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Lancet. 2008 Sep 27;372(9644):1174-83. doi: 10.1016/S0140-6736(08)61242-8. Epub 2008 Aug 29.

Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial.

Collaborators (843)

Yusuf S, Sleight P, Anderson C, Teo K, Copland I, Ramos B, Richardson L, Murphy J, Haehl M, Hilbrich L, Svaerd R, Martin K, Murwin D, Meinicke T, Schlosser A, Schmidt G, Creek R, Schumacher H, Distel M, Aubert B, Pogue J, Dyal L, Schmieder R, Unger T, Asmar R, Mancia G, Diaz R, Paolasso E, Piegas L, Avezum A, Dagenais G, Cardona Munoz E, Probstfield J, Weber M, Young J, Fagard R, Jansky P, Mallion J, Mann J, Böhm M, Eber B, Karatzas NB, Keltai M, Trimarco B, Verdecchia P, Maggioni A, Verheugt FW, Holwerda NJ, Ceremuzynski L, Budaj A, Ferreira R, Chazova I, Rydén L, Svendsen TL, Metsärinne K, Dickstein K, Fodor G, Commerford P, Redon J, Luescher TR, Oto A, Binbrek A, Parkhomenko A, Jennings G, Liu LS, Yu CM, Dans AL, Shah R, Kim JH, Chen JH, Chaithiraphan S, Cairns J, Wilhelmsen L, Chalmers J, Wittes J, Gent M, Hennekens CH, Dagenais G, Anderson N, Avezum A, Budaj A, Fodor G, Keltai M, Maggioni A, Mann J, Parkhomenko A, Yusoff K, Auger P, Bernstein V, Lonn E, Panju A, Anand I, Bigger JT, Linz P, Healey J, Held C, McGorrian C, Rokoss M, Villar J, Sleight P, Anderson C, Creek R, Dans A, Diaz R, Fagard R, Probstfield J, Svaerd R, Teo K, Unger T, Yusuf S, Teo K, Copland I, Ramos B, McDonald A, Pogue J, Dyal L, Schweitzer D, Cunningham J, Wagan E, Boland T, Westfall L, Gulliver N, Oliveira R, McLean-Price C, Kotlan S, Tosto F, Afzal R, Zhao F, Yusuf S, Sleight P, Richardson L, Anderson C, Murphy J, Diaz R, Paolasso E, Ahuad Guerrero RA, Amuchastegui M, Baglivo HP, Bendersky M, Bono J, Bustos B, Caccavo A, Cartasegna LR, Castellanos CR, Cipullo M, Cuneo CA, Fuselli JJ, Guaymas GJ, Hasbani E, Hominal MA, Humphreys JD, Killinger CR, Kuschnir E, Majul CR, Marzetti EM, Nordaby R, Orlandini AD, Paez OB, Piasentin JA, Pomposiello JC, Resk JH, Rodríguez GM, Said Nisi J, Sala JM, Sanchez RA, Schygiel PO, Serra C, Vico ML, Jennings GL, Amerena JV, Arnolda LF, Aylward PE, Bladin CF, Chambers BR, Crimmins DS, Cross DB, Davies L, Davis SM, Eccleston DS, Frayne JH, Herkes GK, Hill AT, Jeffery IM, Karrasch JA, Marwick TH, Parsons MW, Rees DM, Russell A, Schwartz R, Singh BB, Thompson PL, Waites JH, Walsh WF, Watts RW, Whelan AP, Böhm M, Eber BE, Bonelli J, Dolliner P, Hohenecker J, Steurer G, Weber T, Weihs W, Fagard R, Bekaert I, Brohet C, Crasset V, Degaute JP, Dendale P, Dujardin K, Elshot S, Heyndrickx G, Lesseliers H, Quinonez M, Van Mieghem W, Vanhooren G, Vervoort G, Wollaert B, Piegas L, Avezum A, Abrantes JA, Armaganijan D, Bodanese LC, Carvalho AC, Coutinho M, Esteves JP, Fichino MZ, Franco RJ, Leães PE, Maia LN, Marin-Neto JA, Marino RL, Mion D Jr, Oigman W, Pedrosa RC, Pelloso EA, Polanczyk CA, Rabelo A Jr, Rassi S, Reis G, Ribeiro AB, Ribeiro JM, Rocha JC, Rossi FH, Rossi PR, Santos RD, Saraiva JF, Tarastchuk JC, Vidotti MH, Teo K, Dagenais G, Abramson B, Arnold JM, Ashton T, Auger P, Bata I, Bayly K, Beauchef J, Bélanger A, Bernstein V, Bhargava R, Booth AW, Borts D, Bose S, Boulianne M, Bozek B, Cameron M, Chan YK, Constance C, Costi P, Douketis J, Fell D, Giannoccaro JP, Glanz A, Gosselin G, Gould D, Goulet