降压治疗在降低 2 型糖尿病血管并发症中的作用。来自糖尿病视网膜病变坎地沙坦试验-保护 2 研究的结果。

The role of antihypertensive therapy in reducing vascular complications of type 2 diabetes. Findings from the DIabetic REtinopathy Candesartan Trials-Protect 2 study.

机构信息

International Centre for Circulatory Health, Imperial College London, London, UK.

出版信息

J Hypertens. 2011 Jul;29(7):1457-62. doi: 10.1097/HJH.0b013e3283480db9.

DOI:10.1097/HJH.0b013e3283480db9

PMID:21602709

Abstract

BACKGROUND

Recent trials question previously accepted low blood pressure targets in type 2 diabetes to reduce complication risk. We explored this question in the DIabetic REtinopathy Candesartan Trials-Protect 2 clinical trial.

METHODS

A total of 1905 normoalbuminuric participants with type 2 diabetes and mild-moderate retinopathy were randomized to candesartan or placebo. Participants were normotensive [untreated, blood pressure (BP) < 130/85 mmHg] or treated hypertensive [(62%), BP < 160/90 mmHg]. The effects of candesartan on microvascular and macrovascular endpoints alone and in combination were analysed, including subgroup analyses by baseline hypertension status.

RESULTS

Mean age was 57 ± 8 years, 50% were men, mean diabetes duration was 9 ± 5 years and baseline HbA1c was 8.2 ± 1.6%. Mean randomization BP was 123/75 mmHg in the normotensive, and 139/79 mmHg in the treated hypertensive subgroups. During the median 4.7-year follow-up, achieved systolic pressure on candesartan was 128 mmHg in baseline normotensive individuals, and 136 mmHg in treated hypertensive patients. Candesartan reduced combined macrovascular and microvascular complication risk; the age and baseline SBP overall adjusted hazard ratio for candesartan vs. placebo was 0.85 [95% confidence interval (CI) 0.72-0.99], P = 0.040, reflecting hazard ratios of 0.86 (0.66-1.13) for baseline normotensive individuals and 0.83 (0.68-1.02) for hypertensive patients. Hazard ratios were 0.87 (0.74-1.04) for microvascular and 0.84 (0.57-1.25) for macrovascular complications, when analysed separately. However, an interaction (P = 0.06) between hypertensive [hazard ratio 0.67 (0.42-1.07)] and normotensive (1.45, 0.71-2.94) subgroups was observed for macrovascular events.

CONCLUSION

Candesartan modestly reduces vascular complication risk in treated hypertensive diabetic individuals at low risk of cardiovascular disease. Separate analyses of microvascular and macrovascular events suggest that candesartan may not reduce macrovascular events in normotensive persons with type 2 diabetes.

摘要

背景

最近的试验对 2 型糖尿病降低并发症风险的先前接受的低血压目标提出了质疑。我们在 DIabetic REtinopathy Candesartan Trials-Protect 2 临床试验中探讨了这个问题。

方法

共有 1905 名伴有 2 型糖尿病和轻度至中度视网膜病变的非白蛋白尿参与者被随机分配接受坎地沙坦或安慰剂。参与者为血压正常（未治疗，血压<130/85mmHg）或治疗性高血压（62%，血压<160/90mmHg）。分析了坎地沙坦对微血管和大血管终点的单独和联合影响，包括按基线高血压状态进行的亚组分析。

结果

平均年龄为 57±8 岁，50%为男性，平均糖尿病病程为 9±5 年，基线 HbA1c 为 8.2±1.6%。血压正常组的平均随机血压为 123/75mmHg，治疗性高血压组为 139/79mmHg。在中位 4.7 年的随访期间，基线血压正常的患者服用坎地沙坦后的收缩压为 128mmHg，治疗性高血压患者为 136mmHg。坎地沙坦降低了大血管和微血管并发症的综合风险；坎地沙坦与安慰剂相比，年龄和基线 SBP 的总体调整后的危险比为 0.85（95%置信区间 0.72-0.99），P=0.040，反映出基线血压正常的患者的危险比为 0.86（0.66-1.13），高血压患者为 0.83（0.68-1.02）。微血管和大血管并发症的危险比分别为 0.87（0.74-1.04）和 0.84（0.57-1.25）。然而，对于大血管事件，观察到高血压（危险比 0.67（0.42-1.07））和血压正常（1.45，0.71-2.94）亚组之间存在交互作用（P=0.06）。