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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial
The Lancet, Volume 372, No. 9644, Year 2008
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Description
Background: Angiotensin-converting enzyme (ACE) inhibitors reduce major cardiovascular events, but are not tolerated by about 20% of patients. We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular disease or diabetes with end-organ damage. Methods: After a 3-week run-in period, 5926 patients, many of whom were receiving concomitant proven therapies, were randomised to receive telmisartan 80 mg/day (n=2954) or placebo (n=2972) by use of a central automated randomisation system. Randomisation was stratified by hospital. The primary outcome was the composite of cardiovascular death, myocardial infarction, stroke, or hospitalisation for heart failure. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00153101. Findings: The median duration of follow-up was 56 (IQR 51-64) months. All randomised patients were included in the efficacy analyses. Mean blood pressure was lower in the telmisartan group than in the placebo group throughout the study (weighted mean difference between groups 4·0/2·2 [SD 19·6/12·0] mm Hg). 465 (15·7%) patients experienced the primary outcome in the telmisartan group compared with 504 (17·0%) in the placebo group (hazard ratio 0·92, 95% CI 0·81-1·05, p=0·216). One of the secondary outcomes-a composite of cardiovascular death, myocardial infarction, or stroke-occurred in 384 (13·0%) patients on telmisartan compared with 440 (14·8%) on placebo (0·87, 0·76-1·00, p=0·048 unadjusted; p=0·068 after adjustment for multiplicity of comparisons and overlap with primary outcome). 894 (30·3%) patients receiving telmisartan were hospitalised for a cardiovascular reason, compared with 980 (33·0%) on placebo (relative risk 0·92, 95% CI 0·85-0·99; p=0·025). Fewer patients permanently discontinued study medication in the telmisartan group than in the placebo group (639 [21·6%] vs 705 [23·8%]; p=0·055); the most common reason for permanent discontinuation was hypotensive symptoms (29 [0·98%] in the telmisartan group vs 16 [0·54%] in the placebo group). Interpretation: Telmisartan was well tolerated in patients unable to tolerate ACE inhibitors. Although the drug had no significant effect on the primary outcome of this study, which included hospitalisations for heart failure, it modestly reduced the risk of the composite outcome of cardiovascular death, myocardial infarction, or stroke. Funding: Boehringer Ingelheim. © 2008 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Yusuf, Salim
Unknown Affiliation
Teo, Koonkang
Unknown Affiliation
Anderson, Craig S.
Unknown Affiliation
Pogue, Janice M.
Unknown Affiliation
Dyal, Leanne
Unknown Affiliation
Copland, Ingrid
Unknown Affiliation
Schumacher, Helmut
Unknown Affiliation
Dagenais, Gilles R.
Unknown Affiliation
Sleight, Peter J.
Unknown Affiliation
Meinicke, Thomas W.
Unknown Affiliation
Unger, Thomas
Unknown Affiliation
Asmar, Roland G.
Unknown Affiliation
Díaz, Rafaël J.
Unknown Affiliation
Paolasso, Ernesto Andrés C.
Unknown Affiliation
Piegas, Leopoldo Soares Oares
Unknown Affiliation
Avezum, Álvaro Jr
Unknown Affiliation
Probstfield, Jeffrey L.
Unknown Affiliation
Janský, Petr
Unknown Affiliation
Mann, Johannes F.E.
Unknown Affiliation
Keltai, Mátyás
Unknown Affiliation
Verdecchia, Paolo
Unknown Affiliation
Maggioni, Aldo Pietro
Unknown Affiliation
Holwerda, Nicolaas J.H.
Unknown Affiliation
Chazova, Irina Ye
Unknown Affiliation
Rydén, Lars
Unknown Affiliation
Fodor, Jiri George
Unknown Affiliation
Commerford, Patrick Joseph
Unknown Affiliation
Oto, Ali
Unknown Affiliation
Parkhomenko, Alexander N.
Unknown Affiliation
Liu, Lisheng
Unknown Affiliation
Cairns, J. A.
Unknown Affiliation
Wilhelmsen, Lars W.
Unknown Affiliation
Chalmers, John P.
Unknown Affiliation
Wittes, Janet Turk
Unknown Affiliation
Yusoff, Khalid
Unknown Affiliation
Anand, Prof Inder
Unknown Affiliation
Held, Claes
Unknown Affiliation
McGorrian, Catherine M.
