Year: 2021
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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<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.)
DOI: 10.17615/ypnd-nk38
Authors: Chacra, Antonio R., Krum, Henry, Vozár, Juraj, Tognoni, Gianni, Scheen, Andre, Leiter, Lawrence A., Belenkov, Yuri, Califf, Robert M., McMurray, John J., Schaper, Frank, Martinez, Felipe, Sinay, Isaac, Kahn, Steven E., Chow, Chun Chung, Boolell, Mitradev, Mareev, Viacheslav, Villamil, Alberto S., Sandstroem, Herbert, Gaztambide, Sonia, Hua, Tsushung A., Buse, John B., Mazzone, Theodore, Deedwania, Prakash, Levitt, Naomi S., Ilkova, Hasan, Fonseca, Vivian, Horton, Edward, Haffner, Steven M., Laakso, Markku, Stender, Steen, Fulcher, Gregory R., Raptis, Sotirios A., Masson, Chantal, Prager, Rudolf, Soska, Vladimir, Jenssen, Trond, Davies, Melanie J., Giles, Thomas, Schmitz, Ole, Gaciong, Zbigniew, Diem, Peter, Meaney, Eduardo, Rutten, Guy E.H.M., Bethel, M. Angelyn, Charbonnel, Bernard, Buckley, Brendan M., Tuomilehto, Jaako, Pan, Changyu, Holzhauer, Björn, Nesto, Richard, Chiang, Fu Tien, Einhorn, Daniel, Tamás, Gyula, Holman, Rury R.
Institution: University of North Carolina at Chapel Hill
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4301479379