Limited Sampling Strategy for Estimating Area under the Concentration Curve for Mycophenolic Acid in Renal Transplant Recipients with Co-administration of Tacrolimus.

Toda, Takaki; Watanabe, Hiroyuki; Kurosawa, Nahoko; Owada, Eiji; Achiwa, Kazuhito; Yuhki, Yoshimitsu; Tadano, Kohji; Harada, Hiroshi; Seki, Toshimori; Hirano, Tetsuo

doi:10.5649/jjphcs.30.1

Cited by 10 publications

(10 citation statements)

References 24 publications

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“…3 Although many LSSs for estimation of TAC exposure have been reported for the adult kidney transplant population, all existing LSSs for TAC 4-10 use a steroid-based protocol (as documented 4,6,7,9,10 or assumed 5,8 ) and/or involve other concomitant immunosuppressants besides MMF. 4,5,7,8 Similarly, all LSSs of MMF (for estimating mycophenolic acid [MPA] exposure) use a steroid-based protocol 10,[11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] and in only four of these studies are the patients on TAC and not cyclosporine. 10,11,24,25 To our knowledge, no published LSSs are available for TAC or MMF in adult renal transplant recipients on a steroid-free regimen.…”

Section: Introductionmentioning

confidence: 99%

“…4,5,7,8 Similarly, all LSSs of MMF (for estimating mycophenolic acid [MPA] exposure) use a steroid-based protocol 10,[11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] and in only four of these studies are the patients on TAC and not cyclosporine. 10,11,24,25 To our knowledge, no published LSSs are available for TAC or MMF in adult renal transplant recipients on a steroid-free regimen. It is unclear if these same equations (developed using a steroid-based protocol) could be applied to steroid-free protocols using TAC and MMF.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Development and Validation of Limited Sampling Strategies for Tacrolimus and Mycophenolate in Steroid-Free Renal Transplant Regimens

Poulin¹,

Greanya²,

Partovi³

et al. 2011

Therapeutic Drug Monitoring

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To the authors' knowledge, these LSSs are the first to be developed and validated in steroid-free renal transplant recipients and can be used to accurately predict TAC and MPA AUCs for steroid-free regimens. Because the commonly used MPA LSS is based on a steroid regimen and not predictive for steroid-free patients, the newly derived MPA LSS is being applied at the authors' institution. Other renal transplant centers may also wish to validate this equation in their own patients.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and Validation of Limited Sampling Strategies for Tacrolimus and Mycophenolate in Steroid-Free Renal Transplant Regimens

Poulin¹,

Greanya²,

Partovi³

et al. 2011

Therapeutic Drug Monitoring

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“…Regression lines were derived by the Deming regression method. Differences between the measured and estimated values of CCr were analyzed by using the following mean prediction error (ME%) and mean absolute prediction error (MAE%) indices:

\begin{matrix} lefttrue \\ ME (%) = \frac{1}{n} \sum_{i = 1}^{n} [\frac{predicted CCr ‐ CCr}{CCr} \times 100], \\ MAE (%) = \frac{1}{n} \sum_{i = 1}^{n} [\frac{(||, predicted CCr ‐ CCr)}{CCr} \times 100] . \end{matrix}

…”

Section: Methodsmentioning

confidence: 99%

Improvement of renal function estimation equations for elderly Japanese people

Kaburaki

Yoshimura

Kojima

et al. 2018

Health Science Reports

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Background and aimThe Cockcroft‐Gault (C‐G) equation for estimation of creatinine clearance (CCr) is still used in a clinical setting for drug dosage adjustment. Because differences between measured and estimated CCr values have been reported, particularly for Japanese elderly people, the aim of this study was to improve the accuracy of CCr estimation equations, such as C‐G and Orita‐Horio, by fitting to newly obtained data. Also, glomerular filtration rate (GFR) estimation equations, such as the Modification of Diet in Renal Disease (MDRD), the Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI), and the eGFR equation for Japanese people, were studied to compare with measured CCr.MethodData from 313 subjects over the age of 40 years with laboratory data available were used for analysis in this study. Special attention was paid to elderly people, and approximately 70% of the subjects were over the age of 65 years.ResultsThe accuracy of estimation by the two conventional (C‐G, Orita‐Horio) CCr estimation equations was greatly improved by introducing adjusted body weight for which the degree of obesity is over 30% instead of measured body weight. By fitting the coefficients of the estimation equations to the present population, the mean error was reduced by almost half, particularly for people over the age of 75. Although all the values calculated by the GFR estimation equations were underestimated compared with measured CCr due to secretion, a coefficient of determination of above 0.65 was obtained for all GFR estimation equations.ConclusionsImprovement of the fitted CCr estimation equations suggests that reconstruction of renal function estimation equations is required, especially for old people. Further work is required to find optimal renal function (CCr and/or GFR) estimation equations for drug dosage adjustment.

