{"id":348,"date":"2022-06-24T10:22:23","date_gmt":"2022-06-24T02:22:23","guid":{"rendered":"https:\/\/www.transnovo.com\/?p=348"},"modified":"2023-06-02T14:38:31","modified_gmt":"2023-06-02T06:38:31","slug":"%e8%82%be%e7%a7%bb%e6%a4%8d%e5%8f%97%e8%80%85%e4%b8%ad%e4%bb%96%e5%85%8b%e8%8e%ab%e5%8f%b8%e5%b9%b3%e5%9d%a6%e5%b3%b0%e5%80%bc%e7%9a%84%e5%90%b8%e6%94%b6%e6%a8%a1%e5%bc%8f%e5%8f%8a%e7%9b%b8%e5%85%b3","status":"publish","type":"post","link":"https:\/\/transnovo.com\/en\/news\/%e8%82%be%e7%a7%bb%e6%a4%8d%e5%8f%97%e8%80%85%e4%b8%ad%e4%bb%96%e5%85%8b%e8%8e%ab%e5%8f%b8%e5%b9%b3%e5%9d%a6%e5%b3%b0%e5%80%bc%e7%9a%84%e5%90%b8%e6%94%b6%e6%a8%a1%e5%bc%8f%e5%8f%8a%e7%9b%b8%e5%85%b3\/","title":{"rendered":"Uptake patterns of peak tacrolimus pentamidine and associated pharmacogenomic variation in renal transplant recipients"},"content":{"rendered":"

Tacrolimus is the most commonly used immunosuppressive drug in solid organ transplantation. Tacrolimus has a narrow therapeutic window and high inter-patient bioavailability variability. Underdose increases the risk of rejection, while overdose is associated with drug toxicity.Therefore, therapeutic drug monitoring (TDM) must be performed postoperatively.<\/strong><\/p>\n

The area under the 24-hour drug-time curve (AUC0-24) provides a better picture of drug exposure than a single measurement; however, it is difficult to measure AUC0-24 in the clinical setting. currently, drug trough concentrations (C0) are used clinically as a marker of drug exposure.<\/p>\n

Initial absorption of tacrolimus was observed after the administration of the regular dose (twice-daily dose), with blood concentrations following the administration ofWithin 1.5-2 hours<\/strong>Peak levels were reached.However, some patients exhibit different patterns of initial absorption, the<\/strong>Tacrolimus blood levels in these patients 1-4 hours after dosing are similar to those before dosing. The drug-time profile will be different from that expected. These patients will have lower than expected tacrolimus exposure if the dose administered is guided by the drug trough concentration.<\/p>\n

Korean organ transplant surgeons have reported the first study of these patients with a unique initial tacrolimus uptake pattern. The results of the study were published in J Korean Med Sc<\/p>\n

\"\"<\/p>\n

This was a retrospective study in which 95 kidney transplant recipients were enrolled among 1268 patients who received kidney transplants from 2009 to 2017.Primarily, tacrolimus drug trough concentrations (C0) and 1.5-hour post-dose blood concentrations (C1.5) were measured in recipients within one year of transplantation.<\/strong>Thereafter, blood concentrations were collected every hour again and measured at 3 and 4 hours after dosing to verify that C1.5 values were peak. recipients with C1.5\/C0 1.5 were defined as the control group.<\/p>\n

\"\"<\/p>\n

Representative tacrolimus drug-time curves in two groups of recipients.(A) Flat peak group<\/strong>Tacrolimus blood levels 1-4 hours after administration were similar to those before administration.(B) Control group<\/strong>Peak tacrolimus blood levels are reached within the first 1.5-2 hours after administration.<\/p>\n

In this study, there were 28 cases in the flat-peak group and 67 cases in the control group. The mean C1.5\/C0 value was 1.13\u00b10.22 in the flat peak group and 3.78\u00b11.25 in the control group (P=0.002).<\/p>\n

\"\"<\/p>\n

Procedural biopsies were performed on recipients in both groups at 10 days and 1 year after transplantation. Among the biopsy-proven acute rejection reactions (BPAR) included both procedural and indicated biopsy findings. At 3 years post-transplant, the incidence of BPAR was higher in the flat-peak group than in the control group (42.9% vs. 23.9%), but did not reach statistical significance (P=0.080). The mean time interval between transplantation and BPAR diagnosis was 3.9\u00b15.0 (median 1, range 1-12) months in the flat-peak group and 5.2\u00b15.4 (median 3, range 1-12) months in the control group. The overall incidence of BPAR and\/or borderline changes was significantly higher in the flat-peak group (85.7% vs. 59.7%; P=0.007).<\/p>\n

To assess the relationship between the flat peak pattern of tacrolimus and BPAR and\/or borderline changes, a multivariate analysis was performed. The flat peak pattern was an independent risk factor for BPAR and\/or borderline changes (OR, 7.000; 95%CI, 1.489-32.897; P=0.014).<\/p>\n

\"\"<\/p>\n

The glomerular filtration rate (eGFR) was calculated using the MDRD formula. The mean eGFR was significantly higher in controls at 1 week, 3 months, 12 months and 36 months post-transplant. Recipients with a flat peak had a significantly lower estimated glomerular filtration rate at 36 months post-transplantation (P=0.001).<\/p>\n

To investigate the relationship between the flat peak pattern of tacrolimus and eGFR at 36 months post-transplantation, univariate and multifactorial linear regression analyses were performed. In the univariate analysis, peak flattening was associated with a decrease in eGFR at 36 months post-transplantation. However, in multivariate analysis, this association was not significant.<\/p>\n

The study also focused on associated pharmacogenomic variants. Among 28 SNVs in CYP3A4, CYP3A5 and ABCB1 genes, 2 SNVs were found to be significantly associated with the flat peak pattern. rs1922242 and rs2235035 in ABCB1 gene, were significantly associated with the flat peak pattern (adjusted P 0.019 and 0.027, respectively).<\/p>\n

Recipient age, sex, weight, history of diabetes, and donor type were included in multivariate analysis. In multivariate logistic regression models, the flat peak pattern and SNVs in the ABCB1 gene remained significantly correlated.<\/p>\n

The ABCB1 rs1922242TT genotype was significantly more common in the flat peak group (OR, 1.508; 95%CI, 1.184-1.922; adjusted P=0.001).<\/p>\n

\"\"<\/p>\n

The ABCB1 rs2235035AA genotype was significantly more common in the flat peak group (OR, 1.434; 95%CI, 1.132-1.817; adjusted P=for 0.004).<\/p>\n

\"\"<\/p>\n

Logistic regression analysis was performed to investigate the interaction between the 2 SNVs and clinical variables. the coefficient of interaction between the 2 SNVs was statistically significant (OR, 2.698; 95%CI, 1.055-6.902; P=0.041).<\/p>\n

\"\"<\/p>\n

This study is the first to report on recipients with a unique initial absorption pattern of tacrolimus. They did not exhibit a significant peak in the early absorption phase. For patients with a flat peak, the drug-time curve will be different than expected. If tacrolimus dosing is guided based on trough concentrations, total tacrolimus exposure will be lower than predicted, which may increase the risk of acute rejection.<\/p>\n

For tacrolimus blood concentration monitoring, C0 is widely used clinically. however, simultaneous measurement of C1.5 and C0 is important to differentiate between recipients with unique initial absorption patterns. a C1.5\/C0 ratio below 1.5 is associated with an increased risk of BPAR and\/or borderline changes.<\/p>\n

In addition, the role of CYP3A and ABCB1 polymorphisms in patients with a flat peak pattern deserves further investigation.<\/p>\n

\"\"<\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

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