Medication Noncompliance and its Implications in Transplant Recipients

Morrissey, Paul; Flynn, Michelle; Lin, Shih‐Chun

doi:10.2165/00003495-200767100-00007

Cited by 114 publications

(100 citation statements)

References 54 publications

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“…Simpler dosing regimens have been shown to facilitate better adherence behavior (1,2). Potential advantages of improved adherence and more consistent exposure with the extended release profile of tacrolimus QD (3)(4)(5)(6)(7) include a reduction in rejection and graft loss (8)(9)(10) on longer-term follow-up.…”

Section: Prograf (Astellas Pharma Europe Ltd Staines Uk; Hereafter mentioning

confidence: 99%

Once‐Daily Prolonged‐Release Tacrolimus (ADVAGRAF) Versus Twice‐Daily Tacrolimus (PROGRAF) in Liver Transplantation

Trunečka

Boillot

Seehofer³

et al. 2010

American Journal of Transplantation

113

105

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The efficacy and safety of dual-therapy regimens of twice-daily tacrolimus (BID; Prograf) and once-daily tacrolimus (QD; Advagraf) administered with steroids, without antibody induction, were compared in a multicenter, 1:1-randomized, two-arm, parallel-group study in 475 primary liver transplant recipients. A doubleblind, double-dummy 24-week period was followed by an open extension to 12 months posttransplant. The primary endpoint, event rate of biopsy-proven acute rejection (BPAR) at 24 weeks, was 33.7% for tacrolimus BID versus 36.3% for tacrolimus QD (Per-protocol set; p = 0.512; treatment difference 2.6%, 95% confidence interval −7.3%, 12.4%), falling within the predefined 15% noninferiority margin. At 12 months, BPAR episodes requiring treatment were similar for tacrolimus BID and QD (28.1% and 24.7%). Twelvemonth patient and graft survival was 90.8% and 85.6% for tacrolimus BID and 89.2% and 85.3% for tacrolimus QD. Adverse event (AE) profiles were similar for both tacrolimus BID and QD with comparable incidences of AEs and serious AEs. Tacrolimus QD was well tolerated with similar efficacy and safety profiles to tacrolimus BID.

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Section: Prograf (Astellas Pharma Europe Ltd Staines Uk; Hereafter mentioning

confidence: 99%

Once‐Daily Prolonged‐Release Tacrolimus (ADVAGRAF) Versus Twice‐Daily Tacrolimus (PROGRAF) in Liver Transplantation

Trunečka

Boillot

Seehofer³

et al. 2010

American Journal of Transplantation

113

105

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“…13 Simpler dosing regimens facilitate better adherence behavior, reducing graft rejection and loss on longer-term follow-up. 14,15 Previous studies in healthy volunteers showed that twice-daily and once-daily tacrolimus regimens that maintain equivalent total daily doses result in similar exposures to the drug. Furthermore, clinical trials in transplant recipients that substituted one formulation for the other but retained the same total daily dose demonstrated equivalent exposure and similar ratios of C min to AUC0-24 for twice-daily and once-daily tacrolimus.…”

Section: Figure 1 Liver Transplantation At Başkent Universitymentioning

confidence: 99%

Untitled

Song

Lee²,

Hwang³

et al. 2016

Exp Clin Transplant

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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.

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“…It is estimated that non adherence to long-term medication is as high as 50% in developed countries and higher in developing countries (76). Risk factors for nonadherence include nonadherence behavior prior to transplantation, psychiatric illness, personality disorders, poor social support, substance abuse and other high-risk behavior, adolescence, high education level, time since transplantation, lack of adequate follow-up with transplant specialists, inadequate pretransplant education, multiple adverse effects from medications, complex medication regimens, expensive medications and poor access to healthcare (23,75,77).…”

Section: Adherencementioning

confidence: 99%