https://scholars.lib.ntu.edu.tw/handle/123456789/551712
Title: | Effect of nateglinide on the incidence of diabetes and cardiovascular events | Authors: | Holman R.R. Haffner S.M. McMurray J.J. Bethel M.A. Holzhauer B. Hua T.A. Belenkov Y. Boolell M. Buse J.B. Buckley B.M. Chacra A.R. FU-TIEN CHIANG Charbonnel B. Chow C.-C. Davies M.J. Deedwania P. Diem P. Einhorn D. Fonseca V. Fulcher G.R. Gaciong Z. Gaztambide S. Giles T. Horton E. Ilkova H. Jenssen T. Kahn S.E. Krum H. Laakso M. Leiter L.A. Levitt N.S. Mareev V. Martinez F. Masson C. Mazzone T. Meaney E. Nesto R. Pan C. Prager R. Raptis S.A. Rutten G.E.H.M. Sandstroem H. Schaper F. Scheen A. Schmitz O. Sinay I. Soska V. Stender S. Tam?s G. Tognoni G. Tuomilehto J. Villamil A.S. Voz?r J. Califf R.M. |
Issue Date: | 2010 | Journal Volume: | 362 | Journal Issue: | 16 | Start page/Pages: | 1463-1476 | Source: | New England Journal of Medicine | 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. (ClinicalTrials.gov number, NCT00097786.) Copyright ? 2010 Massachusetts Medical Society. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/551712 | ISSN: | 0028-4793 | DOI: | 10.1056/NEJMoa1001122 | SDG/Keyword: | glucose; hemoglobin A1c; nateglinide; placebo; valsartan; adult; article; blood pressure; cardiovascular disease; cardiovascular risk; clinical trial; controlled clinical trial; controlled study; diabetes mellitus; double blind procedure; drug dose increase; drug effect; female; follow up; glucose blood level; health program; heart failure; heart infarction; hemoglobin blood level; hospitalization; human; hypoglycemia; impaired glucose tolerance; lifestyle modification; major clinical study; male; outcome assessment; priority journal; randomized controlled trial; revascularization; stroke; unstable angina pectoris; waist circumference |
Appears in Collections: | 醫學院附設醫院 (臺大醫院) |
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