Improved Adherence to Tacrolimus Once-Daily Formulation in Renal Recipients: A Randomized Controlled Trial Using Electronic Monitoring

被引:198
作者
Kuypers, Dirk R. J. [1 ]
Peeters, Patrick C. [2 ]
Sennesael, Jacques J. [3 ]
Kianda, Mireille N. [4 ]
Vrijens, Bernard [5 ,6 ]
Kristanto, Paulus [5 ]
Dobbels, Fabienne [7 ]
Vanrenterghem, Yves [1 ]
Kanaan, Nada [8 ]
机构
[1] Univ Hosp Leuven, Dept Nephrol & Renal Transplantat, Gasthuisberg, Belgium
[2] Ghent Univ Hosp, Dept Nephrol, Ghent, Belgium
[3] UZ Brussel, Dept Hypertens & Nephrol, Brussels, Belgium
[4] Univ Libre Brussels, Erasme Hosp, Dept Nephrol & Renal Transplantat, B-1050 Brussels, Belgium
[5] AARDEX Grp Ltd, Medicat Adherence Res Ctr, Vise, Belgium
[6] Univ Liege, Dept Biostat & Med Informat, Liege, Belgium
[7] Katholieke Univ Leuven, Ctr Hlth Serv & Nursing Res, Louvain, Belgium
[8] Clin Univ St Luc, Dept Nephrol, B-1200 Brussels, Belgium
关键词
Medical adherence; Tacrolimus; Regimen simplification; Electronic monitoring; Renal transplantation; KIDNEY-TRANSPLANT RECIPIENTS; MODIFIED-RELEASE TACROLIMUS; TWICE-DAILY PROGRAF; IMMUNOSUPPRESSANT THERAPY; DOSING HISTORIES; MEDICATION; REGIMEN; NONADHERENCE; ADVAGRAF; PHARMACOKINETICS;
D O I
10.1097/TP.0b013e3182725532
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. With effective agents available to prevent posttransplantation acute organ rejection, medication adherence becomes a key factor for successful treatment outcomes after renal transplantation. A once-daily, modified-release oral formulation of tacrolimus has been developed to simplify dosing and improve medication adherence. Methods. Adherence Measurement in Stable Renal Transplant Patients Following Conversion From Prograft to Advagraf is a randomized multicenter controlled trial to evaluate adherence between a tacrolimus once-daily regimen and a tacrolimus twice-daily regimen using an electronic monitor to document drug intake. After enrolment, all patients continued the twice-daily regimen for 3 months and then were randomized 2: 1 between the two formulations and followed for 6 months. Adherence was decomposed into patients' persistence and implementation of each regimen. Results. Two hundred nineteen patients (45% male; 3 +/- 2 years after transplantation) were analyzed (145 once daily and 74 twice daily). At 6 months after randomization, 81.5% of the once-daily group and 71.9% of the twice-daily group remained persistent with the treatment (P=0.0824). Among patients who remained engaged with the regimen, 88.2% of the once-daily group and 78.8% of the twice-daily group (P=0.0009) took the prescribed number of daily doses. When the patients took the twice-daily regimen, the average percentage of missed doses was 11.7% in the morning and 14.2% in the evening (P=0.0035). Conclusions. Regimen implementation of tacrolimus once daily is significantly superior to the twice-daily regimen. There was a residual prevalence of suboptimal adherence that will have to be countered by means other than reformulation and regimen simplification. Electronically compiled dosing histories provide detailed data on patient adherence that can be used for efficient medication management.
引用
收藏
页码:333 / 340
页数:8
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