients had dialysis and 56 and 36 patients had doubling of serum creatinine, respectively (hazard ratio, 1.59 [CI, 1.04 to 2.41]; P = 0.031). Albuminuria increased less with telmisartan than with placebo (32% [CI, 23% to 41%] vs. 63% [CI, 52% to 76%]; P < 0.001). Decreases in estimated GFR were greater with telmisartan than with placebo (mean change in estimated GFR, -3.2 mL/min per 1.73 m2 [SD, 18.3] vs. -0.26 mL/min per 1.73 m2 [SD, 18.0]; P < 0.001). Limitation: Only 17 participants had dialysis. Conclusion: In adults with vascular disease but without macroalbuminuria, the effects of telmisartan on major renal outcomes were similar to those of placebo. Primary Funding Source: Boehringer Ingelheim.
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Mann</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Schwabing General Hospital and KfH Kidney Center, Ludwig Maximilians University</s1><s2>Munich</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement></placeName><orgName type="university">Université Louis-et-Maximilien de Munich</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Friedrich Alexander University</s1><s2>Erlangen</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country><wicri:noRegion>Erlangen</wicri:noRegion><wicri:noRegion>Friedrich Alexander University</wicri:noRegion><wicri:noRegion>Friedrich Alexander University</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Population Health Research Institute, McMaster University</s1><s2>Hamilton, Ontario</s2><s3>CAN</s3></inist:fA14><country>Canada</country><wicri:noRegion>Hamilton, Ontario</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Boehringer Ingelheim</s1><s2>Ingelheim</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country><wicri:noRegion>Ingelheim</wicri:noRegion><wicri:noRegion>Boehringer Ingelheim</wicri:noRegion><wicri:noRegion>Boehringer Ingelheim</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Beijing Hypertension League Institute</s1><s2>Beijing</s2><s3>CHN</s3></inist:fA14><country>République populaire de Chine</country><placeName><settlement type="city">Pékin</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>University of Washington</s1><s2>Seattle, Washington</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Washington</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Dante Pazzanese Institute of Cardiology</s1><s2>São Paulo</s2><s3>BRA</s3></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>University of Guadalajara</s1><s2>Guadalajara</s2><s3>MEX</s3></inist:fA14><country>Mexique</country><wicri:noRegion>University of Guadalajara</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Institute of Cardiology and Pneumology, Laval University and Hospital</s1><s2>Quebec, Quebec</s2><s3>CAN</s3></inist:fA14><country>Canada</country><wicri:noRegion>Quebec, Quebec</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University of Buenos Aires</s1><s2>Buenos Aires</s2><s3>ARG</s3></inist:fA14><country>Argentine</country><wicri:noRegion>University of Buenos Aires</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Heart Institute, University of Ottawa</s1><s2>Ottawa, Ontario</s2><s3>CAN</s3></inist:fA14><country>Canada</country><wicri:noRegion>Ottawa, Ontario</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>University of Grenoble</s1><s2>Grenoble</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="région">Rhône-Alpes</region><settlement type="city">Grenoble</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Karolinska Institutet</s1><s2>Stockholm</s2><s3>SWE</s3></inist:fA14><country>Suède</country><wicri:noRegion>Karolinska Institutet</wicri:noRegion></affiliation><affiliation wicri:level="4"><inist:fA14 i1="14"><s1>Prince of Wales Hospital, Chinese University of Hong Kong</s1><s3>HKG</s3></inist:fA14><country>Hong Kong</country><placeName><settlement type="city">Sha Tin</settlement></placeName><orgName type="university">Université chinoise de Hong Kong</orgName></affiliation></author><author><name sortKey="Schmieder, Roland E" uniqKey="Schmieder R">Roland E. Schmieder</name></author><author><name sortKey="Dyal, Leanne" uniqKey="Dyal L">Leanne Dyal</name></author><author><name sortKey="Mcqueen, Matthew J" uniqKey="Mcqueen M">Matthew J. Mcqueen</name></author><author><name sortKey="Schumacher, Helmut" uniqKey="Schumacher H">Helmut Schumacher</name></author><author><name sortKey="Pogue, Janice" uniqKey="Pogue J">Janice Pogue</name></author><author><name>XINGYU WANG</name></author><author><name sortKey="Probstfield, Jeffrey L" uniqKey="Probstfield J">Jeffrey L. Probstfield</name></author><author><name