心血管病と生活習慣病のはざま

初回はすこし前に発表された研究ですが、ＡＣＣＯＲＤｔｒｉａｌです。半年ほど前にＮＩＨの発表されたのを知り、あるていどの広い領域を学ぶことをつづけていきたいとあらためて感じさせられた研究でした。

約１００００人のＤＭ患者を血糖厳格治療群(目標ＨｇｂＡ１ｃ６．０以下)と標準治療群(同７．０-７．９)を目標に血糖コントロールを行い、心血管死、非致死的ＭＩ、非致死的脳卒中を一次エンドポイントにおいたＲＣＴです。予想に反し、血糖厳格治療で一次エンドポイントが増加するという驚きの結果です。

低血糖が多い等、その原因がいろいろ推測されていますが、今後、詳しい結果が知りたいところです。

Effects of intensive glucose lowering in type 2 diabetes.
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<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, NCT00000620.) 2008 Massachusetts Medical Society
http://content.nejm.org/cgi/content/abstract/358/24/2545