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N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.

Irbesartan in patients with atrial fibrillation.

Collaborators (701)

Connolly SJ, Yusuf S, Camm J, Chrolavicius S, Commerford PJ, Flather M, Hart RG, Hohnloser SH, Joyner C, Pfeffer M, Gaudin C, Blumenthal M, Hornick P, Marchese C, Yusuf S, Healey JS, Pogue J, Chrolavicius S, Commerford PJ, Flather M, Hart RG, Hohnloser SH, Joyner C, Pfeffer M, Connolly SJ, Anand I, Arthur H, Avezum A, Budaj A, Ceremuzynski L, De Caterina R, Diaz R, Dorian P, Flaker G, Fox KA, Franzosi MG, Goldhaber S, Golitsyn S, Granger C, Halon D, Hermosillo A, Hunt D, Jansky P, Karatzas N, Keltai M, Kozan O, Lanas F, Lau CP, Le Heuzey JY, Lewis BS, Morais J, Morillo C, Paolasso E, Peters RJ, Pfisterer M, Piegas L, Pipilis A, Sitkei E, Swedberg K, Talajic M, Valentin V, Van Mieghem W, Varigos J, Ameriso S, Atra M, Berwanger O, Bonilla C, Bornstein N, Chamiec T, Chan YK, Cottin Y, Csiba L, Cybulski J, Czepiel A, De Raedt H, Dvorakova H, Eikelboom J, Ergene O, Fodor G, Galli M, Gardinale E, Gross B, Goodfield P, Happola O, Healey J, Himbert D, Jacobsson F, Kalvach P, Kies B, Laine M, Lam A, Lewis S, Leys D, Maggioni AP, Massaro A, Mayosi BM, Okay T, Olah L, Osende JO, Oto A, Peeters A, Penicka M, Perakis A, Pizzolato G, Rafti F, Renkin J, Siva A, Steg PG, Stockins B, Strozynska E, Turazza F, Vanderhoven L, Vizel S, Widimsky P, Zaborski J, Albers G, Hankey G, Hart RG, Norrving B, Shuaib A, Silva J, Wyse DG, Cairns JA, Gent M, Hirsh J, Marler J, Pritchett E, Wittes J, Beresh H, Bonilla L, Floyd L, Gasic Z, Holadyk-Gris I, Lawrence M, Perry S, Rodrigues T, Robinson L, Stevens C, Worthy L, Yuan F, Ahuad Guerrero RA, Allall OA, Amuchastegui LM, Boskis MA, Bustamante Labarta MH, Caccavo A, Castellanos CR, Chiale PA, Cuneo CA, Estepo JF, Fernandez AA, Garrido MA, Guzmán LA, Hershson AR, Hominal MA, Luciardi HL, Marzetti EM, Montana OR, Orlandini A, Prado A, Rabinovich RF, Ramos H, Sanchez AS, Schygiel PO, Selva OH, Vico ML, Vogel DR, Zaidman CJ, Amerena JV, Aroney GM, Ashby DT, Barlow MA, Boyd PT, Colquhoun D, Cooke P, Coulshed DS, Cross DB, Davis MJ, Eccleston D, Eccleston DS, Garrahy P, Heddle WF, Hendriks R, Karrasch JA, Nelson GI, Rees D, Roger SD, Rogers J, Russell AE, Singh BB, Sparks P, Stickland JF, Waites JH, Whitbourn RJ, Eichinger J, Huber K, Rotmann B, Steinwender C, Beeuwsaert R, Boland JL, Brohet CR, Conraads VM, Cools FJ, De Roy L, De Vusser P, Dia E, Mairesse GH, Vankelecom B, Abrantes JM, Armaganijan D, Atie J, Blacher C, Bodanese LC, Braga Braile MV, Carvalho EI, Chaves H, Coelho OR, Cunha CL, De Paola AA, Esteves JP, Filho AM, Francischetti A, Francischetti EA, Guimarães FV, Kerr Saraiva JF, Lima GG, Magalhães ME, Maia LN, Marin-Neto JA, Marino LR, Meneghelo ZM, Nogueira PR, Oigman W, Paiva MS, Precoma DB, Rabelo A Jr, Rassi S, Rassi A Jr, Reis G, Rossi PR, Rossi Neto JM, Sobral Filho DC, Zimmermann SL, Berlingieri JC, Bhargava RK, Blackburn K, Bose S, Boucher P, Carroll SL, Chehayeb R, Connors S, Constance C, Costi P, Coutu B, Crystal E, DeYoung JP, Douketis JD, Exner DV, Fortin C, Fox BA, Glanz AE, Graham JD, Green MS, Grondin F, Gupta MK, Honos G, Jones A, Kouz S, Krahn AD, Kuritzyk RA, Kwan S, Lai CC, Leader RM, Lefebvre M, Lepage S, Ma PT, Mangat I, Manyari DE, Maranda CR, Matangi M, Morris AL, Mukherjee A, Nawaz S, Novak DJ, O'Keefe D, Palaic M, Pandey AS, Panju AA, Picard JP, Poulin F, Rebane TM, Ruel M, Sabbah E, Sapp JL, Selchen DH, Sterns LD, Strauss H, Talbot P, Tarhuni WM, To TB, Vakani MT, Vexler RM, Weigel MA, Wein TH, Winder TR, Wulffhart ZA, Yao L, Zaniol D, Conejeros C, Corbalan R, Dussaillant GR, Escobar E, Hassi M, Parra CA, Saavedra J, Varleta PE, Berka L, Dedek V, Florian J, Hejhal O, Herold M, Klimsa Z, Kotík I, Simon J, Smetana K, Spinar J, Spinarova L, Tousek F, Christiansen LK, Husted S, Nielsen T, Pehrson S, Tuxen C, Harjola VP, Huikuri HV, Melin JH, Peuhkurinen KJ, Bonnet P, Boulliat J, Carlioz RC, Coisne D, Decoulx E, Defaye P, Delarche N, Gacem K, Galley DL, Geslin GP, Gorka