ArticleAnnals of transplantation2019
Pharmacokinetic Profile of Prolonged-Release Tacrolimus When Administered via Nasogastric Tube in De Novo Liver Transplantation: A Sub-Study of the DIAMOND Trial.
Article in Annals of transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Pharmacokinetics of Different Tacrolimus Formulations in the Early Post-Liver Transplant Period: A Scoping Review.Pharmaceutics · 2025Review
- Low Bioavailability of Oral Tacrolimus Suspension in Pediatric Kidney Transplant Patients.Clinical pharmacokinetics · 2020Article
- A Machine Learning-Based Identification of Genes Affecting the Pharmacokinetics of Tacrolimus Using the DMETInternational journal of molecular sciences · 2020Article
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Authors and funding
4 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND For patients unable to swallow during the immediate post-transplant period, immunosuppressant therapy may be initiated by administering prolonged-release tacrolimus as a suspension via a nasogastric tube. MATERIAL AND METHODS In this sub-study of the DIAMOND randomized controlled trial of prolonged-release tacrolimus in de novo liver transplant recipients, we investigated the pharmacokinetic (PK) profile of prolonged-release tacrolimus when administered via nasogastric tube immediately post-transplant. PK analyses were performed on whole-blood samples collected on Day 1 of tacrolimus administration and on Day 3 post-transplantation. Endpoints included AUC0-24, Cmax, Tmax, and Cmin. RESULTS In total, 10 patients were included in the PK sub-study. The overall mean daily dose of prolonged-release tacrolimus administered via nasogastric tube was higher on Day 1 (0.179 mg/kg) vs. Day 3 (0.140 mg/kg). Mean AUC0-24 was higher and less variable on Day 3 vs. Day 1 (AUC0-24 (coefficient of variation; CV): 301 (50.8) vs. 193 (94.5) ng·h/mL). Mean Cmax was lower and median Tmax was shorter on Day 1 vs. Day 3 (Cmax (CV): 15.1 (73.9) vs. 19.1 (47.9) ng/mL; Tmax (range): 2.0 (2.0-24.0) vs. 4.5 (0.5-24.0) h). A similar pattern was also observed when data were normalized for dose and body weight. CONCLUSIONS In contrast to previously reported findings in healthy volunteers, nasogastric administration of prolonged--release tacrolimus suspension in liver transplant patients did not substantially affect the PK profile of tacrolimus vs. intact capsules. Nasogastric administration is thus a feasible option to ensure appropriate early tacrolimus exposure in de novo liver transplant recipients.
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