sortKey="Avezum, Alvaro" uniqKey="Avezum A">Alvaro Avezum</name></author><author><name sortKey="Cardona Munoz, Ernesto" uniqKey="Cardona Munoz E">Ernesto Cardona-Munoz</name></author><author><name sortKey="Dagenais, Gilles R" uniqKey="Dagenais G">Gilles R. Dagenais</name></author><author><name sortKey="Diaz, Rafael" uniqKey="Diaz R">Rafael Diaz</name></author><author><name sortKey="Fodor, George" uniqKey="Fodor G">George Fodor</name></author><author><name sortKey="Maillon, Jean M" uniqKey="Maillon J">Jean M. Maillon</name></author><author><name sortKey="Ryden, Lars" uniqKey="Ryden L">Lars Ryden</name></author><author><name sortKey="Yu, Cheuk M" uniqKey="Yu C">Cheuk M. Yu</name></author><author><name sortKey="Teo, Koon K" uniqKey="Teo K">Koon K. Teo</name></author><author><name sortKey="Yusuf, Salim" uniqKey="Yusuf S">Salim Yusuf</name></author></titleStmt><publicationStmt><idno type="inist">09-0312788</idno><date when="2009">2009</date><idno type="stanalyst">PASCAL 09-0312788 INIST</idno><idno type="RBID">Pascal:09-0312788</idno><idno type="wicri:Area/Main/Corpus">001C94</idno><idno type="wicri:Area/Main/Curation">000C85</idno><idno type="wicri:Area/Main/Exploration">001B92</idno></publicationStmt><seriesStmt><idno type="ISSN">0003-4819</idno><title level="j" type="abbreviated">Ann. intern. med.</title><title level="j" type="main">Annals of internal medicine</title></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antihypertensive agent</term><term>Clinical trial</term><term>Evolution</term><term>Human</term><term>Kidney</term><term>Medicine</term><term>Prognosis</term><term>Randomization</term><term>Telmisartan</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Telmisartan</term><term>Rein</term><term>Evolution</term><term>Pronostic</term><term>Essai clinique</term><term>Randomisation</term><term>Médecine</term><term>Homme</term><term>Antihypertenseur</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: Angiotensin-receptor blockers (ARBs) blunt progression of advanced diabetic nephropathy, but their long-term renal effects in other patients are not clear. Objective: To examine the long-term renal effects of telmisartan versus placebo in adults at high vascular risk. Design: Randomized trial. Patients were randomly assigned by a central automated system between November 2001 and May 2004 and were followed until March 2008. Participants and investigators were blinded to intervention status. Setting: Multicenter, multinational study. Patients: 5927 adults with known cardiovascular disease or diabetes with end-organ damage but without macroalbuminuria or heart failure who cannot tolerate angiotensin-converting enzyme inhibitors. Intervention: Telmisartan, 80 mg/d (n = 2954), or matching placebo (n = 2972) plus standard treatment for a mean of 56 months. Measurements: Composite renal outcome of dialysis or doubling of serum creatinine, changes in estimated glomerular filtration rate (GFR), and changes in albuminuria. Results: No important difference was found in the composite renal outcome with telmisartan (58 patients [1.96%]) versus placebo (46 patients [1.55%]) (hazard ratio, 1.29 [95% CI, 0.87 to 1.89]; P = 0.20). Among the telmisartan and placebo groups, 7 and 10 patients had dialysis and 56 and 36 patients had doubling of serum creatinine, respectively (hazard ratio, 1.59 [CI, 1.04 to 2.41]; P = 0.031). Albuminuria increased less with telmisartan than with placebo (32% [CI, 23% to 41%] vs. 63% [CI, 52% to 76%]; P < 0.001). Decreases in estimated GFR were greater with telmisartan than with placebo (mean change in estimated GFR, -3.2 mL/min per 1.73 m<sup>2</sup> [SD, 18.3] vs. -0.26 mL/min per 1.73 m<sup>2</sup> [SD, 18.0]; P < 0.001). Limitation: Only 17 participants had dialysis. Conclusion: In adults with vascular disease but without macroalbuminuria, the effects of telmisartan on major renal outcomes were similar to those of placebo. Primary Funding Source: Boehringer Ingelheim.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0003-4819</s0></fA01><fA02 i1="01"><s0>AIMEAS</s0></fA02><fA03 i2="1"><s0>Ann. intern. med.</s0></fA03><fA05><s2>151</s2></fA05><fA06><s2>1</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Effect of Telmisartan on Renal Outcomes: A Randomized Trial</s1></fA08><fA11 i1="01" i2="1"><s1>MANN (Johannes F. E.)</s1></fA11><fA11 i1="02" i2="1"><s1>SCHMIEDER (Roland E.)</s1></fA11><fA11 i1="03" i2="1"><s1>DYAL (Leanne)</s1></fA11><fA11 i1="04" i2="1"><s1>MCQUEEN (Matthew J.)</s1></fA11><fA11 i1="05" i2="1"><s1>SCHUMACHER (Helmut)</s1></fA11><fA11 i1="06" i2="1"><s1>POGUE (Janice)</s1></fA11><fA11 i1="07" i2="1"><s1>XINGYU WANG</s1></fA11><fA11 i1="08" i2="1"><s1>PROBSTFIELD (Jeffrey L.)