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【NEJM】强化降糖并不能减少心血管事件的发生（
Methord：We randomly assigned 1791 military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard-therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene.
Results：The median follow-up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard-therapy group and 6.9% in the intensive-therapy group. The primary outcome occurred in 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group (hazard ratio in the intensive-therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P = 0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause (hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P = 0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group.
Conclusions：Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications. NEJM原文。
Complications in Veterans with Type 2 Diabetes.pdf (407.75k) Intensive glucose control fails to reduce cardiovascular events
Results of the Veterans Affairs Diabetes Trial (VADT), a long-term study of US veterans with type 2 diabetes receiving intensive blood glucose control, is now published online December 17, 2008 in the New England Journal of Medicine .
First presented at the American Diabetes Association (ADA) 2008 Scientific Sessions in San Francisco, CA and reported by heartwire at that time, the VADT showed that intensive blood glucose lowering in patients with elevated glycated hemoglobin A1c (HbA1c) levels despite medical treatment had no significant effect on the rates of cardiovascular events, death, or microvascular complications.
"We picked the toughest group of patients we could find because we figured if we could do some good there the benefit would be pretty obvious," lead VADT investigator Dr William Duckworth (Phoenix Veterans Affairs Health Care Center, AZ) told heartwire. "As the results show, though, we weren't able to do any good."
The results of the study are in line with the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Action in Diabetes and Vascular Disease (ADVANCE) studies. The ADVANCE trial showed a reduction in the progression of albuminuria with intensive glucose control but no effect on cardiovascular event rates. ACCORD, on the other hand, was stopped early because of an increased risk of death in patients who underwent intensive blood glucose lowering.
Tough-to-treat patients
Speaking with heartwire, Duckworth said that when the VADT was initiated nearly five years ago, there was little to no evidence that glucose control altered the risk of cardiovascular events. Some studies, including the United Kingdom Prospective Diabetes Study (UKPDS), suggested improvements in microvascular end points, but there were no effects on hard clinical end points such as mortality or MI.
In VADT, investigators randomized 1791 military veterans with diabetes, mean age 60 years, who had a suboptimal response to medical therapy to intensive glucose control or standard glucose control. At the time of randomization, median HbA1c levels were 9.4%. In addition, nearly 75% of patients had hypertension, 40% had a previous cardiovascular event, and patients had been diagnosed with diabetes for a mean 11.5 years.
In both study groups, obese patients were started on two drugs, metformin and rosiglitazone, whereas nonobese patients were started with glimepiride plus rosiglitazone. Patients in the intensive arm started on maximal doses. Insulin was added to most participants to achieve HbA1c levels less than 6.0% in the intensive-treatment arm and less than 9.0% in the standard-therapy arm.
After a median follow-up of 6.5 years, median HbA1c levels were reduced to 8.4% in the standard-lowering arm and to 6.9% in the intensive-glucose-control arm. During this time, 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group experienced a major cardiovascular event, the composite primary end point consisting of MI, stroke, death from cardiovascular causes, congestive heart failure, vascular surgery, inoperable coronary disease, and amputation for ischemic gangrene.
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作者:admin@医学,生命科学 2011-03-27 17:11
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