Marre M, Lièvre M, Vasmant D, Gallois Y, Hadjadj S, Reglier J C, Chatellier G, Mann J, Viberti G C, Passa P
Service d'Endocrinologie, Diabétologie, Maladies Métaboliques, Hôpital Bichat, Paris, France.
Diabetes Care. 2000 Apr;23 Suppl 2:B40-8.
Whether ACE inhibition is useful for type 2 diabetic patients with micro- and macroalbuminuria remains unknown. The Non-Insulin-Dependent Diabetes, Hypertension, Microalbuminuria, Cardiovascular Events and Ramipril (DIABHYCAR) Study was set up to address this issue through a multicenter double-blind parallel placebo-controlled > or = 3-year trial in Europe and North Africa. In this article, we report the characteristics of the randomized patients.
The main selection criteria were as follows: men or women aged > or = 50 years with type 2 diabetes treated with oral antidiabetic drugs, with or without hypertension, with a plasma creatinine level < 150 mumol/l, and with persistent micro- or macroalbuminuria, as assessed centrally by two successive urine samples containing a urinary albumin concentration > or = 20 mg/l. Patient characteristics were studied by comparing patients who were randomized to those who were not, taking their geographical origin into account.
There were 25,455 patients screened for urinary albumin (20,296 from France, 918 from Germany, 1,019 from Northwest Europe, 969 from Central Europe, 959 from Mediterranean Europe, and 1,294 from North Africa). Of these patients, 4,937 were randomized. Compared with the nonrandomized patients, the randomized patients were older, more often men, more obese, had higher systolic/diastolic blood pressure and plasma glucose, smoked more tobacco, drank more alcohol, and had complications more frequently. Using a logistic regression analysis, all the above-mentioned items appeared as independent determinants for randomization into the study, with the exception of alcohol intake. The contribution of each item varied slightly from one geographical origin to another.
The physical, biological, and behavioral characteristics create a poor renal and cardiovascular prognosis for the type 2 diabetic patients randomized to the DIABHYCAR Study because of micro- and macroalbuminuria. Testing the usefulness of ACE inhibition for the type 2 diabetic patients with microalbuminuria seems feasible through the DIABHYCAR Study.
血管紧张素转换酶（ACE）抑制剂对伴有微量和大量蛋白尿的2型糖尿病患者是否有效尚不清楚。非胰岛素依赖型糖尿病、高血压、微量蛋白尿、心血管事件与雷米普利（DIABHYCAR）研究旨在通过在欧洲和北非进行的一项多中心双盲平行安慰剂对照的≥3年试验来解决这一问题。在本文中，我们报告了随机分组患者的特征。
主要入选标准如下：年龄≥50岁的2型糖尿病男性或女性，接受口服降糖药物治疗，有或无高血压，血浆肌酐水平<150μmol/l，且有持续性微量或大量蛋白尿，通过连续两次尿样中心评估，尿白蛋白浓度≥20mg/l。通过比较随机分组患者和未随机分组患者的特征，并考虑其地理来源进行研究。
共筛查了25455例尿白蛋白患者（法国20296例，德国918例，西北欧1019例，中欧969例，地中海欧洲959例，北非1294例）。其中，4937例患者被随机分组。与未随机分组的患者相比，随机分组的患者年龄更大，男性更多，更肥胖，收缩压/舒张压和血糖更高，吸烟更多，饮酒更多，并发症更频繁。使用逻辑回归分析，除饮酒量外，上述所有因素均为随机分组进入研究的独立决定因素。每个因素的影响在不同地理来源之间略有差异。
由于微量和大量蛋白尿，随机分组进入DIABHYCAR研究的2型糖尿病患者的身体、生物学和行为特征导致肾脏和心血管预后不良。通过DIABHYCAR研究检测ACE抑制剂对微量蛋白尿2型糖尿病患者的有效性似乎是可行的。
