Lemos Marcelo M, Watanabe Renato, Carvalho Aluízio B, Jancikic Alessandra D B, Sanches Fabiana M R, Christofalo Dejaldo M, Draibe Sérgio A, Canziani Maria Eugênia F
Department of Internal Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
Clin Nephrol. 2013 Jul;80(1):1-8. doi: 10.5414/CN107630.
Coronary artery calcification (CAC) is highly prevalent among chronic kidney disease (CKD) patients and its strong association with mortality has been recognized early in the course of CKD. The aim of the present study was to test the effect of rosuvastatin and sevelamer hydrochloride on the progression of CAC in nondialyzed CKD patients.
An open-label, randomized and controlled pilot study was conducted including 117 CKD patients (62% men, 56.9 ± 11.2 years, eGFR 36 ± 16.5 ml/min). Patients were randomly assigned to rosuvastatin (n = 38; 10 mg/day), to sevelamer hydrochloride (n = 38; 2,400 mg/day) and to control (n = 41) groups. CAC (by multislice computed tomography) and biochemical analyses were performed at baseline and after 24 months.
At baseline, CAC was observed in 55%, 58% and 61% of patients in the rosuvastatin, sevelamer hydrochloride and control groups, respectively (p = 0.87). Calcium score at baseline as well as its absolute and relative changes during 24 months were similar among the groups. Low density lipoprotein cholesterol (LDL-c) was higher and decreased significantly in the rosuvastatin group (p < 0.01). The analysis adjusting for LDL-c showed that the drug regimens were not associated with the progression of CAC (drug effect p = 0.85; time-effect p < 0.001; interaction p = 0.76).
Treatment with rosuvastatin and sevelamer hydrochloride may not delay the progression of CAC in non-dialysis dependent CKD patients.
冠状动脉钙化（CAC）在慢性肾脏病（CKD）患者中极为普遍，且在CKD病程早期就已认识到其与死亡率密切相关。本研究旨在测试瑞舒伐他汀和盐酸司维拉姆对未透析CKD患者CAC进展的影响。
进行了一项开放标签、随机对照的试点研究，纳入117例CKD患者（62%为男性，年龄56.9±11.2岁，估算肾小球滤过率[eGFR]为36±16.5ml/min）。患者被随机分为瑞舒伐他汀组（n = 38；每日10mg）、盐酸司维拉姆组（n = 38；每日2400mg）和对照组（n = 41）。在基线和24个月后进行CAC（通过多层计算机断层扫描）和生化分析。
基线时，瑞舒伐他汀组、盐酸司维拉姆组和对照组中分别有55%、58%和61%的患者观察到CAC（p = 0.87）。各组基线时的钙评分及其在24个月期间的绝对和相对变化相似。瑞舒伐他汀组的低密度脂蛋白胆固醇（LDL-c）较高且显著降低（p < 0.01）。调整LDL-c后的分析表明，药物治疗方案与CAC进展无关（药物效应p = 0.85；时间效应p < 0.001；交互作用p = 0.76）。
瑞舒伐他汀和盐酸司维拉姆治疗可能无法延缓非透析依赖CKD患者的CAC进展。
