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  • 1. Holman, Rury R.
    et al.
    Haffner, Steven M.
    McMurray, John J.
    Bethel, M. Angelyn
    Holzhauer, Bjoern
    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.
    Sandström, Herbert
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
    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.
    Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events2010In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 362, no 16, p. 1463-1476Article in journal (Refereed)
    Abstract [en]

    BACKGROUND The ability of short-acting insulin secretagogues to reduce the risk of diabetes or cardiovascular events in people with impaired glucose tolerance is unknown. METHODS In a double-blind, randomized clinical trial, we assigned 9306 participants with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors to receive nateglinide (up to 60 mg three times daily) or placebo, in a 2-by-2 factorial design with valsartan or placebo, in addition to participation in a lifestyle modification program. We followed the participants for a median of 5.0 years for incident diabetes (and a median of 6.5 years for vital status). We evaluated the effect of nateglinide on the occurrence of three coprimary outcomes: the development of diabetes; a core cardiovascular outcome that was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure; and an extended cardiovascular outcome that was a composite of the individual components of the core composite cardiovascular outcome, hospitalization for unstable angina, or arterial revascularization. RESULTS After adjustment for multiple testing, nateglinide, as compared with placebo, did not significantly reduce the cumulative incidence of diabetes (36% and 34%, respectively; hazard ratio, 1.07; 95% confidence interval [CI], 1.00 to 1.15; P = 0.05), the core composite cardiovascular outcome (7.9% and 8.3%, respectively; hazard ratio, 0.94, 95% CI, 0.82 to 1.09; P = 0.43), or the extended composite cardiovascular outcome (14.2% and 15.2%, respectively; hazard ratio, 0.93, 95% CI, 0.83 to 1.03; P = 0.16). Nateglinide did, however, increase the risk of hypoglycemia. CONCLUSIONS Among persons with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors, assignment to nateglinide for 5 years did not reduce the incidence of diabetes or the coprimary composite cardiovascular outcomes. (ClinicalTrials.gov number, NCT00097786.)

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