Department of Endocrinology and Metabolism, University of Magdeburg, Magedeburg, Germany.
Clin Drug Investig. 2004;24(4):217-25. doi: 10.2165/00044011-200424040-00003.
This study aimed to assess the blood pressure-lowering potency, renoprotective efficacy and safety of the angiotensin II type 1 (AT(1))-receptor blocker irbesartan in monotherapy or in combination with hydrochlorothiazide or other antihypertensive medications in patients with type 2 diabetes mellitus switched from various antihypertensive pretreatments.
Multicentre, open, prospective, 6-month observational study in 38 016 patients at 9838 general practitioners' offices throughout Germany. Microalbuminuria in type 2 diabetics was measured with semiquantitative immunological Micral-II urine dipstick tests.
Proportion of patients with albuminuria at baseline and at 3 and 6 months. Analysis of adverse events.
The study population consisted of an equal number of males and females, mean body mass index was 28.4 kg/m(2), and mean glycosylated haemoglobin (HbA(1c)) was 7.2%. After the switch to irbesartan (in 86% of patients to the 300mg dosage in mono- or combination therapy), mean systolic/diastolic blood pressure was decreased by 23/12mm Hg. Irbesartan treatment over 6 months reduced the proportion of patients with microalbuminuria from 49.2 to 23.2% (relative reduction: 52.8%; p < 0.05) and the rate of patients with macroalbuminuria from 6.0 to 4.4% (relative reduction: 26.7%; p < 0.05). The renoprotective effect of irbesartan was consistent in various subgroups (analyses by sex, weight, diabetes duration, insulin treatment, strength of blood pressure-lowering effect, and antihypertensive pretreatment). Tolerability was excellent: 99.6% of patients remained free of any adverse events during the study.
The profound blood pressure-lowering and renoprotective effect of irbesartan in type 2 diabetes documented in clinical endpoint studies was confirmed in second-line therapy in a large sample of primary-care patients. Furthermore, in patients switched from previous ACE-inhibitor therapy, the renoprotective effect of irbesartan was of the same magnitude as in the total cohort.
本研究旨在评估血管紧张素Ⅱ型 1（AT（1））受体阻滞剂厄贝沙坦在单药治疗或与氢氯噻嗪或其他抗高血压药物联合治疗 2 型糖尿病患者中的降压效果、肾脏保护作用和安全性，这些患者是从各种抗高血压预处理中转换过来的。
在德国 9838 家普通诊所的 38016 名患者中进行了一项多中心、开放、前瞻性、6 个月的观察性研究。使用半定量免疫性 Micral-II 尿液试纸条检测 2 型糖尿病患者的微量白蛋白尿。
基线和 3 个月和 6 个月时蛋白尿患者的比例。分析不良反应。
研究人群中男性和女性人数相等，平均体重指数为 28.4kg/m2，平均糖化血红蛋白（HbA1c）为 7.2%。转换为厄贝沙坦（86%的患者在单药或联合治疗中使用 300mg 剂量）后，平均收缩压/舒张压降低了 23/12mmHg。厄贝沙坦治疗 6 个月后，蛋白尿患者的比例从 49.2%降至 23.2%（相对减少：52.8%；p<0.05），白蛋白尿患者的比例从 6.0%降至 4.4%（相对减少：26.7%；p<0.05）。厄贝沙坦的肾脏保护作用在各种亚组中是一致的（按性别、体重、糖尿病病程、胰岛素治疗、降压效果强度和抗高血压预处理进行分析）。耐受性极好：在研究期间，99.6%的患者没有发生任何不良反应。
在临床终点研究中证实的厄贝沙坦在 2 型糖尿病中的显著降压和肾脏保护作用在大量初级保健患者的二线治疗中得到了证实。此外，在从以前的 ACE 抑制剂治疗转换过来的患者中，厄贝沙坦的肾脏保护作用与总队列相同。
