Increased Adherence after Switch From Twice Daily Calcineurin Inhibitor Based Treatment to Once Daily Modified Released Tacrolimus in Heart Transplantation: A Pre-experimental Study
Increased Adherence after Switch From Twice Daily Calcineurin Inhibitor Based Treatment to Once Daily Modified Released Tacrolimus in Heart Transplantation: A Pre-experimental Study
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DOI：
10.1016/j.transproceed.2010.09.074
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发表时间：
2010-12-01
影响因子：
0.9
通讯作者：
Katus, H. A.
中科院分区：
文献类型：
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作者：
Doesch, A. O.;Mueller, S.;Katus, H. A.
背景。改良释放他克莫司 (TAC) 是现有免疫抑制剂 TAC 的一种新型每日一次口服制剂。治疗方案的简化与更好的依从性相关。本研究评估了慢性稳定性心脏移植 (HT) 患者从传统的每日两次基于钙调神经磷酸酶抑制剂的治疗方案（TAC 或环孢素 A [CsA]）改为（每日一次）改良释放 TAC 的患者依从性以及安全性和有效性。方法。我们将 54 名慢性稳定患者（41 名男性和 13 名女性）从每天两次服用传统 TAC 或 CsA 改为每天一次服用改良释放 TAC。使用巴塞尔免疫抑制药物依从性评估量表 [BAASIS]）在基线和转换后 4 个月对自我报告的依从性进行评估，这是一份包含 4 项验证的问卷，还包括视觉模拟量表 (VAS)。不遵守被定义为任何自我报告的不遵守任何项目。结果。 4 名患者因腹泻 (n = 1) 或胃肠道不适 (n = 3) 停用改良释放 TAC，留下 50 名患者可评估。 4 个月后，这 4 项中任何一项的基线总体不依从率为 74%，而 4 个月后为 38% (P = .0001)。此后，28 名患者 (56.0%) 的依从性有所改善，18 名患者 (36.0%) 的依从性没有变化，4 名患者 (8.0%) 的依从性下降。 VAS 评分从 82.3% +/- 2.6% 提高到 97.5% +/- 4.8% (P < .0001)。 4 个月后，在血液学、肾功能或肝功能参数方面未观察到显着变化（所有 P = NS）。结论。移植受者的治疗方案通常很复杂，导致药物不依从的发生率很高。这项针对慢性、稳定的心脏移植患者的研究表明，改用改良释放 TAC 后，患者的依从性显着改善，而且通常耐受性良好。
Background. Modified release tacrolimus (TAC) is a new, once-daily oral formulation of the established immunosuppressive agent TAC. Simplification of regimen has been associated with better adherence. This study evaluated patient adherence, as well as safety and efficacy among chronic stable heart transplantation (HT) patients switched from a conventional twice daily calcineurin inhibitor-based regimen (TAC or cyclosporine A [CsA]) to (once daily) modified release TAC.Methods. We switched 54 chronic stable patients (41 males and 13 females) from twice daily dosing with conventional TAC or CsA to once daily dosing with modified release TAC. Self-reported adherence was assessed at baseline and at 4 months after the switch using the Basel Assessment of Adherence with Immunosuppressive Medication Scale [BAASIS]), a 4-item validated questionnaire including also a Visual Analogue Scale (VAS). Nonadherence was defined as any self-reported nonadherence on any item.Results. Modified release TAC was discontinued in 4 patients because of diarrhea (n = 1) or gastrointestinal discomfort (n = 3) leaving 50 evaluable patients. Overall nonadherence at baseline for any of the 4 items was 74% versus 38% after 4 months (P = .0001). Thereafter, adherence improved in 28 patients (56.0%), was unchanged in 18 (36.0%), and decreased in 4 subjects (8.0%). The VAS score improved from 82.3% +/- 2.6% to 97.5% +/- 4.8% (P < .0001). No significant changes were observed after 4 months regarding hematologic, renal, or liver function parameters (all P = NS).Conclusions. Therapeutic regimens for transplant recipients are often complex, contributing to a high incidence of medication nonadherence. This study in chronic, stable, heart transplantation patients demonstrated a significant improvement in patient adherence after a switch to modified release TAC, which was generally well tolerated.