Effect of nateglinide on the incidence of diabetes and cardiovascular events.
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NAVIGATOR Study Group, Holman Rury R, Haffner Steven M, McMurray John J, Bethel M Angelyn, Holzhauer Björn, 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 Andre, Schmitz Ole, Sinay Isaac, Soska Vladimir, Stender Steen, Tamás Gyula, Tognoni Gianni, Tuomilehto Jaako, Villamil Alberto S, Vozár Juraj, Califf Robert M
Аннотация
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.)