Department of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan.
Diabetologia. 2011 Dec;54(12):2978-86. doi: 10.1007/s00125-011-2325-z. Epub 2011 Oct 13.
AIMS/HYPOTHESIS: 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%).
CONCLUSIONS/INTERPRETATION: Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
ClinicalTrials.gov NCT00141453.
目的/假设：血管紧张素受体阻滞剂（ARB）在接受包括血管紧张素转换酶抑制剂（ACEI）在内的现代治疗方案的 2 型糖尿病患者中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（ARB）对显性肾病的 2 型糖尿病患者主要复合终点（血清肌酐加倍、终末期肾病和死亡）的影响。次要终点包括复合心血管结局、肾功能和蛋白尿变化。随机分组和分配到试验组由中央计算机系统进行。参与者、护理人员、进行检查的人员和评估结果的人员对分组情况不知情。
577 名（377 名日本人，200 名中国人）接受抗高血压治疗（73.5%[n=424]接受 ACEI 联合治疗）的患者接受了每日一次奥美沙坦（10-40 毫克）（n=288）或安慰剂（n=289）治疗，为期 3.2±0.6 年（均值±标准差）。在奥美沙坦组，116 例患者发生主要结局（41.1%），而安慰剂组为 129 例（45.4%）（HR 0.97，95%CI 0.75，1.24；p=0.791）。奥美沙坦显著降低血压、蛋白尿和血清肌酐倒数的变化率。奥美沙坦组心血管死亡人数高于安慰剂组（10 例比 3 例），而两组主要不良心血管事件（心血管死亡加非致死性卒中和心肌梗死）和全因死亡相似（主要不良心血管事件 18 例比 21 例，全因死亡 19 例比 20 例）。奥美沙坦组高钾血症的发生率高于安慰剂组（9.2%比 5.3%）。
结论/解释：奥美沙坦耐受性良好，但与 ACEI 联合使用并不能改善肾脏结局。
ClinicalTrials.gov NCT00141453。
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