Effect of valsartan on the incidence of diabetes and cardiovascular events.
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NAVIGATOR Study Group, 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 Gyula, Tognoni Gianni, Tuomilehto Jaako, Villamil Alberto S, Vozár Juraj, Califf Robert M
Аннотация
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.)