Immunosuppression Adherence in Stable Kidney Transplant Patients Converted From Immediate- to Prolonged-Release Tacrolimus in Clinical Practice: A Norwegian Study

Abstract

BackgroundThis study investigated medication adherence in kidney transplant patients (KTPs) converted from immediate-release tacrolimus (IR-T) to prolonged-release tacrolimus (PR-T)-based immunosuppression in routine practice.MethodsNoninterventional, observational, multicenter study in Norway. Included adult KTPs with stable graft function, converted from IR-T (baseline) to PR-T (1 mg:1 mg) in routine practice. Data were collected at baseline, and months 1, 3, 6, and 12 postconversion. Primary endpoint: adherence using the Basel Assessment of Adherence to Immunosuppressive Medication Scale. Secondary assessments: tacrolimus dose and trough levels (target, 3-7 ng/mL), clinical laboratory parameters (eg, estimated glomerular filtration rate [Modified Diet in Renal Disease]), and adverse events.ResultsNinety-one KTPs (mean ± SD age 47.7 ± 14.3 years) were analyzed. Mean ± SD change in PR-T dose from baseline (4.4 ± 2.4 mg/d) to month 12 was −0.1 ± 0.9 mg/d; mean tacrolimus trough levels remained within target. Overall medication adherence increased from 45.6% at baseline to 58.1% at month 1, but was similar to baseline thereafter; taking and timing adherence followed a similar pattern. Odds ratio (OR) for adherence at month 1 (but not at other time points) was greater versus baseline for overall (OR, 1.71; P = 0.0205), taking (OR, 3.38; P = 0.0004), and timing (OR, 1.77, P = 0.0252) dimensions. Mean ± SD Basel Assessment of Adherence to Immunosuppressive Medication Scale visual analogue scale score at baseline was 96.4 ± 5.5%, and increased postconversion. Estimated glomerular filtration rate remained stable (month 12, 61.6 ± 17.7 mL/min per 1.73 m2), as did other laboratory parameters. Two (2.2%) patients had adverse events considered probably/possibly treatment-related.ConclusionsThere was disparity between high, patient-perceived and low, actual adherence. Converting stable KTPs from IR-T to PR-T in routine practice did not impact long-term adherence to immunosuppression; renal function remained stable.

Evaluation of tools for annual capture of adherence to immunosuppressive medications after renal transplantation - a single-centre open prospective trial

“…Finally, this is a study performed during the first post‐transplant year and may not reflect the patient′s overall IS medication intake behaviour during later years. A recently published Norwegian study using BAASIS © during later post‐transplant years showed a higher nonadherence prevalence . During the 1‐year follow‐up, the present study did not demonstrate a worsening in renal function or AR in NoAd patients.…”

Tacrolimus Area Under the Concentration Versus Time Curve Monitoring, Using Home-Based Volumetric Absorptive Capillary Microsampling

“…As many of the developed tools do not evaluate the timing perspectives, an important aspect of immunosuppressive adherence is missing. BAASIS ® has established predictive validities the recent years and is today the most frequently used adherence questionnaire in transplant recipients (194,(202)(203)(204)(205)(206). BAASIS ® follow the recent ABC taxonomy of medication adherence (160), and assess adherence using items of dose taking, timing, drug holidays, drug reduction and discontinuation.…”

Safety and Efficacy of Two Tacrolimus Formulations (Prograf® and Advagraf®) in Malaysian Renal Transplant Patients: A Comparative Study

“…Our study was in agreement with a similar multi-centre study involving over a thousand renal transplant patients whereby it was found that renal functions remained stable upon conversion . Even though a study by Abedini et al have reported a stable renal function following conversion (15), it could well be attributed to the reduced tacrolimus exposure following conversion. Although there may be some protective effect on renal function with the use of Advagraf®, due to the lower single peak exposure observed in this current study, a prospective multicentre study should be conducted in the future to demonstrate if this benefit is of clinical significance.…”