Effect of Nateglinide on the Incidence of Diabetes and
Cardiovascular Events

J 2010

Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

HOLMAN, Rury R., Steven M. HAFFNER, John J. MCMURRAY, M. A. BETHEL, B. HOLZHAUER et. al.

Basic information

Original name

Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events

Authors

HOLMAN, Rury R. (826 United Kingdom of Great Britain and Northern Ireland, guarantor), Steven M. HAFFNER (840 United States of America), John J. MCMURRAY (826 United Kingdom of Great Britain and Northern Ireland), M. A. BETHEL (826 United Kingdom of Great Britain and Northern Ireland), B. HOLZHAUER (756 Switzerland), T. A. HUA (840 United States of America), Y. BELENKOV (643 Russian Federation), M. BOOLELL (756 Switzerland), J. B. BUSE (840 United States of America), B. M. BUCKLEY (372 Ireland), A. R. CHACRA (76 Brazil), F. T. CHIANG (158 Taiwan), B. CHARBONNEL (250 France), C. C. CHOW (156 China), M. J. DAVIES (826 United Kingdom of Great Britain and Northern Ireland), P. DEEDWANIA (840 United States of America), P. DIEM (756 Switzerland), D. EINHORN (840 United States of America), V. FONSECA (840 United States of America), G. R. FULCHER (36 Australia), Z. GACIONG (616 Poland), S. GAZTAMBIDE (724 Spain), T. GILES (840 United States of America), E. HORTON (840 United States of America), H. ILKOVA (76 Brazil), T. JENSSEN (578 Norway), S. E. KAHN (840 United States of America), H. KRUM (36 Australia), M. LAAKSO (246 Finland), L. A. LEITER (124 Canada), N.S. LEVITT (710 South Africa), V. MAREEV (643 Russian Federation), F. MARTINEZ (724 Spain), C. MASSON (756 Switzerland), T. MAZZONE (840 United States of America), E. MEANEY (484 Mexico), R. NESTO (840 United States of America), C. Y. PAN (156 China), R. PRAGER (40 Austria), S. A. RAPTIS (300 Greece), G. RUTTEN (528 Netherlands), H. SANDSTROEM (752 Sweden), F. SCHAPER (276 Germany), A. SCHEEN (56 Belgium), O. SCHMITZ (208 Denmark), I. SINAY (32 Argentina), Vladimír SOŠKA (203 Czech Republic, belonging to the institution), S. STENDER (208 Denmark), G. TAMAS (348 Hungary), G. TOGNONI (380 Italy), J. TUOMILEHTO (246 Finland), A. S. VILLAMIL (32 Argentina), J. VOZAR (703 Slovakia) and R. M. CALIFF (840 United States of America)

Edition

New England Journal of Medicine, USA, MASSACHUSETTS MEDICAL SOC, 2010, 0028-4793

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30200 3.2 Clinical medicine

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 53.486

RIV identification code

RIV/00216224:14110/10:00051691

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1056/NEJMoa1001122

UT WoS

000276894700006

Keywords in English

IMPAIRED GLUCOSE-TOLERANCE; RANDOMIZED CONTROLLED-TRIAL; PHASE INSULIN-SECRETION; 10-YEAR FOLLOW-UP; FASTING GLUCOSE; LIFE-STYLE; PREVENTION; MELLITUS; NIDDM; CLASSIFICATION

Abstract

V originále

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.

Citovat

HOLMAN, Rury R., Steven M. HAFFNER, John J. MCMURRAY, M. A. BETHEL, B. HOLZHAUER, T. A. HUA, Y. BELENKOV, M. BOOLELL, J. B. BUSE, B. M. BUCKLEY, A. R. CHACRA, F. T. CHIANG, B. CHARBONNEL, C. C. CHOW, M. J. DAVIES, P. DEEDWANIA, P. DIEM, D. EINHORN, V. FONSECA, G. R. FULCHER, Z. GACIONG, S. GAZTAMBIDE, T. GILES, E. HORTON, H. ILKOVA, T. JENSSEN, S. E. KAHN, H. KRUM, M. LAAKSO, L. A. LEITER, N.S. LEVITT, V. MAREEV, F. MARTINEZ, C. MASSON, T. MAZZONE, E. MEANEY, R. NESTO, C. Y. PAN, R. PRAGER, S. A. RAPTIS, G. RUTTEN, H. SANDSTROEM, F. SCHAPER, A. SCHEEN, O. SCHMITZ, I. SINAY, Vladimír SOŠKA, S. STENDER, G. TAMAS, G. TOGNONI, J. TUOMILEHTO, A. S. VILLAMIL, J. VOZAR and R. M. CALIFF. Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events. New England Journal of Medicine. USA: MASSACHUSETTS MEDICAL SOC, 2010, vol. 362, No 16, p. 1463-1476. ISSN 0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa1001122.

