Leino Abbie D, Abuls Karlis M, Rodgers John Killian L, Kuntz Kristin K
Department of Pharmacy, The Ohio State Wexner Medical Center, Columbus, Ohio.
College of Pharmacy, 2647The Ohio State University, Columbus, Ohio.
Prog Transplant. 2022 Mar 25:15269248221087440. doi: 10.1177/15269248221087440.
High tacrolimus intrapatient variability is associated with poor outcomes following transplantation. A commonly hypothesized cause of this variability is medication non-adherence, but this has not been conclusively demonstrated. The purpose of this study was to evaluate the relationship between medication adherence and tacrolimus intrapatient variability. This was a retrospective cohort study of kidney transplant recipients. Adherence was assessed at the 12-month clinic visit as a composite of patient self-report, pharmacist assessment, and lab monitoring frequency. Tacrolimus intrapatient variability was calculated as the coefficient of variation (CV). Linear regression and receiver operating curve (ROC) analysis were used to assess the relationship between adherence and CV. Nonadherence was identified in 37.5% of patients. The median CV was 27.1% for adherent patients and 29.8% for non-adherent patients ( = 0.051). In the multivariable analysis, the only significant predictor of CV was the incidence of dose changes ( = 0.002). ROC analysis demonstrated poor discriminant power with an AUC of 0.597. The results fail to support a clinically meaningful relationship between medication adherence and tacrolimus CV. There is very little evidence at this time that adherence is the primary contributing factor to tacrolimus intrapatient variability and, by extension, that CV can be used as a surrogate for adherence.
他克莫司患者体内高变异性与移植后不良预后相关。这种变异性的一个常见假设原因是药物治疗依从性差,但尚未得到确凿证实。本研究的目的是评估药物治疗依从性与他克莫司患者体内变异性之间的关系。这是一项针对肾移植受者的回顾性队列研究。在12个月的门诊就诊时,将患者自我报告、药剂师评估和实验室监测频率综合起来评估依从性。他克莫司患者体内变异性计算为变异系数(CV)。采用线性回归和受试者工作特征曲线(ROC)分析来评估依从性与CV之间的关系。37.5%的患者被确定为不依从。依从性患者的CV中位数为27.1%,不依从患者为29.8%(P = 0.051)。在多变量分析中,CV的唯一显著预测因素是剂量变化的发生率(P = 0.002)。ROC分析显示判别能力较差,曲线下面积(AUC)为0.597。结果不支持药物治疗依从性与他克莫司CV之间存在具有临床意义的关系。目前几乎没有证据表明依从性是他克莫司患者体内变异性的主要促成因素,因此,CV不能用作依从性的替代指标。