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“…Of these, nine articles presented 25 LSSs derived from patients cotreated with cyclosporine [29][30][31][32][33][34][35][36][37] and four articles presented 53 LSSs derived from patients cotreated with tacrolimus. [38][39][40][41] Patients and Data Collection Table 1 shows the baseline demographic and clinical characteristics of study participants. These were comparable to those of our overall transplant population (data not shown).…”

Section: Limited Sampling Strategiesmentioning

confidence: 99%

“…38-41 Pawinski et al 38 collected 50 MPA AUC 0-12 profiles from 21 renal transplant recipients at 1 to 2 weeks and at 3 months posttransplant. No mention was made of the race of participants or cotreatment with corticosteroids.The remaining three studies all involved Japanese kidney transplant recipients [39][40][41]. All were treated with MMF, tacrolimus, and corticosteroids, but across the studies, MPA…”

mentioning

confidence: 99%

Evaluation of Limited Sampling Strategies for Mycophenolic Acid After Mycophenolate Mofetil Intake in Adult Kidney Transplant Recipients

Barraclough

Isbel²,

Franklin³

et al. 2010

Therapeutic Drug Monitoring

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Multiple limited sampling strategies (LSSs) have been proposed for estimation of mycophenolic acid (MPA) area under the concentration-time curve from 0 to 12 hours postdose (AUC 0-12) after mycophenolate mofetil intake. The aim of this study was to provide summary information on all published LSSs for MPA and to evaluate their predictive performance in an independent population of kidney transplant recipients. Seventy-eight LSSs for MPA were identified. Sixty-nine full AUC profiles were collected from 45 subjects (25 cotreated with cyclosporine and 20 with tacrolimus). Predicted MPA AUC 0-12, calculated by applying the relevant concentration measurements within the LSS equations, was compared with full AUC calculated by using all concentration measurements in the linear trapezoidal rule. Four error indices (median prediction error, median percentage prediction error [MPPE], root median squared prediction error, and median absolute percentage prediction error [MAPE]) were used to evaluate bias and imprecision. Twelve of the 25 LSSs for cyclosporine-cotreated recipients and one of the 53 LSSs for tacrolimus-cotreated recipients displayed acceptable (less than 15%) bias and imprecision. In the cyclosporine group, two equations demonstrated the highest predictive power, one that used four time points in the first 6 hours postdose (r2 = 0.84, MPPE 1.6%, MAPE 7.8%) and one that used four time points in the first 4 hours postdose (r2 = 0.76, MPPE -0.8%, MAPE 10.2%). In the tacrolimus group, an equation that used two time points in the first 4 hours postdose was superior (r2 = 0.80, MPPE -3.0%, MAPE 13.6%). Application of the LSSs most appropriate for cyclosporine-cotreated patients to the tacrolimus-cotreated group resulted in clinically unacceptable bias and imprecision and vice versa. High variability in performance of LSSs highlights the importance of validating any LSS before applying it to an alternative population. Attention to comedication use is of particular relevance when choosing a LSS.

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Limited Sampling Strategy for Estimating Area under the Concentration Curve for Mycophenolic Acid in Renal Transplant Recipients with Co-administration of Tacrolimus.

Cited by 10 publications

References 24 publications

Development and Validation of Limited Sampling Strategies for Tacrolimus and Mycophenolate in Steroid-Free Renal Transplant Regimens

Development and Validation of Limited Sampling Strategies for Tacrolimus and Mycophenolate in Steroid-Free Renal Transplant Regimens

Improvement of renal function estimation equations for elderly Japanese people

Evaluation of Limited Sampling Strategies for Mycophenolic Acid After Mycophenolate Mofetil Intake in Adult Kidney Transplant Recipients

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