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Title: Effect of nateglinide on the incidence of diabetes and cardiovascular events
Authors: Holman, R. R.
Bethel, M. A.
McMurray, J. J.
Haffner, S. M.
Davies, M. J.
Haffner, S. M.
Califf, R. M.
Buse, J. B.
Holzhauer, B.
Boolell, M.
Masson, C.
Diem, P.
Hua, T. A.
Belenkov, Y.
Mareev, V.
Buckley, B. M.
Chacra, A. R.
Chiang, F-T.
Charbonnel, B.
Chow, C-C.
Pan, C.
Deedwania, P.
Einhorn, D.
Fonseca, V.
Giles, T.
Fulcher, G. R.
Krum, H.
Gaciong, Z.
Gaztambide, S.
Horton, E.
Ilkova, H.
Jenssen, T.
Jenssen, T.
Kahn, S. E.
Laakso, M.
Tuomilehto, J.
Leiter, L. A.
Levitt, N. S.
Martinez, F.
Sinay, I.
Villamil, A. S.
Mazzone, T.
Meaney, E.
Nesto, R.
Prager, R.
Raptis, S. A.
Rutten, G. E. H. M.
Sandstroem, H.
Schaper, F.
Scheen, A.
Schmitz, O.
Stender, S.
Soska, V.
Tamás, G.
Tognoni, G.
Vozár, J.
First Published: 22-Apr-2010
Publisher: Massachusetts Medical Society
Citation: New England Journal of Medicine, 2010, 362 (16), pp. 1463-1476
Abstract: 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. ( number, NCT00097786.)
DOI Link: 10.1056/NEJMoa1001122
ISSN: 0028-4793
eISSN: 1533-4406
Type: Journal Article
Rights: Archived with reference to SHERPA/RoMEO and publisher website.
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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