糖尿病患者用ARB降压与用CCB降压的临床结局相似

Similar Clinical Outcomes With ARB, CCB for HTN in Diabetics

糖尿病患者用ARB降压与用CCB降压的临床结局相似
April 8, 2011 (New Orleans, Louisiana) — Although guidelines tend to prefer ACE inhibitors or ARBs as the basis for hypertension drug therapy in diabetics, in whom they can protect against nephropathy, the jury is still out on whether CCBs might lead to better clinical outcomes, according to Dr Toyoaki Murohara (Nagoya University School of Medicine, Japan).

2011年4月8日（新奥尔良，路易斯安那州） - 根据Toyoaki Murohara博士（日本名古屋大学医学院）报道，虽然在治疗糖尿病高血压的患者时，指南倾向于推荐ACE抑制剂或ARB类降压药为基础用药，以防止肾病，但目前仍有研究试图证明是否CCB类药物会导致更好的临床结局。
In the NAGOYA-HEART Study, whose primary findings Murohara reported here at the American College of Cardiology (ACC) 2011 Scientific Sessions/i2 Summit, there was no difference between the two antihypertensive strategies in patients with type 2 diabetes or impaired glucose tolerance with respect to a primary composite end point consisting of acute MI, stroke, coronary revascularization, heart-failure hospitalization, or sudden cardiac death over three years or in the secondary end point of all-cause mortality.

在美国心脏病学院（ACC）2011年科学年会/i2会议上Murohara报道，在名古屋心脏研究中，主要研究结果是在2性糖尿病和糖耐量异常的患者，主要复合终点包括三年急性心肌梗塞、中风、冠状动脉血管重建术、心衰竭住院或心脏猝死和次要终点全因死亡率，两种降压药物之间均无差异。
Although the end point wasn't prespecified, heart-failure hospitalizations were significantly fewer among those getting ARB-based therapy.

虽然终点并未预先设定，心衰竭住院在ARB为基础的治中更少。
To heartwire , Murohara said the findings support current guidelines in indicating a preference for ARBs in hypertensive diabetics, largely because they, but not CCBs, have been shown to curtail progression to heart failure--as was suggested in the NAGOYA HEART Study.

Murohara告诉heartwire记者说，研究结果支持目前指南中在糖尿病高血压患者首选ARBs类药物，很大程度上是因为ARBs类药物，而不是CCBs，已显示出可减少心脏衰竭恶化 - 正如在名古屋心脏研究显示的结果。

The trial equally randomized 1150 patients with hypertension--82% of whom also had type 2 diabetes and 18% of whom had impaired glucose tolerance--at 46 centers in Japan to blood-pressure-lowering therapy based on either the ARB valsartan (Diovan, Novartis) or the CCB amlodipine (Norvasc, Pfizer).

该试验将1150例高血压患者随机分为数量相同的两组 - 82％的患者同时患有2型糖尿病，18％的患者糖耐量异常- 在日本共46个中心参加本研究，所用药物是ARB类药物缬沙坦（代文，诺华公司）或CCB类药物氨氯地平（络活喜，辉瑞公司）。

The open-label therapy was aimed at a blood-pressure goal of <130/80 mm Hg; clinical outcomes were adjudicated in blinded fashion.

这项开放标签治疗的目标血压是<130/80 mm Hg；临床结果以双盲的方式进行判定。

The treatment groups were similar at baseline with respect to age (mean 63 years); body-mass index; medications; standard CV risk factors; and lipid and renal biomarkers. Men made up two-thirds of the population. Excluded were patients with renal dysfunction or an LVEF <40 and those with a CV-disease event within the past six months; 69% had no history of coronary disease or stroke.

两治疗组在基线年龄（平均63岁）、体重指数、药物、标准心血管危险因素、血脂和肾功能生物标志物方面均相似。这个人群中男性占三分之二。排除标准是肾功能不全或左心室射血分数<40和在过去六个月曾发生CV事件的患者;；69％的患者没有冠状动脉疾病或中风病史。

Blood-pressure and glycated hemoglobin levels were "equally controlled" over the follow-up averaging 3.2 years, according to Murohara. The composite primary end point occurred in 9.4% of patients on valsartan and 9.7% of those on amlodipine, for an ARB-vs-CCB hazard ratio (HR) of 0.97 (95% CI 0.66–1.40; p=0.85). All-cause mortality was 3.8% and 2.8%, respectively, also not a significant difference. The analysis was controlled for age, sex, statin use, smoking status, and whether the patient had diabetes or impaired glucose tolerance.

根据Murohara报道，血压和糖化血红蛋白水平在后续平均3.2年中控制相似。复合主要终点在缬沙坦为9.4％，在氨氯地平组是9.7％，ARB-vs-CCB危险比（HR）为0.97（95％CI为0.66-1.40；p= 0.85）。全因死亡率分别为3.8％和2.8％，也没有显着差异。该分析校正了年龄、性别、使用他汀类药物、吸烟状况、以及是否有糖尿病或糖耐量异常。

The rate of HF hospitalization, the only component of the primary end point to show a significant difference, was 0.5% for valsartan and 2.6% for amlodipine (p=0.012).

HF住院率是主要终点中显示有显着差异的唯一指标，缬沙坦组为0.5％，氨氯地平组为2.6％（p= 0.012）。

There weren't enough patients to show any differential subgroup effects of the two regimens, Murohara said. Therefore, it couldn't be shown whether valsartan might have prevented patients with impaired glucose tolerance from progressing to overt diabetes. As previously reported by heartwire , such a protective effect was suggested for ARBs in the NAVIGATOR trial but not for ACE inhibitors in the DREAM trial, although neither were hypertension trials.

没有足够的患者表现出两种方案中有任何亚组不同，Murohara说。因此，本研究未能显示缬沙坦是否有可能阻止糖耐量受损进展为显性糖尿病患者的作用。先前heartwire曾报道，在NAVIGATOR试验中ARBs类药物具有这种保护作用，而在DREAM试验中ACE抑制剂并未发现这种作用，尽管这两项试验均非高血压试验。