安博维PRIME引领成功之路-培训课件.ppt

* Slide 11: RENAAL入选患者按地区划分 RENAAL研究是一项真正的国际性研究，因为其患者样本来自北美(46%)、欧洲(19%)、拉丁美洲(18%)以及亚洲(17%)。 * Slide 14: RENAAL首要综合终点的组成 这张幻灯片显示了对首要综合终点的各组成部分的Kaplan-Meier 曲线。血清肌酐加倍和终末期肾病(ESRD)都是重要的肾脏终点。 一天一次氯沙坦+常规治疗显著降低发展至血清肌酐加倍的危险性(25%；p=0.006)以及ESRD的危险性(28%；p=0.002)。2 ESRD或死亡的综合终点的危险性也有显著降低(20%;p=0.010)。氯沙坦+常规治疗未使单纯死亡的危险性有显著性下降。 2 * * * Slide 23: RENAAL 蛋白尿自基线的改变 RENAAL研究一项关键的入选标准是蛋白尿水平。在研究中使用晨尿标本，蛋白尿定义为尿白蛋白：肌酐比率。这张幻灯片显示氯沙坦+常规治疗组减少2型糖尿病患者蛋白尿的明显效果。在安慰剂+常规治疗组，蛋白尿没有下降。相反，氯沙坦每天一次在整个研究期间明显减少蛋白尿。下降程度为36个月时大约减少40%。氯沙坦+常规治疗组使蛋白尿平均下降35%(p0.001 vs 安慰剂+常规治疗)。2 * Slide 29: RENAAL结论 * Results from RENAAL are supportive of those from IDNT, with similar renoprotective and cardiovascular effects. Only the PRIME program with irbesartan evaluates morbidity and/or mortality in patients with type 2 diabetes across the continuum of early and late stages of diabetic renal disease. The positive results from both IDNT1 and RENAAL2 help define the role of angiotensin II receptor antagonists in the management of patients with type 2 diabetes and late-stage renal disease. The primary endpoint of both trials are positive, demonstrating that irbesartan and losartan successfully reduced the risk of progression of late-stage type 2 diabetic renal disease. The irbesartan group in IDNT demonstrates a 20% RRR vs. the control group for the primary endpoint of doubling of serum creatinine, development of end-stage renal disease, or death from any cause (p=0.02), and a 23% RRR vs. the amlodipine group (p=0.006). The losartan group in RENAAL demonstrates a 16% RRR vs. the control group for an identical primary endpoint (p=0.02). There was no significant difference among the three treatment groups in IDNT for the secondary cardiovascular endpoint, suggesting that irbesartan provides similar cardiovascular protection as seen with other commonly used antihypertensive agents. Similarly, there was no significant difference between the losartan and control groups in RENAAL for a similar cardiovascular secondar