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Title: Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events
Authors: Holman, Rury R.
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. [UNIFESP]
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.
Sandstroem, Herbert
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.
Univ Oxford
Univ Glasgow
Univ Leicester
Univ Texas Hlth Sci Ctr San Antonio
Duke Univ
Univ N Carolina
Novartis Pharmaceut
Univ Hosp Bern
Univ Bern
Moscow MV Lomonosov State Univ
Natl Univ Ireland Univ Coll Cork
Universidade Federal de São Paulo (UNIFESP)
Natl Taiwan Univ Hosp
Univ Hosp
Chinese Univ Hong Kong
301 Hosp
Calif State Univ Fresno
VA Cent Calif Hlth Care Syst
Univ Calif San Diego
Scripps Whittier Diabet Inst
Tulane Univ
Univ Sydney
Monash Univ
Warsaw Med Univ
Hosp Univ Cruces
Joslin Diabet Ctr
Istanbul Univ
Oslo Univ Hosp
Univ Tromso
VA Puget Sound Hlth Care Syst
Univ Washington
Univ Kuopio
Kuopio Univ Hosp
Univ Helsinki
S Ostrobothnia Cent Hosp
Univ Toronto
Univ Cape Town
Natl Univ Cordoba
Univ Buenos Aires
Univ Illinois
Hosp 10 Octubre
Lahey Clin Fdn
Krankenhaus Hietzing Neurolog
Attikon Univ Hosp
Univ Med Ctr
Umea Univ
Tech Univ Dresden
Univ Liege
Aarhus Univ
Univ Copenhagen
Fac Hosp St Anna
Semmelweis Univ
Ist Ric Farmacol Mario Negri
Diabetol Outpatient Clin
Issue Date: 22-Apr-2010
Publisher: Massachusetts Medical Soc
Citation: New England Journal of Medicine. Waltham: Massachusetts Medical Soc, v. 362, n. 16, p. 1463-1476, 2010.
Abstract: 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. ( number, NCT00097786.)
ISSN: 0028-4793
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