BACKGROUND & AIMS:
OBJECTIVE:The RED LEVEL study (REnal Disease: LErcanidipine Valuable Effect on urine protein Losses) directly compares, in an explorative fashion, the effects of lercanidipine + enalapril and amlodipine + enalapril combinations on renal parameters in hypertensive subjects.
RESEARCH DESIGN AND METHODS:This was a 1 year, prospective, multi-center, randomized, open-label, blinded-endpoint (PROBE) study in hypertensive patients with albuminuria.
MAIN OUTCOME MEASURES:Renal function (albuminuria, serum creatinine, creatinine clearance, estimated glomerular filtration rate and proteinuria); blood pressure.
RESULTS:Albuminuria was significantly reduced, compared with baseline values, with the lercanidipine + enalapril combination over the entire study period; at month 3, month 6 and month 12, changes from baseline were: -162.5 (p-value = 0.0439), -425.8 (p-value = 0.0010), -329.0 (p-value = 0.0011) mg/24 h), respectively. On the other hand, this improvement was not observed with enalapril + amlodipine. Other parameters of renal function such as serum creatinine, creatinine clearance, estimated glomerular filtration rate and proteinuria did not change over the study. Both lercanidipine + enalapril and amlodipine + enalapril significantly reduced systolic and diastolic blood pressure values from baseline all over the study period with no significant differences between groups. Safety outcomes were comparable between the two groups.
CONCLUSIONS:Overall, the results of this explorative study lend support to the anti-albuminuric effect of the lercanidipine + enalapril combination and to the long term renal-protective effects of this combination in patients with hypertension.
背景与目标:
目的:RED LEVEL研究(肾病:乐卡地平对尿蛋白损失的重要作用)以探索性方式直接比较了乐卡地平那拉普利和氨氯地平那拉普利组合对高血压受试者肾脏参数的影响。
研究设计与方法:这是一项针对高血压蛋白尿患者的为期1年的前瞻性,多中心,随机,开放标签,盲点(PROBE)研究。
主要观察指标:肾功能(白蛋白尿,血清肌酐,肌酐清除率,估计的肾小球滤过率和蛋白尿);血压。
结果:在整个研究期间,使用lercanidipine®enalapril联合用药,与基线值相比,白蛋白尿明显减少;在第3个月,第6个月和第12个月时,与基线相比的变化为:-162.5(p值== 0.0439),-425.8(p值= 0.0010),-329.0(p值= 0.0011)mg / 24 h,分别。另一方面,依那普利氨氯地平未观察到这种改善。在本研究中,其他肾功能参数,例如血清肌酐,肌酐清除率,估计的肾小球滤过率和蛋白尿均未改变。在整个研究期间,lercanidipine enalapril和amlodipine enalapril均较基线显着降低了收缩压和舒张压值,各组之间无显着差异。两组的安全性结果可比。
结论:总的来说,这项探索性研究的结果为乐卡地平那那普利组合的抗白蛋白尿作用以及该组合对高血压患者的长期肾脏保护作用提供了支持。