Please use this identifier to cite or link to this item: http://repositorio.unifesp.br/handle/11600/32479
Title: Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events
Authors: McMurray, John J.
Holman, Rury R.
Haffner, Steven M.
Bethel, M. Angelyn
Holzhauer, Bjoern
Hua, Tsushung A.
Belenkov, Yuri
Boolell, Mitradev
Buse, John B.
Buckley, Brendan M.
Chacra, Antonio R. [UNIFESP]
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
Tamas, Gyula
Tognoni, Gianni
Tuomilehto, Jaako
Villamil, Alberto S.
Vozar, Juraj
Califf, Robert M.
NAVIGATOR Study Grp
Univ Glasgow
Univ Oxford
Univ Texas Hlth Sci Ctr San Antonio
Duke Univ
Novartis Pharmaceut
Moscow MV Lomonosov State Univ
Univ N Carolina
Natl Univ Ireland Univ Coll Cork
Universidade Federal de São Paulo (UNIFESP)
Natl Taiwan Univ Hosp
Univ Hosp
Chinese Univ Hong Kong
Univ Leicester
Calif State Univ Fresno
VA Cent Calif Hlth Care Syst
Univ Hosp Bern
Univ Bern
Univ Calif San Diego
Scripps Whittier Diabet Inst
Tulane Univ
Univ Sydney
Warsaw Med Univ
Hosp Univ Cruces
Joslin Diabet Ctr
Istanbul Univ
Oslo Univ Hosp
Univ Tromso
VA Puget Sound Hlth Care Syst
Univ Washington
Monash Univ
Univ Kuopio
Kuopio Univ Hosp
Univ Toronto
Univ Cape Town
Natl Univ Cordoba
Univ Illinois
Hosp Primero Octubre
Lahey Clin Fdn
301 Hosp
Krankenhaus Hietzing Neurol
Attikon Univ Hosp
Univ Med Ctr
Umea Univ
Tech Univ Dresden
Univ Liege
Aarhus Univ
Inst Cardiovasc Buenos Aires
Fac Hosp St Anna
Univ Copenhagen
Semmelweis Univ
Ist Ric Farmacol Mario Negri
Univ Helsinki
S Ostrobothnia Cent Hosp
Univ Buenos Aires
Diabetol Outpatient Clin
Issue Date: 22-Apr-2010
Publisher: Massachusetts Medical Soc
Citation: New England Journal of Medicine. Waltham: Massachusetts Medical Soc, v. 362, n. 16, p. 1477-1490, 2010.
Abstract: BACKGROUNDIt 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.METHODSIn 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.RESULTSThe 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).CONCLUSIONSAmong 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.)
URI: http://repositorio.unifesp.br/handle/11600/32479
ISSN: 0028-4793
Other Identifiers: http://dx.doi.org/10.1056/NEJMoa1001121
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