De Novo Kidney Transplant Recipients Need Higher Doses of Advagraf Compared With Prograf to Get Therapeutic Levels

Crespo, Marta; Mir, Marisa; Marin, M. Romeo; Hurtado, Sara; Estadella, C.; Guri, X.; Rap, Oana; Moral, R. Del; Puig, Josep; Lloveras, J

doi:10.1016/j.transproceed.2009.05.014

Cited by 72 publications

(52 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These findings are consistent with other observational studies. [4][5][6] It seems that a higher dosage of tacrolimus is required to achieve the same tacrolimus level as baseline. However, in stable transplant recipients, as the tacrolimus target trough levels are kept between 4 and 6 ng/mL, dosage modifications are usually not necessary or are minor.…”

Section: Discussionmentioning

confidence: 99%

“…9 Trials are summarized in Table 4. [4][5][6][7][8][9][10][11] We were one of the first transplant centers in Canada to switch twice-daily to OD ER tacrolimus in stable kidney transplants who had been followed-up for 2 years. Despite the observational nature of our study and the absence of a control group, we demonstrated that conversion to ER tacrolimus was safe and convenient in one-third of kidney transplant recipients.…”

Section: Discussionmentioning

confidence: 99%

“…These observations are similar to previous published studies. [4][5][6][7][8][9][10][11] We usually do not use ER tacrolimus as induction in de novo kidney transplants as the dosage of tacrolimus is easier to adjust with the twice-daily formulation. However, OD tacrolimus can be useful in patients in whom we want to decrease the initial exposure to calcineurin inhibitors (eg, severe acute tubular necrosis).…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Untitled

Tran

Vallée²,

Collette³

et al. 2014

Exp Clin Transplant

View full text Add to dashboard Cite

Objectives: Tacrolimus extended-release formulation has been approved for use in Canada since October 2008. In initial studies, efficacy and safety profile were demonstrated as similar for both formulations (twice-daily tacrolimus and extended-release formula tacrolimus). To validate the safety and efficacy of extended-release formula tacrolimus, we conducted a prospective observational study. Materials and Methods: At our institution, between January 2009 and January 2010, the switch from tacrolimus to extended-release formula tacrolimus was done in 130 stable kidney recipients. Clinical data were accessed at baseline (data before conversion), 1 to 2 weeks, 1 month, 3 months, 6 months, 12 months, and 24 months after conversion. Results: One hundred thirty renal transplant recipients were included in the current study. During the observation period, we saw no acute rejection and no change in graft function (mean serum creatinine levels remained stable). However, compared with baseline, mean tacrolimus trough levels were significantly reduced at 1 to 2 weeks, at 1 month, 6 months, 12 months, and at 24 months after conversion. Regarding the safety profile, no significant changes were noted in blood glucose, potassium, and magnesium. Approximately 35% of recipients preferred the extended-release formula tacrolimus to twice-daily tacrolimus. Conclusions: Conversion from twice-daily tacrolimus to extended-release once-daily tacrolimus appears to be safe and convenient up to 2 years after conversion in some recipients.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Untitled

Tran

Vallée²,

Collette³

et al. 2014

Exp Clin Transplant

View full text Add to dashboard Cite

show abstract

“…Most previous pharmacokinetics studies comparing twice-daily and once-daily tacrolimus in de novo transplant recipients have reported that, after once-daily tacrolimus administration, C min values are reduced in the immediate posttransplant period and higher doses of the drug are required to maintain target concentrations. 9,24,25 A previous multicenter comparison of the safety and efficacy of tacrolimus administered once-versus twice-daily to de novo LDLT recipients also demonstrated lower C min values and a higher dose requirement for once daily tacrolimus than for twice-daily tacrolimus when normalized to mr doses of tacrolimus (unpublished data). Here, a higher dose of once-daily tacrolimus was required to maintain target concentrations during the posttransplant period, especially immediately after the conversion from intravenous to oral administration of the drug.…”

