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Bioequivalence of twice-daily oral tacrolimus in transplant recipients: More evidence for consensus?


In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.


Vyšlo v časopise: Bioequivalence of twice-daily oral tacrolimus in transplant recipients: More evidence for consensus?. PLoS Med 14(11): e32767. doi:10.1371/journal.pmed.1002429
Kategorie: Perspective
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002429

Souhrn

In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.


Zdroje

1. Evans RW, Applegate WH, Briscoe DM, Cohen DJ, Rorick CC, Murphy BT, et al. Cost-Related Immunosuppressive Medication Nonadherence Among Kidney Transplant Recipients. Clinical Journal of the American Society of Nephrology. 2010;5(12):2323–8. doi: 10.2215/CJN.04220510 20847093

2. White SL, Chadban SJ, Jan S, Chapman JR, Cass A. How can we achieve global equity in provision of renal replacement therapy? Bull World Health Organ. 2008;86(3):229–37. doi: 10.2471/BLT.07.041715 18368211.

3. Alloway RR, Vinks AA, Fukuda T, Mizuno T, King EC, Zou Y, et al. Bioequivalence between brand and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial. PLoS Med. 2017;14(11):e1002428. https://doi.org/10.1371/journal.pmed.1002428

4. Ekberg H, Tedesco-Silva H, Demirbas A, Vítko Š, Nashan B, Gürkan A, et al. Reduced Exposure to Calcineurin Inhibitors in Renal Transplantation. N Engl J Med. 2007;357(25):2562–75. doi: 10.1056/NEJMoa067411 18094377.

5. Vanhove T, Vermeulen T, Annaert P, Lerut E, Kuypers DRJ. High Intrapatient Variability of Tacrolimus Concentrations Predicts Accelerated Progression of Chronic Histologic Lesions in Renal Recipients. Am J Transplant. 2016;16(10):2954–63. doi: 10.1111/ajt.13803 27013142.

6. Hsiau M, Fernandez HE, Gjertson D, Ettenger RB, Tsai EW. Monitoring nonadherence and acute rejection with variation in blood immunosuppressant levels in pediatric renal transplantation. Transplantation. 2011;92(8):918–22. doi: 10.1097/TP.0b013e31822dc34f 21857278.

7. Molnar AO, Fergusson D, Tsampalieros AK, Bennett A, Fergusson N, Ramsay T, et al. Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis. BMJ. 2015;350. doi: 10.1136/bmj.h3163 26101226

8. van Gelder T. European Society for Organ Transplantation Advisory Committee Recommendations on Generic Substitution of Immunosuppressive Drugs. Transplant International. 2011;24(12):1135–41. doi: 10.1111/j.1432-2277.2011.01378.x 22032583

9. Taber DJ, Su Z, Fleming JN, McGillicuddy JW, Posadas-Salas MA, Treiber FA, et al. Tacrolimus Trough Concentration Variability and Disparities in African American Kidney Transplantation. Transplantation. 9000; Online First. doi: 10.1097/tp.0000000000001840 28658199

10. Nunes V, Neilson J, N O’Flynn N, Calvert N, Kuntze S, Smithson H, et al. Clinical Guidelines and Evidence Review for Medicines Adherence: Involving Patients in Decisions About Prescribed Medicines and Supporting Adherence. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners; 2009.

11. Siefried KJ, Mao L, Kerr S, Cysique LA, Gates TM, McAllister J, et al. Socioeconomic factors explain suboptimal adherence to antiretroviral therapy among HIV-infected Australian adults with viral suppression. PLoS ONE. 2017;12(4):e0174613. doi: 10.1371/journal.pone.0174613 28369066.

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Interné lekárstvo

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PLOS Medicine


2017 Číslo 11
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