HMG-CoA还原酶抑制剂对终末期糖尿病肾病2型糖尿病患者生存率的影响。

Effect of HMG-CoA-reductase inhibitors on survival in type 2 diabetes patients with end stage diabetic nephropathy.

作者信息

Götz A K, Böger C A, Hirschmann C, Schmitz G, Riegger G A J, Krämer B K

机构信息

Klinik und Poliklinik für Innere Medizin II, University of Regensburg, Franz-Josef-Strauss-Allee 11, D-93053 Regensburg, Germany.

出版信息

Eur J Med Res. 2005 Apr 20;10(4):155-60.

PMID:15946911

Abstract

INTRODUCTION

We studied the effect of HMG-CoA-reductase inhibitor (= CSE-I) treatment on mortality in a population of hemodialysis patients with diabetic nephropathy due to type 2 diabetes. Since the efficacy of CSE-I in dialysis patients is discussed controversially, we tested the hypothesis that only patients with LDL-cholesterol > 100 mg/dl benefit from CSE-I.

METHODS

We enrolled all 445 prevalent chronic hemodialysis patients with end-stage diabetic nephropathy from 30 centres in Southern Germany from August 1999 to January 2000 for prospective study until December 2003. Fasting lipid profiles prior to dialysis session and a complete clinical phenotype were determined at inclusion. We formed 2 patient groups (serum LDL > vs. < or = 100 mg/dl). Only CSE-I were used as lipid lowering therapy in our cohort. 122 Patients were on CSE-I therapy during the study. All cause mortality (ACM) was the primary end point. Survival analysis was performed by Kaplan Meier and multivariate Cox regression analysis.

RESULTS

Multivariate regression analysis and Kaplan Meier survival analysis showed a decrease in risk for ACM for patients on CSE-I therapy, irrespective of lipid status (multivariate hazard ratio (= HR) 0.58; p = 0.049; ACM 72.1% (no CSE-I) vs. 59.7% (+ CSE-I); mean survival 2.37 +/- 0.08 years (no CSE-I) vs. 2.77 +/- 0.12 years (+ CSE-I), p = 0.003). In patients with LDL > 100 mg/dl, statin treatment was also associated with reduced ACM: 48.0% (+ CSE-I) vs. 70.1% (no CSE-I), (multivariate HR 0.28, CI 95% 0.11 - 0.75, p = 0.01), but not in patients with LDL < or = 100 mg/dl (HR 0.84, CI 95% 0.41 - 1.72 p = 0.63).

CONCLUSION

Our data indicates that hemodialysis patients with type 2 diabetic nephropathy may benefit from statin therapy irrespective of baseline LDL-cholesterol level. Patients with LDL > 100 mg/dl benefit most when treated with CSE-I.

摘要

引言

我们研究了HMG-CoA还原酶抑制剂（= CSE-I）治疗对2型糖尿病所致糖尿病肾病血液透析患者死亡率的影响。由于CSE-I在透析患者中的疗效存在争议，我们检验了仅低密度脂蛋白胆固醇（LDL）> 100 mg/dl的患者能从CSE-I治疗中获益的假设。

方法

我们纳入了1999年8月至2000年1月期间来自德国南部30个中心的所有445例患有终末期糖尿病肾病的慢性血液透析患者进行前瞻性研究，直至2003年12月。在纳入研究时测定透析前的空腹血脂谱和完整的临床表型。我们将患者分为两组（血清LDL > 与≤ 100 mg/dl）。在我们的队列中仅使用CSE-I作为降脂治疗。122例患者在研究期间接受CSE-I治疗。全因死亡率（ACM）是主要终点。采用Kaplan-Meier法和多变量Cox回归分析进行生存分析。

结果

多变量回归分析和Kaplan-Meier生存分析显示，接受CSE-I治疗的患者ACM风险降低，与血脂状态无关（多变量风险比（= HR）0.58；p = 0.049；ACM：未接受CSE-I治疗组为72.1%，接受CSE-I治疗组为59.7%；平均生存期：未接受CSE-I治疗组为2.37 ± 0.08年，接受CSE-I治疗组为2.77 ± 0.12年，p = 0.003）。在LDL > 100 mg/dl的患者中，他汀类药物治疗也与ACM降低相关：接受CSE-I治疗组为48.0%，未接受CSE-I治疗组为70.1%（多变量HR 0.28，95%置信区间0.11 - 0.75，p = 0.01），但在LDL≤ 100 mg/dl的患者中无此关联（HR 0.84，95%置信区间0.41 - 1.72，p = 0.63）。