Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events
Creators: name: Chacra, Antonio R.
name: Krum, Henry
name: Vozár, Juraj
name: Tognoni, Gianni
name: Scheen, Andre
name: Leiter, Lawrence A.
name: Belenkov, Yuri
name: Califf, Robert M.
name: McMurray, John J.
name: Schaper, Frank
name: Martinez, Felipe
name: Sinay, Isaac
name: Kahn, Steven E.
name: Chow, Chun Chung
name: Boolell, Mitradev
name: Mareev, Viacheslav
name: Villamil, Alberto S.
name: Sandstroem, Herbert
name: Gaztambide, Sonia
name: Hua, Tsushung A.
name: Buse, John B.
name: Mazzone, Theodore
name: Deedwania, Prakash
name: Levitt, Naomi S.
name: Ilkova, Hasan
name: Fonseca, Vivian
name: Horton, Edward
name: Haffner, Steven M.
name: Laakso, Markku
name: Stender, Steen
name: Fulcher, Gregory R.
name: Raptis, Sotirios A.
name: Masson, Chantal
name: Prager, Rudolf
name: Soska, Vladimir
name: Jenssen, Trond
name: Davies, Melanie J.
name: Giles, Thomas
name: Schmitz, Ole
name: Gaciong, Zbigniew
name: Diem, Peter
name: Meaney, Eduardo
name: Rutten, Guy E.H.M.
name: Bethel, M. Angelyn
name: Charbonnel, Bernard
name: Buckley, Brendan M.
name: Tuomilehto, Jaako
name: Pan, Changyu
name: Holzhauer, Björn
name: Nesto, Richard
name: Chiang, Fu Tien
name: Einhorn, Daniel
name: Tamás, Gyula
name: Holman, Rury R.
Publisher: name: The University of North Carolina at Chapel Hill University Libraries
Year: 2010

description: 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.)