Unknown Affiliation
Villar, Juan Carlos
Unknown Affiliation
Dans, Antonio L.L.
Unknown Affiliation
McDonald, Andrew M.
Unknown Affiliation
Afzal, Rizwan
Unknown Affiliation
Zhao, Feng
Unknown Affiliation
Yusuf, Salim N.
Unknown Affiliation
Ahuad-Guerrero, Rodolfo Andres
Unknown Affiliation
Baglivo, Hugo P.
Unknown Affiliation
Bendersky, Mario A.
Unknown Affiliation
Bono, Julio Oscar Emilio
Unknown Affiliation
Bustos, Betina
Unknown Affiliation
Caccavo, Alberto
Unknown Affiliation
Cartasegna, Luis Rodolfo
Unknown Affiliation
Cipullo, Marcela A.
Unknown Affiliation
Cuneo, Carlos Alberto
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Hasbani, Eduardo G.
Unknown Affiliation
Hominal, Miguel Angel
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Kuschnir, Emilio
Unknown Affiliation
Majul, Claudio Rodolfo
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Orlandini, Andrés D.
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Sala, Jorgelina M.
Unknown Affiliation
Sànchez, Ramiro A.
Unknown Affiliation
Schygiel, Pablo Omar
Unknown Affiliation
Vico, Marisa Liliana
Unknown Affiliation
Jennings, Garry L.R.
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Amerena, John V.
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Aylward, Philip E.
Unknown Affiliation
Cross, David B.
Unknown Affiliation
Herkes, Geoffrey Kenneth
Unknown Affiliation
Marwick, Thomas H.
Unknown Affiliation
Parsons, Mark W.
Unknown Affiliation
Rees, David M.
Unknown Affiliation
Thompson, Peter Lindsay
Unknown Affiliation
Weber, Thomas
Unknown Affiliation
Fagard, Robert H.
Unknown Affiliation
Degaute, Jean Paul
Unknown Affiliation
Dendale, Paul P.
Unknown Affiliation
Dujardin, Karl
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van Mieghem, Walter
Unknown Affiliation
Piegas, Leopoldo Soares
Unknown Affiliation
Abrantes, José Antonio M.
Unknown Affiliation
Maia, Lília Nigro
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Marin-Neto, José Antonio
Unknown Affiliation
Mion Júnior, Décio
Unknown Affiliation
Oigman, Wille
Unknown Affiliation
Polanczyk, Carisi Anne
Unknown Affiliation
Reis, Gilmar
Unknown Affiliation
Rossi, Paulo R.F.
Unknown Affiliation
Santos, Raul D.
Unknown Affiliation
Saraiva, José Francisco Kerr
Unknown Affiliation
Teo, Koon K.
Unknown Affiliation
Arnold, John Malcolm O.
Unknown Affiliation
Bata, Iqbal R.
Unknown Affiliation
Douketis, James Demetrios
Unknown Affiliation
Gosselin, Gilbert
Unknown Affiliation
Gupta, Milan K.
Unknown Affiliation
Honos, George N.
Unknown Affiliation
Imrie, John J.
Unknown Affiliation
Lönn, Eva Marie
Unknown Affiliation
Milot, Alain
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Tobe, Sheldon W.
Unknown Affiliation
Tytus, Richard H.
Unknown Affiliation
Liu, Licette C.Y.
Unknown Affiliation
Bai, Xiaojun
Unknown Affiliation
Lu, Fanghong
Unknown Affiliation
Pan, Changyu
Unknown Affiliation
Zhu, Jun
Unknown Affiliation
Svendsen, Tage Lysbo
Unknown Affiliation
Metsärinne, Kaj P.
Unknown Affiliation
Antikaínen, Riitta L.
Unknown Affiliation
Kantola, Ilkka M.
Unknown Affiliation
Kastarinen, Mika J.
Unknown Affiliation
Mallion, Jean Michel
Unknown Affiliation
El Sawy, A.
Unknown Affiliation
Magnani, Corrado
Unknown Affiliation
Böhm, Michael
Unknown Affiliation
Horacek, Thomas
Unknown Affiliation
Schmieder, Roland E.
Unknown Affiliation
Scholze, Juergen E.
Unknown Affiliation
Schwaab, Bernhard
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Steinhagen-Thiessen, Elisabeth
Unknown Affiliation
Karatzas, Nicholas B.
Unknown Affiliation
Elisaf, Moses S.
