Department of Medical Endocrinology, Rigshospitalet, University of Copenhagen, Denmark.
J Renin Angiotensin Aldosterone Syst. 2012 Sep;13(3):387-93. doi: 10.1177/1470320311434818. Epub 2012 Feb 14.
Patients with type 2 diabetes are at enhanced risk for macro- and microvascular complications. Albuminuria and/or reduced kidney function further enhances the vascular risk. We initiated the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). Aliskiren, a novel direct renin inhibitor, which lowers plasma renin activity, may thereby provide greater cardio-renal protection compared with angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) alone.
ALTITUDE is a randomized, double-blind, placebo-controlled study in high risk type 2 diabetic patients receiving aliskiren 300 mg once daily or placebo added to recommended cardio-renal protective treatment including ACEi or ARB, but not both. The number of patients randomized was 8606.
Baseline characteristics (median, IQR) are: age 65 (58, 72) years, male 68%, BMI 29.1 (25.7, 32.2) kg/m(2), cardiovascular disease 47.9%, blood pressure 134.7 (126, 150)/74.3 (67, 81) mmHg, HbA(1c) 7.5 (6.6, 8.6)%, LDL-cholesterol 2.4 (1.9, 3.0) mmol/L, haemoglobin 130 (119, 143) g/L, serum creatinine 115 (91, 137) µmol/L, eGFR 51.7 (42, 65) ml/min per 1.73 m(2), geometric mean UACR 198.9 (52, 2886) mg/g and frequency of micro/macroalbuminuria 25.7% and 58.2%. ALTITUDE is an event-driven trial to continue until 1628 patients experience a primary cardiovascular-renal event.
ALTITUDE will determine the potential cardio-renal benefit and safety of aliskiren in combination with ACEi or ARB in high risk patients with type 2 diabetes.
2 型糖尿病患者发生大血管和微血管并发症的风险增加。白蛋白尿和/或肾功能下降进一步增加血管风险。我们启动了使用心血管-肾脏终点的阿利克仑 2 型糖尿病试验（ALTITUDE）。阿利克仑是一种新型直接肾素抑制剂，可降低血浆肾素活性，与单独使用血管紧张素转换酶抑制剂（ACEi）或血管紧张素受体阻滞剂（ARB）相比，可能提供更大的心脏肾脏保护作用。
ALTITUDE 是一项在高风险 2 型糖尿病患者中进行的随机、双盲、安慰剂对照研究，这些患者接受每日一次阿利克仑 300mg 或安慰剂治疗，同时加用推荐的心脏肾脏保护治疗，包括 ACEi 或 ARB，但不包括两者同时使用。随机患者人数为 8606 人。
基线特征（中位数，四分位距）为：年龄 65（58，72）岁，男性 68%，BMI 29.1（25.7，32.2）kg/m2，心血管疾病 47.9%，血压 134.7（126，150）/74.3（67，81）mmHg，HbA1c 7.5（6.6，8.6）%，LDL-胆固醇 2.4（1.9，3.0）mmol/L，血红蛋白 130（119，143）g/L，血清肌酐 115（91，137）µmol/L，eGFR 51.7（42，65）ml/min per 1.73 m2，几何均数 UACR 198.9（52，2886）mg/g，微量白蛋白尿和大量白蛋白尿的发生率分别为 25.7%和 58.2%。ALTITUDE 是一项事件驱动试验，将继续进行，直到 1628 例患者发生主要心血管-肾脏事件。
ALTITUDE 将确定阿利克仑与 ACEi 或 ARB 联合应用于 2 型糖尿病高危患者的心脏肾脏获益和安全性。
