Yazbek Daniel Constantino, de Carvalho Aluizio Barbosa, Barros Cinara Sá, Medina Pestana Jose Osmar, Canziani Maria Eugênia F
Nephrology Division, Federal University of São Paulo, São Paulo, SP, Brazil.
PLoS One. 2016 Apr 21;11(4):e0151797. doi: 10.1371/journal.pone.0151797. eCollection 2016.
Coronary calcification (CAC) is highly prevalent in kidney transplant recipients (KTRs) and has been associated with cardiovascular morbidity and mortality. Some studies have shown a reduction in CAC progression with statin therapy in the general and chronic kidney disease (CKD) populations.
The aim of the present study was to evaluate the effect of statins on CAC progression in incident kidney transplant recipients. Patients were randomly assigned to the statin (n = 61, 10 mg daily) and control group (n = 59). CAC and biochemical analyses were performed at baseline and 12 months.
At baseline, CAC was observed in 30% and 21% of patients in the statin and control groups, respectively (p = 0.39). The calcium score at baseline and its absolute and relative changes over 12 months of follow up were similar among the groups. In the statin group, total cholesterol (p < 0.001), low density lipoprotein cholesterol (p < 0.001) and triglycerides (p = 0.005) decreased, and the estimated glomerular function rate increased (p<0.001) significantly. CRP levels remained stable (p = 0.52) in the statin group but increased in the control group (p = 0.01). In the multivariate model, there was no difference in CAC progression between the groups (group effect p = 0.034; time-effect p = 0.23; interaction p = 0.74). Similar results were obtained when only patients with ≥ 10AU calcium score (calcified) were analyzed (group effect p = 0.051; time-effect p = 0.58; interaction p = 0.99).
Although statins reduce the levels of cholesterol, triglycerides, inflammation and improve graft function, the dose adopted in the current study did not delay CAC progression within 12 months of follow up.
Brazilian Clinical Trials Registry RBR-32RFMB.
冠状动脉钙化(CAC)在肾移植受者(KTRs)中非常普遍,并且与心血管疾病的发病率和死亡率相关。一些研究表明,在普通人群和慢性肾脏病(CKD)人群中,他汀类药物治疗可使CAC进展减缓。
本研究的目的是评估他汀类药物对初发肾移植受者CAC进展的影响。患者被随机分为他汀类药物组(n = 61,每日10 mg)和对照组(n = 59)。在基线和12个月时进行CAC和生化分析。
在基线时,他汀类药物组和对照组分别有30%和21%的患者观察到CAC(p = 0.39)。各治疗组间基线时的钙评分及其在12个月随访期间的绝对和相对变化相似。在他汀类药物组中,总胆固醇(p < 0.001)、低密度脂蛋白胆固醇(p < 0.001)和甘油三酯(p = 0.005)降低,估计肾小球滤过率显著升高(p<0.001)。他汀类药物组的CRP水平保持稳定(p = 0.52),而对照组则升高(p = 0.01)。在多变量模型中,两组间CAC进展无差异(组效应p = 0.034;时间效应p = 0.23;交互作用p = 0.74)。仅分析钙评分≥10AU(钙化)的患者时,也获得了类似结果(组效应p = 0.051;时间效应p = 0.58;交互作用p = 0.99)。
尽管他汀类药物可降低胆固醇、甘油三酯水平,减轻炎症并改善移植肾功能,但本研究采用的剂量在12个月随访期内并未延缓CAC进展。
巴西临床试验注册中心RBR-32RFMB。