</s1></fA11><fA11 i1="09" i2="1"><s1>AVEZUM (Alvaro)</s1></fA11><fA11 i1="10" i2="1"><s1>CARDONA-MUNOZ (Ernesto)</s1></fA11><fA11 i1="11" i2="1"><s1>DAGENAIS (Gilles R.)</s1></fA11><fA11 i1="12" i2="1"><s1>DIAZ (Rafael)</s1></fA11><fA11 i1="13" i2="1"><s1>FODOR (George)</s1></fA11><fA11 i1="14" i2="1"><s1>MAILLON (Jean M.)</s1></fA11><fA11 i1="15" i2="1"><s1>RYDEN (Lars)</s1></fA11><fA11 i1="16" i2="1"><s1>YU (Cheuk M.)</s1></fA11><fA11 i1="17" i2="1"><s1>TEO (Koon K.)</s1></fA11><fA11 i1="18" i2="1"><s1>YUSUF (Salim)</s1></fA11><fA14 i1="01"><s1>Schwabing General Hospital and KfH Kidney Center, Ludwig Maximilians University</s1><s2>Munich</s2><s3>DEU</s3></fA14><fA14 i1="02"><s1>Friedrich Alexander University</s1><s2>Erlangen</s2><s3>DEU</s3></fA14><fA14 i1="03"><s1>Population Health Research Institute, McMaster University</s1><s2>Hamilton, Ontario</s2><s3>CAN</s3></fA14><fA14 i1="04"><s1>Boehringer Ingelheim</s1><s2>Ingelheim</s2><s3>DEU</s3></fA14><fA14 i1="05"><s1>Beijing Hypertension League Institute</s1><s2>Beijing</s2><s3>CHN</s3></fA14><fA14 i1="06"><s1>University of Washington</s1><s2>Seattle, Washington</s2><s3>USA</s3></fA14><fA14 i1="07"><s1>Dante Pazzanese Institute of Cardiology</s1><s2>São Paulo</s2><s3>BRA</s3></fA14><fA14 i1="08"><s1>University of Guadalajara</s1><s2>Guadalajara</s2><s3>MEX</s3></fA14><fA14 i1="09"><s1>Institute of Cardiology and Pneumology, Laval University and Hospital</s1><s2>Quebec, Quebec</s2><s3>CAN</s3></fA14><fA14 i1="10"><s1>University of Buenos Aires</s1><s2>Buenos Aires</s2><s3>ARG</s3></fA14><fA14 i1="11"><s1>Heart Institute, University of Ottawa</s1><s2>Ottawa, Ontario</s2><s3>CAN</s3></fA14><fA14 i1="12"><s1>University of Grenoble</s1><s2>Grenoble</s2><s3>FRA</s3></fA14><fA14 i1="13"><s1>Karolinska Institutet</s1><s2>Stockholm</s2><s3>SWE</s3></fA14><fA14 i1="14"><s1>Prince of Wales Hospital, Chinese University of Hong Kong</s1><s3>HKG</s3></fA14><fA17 i1="01" i2="1"><s1>TRANSCEND (Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease) Investigators</s1><s3>INC</s3></fA17><fA20><s1>1-10</s1></fA20><fA21><s1>2009</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>2014</s2><s5>354000187992480010</s5></fA43><fA44><s0>0000</s0><s1>© 2009 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>22 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>09-0312788</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Annals of internal medicine</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Background: Angiotensin-receptor blockers (ARBs) blunt progression of advanced diabetic nephropathy, but their long-term renal effects in other patients are not clear. Objective: To examine the long-term renal effects of telmisartan versus placebo in adults at high vascular risk. Design: Randomized trial. Patients were randomly assigned by a central automated system between November 2001 and May 2004 and were followed until March 2008. Participants and investigators were blinded to intervention status. Setting: Multicenter, multinational study. Patients: 5927 adults with known cardiovascular disease or diabetes with end-organ damage but without macroalbuminuria or heart failure who cannot tolerate angiotensin-converting enzyme inhibitors. Intervention: Telmisartan, 80 mg/d (n = 2954), or matching placebo (n = 2972) plus standard treatment for a mean of 56 months. Measurements: Composite renal outcome of dialysis or doubling of serum creatinine, changes in estimated glomerular filtration rate (GFR), and changes in albuminuria. Results: No important difference was found in the composite renal outcome with telmisartan (58 patients [1.96%]) versus placebo (46 patients [1.55%]) (hazard ratio, 1.29 [95% CI, 0.87 to 1.89]; P = 0.20). Among the telmisartan and placebo groups, 7 and 10 patients had dialysis and 56 and 36 patients had doubling of serum creatinine, respectively (hazard ratio, 1.59 [CI, 1.04 to 2.41]; P = 0.031). Albuminuria increased less with telmisartan than with placebo (32% [CI, 23% to 41%] vs. 63% [CI, 52% to 76%]; P < 0.001). Decreases in estimated GFR were greater with telmisartan than with placebo (mean change in estimated GFR, -3.2 mL/min per 1.73 m<sup>2</sup> [SD, 18.3] vs. -0.26 mL/min per 1.73 m<sup>2</sup> [SD, 18.0]; P < 0.001). Limitation: Only 17 participants had dialysis. Conclusion: In adults with vascular disease but without macroalbuminuria, the effects of telmisartan on major renal outcomes were similar to those of placebo. 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