Effect of nateglinide on the incidence of diabetes and cardiovascular events
| Autor: | Isaac Sinay, Felipe Martinez, Daniel Einhorn, Alberto S. Villamil, Antonio Roberto Chacra, Naomi S. Levitt, Markku Laakso, Mitradev Boolell, Brendan M. Buckley, Viacheslav Mareev, Chantal Masson, Gianni Tognoni, Chang-yu Pan, Gregory R. Fulcher, Prakash Deedwania, Yuri N. Belenkov, Fu-Tien Chiang, Tsushung A. Hua, Thomas D. Giles, Edward S. Horton, Steven M. Haffner, Hasan Ilkova, John B. Buse, Melanie J. Davies, Sotirios A. Raptis, Sonia Gaztambide, Björn Holzhauer, Vivian Fonseca, André Scheen, Peter Diem, Gyula Tamás, Ole Schmitz, R. Prager, Richard W. Nesto, Rury R. Holman, J. Tuomilehto, Bernard Charbonnel, Lawrence A. Leiter, Herbert Sandstroem, John J.V. McMurray, Eduardo Meaney, Frank Schaper, Juraj Vozar, Robert M. Califf, Theodore Mazzone, Guy E.H.M. Rutten, Zbigniew Gaciong, Trond Jenssen, Steen Stender, Vladimír Soška, Henry Krum, M. Angelyn Bethel, Steven E. Kahn, Chun Chung Chow |
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| Rok vydání: | 2010 |
| Předmět: |
Blood Glucose
Male Tetrazoles Nateglinide Kaplan-Meier Estimate 030204 cardiovascular system & hematology Impaired glucose tolerance 0302 clinical medicine Risk Factors Cumulative incidence Treatment Failure Incidence Hazard ratio Valine General Medicine Middle Aged 3. Good health Cardiovascular Diseases Cardiology Valsartan Drug Therapy Combination Female medicine.drug medicine.medical_specialty Phenylalanine 030209 endocrinology & metabolism Hypoglycemia 03 medical and health sciences Double-Blind Method Cyclohexanes Diabetes mellitus Internal medicine Glucose Intolerance medicine Humans Hypoglycemic Agents Exercise Kaplan-Meiers Estimate Proportional Hazards Models business.industry Proportional hazards model Body Weight medicine.disease Confidence interval Surgery Diabetes Mellitus Type 2 business Angiotensin II Type 1 Receptor Blockers Follow-Up Studies |
| Zdroj: | 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, Chiang, F-T, 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, Tamás, G, Tognoni, G & NAVIGATOR Study Group 2010, ' Effect of nateglinide on the incidence of diabetes and cardiovascular events ', The New England Journal of Medicine, vol. 362, no. 16, pp. 1463-76 . https://doi.org/10.1056/NEJMoa1001122 |
| ISSN: | 1533-4406 |
| DOI: | 10.1056/NEJMoa1001122 |
| Popis: | Udgivelsesdato: 2010-Apr-22 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.) |
| Databáze: | OpenAIRE |
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