Three-Month Experience With Tacrolimus Once-Daily Regimen in Stable Renal Allografts

Ojea, B. Diez; Álvarez, M. Alonso; Fernandez, SN; Gallardo, M. Baños; Melendreras, S. García; Huertas, Ernesto Gómez

doi:10.1016/j.transproceed.2009.06.048

Cited by 29 publications

(8 citation statements)

References 8 publications

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“…Nevertheless, the low acute rejection rate suggests that the degree of immunosuppression was sufficient to avoid rejection, and comparable to that achieved with similar doses of standard‐release tacrolimus. Previous observational studies in renal recipients have also reported a modest increase in dose requirements after conversion from the standard‐release tacrolimus to the prolonged‐release formulation (13–16). Diez Ojea et al found that, among 82 stable renal transplant recipients converted to once‐daily tacrolimus on a 1 mg: 1 mg basis, 7.6% required a dose adjustment (16).…”

Section: Discussionmentioning

confidence: 99%

“…Previous observational studies in renal recipients have also reported a modest increase in dose requirements after conversion from the standard‐release tacrolimus to the prolonged‐release formulation (13–16). Diez Ojea et al found that, among 82 stable renal transplant recipients converted to once‐daily tacrolimus on a 1 mg: 1 mg basis, 7.6% required a dose adjustment (16). However, after an initial decrease in trough levels at day 7, no additional changes were observed during 3 months of follow‐up.…”

Section: Discussionmentioning

confidence: 99%

“…Since the marketing of once‐daily tacrolimus, few studies in small cohorts of stable kidney transplant recipients have reported the experience in clinical practice with the conversion to the new formulation as maintenance immunosuppression (13–17). However, large multicentric studies assessing the detailed evolution of efficacy and safety of conversion to prolonged‐release tacrolimus in routine clinical practice are lacking.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Conversion from Twice-daily to Once-daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients

Guirado

Cantarell

Franco

et al. 2011

American Journal of Transplantation

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Group of new projects in transplantation (Grupo español de actualizaciones en trasplante).Prolonged-release tacrolimus was developed to provide a more convenient once-daily dosing that could improve patient adherence. We conducted a multicenter, prospective, observational, 12-month study to describe the efficacy, safety and patient preference of conversion from tacrolimus twice-daily to once-daily formulation in stable kidney transplant recipients in routine clinical practice. Conversion was made on a 1 mg : 1 mg basis (1 mg : 1.1 mg in patients with trough levels <6 ng/mL). The study included 1832 patients (mean age (±SD): 50.0 ± 13.4 years; 62.7% male). After conversion, a modest reduction in tacrolimus trough levels, necessitating an increase in daily dose, was observed (mean changes at 12 months of -9.1% and +1.24%, respectively; p < 0.0001). Mean glomerular filtration rate did not change significantly (56.5 ± 19.7 mL/min at conversion vs. 55.7 ± 20.6 mL/min at 12 months). Proteinuria, blood pressure, lipid, hepatic and glucose parameters remained stable. Eight patients (0.4%) had acute rejection and 34 patients (1.85%) discontinued treatment. Almost all patients (99.4%) preferred the once-daily formulation, because of less frequent dosing (66%) and improved adherence (34%). In conclusion, at similar doses to twice-daily tacrolimus, once-daily formulation provided stable renal function, a low acute rejection rate, and good tolerability in stable kidney transplant recipients in the routine clinical practice setting.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Conversion from Twice-daily to Once-daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients

Guirado

Cantarell

Franco

et al. 2011

American Journal of Transplantation

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“…Despite these dosage increases, the average trough concentrations remained almost 10 % lower after conversion to once-daily dosing [17]. Another study involving 82 stable kidney transplant recipients found that only five patients needed a later dose adjustment after converting from Prograf Ò to Advagraf Ò ; however, that study also found that in the 61 patients with no dosage adjustment, trough concentrations decreased significantly (by about 15 %) in the first week after the switch [18]. It is not clear why these recipients did not have their dosages increased to adjust to the same target trough tacrolimus concentrations as previously.…”

Section: Pharmacokineticsmentioning

confidence: 99%

Clinical Pharmacokinetics of Once-Daily Tacrolimus in Solid-Organ Transplant Patients

