Effects of Intensive Glucose Lowering in Type 2 Diabetes

Autor: Peter Kaiser, Robert Cuddihy, William Sivitz, Salim Yusuf, Heather Lochnan, Peter Senior, B. L. Gregoire Nyomba, Michael Vallis, J. Bruce Redmon, Dianne Stephens, Igor Wilderman, Neda Rasouli, John Buse, Jeffrey Katula, Hertzel Gerstein, Frida Arrey, Robert Nick Bryan
Rok vydání: 2008
Předmět:
Zdroj: New England Journal of Medicine. 358:2545-2559
ISSN: 1533-4406
0028-4793
0000-0620
DOI: 10.1056/nejmoa0802743
Popis: 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, 10,251 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. 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=0.16). 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
Databáze: OpenAIRE