H, Levy S, Mansour M, Olive T, Poulard JE, Pruvot C, Andresen D, Bauer WR, Berghöfer G, Boehm G, Borchers M, Darius H, Duray GZ, Felix SB, Fritz HG, Greulich S, Haberl R, Horacek T, Illies G, Janko S, Kalusche D, Katus HA, Klepzig H, Loos UF, Mitrovic V, Munzel TF, Ochs HR, Pollock BW, Schimpf R, Schmidt AE, Schoebel WA, Schumacher M, Seidl K, Spitzer SG, Stangl V, Stenzel G, Volkmann HJ, Wachter R, Wunderlich J, Zacharzowsky UB, Antonakoudis H, Georgakopoulos ND, Goudevenos I, Goumas GG, Iliopoulos TA, Kallikazaros I, Pyrgakis VN, Skoufas P, Vardas P, Chan HW, Chan WK, Fung JW, Li SK, Wong KS, Borbola J, Czuriga I, Forster T, Greulich S, Jobbagy L, Keltai K, Kovacs A, Kurta G, Laszlo Z, Rapi J, Regos L, Rostas L, Szakal I, Tomcsanyi J, Toth C, Bloch L, Khader N, Klainman EI, Lotan C, Marmor A, Omary MZ, Reisin LH, Zeltser D, Argiolas G, Bassi P, Bianconi L, Bicego D, Caiazza A, Cosmi D, Fanelli R, Garini A, Lunati MG, Moretti L, Mos L, Nanni S, Olivieri C, Peila C, Pengo V, Pignatti F, Pontiroli AE, Renda G, Rossi PC, Stramba-Badiale M, Terrosu P, Ang CK, Omar R, Wan Ahmad WA, Alvarado-Ruiz R, Calvo-Vargas C, Cordero-Caba J, Jerjes-Sawchez C, Lara S, Lopez-Rosas E, Molina L, Petersen-Aranguren F, Robles F, Torres I, Bronzwaer PN, Groutars RG, Holwerda NJ, Jørstad HT, Lok DJ, Michels HR, Nierop PR, Peters R, Pieterse MG, Troquay RP, van der Heijden R, Van Gelder IC, van Kempen LH, Kontny F, Øie BK, Omland TM, Otterstad JE, von Brandis C, Bronisz M, Bujak R, Chizynski K, Czerski T, Dalkowski M, Dluzniewski M, Gessek J, Gieroba A, Gniot JR, Gorny J, Hałaczkiewicz HK, Janik K, Janion M, Jaxa-Chamiec T, Jerzykowska O, Kawka-Urbanek T, Kincel K, Kocon S, Kopaczewski JF, Krasowski W, Krauze-Wielicka M, Malinowski S, Miastkowski Z, Mormul J, Obrebska-Tabaczka E, Ogorek MF, Piasecka-Krysiak E, Piepiorka AW, Piotrowski W, Pluta W, Rekosz J, Reszka Z, Sosnowski M, Stopinski M, Szelemej R, Szolkiewicz M, Szpajer M, Trusz-Gluza M, Zalska B, Alves LB, Antunes E, de Sousa J, Martins L, Mendonça MI, Silvestre I, Akatova EV, Aleksandrov O, Antuch E, Arutyunov GP, Bart B, Belousov YB, Chernichka I, Dovgalevsky P, Gratsiansky NA, Ivleva AY, Kislyak O, Mareev V, Maykov EB, Miljagin V, Novikova TN, Panchenko EP, Reshetko O, Ruda M, Semernin E, Sidorenko BA, Sinopalnikov AJ, Skvortsova VI, Solomatin AS, Suslina ZA, Titkov YS, Tsyrline V, Bin Omar AR, Chan B, Chang HM, Foo DC, Teo WS, Bhana SA, Brown BG, Ebrahim IO, Essop MR, Gibson GJ, King J, Klug EQ, Okreglicki A, Pretorius M, Roos JS, Snyders FA, Steingo L, Theron HD, van Zyl LJ, Cano L, Laguna F, Madrid AH, Mont L, Orriach M, Puig JG, Pulpon LA, Sabate X, Villacastín JP, Blomström P, Jacobsson F, Johansson L, Klintberg L, Lycksell M, Nilssen OR, Rasmanis G, Saldeen Nilehn KE, Ulvenstam G, Dubach P, Gallino A, Haller A, Kälin BK, Mach F, Moccetti T, Muench UH, Tettenborn BE, Chou HT, Chu SH, Hou CJ, Lai WT, Lin JL, Lin LJ, Ueng KC, Bakar M, Ilerigelen B, Kumral E, Nisanci Y, Savas ZI, Adgey J, Batin PD, Brack M, Cargill RI, Davey PP, Davies J, Delahunty N, Glen SK, Jennings K, Kadr HH, Levy TM, Lip GY, Moriarty AJ, Pearson C, Purvis JA, Pye M, Savelieva I, Senior R, Trouton TG, Wilkinson PR, Ahmed I, Amin M, Anderson JL, Antonishen MC, Augustine JP, Baruch L, Bauernfeind RA, Belew KM, Bilazarian SD, Black RA, Burton E, Carr KW, Cebe JE, Chandrashekhar Y, Cheirif JB, Chen C, Cohen M, Cossu SF, Crossley G, Das D, Deering TF, Denny DM, Desai VS, Duong-Wagner TH, Fahmy RN, Fishbein GJ, Gelernt MD, Gerber J, Giacomini J, Glass JM, Goldberg MC, Greenspon AJ, Grena PG, Guarnieri T, Hack TC, Harrison BJ, Hill D, Hilliard GK, Honan MB, Hunter J, Jacobson AK, Jarmukli NF, Klancke K, Knight PO, Kobayashi JF, Labovitz AJ, Little T, Machell CH, Mallis GI, Marshall JJ, Menapace FJ, Mirka A, O'Neill PG, O'Shaughnessy CD, Peart BC, Quick A, Ravipudi S, Rivera E, Sackett MC, Salerno DM, Schneider RM, Schussheim AE, Shettigar UR, Short WG, Simek CL, Sutton VM, Teerlink JR, Treasure CB, Vidaillet H, Vijay NK, Walker J, White R, Wickemeyer WJ, Winters SL, Yasin M, Young DR, Zoble RG.