Staatz

Tett

2015

Clin Pharmacokinet

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Tacrolimus is a pivotal immunosuppressant agent used in solid-organ transplantation. It was originally formulated for oral administration as Prograf(®), a twice-daily immediate-release capsule. In an attempt to improve patient adherence, retain manufacturer market share and/or reduce health care costs, newer once-daily prolonged-release formulations of tacrolimus (Advagraf(®) and Envarsus(®) XR) and various generic versions of Prograf(®) are becoming available. Tacrolimus has a narrow therapeutic index. Small variations in drug exposure due to formulation differences can have a significant impact on patient outcomes. The aim of this review is to critically analyse the published data on the clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients. Forty-three traditional (non-compartmental) and five population pharmacokinetic studies were identified and evaluated. On the basis of the stricter criteria for narrow-therapeutic-index drugs, Prograf(®), Advagraf(®) and Envarsus(®) XR are not bioequivalent [in terms of the area under the concentration-time curve from 0 to 24 h (AUC0-24) or the minimum concentration (C min)]. Patients may require a daily dosage increase if converted from Prograf(®) to Advagraf(®), while a daily dosage reduction appears necessary for conversion from Prograf(®) to Envarsus(®) XR. Prograf(®) itself, or generic immediate-release tacrolimus, can be administered in a once-daily regimen with a lower than double daily dose being reported to give 24-h exposure equivalent to that of a twice-daily regimen. Intense clinical and concentration monitoring is prudent in the first few months after any conversion to once-daily tacrolimus dosing; however, there is no guarantee that therapeutic drug monitoring strategies applicable to one formulation (or twice-daily dosing) will be equally applicable to another. The correlation between the tacrolimus AUC0-24 and C min is variable and not strong for all three formulations, indicating that trough measurements may not always give a good indication of overall drug exposure. Further investigation is required into whether the prolonged-release formulations have reduced within-subject pharmacokinetic variability, which would be a distinct advantage. Whether the effects of factors that influence tacrolimus absorption and pre-systemic metabolism (patient genotype status; gastrointestinal disease and disorders) and drug interactions differ across the formulations needs to be further elucidated. Most pharmacokinetic comparison studies to date have involved relatively stable patients, and many have been sponsored by the pharmaceutical companies manufacturing the new formulations. Larger randomized, controlled trials are needed in different transplant populations to determine whether there are differences in efficacy and toxicity across the formulations and whether formulation conversion is worthwhile in the longer term. While it has been suggested that once-daily administration of tacrolimus may improve patient compliance, further studies a...

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“…[14]a nd DiezOjea etal. [15]who showed thatboththe doseand C trough weresimilarbetween TAC-onceand TAC-twiceat3monthsafterr enaltransplantation.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic properties of a once-daily formulation of tacrolimus in patients with renal transplantation

Imanishi¹,

Matsui²,

Ishida³

et al. 2011

Arzneimittelforschung

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The present study was designed to determine the pharmacokinetic profiles of a once-daily formulation of tacrolimus (CAS 104987-11-3; TAC-once) in patients before and after introduction of renal transplantation. Pharmacokinetic parameters for tacrolimus were almost comparable among patients receiving TAConce before, 2 weeks after and 3 weeks after renal transplantation. Among various parameters, C(trough) correlated most closely with the area under the concentration-time curve during 24 h (AUCo-24) (R2 = 0.82, P < 0.001), while no consistent correlation was observed between AUCo_24 and concentrations at 2 h or 4 h, or the dose of TAC-once. The clinical outcomes such as the incidence of acute re-jection, renal tissue injury and cytomegalovirus infection were evaluated during the first 3 weeks and 3 months after transplantation, and the data were compared with the historical data obtained from patients who had received the conventional twice-daily formulation of tacrolimus (TAC-twice). There were no significant differences in the incidence of such clinical outcomes between the two groups. These findings suggest that C(trough) is useful for therapeutic monitoring of tacrolimus in patients receiving TAC-once. In addition, pharmacokinetics and clinical outcomes were comparable between TAC-once and TAC-twice formulations.

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Three-Month Experience With Tacrolimus Once-Daily Regimen in Stable Renal Allografts

Cited by 29 publications

References 8 publications

Efficacy and Safety of Conversion from Twice-daily to Once-daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients

Efficacy and Safety of Conversion from Twice-daily to Once-daily Tacrolimus in a Large Cohort of Stable Kidney Transplant Recipients

Clinical Pharmacokinetics of Once-Daily Tacrolimus in Solid-Organ Transplant Patients

Pharmacokinetic properties of a once-daily formulation of tacrolimus in patients with renal transplantation

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