Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study.
Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study.
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Olmesartan对2型糖尿病的肾脏和心血管结局的影响，患有明显的肾病：一项多中心，随机，安慰剂对照研究。
DOI：
10.1007/s00125-011-2325-z
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发表时间：
2011-12
期刊：
影响因子：
8.2
通讯作者：
Makino, H.
中科院分区：
文献类型：
--
作者：
Imai, E.;Chan, J. C. N.;Ito, S.;Yamasaki, T.;Kobayashi, F.;Haneda, M.;Makino, H.
血管紧张素受体阻滞剂（ARB）对使用血管紧张素转换酶抑制剂（ACEI）治疗的2型糖尿病患者的肾脏和心血管保护作用仍存在争议。我们研究了奥美沙坦（一种ARB）对伴有明显肾病的2型糖尿病患者血清肌酐加倍、终末期肾病和死亡的主要复合结局的影响。次要结局包括复合心血管结局、肾功能变化和蛋白尿。通过中央计算机系统进行随机化和试验组分配。参与者、护理人员、进行检查的人和评估结果的人对分组不知情。577例（377例日本患者，200例中国患者）接受抗高血压治疗（73.5% [n = 424]接受ACEI合并治疗）的患者接受奥美沙坦（10-40 mg）（n = 288）或安慰剂（n = 289）每日一次治疗，治疗时间为3.2 ± 0.6年（平均值±SD）。在奥美沙坦组中，116例患者（41.1%）发生了主要结局，而安慰剂组中有129例患者（45.4%）发生了主要结局（HR 0.97，95% CI 0.75，1.24; p = 0.791）。奥美沙坦可显著降低血压、尿蛋白和血清肌酐倒数变化率。奥美沙坦组的心血管死亡高于安慰剂组（10例vs 3例），而两组之间的主要心血管不良事件（心血管死亡+非致死性卒中和心肌梗死）和全因死亡相似（主要心血管不良事件18例vs 21例，全因死亡; 19例vs 20例）。奥美沙坦组的高钾血症发生率高于安慰剂组（9.2% vs 5.3%）。奥美沙坦耐受性良好，但在ACEI基础上不能改善肾脏结局。 试验注册：ClinicalTrials.gov NCT 00141453资金：ORIENT研究得到了Daiichi Sankyo的研究资助。本文的在线版本（doi：10.1007/s 00125 -011-2325-z）包含同行评审但未经编辑的补充材料，包括ORIENT研究者名单，可供授权用户使用。
The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI). We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment. Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [n = 424] received concomitant ACEI), were given either once-daily olmesartan (10–40 mg) (n = 288) or placebo (n = 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24; p = 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%). Olmesartan was well tolerated but did not improve renal outcome on top of ACEI. Trial registration: ClinicalTrials.gov NCT00141453 Funding: The ORIENT study was supported by a research grant from Daiichi Sankyo. The online version of this article (doi:10.1007/s00125-011-2325-z) contains peer-reviewed but unedited supplementary material, including a list of the ORIENT study investigators, which is available to authorised users.
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168.9
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