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Tran, Dung Duc; Vallée, Michel; Collette, Suzon; Senécal, Lynne; Lafrance, Jean‐Philippe; Dandavino, R; Boucher, Anne

doi:10.6002/ect.2013.0165

Cited by 6 publications

(9 citation statements)

References 10 publications

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“…The switch to a once-daily extended release of tacrolimus was found to be medically safe and more convenient for renal transplant recipients. 32 – 34 , 69 In liver transplant recipients the conversion was even found to improve medical outcomes. 70 Thus, efforts should be made to reduce the dosing schedule in the future.…”

Section: Discussionmentioning

confidence: 99%

<p>Optimization of Electronically Monitored Non-Adherence in Highly Adherent Renal Transplant Recipients by Reducing the Dosing Frequency – A Prospective Single-Center Observational Study</p>

Lieb¹,

Schiffer²,

Erim³

2020

PPA

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Background: Non-adherence (NA) after renal transplantation poses a major risk for allograft rejection, graft loss, and patient mortality. Yet, there is still ambiguity about its etiology and its possible relationships with patient-related factors. In order to prevent poor outcomes after transplantation, it is crucial to gain a more refined understanding of potential determinants, to identify patients at risk, and to intervene accordingly. The objective of this study was to assess potential risk factors of NA by prospectively applying electronic monitoring. Materials and Methods: This was a single-center prospective observational study. Prior to study initiation, sociodemographic, biomedical, and psychosocial variables (depression, healthrelated quality of life, self-efficacy, social support, attachment, experiences and attitudes towards immunosuppressive medication, emotional responses after organ transplantation, satisfaction with information about immunosuppressive medication, and perceptions and beliefs about medications) were assessed. Thereafter, immunosuppressive adherence behavior was measured prospectively via electronic monitoring (EM, VAICA©) during a 3-month period to receive the percentage frequency of Taking and Timing Adherence (±2h, ±30min) for each patient. Focus of this study was the phase of medication implementation. Results: A total of 78 patients participated in our study (mean age 55.28, 56% male). We found rates of 99.39% for Taking Adherence, 98.34% for Timing Adherence ±2h, and 93.34% for Timing Adherence ±30min, respectively. Multiple regression analyses revealed that the type of medication could significantly predict Taking Adherence. Patients receiving Advagraf© (once daily) depicted better Taking Adherence than patients receiving Prograf© (twice daily) (p=0.04). No associations were found for Timing Adherence (±2h, ±30min). Sociodemographic, biomedical, or psychosocial variables were not found to be associated with adherence behavior. Discussion: In highly adherent populations, only a few factors can be altered to improve adherence. Changing the immunosuppressive regimen from twice-daily to once-daily could be an option for optimizing adherence. However, risk factors for NA could be different in a less adherent population.

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Section: Discussionmentioning

confidence: 99%

<p>Optimization of Electronically Monitored Non-Adherence in Highly Adherent Renal Transplant Recipients by Reducing the Dosing Frequency – A Prospective Single-Center Observational Study</p>

Lieb¹,

Schiffer²,

Erim³

2020

PPA

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“…Our results also suggest satisfaction with the simplified regimen for most of the patients who were randomized to once-daily dosing as demonstrated by the large percentage of patients who preferred to continue with this regimen following study completion. 10 Preference for maintenance of twice-daily dosing was driven by interest in maintaining routine, requirements of other medications to be taken twice daily, and worries that changing dosing may impact health. Interestingly, although tacrolimus serum levels did not differ at the outset of the study, at the conclusion of the study, levels were significantly higher in the twice-daily dosing group.…”

Section: Discussionmentioning

confidence: 99%

“…8 Research examining once-daily in comparison to twice-daily tacrolimus dosing in renal transplant recipients has indicated that switching from a twice-daily dose is safe and does not lead to significant changes in blood glucose, potassium, or magnesium in this group. 9,10 In addition, in a 2-year study in renal transplant recipients, approximately 35% of participants indicated a preference for once-daily dosing. 10 More recent research indicates improved adherence as measured via electronic monitoring in one randomized controlled trial in this group.…”

Section: Introductionmentioning

confidence: 99%

“…9,10 In addition, in a 2-year study in renal transplant recipients, approximately 35% of participants indicated a preference for once-daily dosing. 10 More recent research indicates improved adherence as measured via electronic monitoring in one randomized controlled trial in this group. 1 Nonetheless, other studies using self-report measures of adherence indicate mixed results.…”

Section: Introductionmentioning

confidence: 99%

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Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial

