TRough versus AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in adult allogeneic stem cell recipients (TRAM study)

Kuijvenhoven, Marianne; Wilhelm, Abraham J.; Meijer, Ellen; Janssen, Jeroen; Swart, Eleonora L.

doi:10.1111/ejh.13674

Cited by 3 publications

(1 citation statement)

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“…For this purpose, professional work groups involved in different analytic and evaluating phases of the TDM procedures have regularly aimed at providing guidelines for improved immunosuppression, such as the report of the European consensus conference in 2009 on opportunities to optimize tacrolimus therapy in solid organ transplantation [ 20 ], the Second Consensus Report Therapeutic Drug Monitoring of Tacrolimus-Personalized Therapy, recommendations of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) on the therapeutic drug monitoring of tacrolimus [ 21 ]. In the search for optimal target TDM levels, the TRAM study found no difference In CsA-induced toxicity with the area under the curve (AUC)-based TDM versus the trough-based TDM, although target values were achieved earlier and maintained more consistently in the AUC group [ 22 ]. In addition, inter- and intrapatient variabilities in pharmacokinetics (PK) have been quantified for population PK models to be used to predict the optimal dose of a drug in an individual patient.…”

Section: Discussionmentioning

confidence: 99%

A Drug Safety Concept (I) to Avoid Polypharmacy Risks in Transplantation by Individual Pharmacotherapy Management in Therapeutic Drug Monitoring of Immunosuppressants

Wolf

2023

Pharmaceutics

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For several, also vital medications, such as immunosuppressants in solid organ and hematopoietic stem cell transplantation, therapeutic drug monitoring (TDM) remains the only strategy for fine-tuning the dosage to the individual patient. Especially in severe clinical complications, the intraindividual condition of the patient changes abruptly, and in addition, drug-drug interactions (DDIs) can significantly impact exposure, due to concomitant medication alterations. Therefore, a single TDM value can hardly be the sole basis for optimal timely dose adjustment. Moreover, every intraindividually varying situation that affects the drug exposure needs synoptic consideration for the earliest adjustment. To place the TDM value in the context of the patient’s most detailed current condition and concomitant medications, the Individual Pharmacotherapy Management (IPM) was implemented in the posttransplant TDM of calcineurin inhibitors assessed by the in-house laboratory. The first strategic pillar are the defined patient scores from the electronic patient record. In this synopsis, the Summaries of Product Characteristics (SmPCs) of each drug from the updated medication list are reconciled for contraindication, dosing, adverse drug reactions (ADRs), and DDIs, accounting for defined medication scores as a second pillar. In parallel, IPM documents the resulting review of each TDM value chronologically in a separate electronic Excel file throughout each patient’s transplant course. This longitudinal overview provides a further source of information at a glance. Thus, the applied two-arm concept of TDM and IPM ensures an individually tailored immunosuppression in the severely susceptible early phase of transplantation through digital interdisciplinary networking, with instructive and educative recommendations to the attending physicians in real-time. This concept of contextualizing a TDM value to the precise patient’s condition and comedication was established at Halle University Hospital to ensure patient, graft, and drug safety.

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Section: Discussionmentioning

confidence: 99%