STOCKHOLM (EGMN) – Olmesartan significantly reduced the time to microalbuminuria in a randomized, placebo-controlled, double-blind multicenter study of 4,447 patients with type 2 diabetes.
The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) Trial investigated whether early treatment with olmesartan, an angiotensin receptor blocker (ARB), would delay the occurrence of microalbuminuria in patients with type 2 diabetes who had at least one other cardiovascular risk factor but who had normal albumin excretion at baseline.
At baseline, the patients had a mean age of 58 years, diabetes duration of 6 years, body mass index of 30 kg/m2, and hemoglobin A1c of 7.6%. Mean blood pressure at baseline was 137/80 mm Hg, and the mean estimated glomerular filtration rate was 85 mL/min/1.73 m2. The patients received either 40 mg of olmesartan or placebo once daily for a median of 3.2 years.
In both groups, additional antihypertensive drug treatment other than ARBs or angiotensin converting enzyme inhibitors was used to reach the target blood pressure of less than 130/80 mm Hg. That goal was reached by 78% of the olmesartan group and 71% of the placebo group by 48 months, Dr. Hermann Haller reported at the annual meeting of the European Association for the Study of Diabetes.
The cumulative incidence of microalbuminuria, defined as excretion of more than 35 mg albumin/g urine creatinine for women and more than 25 mg albumin/g urine creatinine for men in morning spot urine, was 8.2% of the olmesartan patients vs. 9.8% of the placebo group, giving a highly significant risk reduction of 23%, said Dr. Haller of Hannover (Germany) Medical School.
Correction for the small differences in blood pressure between the two groups showed that the majority of the effect was blood pressure–independent, he said.
Overall cardiovascular morbidity and mortality rates were low and similar between the two groups, with just 4.3% of the olmesartan group and 4.2% of the placebo group experiencing any cardiovascular event or death. Total mortality occurred in 1.2% and 1.7%, respectively. Cardiovascular mortality, however, was higher in the olmesartan group (15 deaths vs. 3 deaths, or 0.7% vs. 0.1%), possibly because of hypotensive episodes among patients with preexisting cardiovascular disease.
There were no adverse effects of olmesartan on hard renal outcomes. An observational follow-up study is ongoing to further elucidate the long-term benefits of microalbuminuria prevention, Dr. Haller said.
The study was sponsored by Daiichi-Sankyo, which manufactures olmesartan under the name Benicar.
Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
斯德哥尔摩(EGMN)—— 一项纳入4,447例2型糖尿病患者的随机、安慰剂对照、双盲、多中心试验表明，血管紧张素受体阻滞剂(ARB)奥美沙坦可显著延迟患者出现微量白蛋白尿的时间。这项名为“随机奥美沙坦与糖尿病微量白蛋白尿预防(ROADMAP)”的试验研究了对于至少还存在另一种心血管危险因素但基线白蛋白排泄率正常的2型糖尿病患者，早期使用奥美沙坦是否能延迟微量白蛋白尿出现的时间，此研究由德国汉诺威医学院的Hermann Haller博士带领完成。
在该研究中，基线时患者的平均年龄58岁，糖尿病病程6年，体重指数为30 kg/m2，血红蛋白A1c 为7.6%。基线时的平均血压为137/80 mmHg，肾小球滤过率的平均估值为85 ml/(min·1.73 m2)。患者分别接受奥美沙坦40 mg或安慰剂，每日1次，服药的中位时间为3.2年。
两组患者都接受了除ARB或血管紧张素转换酶抑制剂以外的其他抗高血压药物治疗以达到目标血压<130/80 mmHg。第48个月，奥美沙坦组和安慰剂组分别有78%和71%的患者达到了这一目标血压。奥美沙坦组和安慰剂组微量白蛋白尿的累积发生率分别为8.2%和9.8%，风险减少了23%，具有非常显著的统计学意义。对两组患者血压上的细小差异进行校正后发现，大部分效应都属于非血压依赖性。两组患者总的心血管患病率和死亡率相似，都比较低，奥美沙坦组和安慰剂组出现了心血管事件或死亡的患者比例分别只有4.3%和4.2%，总死亡率分别为1.2%和1.7%。但奥美沙坦组的心血管病死率高于安慰剂组(15例对3例，或0.7% 对0.1%)。
奥美沙坦对主要肾脏结局并无任何不良影响。
该试验由奥美沙坦的生产商日本第一制药三共株式会社资助，奥美沙坦的商品名为Benicar。
爱思唯尔 版权所有
