Journal article
Effects of intensive glucose lowering in type 2 diabetes
The New England journal of medicine, Vol.358(24), pp.2545-2559
06/12/2008
DOI: 10.1056/NEJMoa0802743
PMCID: PMC4551392
PMID: 18539917
Abstract
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.
In this randomized study, 10,251 patients (mean age, 62.2 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, 38% were women, and 35% 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.
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 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; 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).
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, NCT00000620.)
Details
- Title: Subtitle
- Effects of intensive glucose lowering in type 2 diabetes
- Creators
- Hertzel C GersteinMichael E MillerRobert P ByingtonDavid C Goff JrJ Thomas BiggerJohn B BuseWilliam C CushmanSaul GenuthFaramarz Ismail-BeigiRichard H Grimm JrJeffrey L ProbstfieldDenise G Simons-MortonWilliam T FriedewaldAction to Control Cardiovascular Risk in Diabetes Study Group
- Contributors
- L Snetselaar (Contributor) - University of Iowa, Fraternal Order of Eagles Diabetes Research Center
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.358(24), pp.2545-2559
- DOI
- 10.1056/NEJMoa0802743
- PMID
- 18539917
- PMCID
- PMC4551392
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Grant note
- N01-HC-95180 / NHLBI NIH HHS N01HC95180 / NHLBI NIH HHS N01-HC-95183 / NHLBI NIH HHS N01HC95181 / NHLBI NIH HHS IAA-Y1-HC-9035 / NHLBI NIH HHS N01HC95184 / NHLBI NIH HHS IAA-Y1-HC-1010 / NHLBI NIH HHS N01-HC-95182 / NHLBI NIH HHS P30 NR005035 / NINR NIH HHS N01HC95179 / NHLBI NIH HHS N01HC95178 / NHLBI NIH HHS N01HC95183 / NHLBI NIH HHS Y01 HC009035 / NHLBI NIH HHS N01-HC-95178 / NHLBI NIH HHS N01-HC-95181 / NHLBI NIH HHS Y01 HC001010 / NHLBI NIH HHS N01-HC-95179 / NHLBI NIH HHS N01HC95182 / NHLBI NIH HHS N01-HC-95184 / NHLBI NIH HHS
- Language
- English
- Date published
- 06/12/2008
- Academic Unit
- Epidemiology; Fraternal Order of Eagles Diabetes Research Center; Internal Medicine
- Record Identifier
- 9984215043902771
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