S, Gupta MK, Gyenes G, Heath JW, Hiscock JG, Hoag G, Honos G, Imrie J, Kuritzky R, Lai C, Lalani AV, Lamy A, LeBouthillier P, Lonn E, Lubelsky B, Mackey A, Meunier M, Milot A, Nawaz S, Panju A, Pilon C, Pilon D, Polasek P, Proulx G, Rebane T, Ricci AJ, Sabbah E, Savard D, Sharma NK, Shu D, Sigal RJ, St Hilaire R, St Maurice F, Starra R, Sussex B, Talbot P, Tan KW, To TB, Tobe SW, Tytus R, Vexler R, Whitsitt P, Liu L, Bai X, Cao S, Chen X, Dong L, Feng J, Fu S, Gong L, He Z, Jiang Y, Li J, Li L, Li Q, Li X, Liao Y, Lu F, Lu Z, Ma S, Niu F, Pan C, Qian F, Sun G, Sun M, Sun N, Wang L, Wang S, Wang S, Wang Y, Wu Z, Yan X, Yang H, Yang X, Yuan S, Zhang C, Zhang F, Zhang S, Zhang T, Zhao D, Zheng B, Zhou S, Zhu J, Zhu S, Janský P, Dedek V, Dvorák J, Holaj R, Kotous J, Nemcova H, Pech M, Pederzoliová E, Polák M, Povolný J, Smetana K, Spác J, Svendsen TL, Götzsche L, Juhl HF, Koelendorf K, Lund P, Nielsen ES, Pedersen F, Rasmussen LH, Rasmussen SL, Thygesen K, Tuxen C, Metsärinne K, Antikainen R, Jääskivi M, Kantola I, Kastarinen M, Kohonen-Jalonen P, Koistinen A, Lehmus E, Nuuttila R, Tuomilehto J, Tuominen ML, Mallion J, Abenhaim N, Allix J, Boucher L, Bourgoin M, Boye A, Breton N, Cadinot D, Campagne A, Churet J, Constantin G, De Sainte Lorette E, El Sawy A, Farhat S, Lacoin F, Magnani C, Pineau-Valenciennes D, Pithon M, Quéguiner A, Sicard J, Taminau D, Vilarem H, Vogel JY, Böhm M, Mann J, Brado B, Claus G, Dietz U, Griebenow R, Haak T, Hahn K, Hampel R, Holle G, Horacek T, Jordan J, Klein C, Motz W, Muenzel T, Minnich J, Nebelsieck H, Rybak K, Samer H, Schaefer T, Schmieder R, Scholze J, Schwaab B, Sechtem U, Sehnert W, Steinhagen-Thiessen E, Stenzel G, Trenkwalder P, Wedler B, Zippel J, Karatzas N, Achimastos A, Efstratopoulos A, Elisaf M, Georgakopoulos ND, Louridas G, Pyrgakis V, Symeonidis D, Vogiatzis I, Voyaki S, Yu CM, Chan CK, Chan WK, Lam L, Lau CP, Lau YK, Sanderson JE, Wong KS, Yue CS, Keltai M, Czuriga I, Edes I, Farsang CS, Kalina A, Karlócai K, Keltai K, Kozma M, László Z, Papp A, Polák GY, Préda I, Rónaszéki A, Sereg M, Simon K, Szegedi J, Szilágyi H, Tóth K, Vándorfi GY, Vértes A, Crean PA, Maher VM, Stanton AV, Trimarco B, Verdecchia P, Maggioni A, Achilli A, Rosei EA, Ambrosio GB, Bentivoglio M, Branzi A, Chersevani D, Chiariello M, Cirrincione V, Dembech C, Ferrari R, Gattobigio R, Giovannini E, Lauro R, Lembo G, Moretti L, Pancaldi L, Pede S, Pettinati G, Reboldi G, Ricci R, Rosiello G, Rozza F, Sardone MG, Tavazzi L, Terrosu P, Venco A, Vetrano A, Volpe M, Shah RP, Singaraveloo M, Ahmad WA, Yusof Z, Yusoff K, Zambahari R, Cardona Munoz E, Alcocer L, Arriaga Nava R, Bricio-Ramírez RI, De la Peña Topete G, Elizondo Sifuentes LA, Hernández García HR, Macías Islas MA, Martinez-Lugo C, Noriega-Arellano JA, Pascoe-Gonzalez S, Olvera Ruiz R, Parra Carrillo JZ, Velasco-Sánchez G, Vidrio Velásquez M, Verheugt FW, Holwerda NJ, Boermans AJ, Buiks CP, de Graaf JJ, Eefting FD, Michels HR, Poldermans D, Schrijver G, Sedney MI, Slagboom T, Smilde JG, Storms GE, van Bergen PF, van Doesburg GJ, van Kempen LH, van Mierlo HF, Veerman A, Vermetten FA, Willems FF, Doughty RN, Friedlander DH, Lainchbury JG, Luke RA, Nairn PL, Peek D, Richards AM, Singh GP, White HD, Wong SP, Dickstein K, Lier JO, Otterstad JE, Rønnevik PK, Skeie