@article{919381,
   author = {Holman, Rury R. and Haffner, Steven M. and McMurray, John J. and Bethel, M. A. and Holzhauer, B. and Hua, T. A. and Belenkov, Y. and Boolell, M. and Buse, J. B. and Buckley, B. M. and Chacra, A. R. and Chiang, F. T. and Charbonnel, B. and Chow, C. C. and Davies, M. J. and Deedwania, P. and Diem, P. and Einhorn, D. and Fonseca, V. and Fulcher, G. R. and Gaciong, Z. and Gaztambide, S. and Giles, T. and Horton, E. and Ilkova, H. and Jenssen, T. and Kahn, S. E. and Krum, H. and Laakso, M. and Leiter, L. A. and Levitt, N.S. and Mareev, V. and Martinez, F. and Masson, C. and Mazzone, T. and Meaney, E. and Nesto, R. and Pan, C. Y. and Prager, R. and Raptis, S. A. and Rutten, G. and Sandstroem, H. and Schaper, F. and Scheen, A. and Schmitz, O. and Sinay, I. and Soška, Vladimír and Stender, S. and Tamas, G. and Tognoni, G. and Tuomilehto, J. and Villamil, A. S. and Vozar, J. and Califf, R. M.},
   article_location = {USA},
   article_number = {16},
   doi = {http://dx.doi.org/10.1056/NEJMoa1001122},
   keywords = {IMPAIRED GLUCOSE-TOLERANCE; RANDOMIZED CONTROLLED-TRIAL; PHASE INSULIN-SECRETION; 10-YEAR FOLLOW-UP; FASTING GLUCOSE; LIFE-STYLE; PREVENTION; MELLITUS; NIDDM; CLASSIFICATION},
   language = {eng},
   issn = {0028-4793},
   journal = {New England Journal of Medicine},
   title = {Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events},
   volume = {362},
   year = {2010}
}

TY  - JOUR
ID  - 919381
AU  - Holman, Rury R. - Haffner, Steven M. - McMurray, John 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. Y. - Prager, R. - Raptis, S. A. - Rutten, G. - Sandstroem, H. - Schaper, F. - Scheen, A. - Schmitz, O. - Sinay, I. - Soška, Vladimír - Stender, S. - Tamas, G. - Tognoni, G. - Tuomilehto, J. - Villamil, A. S. - Vozar, J. - Califf, R. M.
PY  - 2010
TI  - Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events
JF  - New England Journal of Medicine
VL  - 362
IS  - 16
SP  - 1463-1476
EP  - 1463-1476
PB  - MASSACHUSETTS MEDICAL SOC
SN  - 00284793
KW  - IMPAIRED GLUCOSE-TOLERANCE
KW  - RANDOMIZED CONTROLLED-TRIAL
KW  - PHASE INSULIN-SECRETION
KW  - 10-YEAR FOLLOW-UP
KW  - FASTING GLUCOSE
KW  - LIFE-STYLE
KW  - PREVENTION
KW  - MELLITUS
KW  - NIDDM
KW  - CLASSIFICATION
N2  - 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.
ER  -

HOLMAN, Rury R., Steven M. HAFFNER, John J. MCMURRAY, M. A. BETHEL, B. HOLZHAUER, T. A. HUA, Y. BELENKOV, M. BOOLELL, J. B. BUSE, B. M. BUCKLEY, A. R. CHACRA, F. T. CHIANG, B. CHARBONNEL, C. C. CHOW, M. J. DAVIES, P. DEEDWANIA, P. DIEM, D. EINHORN, V. FONSECA, G. R. FULCHER, Z. GACIONG, S. GAZTAMBIDE, T. GILES, E. HORTON, H. ILKOVA, T. JENSSEN, S. E. KAHN, H. KRUM, M. LAAKSO, L. A. LEITER, N.S. LEVITT, V. MAREEV, F. MARTINEZ, C. MASSON, T. MAZZONE, E. MEANEY, R. NESTO, C. Y. PAN, R. PRAGER, S. A. RAPTIS, G. RUTTEN, H. SANDSTROEM, F. SCHAPER, A. SCHEEN, O. SCHMITZ, I. SINAY, Vladimír SOŠKA, S. STENDER, G. TAMAS, G. TOGNONI, J. TUOMILEHTO, A. S. VILLAMIL, J. VOZAR and R. M. CALIFF. Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events. \textit{New England Journal of Medicine}. USA: MASSACHUSETTS MEDICAL SOC, 2010, vol.~362, No~16, p.~1463-1476. ISSN~0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa1001122.

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