ORBi: Holman Rury R - Effect of nateglinide on the incidence of diabetes and cardiovascular events.

Reference : Effect of nateglinide on the incidence of diabetes and cardiovascular events.


	Document type :	Scientific journals : Article
	Discipline(s) :	Human health sciences : Pharmacy, pharmacology & toxicology Human health sciences : Cardiovascular & respiratory systems Human health sciences : Endocrinology, metabolism & nutrition
	To cite this reference:	http://hdl.handle.net/2268/25946

Title :	Effect of nateglinide on the incidence of diabetes and cardiovascular events.
Language :	English
Author, co-author :	Holman, Rury R [> > > >]
	Haffner, Steven M [> > > >]
	McMurray, John J [> > > >]
	Bethel, M Angelyn [> > > >]
	Holzhauer, Bjorn [> > > >]
	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 [> > > >]
	Sandstroem, Herbert [> > > >]
	Schaper, Frank [> > > >]
	Scheen, André [Université de Liège - ULg > Département des sciences cliniques > Diabétologie, nutrition et maladie métaboliques - Médecine interne générale >]
	Schmitz, Ole [> > > >]
	Sinay, Isaac [> > > >]
	Soska, Vladimir [> > > >]
	Stender, Steen [> > > >]
	Tamas, Gyula [> > > >]
	Tognoni, Gianni [> > > >]
	Tuomilehto, Jaako [> > > >]
	Villamil, Alberto S [> > > >]
	Vozar, Juraj [> > > >]
	Califf, Robert M [> > > >]
Publication date :	2010
Journal title :	New England Journal of Medicine [=NEJM]
Publisher :	Massachusetts Medical Society
Volume :	362
Issue/season :	16
Pages :	1463-76
Peer reviewed :	Yes (verified by ORBi)
Audience :	International
ISSN :	0028-4793
e-ISSN :	1533-4406
City :	Waltham
Country :	MA
Keywords :	[en] Angiotensin II Type 1 Receptor Blockers/therapeutic use ; Blood Glucose/analysis/drug effects ; Body Weight/drug effects ; Cardiovascular Diseases/epidemiology/mortality/prevention & control ; Cyclohexanes/adverse effects/therapeutic use ; Diabetes Mellitus, Type 2/epidemiology/prevention & control ; Double-Blind Method ; Drug Therapy, Combination ; Exercise ; Female ; Follow-Up Studies ; Glucose Intolerance/diet therapy/drug therapy/therapy ; Humans ; Hypoglycemic Agents/adverse effects/therapeutic use ; Incidence ; Kaplan-Meiers Estimate ; Male ; Middle Aged ; Phenylalanine/adverse effects/analogs & derivatives/therapeutic use ; Proportional Hazards Models ; Risk Factors ; Tetrazoles/therapeutic use ; Treatment Failure ; Valine/analogs & derivatives/therapeutic use
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.)
Target :	Researchers ; Professionals
Permalink :	http://hdl.handle.net/2268/25946
DOI :	10.1056/NEJMoa1001122
Other URL :	http://www.nejm.org
Commentary :	2010 Massachusetts Medical Society

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