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Randomized Controlled Trial
. 2008 Jun 12;358(24):2545-59.
doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.

Effects of intensive glucose lowering in type 2 diabetes

Action to Control Cardiovascular Risk in Diabetes Study Group; Hertzel C Gerstein, Michael E Miller, Robert P Byington, David C Goff Jr, J Thomas Bigger, John B Buse, William C Cushman, Saul Genuth, Faramarz Ismail-Beigi, Richard H Grimm Jr, Jeffrey L Probstfield, Denise G Simons-Morton, William T Friedewald
Collaborators
Randomized Controlled Trial

Effects of intensive glucose lowering in type 2 diabetes

Action to Control Cardiovascular Risk in Diabetes Study Group et al. N Engl J Med. .

Abstract

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. VSports手机版.

Methods: In this randomized study, 10,251 patients (mean age, 62 V体育安卓版. 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. .

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 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 V体育ios版. 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). .

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 VSports最新版本. (ClinicalTrials. gov number, NCT00000620. ) .

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"V体育ios版" Figures

Figure 1
Figure 1. Median Glycated Hemoglobin Levels at Each Study Visit
I bars denote interquartile ranges.
Figure 2
Figure 2. Kaplan–Meier Curves for the Primary Outcome and Death from Any Cause
Figure 3
Figure 3. Hazard Ratios for the Primary Outcome and Death from Any Cause in Prespecified Subgroups
Data regarding glycated hemoglobin levels at baseline are presented for 10,288 patients because a baseline level was not available for 23 patients. Horizontal bars represent the 95% confidence interval, and vertical dashed lines indicate the overall hazard ratio. The size of each square is proportional to the number of patients.
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References

    1. Goff DC, Jr, Gerstein HC, Ginsberg HN, et al. Prevention of cardiovascular disease in persons with type 2 diabetes mellitus: current knowledge and rationale for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007;99:4i–20i. - PubMed
    1. Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004;141:421–31. - PubMed
    1. Gerstein HC, Pogue J, Mann JF, et al. The relationship between dysglycaemia and cardiovascular and renal risk in diabetic and non-diabetic participants in the HOPE study: a prospective epidemiological analysis. Diabetologia. 2005;48:1749–55. - PubMed
    1. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–12. - "V体育平台登录" PMC - PubMed
    1. American Diabetes Association Standards of medical care in diabetes — 2008. Diabetes Care. 2008;31(Suppl 1):S12–S54. - PubMed

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