S, Dans AL, Abola MT, dela Vega SA, Gurango JA, Punzalan FE, Roxas AA, Tumanan-Mendoza BA, Ceremuzynski L, Budaj A, Binio Z, Bronisz M, Buszman P, Czerski T, Dalkowski M, Gessek J, Gieroba A, Janik K, Janion M, Kawka-Urbanek T, Klabisz R, Krauze-Wielicka M, Malinowski S, Miekus P, Mormul J, Ogorek M, Opolski G, Skura M, Szpajer M, Tendera M, Waszyrowski T, Wierzchowiecki M, Zalska B, Ferreira R, Correia C, Cunha L, Ferro JM, Ribeiro VG, da Silva PM, Carrageta MO, Sá E, Gomes MV, Chazova I, Ageev F, Belenkov Y, Ivleva A, Karpov Y, Shestakova M, Shlyakhto E, Shustov S, Sidorenko B, Chen CP, Kwok B, Fodor G, Dukát A, Gonsorcík J, Hranai M, Pella D, Ruffini L, Rybar R, Commerford P, Brown B, Dalby AJ, Gibson GJ, Herbst L, King J, Klug E, Middle M, Naidoo DP, Podgorski G, Pretorius M, Ranjith N, Silwa-Hahnle K, Theron H, Kim JH, Chae SC, Chung NS, Hong KP, Jeong MH, Kang HJ, Kim JJ, Kim MH, Seo HS, Shin EK, Redón J, Barrios V, Calvo C, Campos MM, De Teresa E, Forner MJ, Galve E, Gil-Extremera B, Gonzalez-Albarran O, Martell N, Mazón P, Muñoz J, Ruilope LM, Ruiz J, Vinyoles E, Rydén L, Alvång A, Boström PA, Dellborg M, Ericsson UB, Herlitz J, Juhlin T, Pedersen K, Sträng B, Sundqvist B, Tengmark BO, Ulvenstam G, Westerdahl B, Luescher TR, Dubach P, Moccetti T, Noll G, Schläpfer H, Weber K, Chen JH, Chao TH, Chen CY, Cheng JJ, Chiou HC, Fu M, Lai WT, Liu PY, Tsai CD, Yeh PS, Chaithiraphan S, Chantadansuwan T, Jirasirirojanakorn K, Krittayaphong R, Laothavorn P, Mahanonda N, Sitthisook S, Tanomsup S, Tansuphaswadikul S, Tatsanavivat P, Oto A, Caglar N, Ergin A, Oguz A, Ongen Z, Sansoy V, Tetiker T, Usal A, Parkhomenko A, Amosova E, Dykun Y, Dzyak G, Grishyna O, Kononenko L, Kovalenko V, Netyazhenko V, Pertseva T, Sirenko Y, Binbrek AS, Al Hatou E, Al Madhi S, Al-Sousi AA, Alomairi M, Radaideh G, Sleight P, Adgey AA, Barer DH, Barnett AH, Bridges AB, Cowie AS, Cruickshank JK, De Belder AJ, Donnelly R, Francis CM, Fuentealba-Melo P, Gough N, Jackson PR, Jackson SH, McEneaney DJ, Moriarty AJ, Murdoch DL, O'Hare JP, Penny WJ, Reid CJ, Vora JP, Probstfield J, Weber M, Young J, Adler FM, Anand IS, Anderson JL, Pagán JS, Basile JN, Bass PF 3rd, Brautigam DF, Carr AA, Chinn J, Chiu D, Cho NR, Ciocon JO, Colón-Ortíz PJ, Cruz JB, Dachman WD, Dorfman SG, Drummond W, East C, Eelani F, Ellison HS, Felicetta JV, Force RW, Goldberg MC, Goldman SG, Gomez Adrover R, Goss SL, Graham SP, Granger CB, Greenspan MM, Grimm RH, Habib GB, Hart PD, Hartney TJ, Henriquez MA, Holland JJ, Hoogwerf BJ, Hossfeld M, Hyman D, Jacobson AK, Jelley MJ, Jones TV, Kaplan RA, Karalis DG, Katz LA, Khan M, Kipperman RM, Kozinn MJ, Lader EW, Landau C, Lewis SJ, Liang CS, Linz PE, Lo TS, Lopez-Arostegui F, McGuire DK, Mercando AD, Mersey JH, Narayan P, Oparil S, Padhiar DN, Phillips AL, Prisant LM, Qureshi N, Randall RR, Retta TM, Rizvi MD, Saklayen MG, Sastrasinh S, Savani IK, Schlau A, Schultz HS, Schweiger MJ, Sosa-Padilla M, Stuver TP, Subich DC, Swagler WA 3rd, Taitano M, Tavarez-Valle JA, Taylor EM, Wickemeyer WJ, Wiegmann TB, Zhao XQ.

Erratum in

  • Lancet. 2008 Oct 18;372(9647):1384.

Abstract

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.

Comment in

PMID:
18757085
[PubMed - indexed for MEDLINE]
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