Renders L, Mayer-Kadner I, Koch C, Schärffe S, Burkhardt K, Veelken R, Schmieder R E, Hauser I A
Medizinische Klinik IV, University of Erlangen-Nürnberg, Erlangen, Germany.
Nephrol Dial Transplant. 2001 Jan;16(1):141-6. doi: 10.1093/ndt/16.1.141.
Hyperlipidaemia is an important risk factor for cardiovascular disease in renal transplant recipients. The aim of this study was to test the efficacy and possible drug-drug interactions of the new HMG-CoA reductase inhibitors (statins) atorvastatin and cerivastatin in cyclosporin A (CsA)-treated renal transplant patients. Subjects and methods. Thirty patients with stable graft function and LDL cholesterol of 130 mg/dl were randomly assigned to active treatment groups (10 mg atorvastatin or 0.2 mg cerivastatin), or a control group. CsA blood trough levels were controlled on a weekly basis and adapted if they changed more than 25% from baseline values (100-150 ng/ml). Lipid levels and routine laboratory parameters before and after a treatment period of 3 months were compared.
In the group treated with cerivastatin no significant changes in CsA blood trough levels occurred (CsA 116+/-21 ng/ml vs 110+/-20 ng/ml). In contrast, in the group treated with atorvastatin, four of 10 patients had a rise in CsA blood trough levels of more than 25% within 7-14 days of starting therapy. In the remaining patients no significant changes in CsA drug levels occurred. After therapy with atorvastatin or cerivastatin, total cholesterol, LDL cholesterol, and triglycerides were significantly lower compared with baseline conditions. No changes of CsA or lipoprotein levels were present in the control group.
In our study population both statins were very effective in lowering elevated LDL cholesterol levels. Cerivastatin did not influence CsA blood trough levels, whereas atorvastatin increased CsA levels in four of 10 patients. Further research in a larger study is necessary in order to confirm these results and to investigate the possible reasons for this drug interaction.
高脂血症是肾移植受者心血管疾病的重要危险因素。本研究旨在测试新型HMG-CoA还原酶抑制剂（他汀类药物）阿托伐他汀和西立伐他汀在接受环孢素A（CsA）治疗的肾移植患者中的疗效及可能的药物相互作用。
受试者与方法。30例移植肾功能稳定且低密度脂蛋白胆固醇水平为130mg/dl的患者被随机分为活性治疗组（10mg阿托伐他汀或0.2mg西立伐他汀）或对照组。每周监测CsA血药谷浓度，若其较基线值（100 - 150ng/ml）变化超过25%则进行调整。比较3个月治疗期前后的血脂水平和常规实验室参数。
接受西立伐他汀治疗的组中，CsA血药谷浓度无显著变化（CsA 116±21ng/ml对110±20ng/ml）。相比之下，接受阿托伐他汀治疗的组中，10例患者中有4例在开始治疗的7 - 14天内CsA血药谷浓度升高超过25%。其余患者的CsA药物水平无显著变化。阿托伐他汀或西立伐他汀治疗后，总胆固醇、低密度脂蛋白胆固醇和甘油三酯水平与基线相比显著降低。对照组的CsA或脂蛋白水平无变化。
在我们的研究人群中，两种他汀类药物在降低升高的低密度脂蛋白胆固醇水平方面都非常有效。西立伐他汀不影响CsA血药谷浓度，而阿托伐他汀使10例患者中的4例CsA水平升高。有必要进行更大规模的进一步研究以证实这些结果并调查这种药物相互作用的可能原因。
