Article (Scientific journals)
Effect of nateglinide on the incidence of diabetes and cardiovascular events.
Holman, Rury R; Haffner, Steven M; McMurray, John J et al.
2010In New England Journal of Medicine, 362 (16), p. 1463-76
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Keywords :
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.)
Disciplines :
Cardiovascular & respiratory systems
Pharmacy, pharmacology & toxicology
Endocrinology, metabolism & nutrition
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 - ULiège > 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
More authors (44 more) Less
Language :
English
Title :
Effect of nateglinide on the incidence of diabetes and cardiovascular events.
Publication date :
2010
Journal title :
New England Journal of Medicine
ISSN :
0028-4793
eISSN :
1533-4406
Publisher :
Massachusetts Medical Society, Waltham, United States - Massachusetts
Volume :
362
Issue :
16
Pages :
1463-76
Peer reviewed :
Peer Reviewed verified by ORBi
Additional URL :
Commentary :
2010 Massachusetts Medical Society
Available on ORBi :
since 03 May 2010

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