Unknown Affiliation
Louridas, Georgios E.
Unknown Affiliation
Lam, Chiu Wa Linda
Unknown Affiliation
Sanderson, John Elsby
Unknown Affiliation
Farsang, Csaba S.
Unknown Affiliation
Karlócai, Kristóf
Unknown Affiliation
Keltai, Katalin
Unknown Affiliation
Sereg, Mátyás
Unknown Affiliation
Tóth, Kálmán S.B.
Unknown Affiliation
Maher, Vincent M.G.
Unknown Affiliation
Stanton, Alice V.
Unknown Affiliation
Ambrosio, G. B.
Unknown Affiliation
Ferrari, Roberto
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Lauro, Renato
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Reboldi, Gianpaolo
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Rozza, Francesco
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Tavazzi, Luigi T.
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Terrosu, Pierfranco
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Volpe, Massimo
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Yusoff, Khalid
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Cardona-Muñoz, Ernesto Germán
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Alcocer, Luis Antonio
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Verheugt, Freek W.Aa
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de Graaf, Jacqueline J.
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Poldermans, Don
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Slagboom, Ton S.
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van Bergen, Paul F.M.M.
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Willems, Frank F.
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Doughty, Robert N.Eil
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Lainchbury, John G.
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Richards, Arthur Mark
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Singh, Gurminder P.
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White, Harvey D.
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Dickstein, Kenneth
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Abola, Maria Teresa B.
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Tumanan-Mendoza, Bernadette A.
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Tendera, Michal B.
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Ferreira, Rafael
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Cunha, Luís S.
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Ferro, José Manuel
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da Silva, Pedro Marqués
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Belenkov, Yu N.
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Karpov, Yu Aleksandrovich
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Schlyakhto, Evgeny Vladimirovich
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Kwok, Bernard Wing Kwok
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Dukát, Andrej
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Pella, Daniel
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Brown, Basil G.
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Dalby, Anthony John
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Klug, Eric Q.
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Middle, Michelle Vivienne
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Naidoo, Datshanna Prakesh
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Podgorski, Gracjan P.
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Pretorius, Martha M.
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Ranjith, Naresh
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Theron, Hendrik Du Toit
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Kim, Jae-hyung
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Chung, Namsik
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Jeong, Myungho
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Kim, Moo-hyun
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Seo, Hongseog Seong
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Barrios, V.
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Calvo, Carlos A.
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Forner, María José
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Ruilope, Luís Miguel
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Ryde´n, Lårs E.
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Dellborg, Mikael
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Herlitz, Johan D.
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Tengmark, Bengt Olov
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Moccetti, Tiziano
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Noll, Georg
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Krittayaphong, Rungroj
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Tanomsup, Supachai
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Tansuphaswadikul, Somsit
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Oǧuz, Aytekin
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Öngen, Zeki
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Sirenko, Yu M.
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Binbrek, Azan Salem
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Al Madhi, Sawsan Abdul Salam
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Radaideh, Ghazi Ahmad
Unknown Affiliation
Barer, David H.
Unknown Affiliation
Barnett, Anthony H.
Unknown Affiliation
Cruickshank, John Kennedy
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de Belder, Adam J.
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Donnelly, Richard J.
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Moriarty, Andrew J.
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O’Hare, Joseph Paul
Unknown Affiliation
Probstfield, Jeffrey L.
Unknown Affiliation
Weber, Michael A.
Unknown Affiliation
Anand, Inder Singh
Unknown Affiliation
Basile, Jan Neil
Unknown Affiliation
Carr, Albert A.
Unknown Affiliation
Habib, Gilbert B.
Unknown Affiliation
Hart, Peter D.
Unknown Affiliation
Hartney, Thomas J.
Unknown Affiliation
Khan, Maheer U.
Unknown Affiliation
Kozinn, Marc J.
Unknown Affiliation
Lader, Ellis W.
Unknown Affiliation
Lewis, Stephen J.G.
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Liang, C. S.
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McGuire, Darren K.
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Oparil, Suzanne
Unknown Affiliation
Schweiger, Marc J.
Unknown Affiliation
Statistics
Citations: 871
Authors: 223
Identifiers
Doi:
10.1016/S0140-6736(08)61242-8
ISSN:
01406736
Research Areas
Environmental
Health System And Policy
Noncommunicable Diseases
Study Design
Randomised Control Trial
Cohort Study