Section: Figure 1 Liver Transplantation At Başkent Universitymentioning

confidence: 84%

Untitled

Song

Lee²,

Hwang³

et al. 2016

Exp Clin Transplant

View full text Add to dashboard Cite

Objectives: Sustained-release once-daily tacrolimus pharmacokinetics have not yet been characterized in de novo living-donor liver transplant recipients. Here, a 12-week, phase IV, single center, open-label, prospective pilot study was conducted to investigate the pharmacokinetics of this formulation in these patients. Materials and Methods: Patients received continuous intravenous infusion of tacrolimus on days 0 to 5 after transplant, which was followed by oral once-daily sustained-release tacrolimus. Two 24-hour pharmacokinetics profiles were generated for 10 patients on days 6 and 14. Secondary endpoints were minimum (trough level) and maximum whole blood concentrations, time to maximum concentration, and incidences of acute rejection, patient and graft survival, and adverse events. Results: Mean doses (± standard deviation) of sustained-release tacrolimus on days 6 and 14 were 0.14 ± 0.03 and 0.17 ± 0.04 mg/kg. Levels were within the recommended range throughout the study. When the actual dose was examined, area under the curve from 0 to 24 hours on day 14 was 1.8-fold higher than that on day 6 (423.9 vs 235.7 ng × h/mL). When tacrolimus was normalized to 0.1 mg/kg, area under the curve from 0 to 24 hours on day 14 was 1.5-fold higher than on day 6 (279.3 vs 183.4 ng × h/mL). When we used the actual dose, we found the correlation coefficient between area under the curve from 0 to 24 hours and trough level to be higher on day 6 (r = 0.87) than on day 14 (r = 0.691). No acute rejections, graft losses, patient deaths, or drug-related adverse events were reported. Conclusions: Initial intravenous followed by sustainedrelease tacrolimus was safe and efficacious in livingdonor liver transplant recipients. The mean area under the curve from 0 to 24 hours on day 14 was higher than previously reported; this difference may reflect cautious dosing regimens.

show abstract

“…21 The efficacy and safety data from 14 additional observational studies are consistent with the randomized controlled trial data (Table 1). [19][20][21][22][23][24][25][26][27][28][29][30][31][32] Although the effect of TAC QD versus TAC BID on adherence in de novo transplantation has not been systematically tested, an industry-sponsored modeling analysis that extrapolated the effect on adherence, as well as outcomes from a literature review of other studies of twiceversus once-daily medication, suggested that, after 5 years, graft survival would be 6.1% higher in the TAC QD group, which would result in a cost saving of US $9,411 per patient over the 5 years. 33 TAC QD is a useful treatment option that may reduce pill burden in patients adapting to life after transplantation, but an advantage in terms of efficacy or safety has not been demonstrated.…”

mentioning

confidence: 99%

Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

Reschen¹,

O’Callaghan²

2014

TRRM

View full text Add to dashboard Cite

Tacrolimus is the key immunosuppressant used to prevent allograft rejection in kidney and liver transplant recipients. Despite the efficacy of tacrolimus and adjunctive immunosuppressants, a substantial number of patients experience episodes of acute rejection and late graft loss. Nonadherence is an etiological factor in both acute rejection and graft loss. In 2007, a prolonged release version of tacrolimus became available that allows once daily administration, thus halving the pill burden compared to the standard twice-daily tacrolimus. An increasing number of studies in de novo transplantation and in treatment conversion have evaluated the pharmacokinetic profile, efficacy, and safety of prolonged-release tacrolimus. We have reviewed the literature on the use of prolonged-release tacrolimus and hope that this will be of value in the design of protocols for transplant immunosuppression.

show abstract

De Novo Kidney Transplant Recipients Need Higher Doses of Advagraf Compared With Prograf to Get Therapeutic Levels

Cited by 72 publications

References 4 publications

Untitled

Untitled

Untitled

Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

Contact Info

Product

Resources

About