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, G. Tamás, Gianni Tognoni, Jaako Tuomilehto, Alberto S. Villamil, Juraj Vozár

Research output: Contribution to journalArticle

445 Citations (Scopus)

Abstract

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

Original languageEnglish
Pages (from-to)1477-1490
Number of pages14
JournalNew England Journal of Medicine
Volume362
Issue number16
DOIs
Publication statusPublished - Apr 22 2010

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Valsartan
Glucose Intolerance
Incidence
Unstable Angina
Placebos
nateglinide
Hospitalization
Renin-Angiotensin System
Double-Blind Method
Life Style
Cause of Death
Cardiovascular Diseases
Randomized Controlled Trials
Heart Failure
Stroke
Myocardial Infarction
Confidence Intervals
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Califf, R. M., McMurray, J. J., Holman, R. R., Haffner, S. M., Bethel, M. A., Holzhauer, B., ... Vozár, J. (2010). Effect of valsartan on the incidence of diabetes and cardiovascular events. New England Journal of Medicine, 362(16), 1477-1490. https://doi.org/10.1056/NEJMoa1001121

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

In: New England Journal of Medicine, Vol. 362, No. 16, 22.04.2010, p. 1477-1490.

Research output: Contribution to journalArticle

Califf, RM, McMurray, JJ, Holman, RR, Haffner, SM, Bethel, MA, Holzhauer, B, Hua, TA, Belenkov, Y, Boolell, M, Buse, JB, Buckley, BM, Chacra, AR, Chiang, FT, Charbonnel, B, Chow, CC, Davies, MJ, Deedwania, P, Diem, P, Einhorn, D, Fonseca, V, Fulcher, GR, Gaciong, Z, Gaztambide, S, Giles, T, Horton, E, Ilkova, H, Jenssen, T, Kahn, SE, Krum, H, Laakso, M, Leiter, LA, Levitt, NS, Mareev, V, Martinez, F, Masson, C, Mazzone, T, Meaney, E, Nesto, R, Pan, C, Prager, R, Raptis, SA, Rutten, GEHM, Sandstroem, H, Schaper, F, Scheen, A, Schmitz, O, Sinay, I, Soska, V, Stender, S, Tamás, G, Tognoni, G, Tuomilehto, J, Villamil, AS & Vozár, J 2010, 'Effect of valsartan on the incidence of diabetes and cardiovascular events', New England Journal of Medicine, vol. 362, no. 16, pp. 1477-1490. https://doi.org/10.1056/NEJMoa1001121
Califf RM, McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B et al. Effect of valsartan on the incidence of diabetes and cardiovascular events. New England Journal of Medicine. 2010 Apr 22;362(16):1477-1490. https://doi.org/10.1056/NEJMoa1001121
Califf, Robert M. ; McMurray, John J. ; Holman, Rury R. ; Haffner, Steven M. ; Bethel, M. Angelyn ; Holzhauer, Björn ; Hua, Tsushung A. ; Belenkov, Yuri ; Boolell, Mitradev ; Buse, John B. ; Buckley, Brendan M. ; Chacra, Antonio R. ; Chiang, Fu Tien ; Charbonnel, Bernard ; Chow, Chun Chung ; Davies, Melanie J. ; Deedwania, Prakash ; Diem, Peter ; Einhorn, Daniel ; Fonseca, Vivian ; Fulcher, Gregory R. ; Gaciong, Zbigniew ; Gaztambide, Sonia ; Giles, Thomas ; Horton, Edward ; Ilkova, Hasan ; Jenssen, Trond ; Kahn, Steven E. ; Krum, Henry ; Laakso, Markku ; Leiter, Lawrence A. ; Levitt, Naomi S. ; Mareev, Viacheslav ; Martinez, Felipe ; Masson, Chantal ; Mazzone, Theodore ; Meaney, Eduardo ; Nesto, Richard ; Pan, Changyu ; Prager, Rudolf ; Raptis, Sotirios A. ; Rutten, Guy E H M ; Sandstroem, Herbert ; Schaper, Frank ; Scheen, Andre ; Schmitz, Ole ; Sinay, Isaac ; Soska, Vladimir ; Stender, Steen ; Tamás, G. ; Tognoni, Gianni ; Tuomilehto, Jaako ; Villamil, Alberto S. ; Vozár, Juraj. / Effect of valsartan on the incidence of diabetes and cardiovascular events. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 16. pp. 1477-1490.
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AU - Bethel, M. Angelyn

AU - Holzhauer, Björn

AU - Hua, Tsushung A.

AU - Belenkov, Yuri

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AU - Buse, John B.

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AU - Davies, Melanie J.

AU - Deedwania, Prakash

AU - Diem, Peter

AU - Einhorn, Daniel

AU - Fonseca, Vivian

AU - Fulcher, Gregory R.

AU - Gaciong, Zbigniew

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AU - Jenssen, Trond

AU - Kahn, Steven E.

AU - Krum, Henry

AU - Laakso, Markku

AU - Leiter, Lawrence A.

AU - Levitt, Naomi S.

AU - Mareev, Viacheslav

AU - Martinez, Felipe

AU - Masson, Chantal

AU - Mazzone, Theodore

AU - Meaney, Eduardo

AU - Nesto, Richard

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AU - Tamás, G.

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AU - Villamil, Alberto S.

AU - Vozár, Juraj

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