Abstract

BACKGROUND:

The risk of cardiovascular events among patients with atrial fibrillation is high. We evaluated whether irbesartan, an angiotensin-receptor blocker, would reduce this risk.

METHODS:

We randomly assigned patients with a history of risk factors for stroke and a systolic blood pressure of at least 110 mm Hg to receive either irbesartan at a target dose of 300 mg once daily or double-blind placebo. These patients were already enrolled in one of two trials (of clopidogrel plus aspirin versus aspirin alone or versus oral anticoagulants). The first coprimary outcome was stroke, myocardial infarction, or death from vascular causes; the second was this composite outcome plus hospitalization for heart failure.

RESULTS:

A total of 9016 patients were enrolled and followed for a mean of 4.1 years. The mean reduction in systolic blood pressure was 2.9 mm Hg greater in the irbesartan group than in the placebo group, and the mean reduction in diastolic blood pressure was 1.9 mm Hg greater. The first coprimary outcome occurred at a rate of 5.4% per 100 person-years in both groups (hazard ratio with irbesartan, 0.99; 95% confidence interval [CI], 0.91 to 1.08; P=0.85). The second coprimary outcome occurred at a rate of 7.3% per 100 person-years among patients receiving irbesartan and 7.7% per 100 person-years among patients receiving placebo (hazard ratio, 0.94; 95% CI, 0.87 to 1.02; P=0.12). The rates of first hospitalization for heart failure (a prespecified secondary outcome) were 2.7% per 100 person-years among patients receiving irbesartan and 3.2% per 100 person-years among patients receiving placebo (hazard ratio, 0.86; 95% CI, 0.76 to 0.98). Among patients who were in sinus rhythm at baseline, there was no benefit of irbesartan in preventing hospitalization for atrial fibrillation or atrial fibrillation recorded on 12-lead electrocardiography, nor was there a benefit in a subgroup that underwent transtelephonic monitoring. More patients in the irbesartan group than in the placebo group had symptomatic hypotension (127 vs. 64) and renal dysfunction (43 vs. 24).

CONCLUSIONS:

Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation. (Funded by Bristol-Myers Squibb and Sanofi-Aventis; ClinicalTrials.gov number, NCT00249795.).

PMID:
21388310
DOI:
10.1056/NEJMoa1008816
[Indexed for MEDLINE]
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