TY - JOUR
T1 - Effects of intensive glucose lowering in type 2 diabetes
AU - Gerstein, Hertzel C.
AU - Miller, Michael E.
AU - Byington, Robert P.
AU - Goff, David C.
AU - Bigger, J. Thomas
AU - Buse, John B.
AU - Cushman, William C.
AU - Genuth, Saul
AU - Ismail-Beigi, Faramarz
AU - Grimm, Richard H.
AU - Probstfield, Jeffrey L.
AU - Simons-Morton, Denise G.
AU - Friedewald, William T.
AU - Gotto, A. M.
AU - Bailey, K.
AU - Gohdes, D.
AU - Haffner, S.
AU - Hiss, R.
AU - Jamerson, K.
AU - Lee, K.
AU - Nathan, D.
AU - Sowers, J.
AU - Walters, L.
AU - Friedewald, W. T.
AU - Buse, J. B.
AU - Bigger, J. T.
AU - Byington, R. P.
AU - Cushman, W. C.
AU - Gerstein, H. C.
AU - Ginsberg, H. N.
AU - Goff, D. C.
AU - Probstfield, J. L.
AU - Simons-Morton, D. G.
AU - Gerstein, H. C.
AU - Yusuf, S.
AU - Punthakee, Z.
AU - Russo, R.
AU - Anand, S.
AU - Cracknell, B.
AU - Cukierman-Yaffe, T.
AU - Gafni, A.
AU - Guyatt, G.
AU - Hall, S.
AU - Kaszyca, J.
AU - Lonn, E.
AU - Seaquist, E. R.
AU - Redmon, J. B.
AU - Peterson, K.
AU - Feldman, J. L.
AU - Mendenhall, T. J.
AU - The Action to Control Cardiovascular Risk in Diabetes Study Group
N1 - Publisher Copyright:
© 2008 Massachusetts Medical Society. All rights reserved.
PY - 2008/6/12
Y1 - 2008/6/12
N2 - Background Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors. Methods In this randomized study, 10,250 patients (mean age, 60.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 37% were women, and 7% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. Results At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 70 patients in the intensive-therapy group, as compared with 359 in the standard-therapy group (hazard ratio, 0.88; 92% confidence interval [CI], 0.76 to 1.04; P = 0.16). At the same time, 255 patients in the intensive-therapy group died, as compared with 203 patients in the standardtherapy group (hazard ratio, 1.22; 92% CI, 1.01 to 1.45; P = 0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001). Conclusions As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000600.).
AB - Background Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors. Methods In this randomized study, 10,250 patients (mean age, 60.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 37% were women, and 7% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. Results At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 70 patients in the intensive-therapy group, as compared with 359 in the standard-therapy group (hazard ratio, 0.88; 92% confidence interval [CI], 0.76 to 1.04; P = 0.16). At the same time, 255 patients in the intensive-therapy group died, as compared with 203 patients in the standardtherapy group (hazard ratio, 1.22; 92% CI, 1.01 to 1.45; P = 0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001). Conclusions As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000600.).
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U2 - 10.1056/NEJMoa0802743
DO - 10.1056/NEJMoa0802743
M3 - Article
C2 - 18539917
AN - SCOPUS:45149131667
SN - 0028-4793
VL - 358
SP - 2545
EP - 2559
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 24
ER -