Effect of valsartan on the incidence of diabetes and cardiovascular events

Robert M. Califf, John J. McMurray, Rury R. Holman, Steven M. Haffner, M. Angelyn Bethel, Björn Holzhauer, Tsushung A. Hua, Yuri Belenkov, Mitradev Boolell, John B. Buse, Brendan M. Buckley, Antonio R. Chacra, Fu Tien Chiang, Bernard Charbonnel, Chun Chung Chow, Melanie J. Davies, Prakash Deedwania, Peter Diem, Daniel Einhorn, Vivian FonsecaGregory R. Fulcher, Zbigniew Gaciong, Sonia Gaztambide, Thomas Giles, Edward Horton, Hasan Ilkova, Trond Jenssen, Steven E. Kahn, Henry Krum, Markku Laakso, Lawrence A. Leiter, Naomi S. Levitt, Viacheslav Mareev, Felipe Martinez, Chantal Masson, Theodore Mazzone, Eduardo Meaney, Richard Nesto, Changyu Pan, Rudolf Prager, Sotirios A. Raptis, Guy E.H.M. Rutten, Herbert Sandstroem, Frank Schaper, Andre Scheen, Ole Schmitz, Isaac Sinay, Vladimir Soska, Steen Stender, Gyula Tamás, Gianni Tognoni, Jaako Tuomilehto, Alberto S. Villamil, Juraj Vozár

Resultado de la investigación: Contribución a una revistaArtículo

459 Citas (Scopus)

Resumen

Background: It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. Methods: In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of 5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstable angina; and a core composite outcome that excluded unstable angina and revascularization. Results: The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group (hazard ratio in the valsartan group, 0.86; 95% confidence interval [CI], 0.80 to 0.92; P<0.001). Valsartan, as compared with placebo, did not significantly reduce the incidence of either the extended cardiovascular outcome (14.5% vs. 14.8%; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P = 0.43) or the core cardiovascular outcome (8.1% vs. 8.1%; hazard ratio, 0.99; 95% CI, 0.86 to 1.14; P = 0.85). Conclusions: Among patients with impaired glucose tolerance and cardiovascular disease or risk factors, the use of valsartan for 5 years, along with lifestyle modification, led to a relative reduction of 14% in the incidence of diabetes but did not reduce the rate of cardiovascular events. (ClinicalTrials.gov number, NCT00097786.). Copyright © 2010 Massachusetts Medical Society. All rights reserved.
Idioma originalInglés estadounidense
Páginas (desde-hasta)1477-1490
Número de páginas1327
PublicaciónNew England Journal of Medicine
DOI
EstadoPublicada - 22 abr 2010
Publicado de forma externa

Huella Profundice en los temas de investigación de 'Effect of valsartan on the incidence of diabetes and cardiovascular events'. En conjunto forman una huella única.

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    Califf, R. M., McMurray, J. J., Holman, R. R., Haffner, S. M., Bethel, M. A., Holzhauer, B., Hua, T. A., Belenkov, Y., Boolell, M., Buse, J. B., Buckley, B. M., Chacra, A. R., Chiang, F. T., Charbonnel, B., Chow, C. C., Davies, M. J., Deedwania, P., Diem, P., Einhorn, D., ... Vozár, J. (2010). Effect of valsartan on the incidence of diabetes and cardiovascular events. New England Journal of Medicine, 1477-1490. https://doi.org/10.1056/NEJMoa1001121