Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

Autor Holman, Rury R. Google Scholar
Haffner, Steven M. Google Scholar
McMurray, John J. Google Scholar
Bethel, M. Angelyn Google Scholar
Holzhauer, Bjoern Google Scholar
Hua, Tsushung A. Google Scholar
Belenkov, Yuri Google Scholar
Boolell, Mitradev Google Scholar
Buse, John B. Google Scholar
Buckley, Brendan M. Google Scholar
Chacra, Antonio R. Autor UNIFESP Google Scholar
Chiang, Fu-Tien Google Scholar
Charbonnel, Bernard Google Scholar
Chow, Chun-Chung Google Scholar
Davies, Melanie J. Google Scholar
Deedwania, Prakash Google Scholar
Diem, Peter Google Scholar
Einhorn, Daniel Google Scholar
Fonseca, Vivian Google Scholar
Fulcher, Gregory R. Google Scholar
Gaciong, Zbigniew Google Scholar
Gaztambide, Sonia Google Scholar
Giles, Thomas Google Scholar
Horton, Edward Google Scholar
Ilkova, Hasan Google Scholar
Jenssen, Trond Google Scholar
Kahn, Steven E. Google Scholar
Krum, Henry Google Scholar
Laakso, Markku Google Scholar
Leiter, Lawrence A. Google Scholar
Levitt, Naomi S. Google Scholar
Mareev, Viacheslav Google Scholar
Martinez, Felipe Google Scholar
Masson, Chantal Google Scholar
Mazzone, Theodore Google Scholar
Meaney, Eduardo Google Scholar
Nesto, Richard Google Scholar
Pan, Changyu Google Scholar
Prager, Rudolf Google Scholar
Raptis, Sotirios A. Google Scholar
Rutten, Guy E. H. M. Google Scholar
Sandstroem, Herbert Google Scholar
Schaper, Frank Google Scholar
Scheen, Andre Google Scholar
Schmitz, Ole Google Scholar
Sinay, Isaac Google Scholar
Soska, Vladimir Google Scholar
Stender, Steen Google Scholar
Tamas, Gyula Google Scholar
Tognoni, Gianni Google Scholar
Tuomilehto, Jaako Google Scholar
Villamil, Alberto S. Google Scholar
Vozar, Juraj Google Scholar
Califf, Robert M. Google Scholar
NAVIGATOR Study Grp Google Scholar
Instituição Univ Oxford
Univ Glasgow
Univ Leicester
Univ Texas Hlth Sci Ctr San Antonio
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Novartis Pharmaceut
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Universidade Federal de São Paulo (UNIFESP)
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Scripps Whittier Diabet Inst
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Ist Ric Farmacol Mario Negri
Diabetol Outpatient Clin
Resumo BACKGROUNDThe ability of short-acting insulin secretagogues to reduce the risk of diabetes or cardiovascular events in people with impaired glucose tolerance is unknown.METHODSIn 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.RESULTSAfter 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.CONCLUSIONSAmong 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.)
Idioma Inglês
Financiador Novartis Pharma
Data de publicação 2010-04-22
Publicado em New England Journal of Medicine. Waltham: Massachusetts Medical Soc, v. 362, n. 16, p. 1463-1476, 2010.
ISSN 0028-4793 (Sherpa/Romeo, fator de impacto)
Publicador Massachusetts Medical Soc
Extensão 1463-1476
Fonte http://dx.doi.org/10.1056/NEJMoa1001122
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000276894700006
Endereço permanente http://repositorio.unifesp.br/handle/11600/32480

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