Paterson

Demian

Shapiro

et al. 2019

Can J Kidney Health Dis

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Background: Prevalence of immunosuppressant nonadherence in renal transplant recipients is high despite negative clinical outcomes associated with nonadherence. Simplification of dosing has been demonstrated to improve adherence in renal transplant recipients as measured through electronic monitoring and self-report. Objective: The purpose of this study was to replicate and extend previous findings by measuring adherence with multiple methods in a Canadian sample. Design: The study design was a randomized controlled medication dosing trial in adult renal transplant patients. The trial length was 4 months. Setting: This study was conducted within the Solid Organ Transplant (SOT) Clinic at Vancouver General Hospital (VGH; Vancouver, Canada). Patients: A total of 46 adult renal recipients (at least 1 year post-transplant) were recruited through the SOT clinic. With 8 withdrawals, 38 individuals completed all phases of the study. Measurements: Medication adherence was measured for a period of 4 months using multiple methods, including electronic monitoring (MEMS [Medication Event Monitoring System]), pharmacy refill data (medication possession ratio [MPR]), and by self-report using the Adherence subscale of the Transplant Effects Questionnaire (TEQ). Methods: Participants were randomized to twice-daily (n = 19) or once-daily tacrolimus dosing (n = 19) and followed over a 4-month period via monthly clinic study visits. Comparisons between the treatment groups were performed using the Mann-Whitney U and chi-square tests, for continuous and categorical variables, respectively. Results: As outlined in Table 3, the once-daily dosing group showed significantly better MEMS Dose Adherence ( P = .001), whereas MEMS Timing Adherence showed a tendency toward better adherence for this group, but was not significant ( P = .052). MEMS Days Adherent ( P = .418), MPR% ( P = .123), and self-reported adherence ( P = .284) did not differ between the once- and twice-daily dosing groups when measured as continuous variables. The MPR% was significantly better for the once-daily dosing group when measured dichotomously but not continuously ( P = .044). Notably, most of those exposed to once-daily dosing (63.2%) preferred this to the twice-daily regimen. Limitations: Limitations included small sample size and short follow-up period, precluding the examination of clinical outcome differences. Conclusions: Results for dose adherence replicate the finding that dose simplification increases adherence to immunosuppressants as measured through electronic monitoring. Such an advantage for the once-daily dosing group was not seen across the 2 other electronic monitoring measurement variables (days and timing adherence). This study extends previous research by examining adherence in once versus twice-daily dosing via prescription refill data in a Canadian sample. Given the gravity of potential health outcomes associated with nonadherence, although results indicate inconsistencies in significance testing across measurement methods, the medium to large effect sizes seen in the data favoring better adherence with once-daily dosing provide an indication of the potential clinical significance of these findings. Trial registration: This study was registered with ClinicalTrials.gov (NCT01334333) on April 11, 2011.

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“…Where dose adjustment was required, 1 change was sufficient and the mean change in daily dose was relatively small: 0.6–0.7 mg/day [18]. Late conversion studies (median of 3.9 and 5.4 years post renal transplant) have shown that compared with baseline, mean tacrolimus trough levels tend to fall slightly following conversion from immediate- to prolonged-release tacrolimus, but stabilize thereafter [16,18]. Lauzurica et al reported that median trough levels fell from 6.7 ng/mL at day 1 to 6.0 ng/mL at week 1, stabilizing to between 5.8 and 6.7 ng/ml for the remainder of the study [18].…”

Section: Discussionmentioning

confidence: 99%

A Prospective, Observational Study of Conversion From Immediate- to Prolonged-Release Tacrolimus in Renal Transplant Recipients in France: The OPALE Study

Moal

Grimbert

Beauvais³

et al. 2019

Ann Transplant

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BackgroundPotential benefits of once-daily, prolonged-release tacrolimus over the immediate-release formulation include improved adherence to immunosuppressives post transplantation. An observational study was performed to characterize real-world practice surrounding conversion from immediate- to prolonged-release tacrolimus in kidney transplant recipients.Material/MethodsWe performed a prospective, observational study of renal transplant recipients converted from immediate- to prolonged-release tacrolimus capsules. Conversion took place at the baseline visit, within the first 6 months of transplantation (early conversion group) or between 6 and 12 months of transplantation (late conversion group). Data collection was performed at routine follow-up at 6 and 12 months. Endpoints included conversion ratio from immediate- to prolonged-release tacrolimus, reasons for conversion, additional visits due to conversion, safety, and tolerability.ResultsThe analysis population comprised 591 patients. Baseline characteristics were similar between the 2 groups. The mean conversion ratio of the daily dose of tacrolimus was 0.98±0.17 in the early group and 0.99±0.09 in the late group. Time from conversion (mean ±SD) to first measurement of trough tacrolimus blood concentration was 12.1±11.6 and 27.6±26.7 days in the early and late groups, respectively. The highest number of additional visits required was 6 in the early conversion group, in 3 patients (0.7%), and 3 in the late conversion group, in 2 patients (1.6%). Conversion from immediate- to prolonged-release tacrolimus was associated with a very low rate of graft rejection.ConclusionsFavorable clinical outcomes and safety profiles were observed with conversion from immediate- to prolonged-release tacrolimus over 1 year following renal transplantation, with no marked differences between the early and late conversion groups.

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Untitled

Cited by 6 publications

References 10 publications

<p>Optimization of Electronically Monitored Non-Adherence in Highly Adherent Renal Transplant Recipients by Reducing the Dosing Frequency – A Prospective Single-Center Observational Study</p>

<p>Optimization of Electronically Monitored Non-Adherence in Highly Adherent Renal Transplant Recipients by Reducing the Dosing Frequency – A Prospective Single-Center Observational Study</p>

Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial

A Prospective, Observational Study of Conversion From Immediate- to Prolonged-Release Tacrolimus in Renal Transplant Recipients in France: The OPALE Study

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