Background. Many of immunosuppressive drugs have been prescribed as twice-daily dosing. Simplified once-daily dosing of the entire drug regimen can enable patients to improve treatment satisfaction and thereby enhance medication adherence. We examined the safety, efficacy, and treatment satisfaction of the simplified once-daily immunosuppressive regimen using extended-release tacrolimus, sirolimus, and corticosteroids.

Methods. This study was a prospective, multicenter, controlled, cohort trial. Adult renal transplant patients with a stable renal function were eligible for enrollment in this conversion study if they received transplants more than 3 months prior to study enrollment, and were taking tacrolimus. Efficacy failure (biopsy-confirmed acute rejection, death, graft loss), safety, and renal function were evaluated until 6 months post-conversion. Measurements of treatment satisfaction were performed immediately before introduction of the simplified regimen and 6 months afterward.

Results. One hundred sixty kidney recipients comprised the intent-to-treat (ITT) population. Twenty recipients prematurely discontinued the study by various reasons. No graft loss and one patient death at home had been reported. The incidence of treated biopsy-confirmed acute rejection until 6 months post-conversion was 0.62%. The mean eGFR of the was not significantly changed (P>0.050), but 24-hour urinary excretion of protein before conversion was significantly lower (87.1±140.9 mg/day) than that at 6 months postconversion (206.5±433.5 mg/day, P<0.001) in per-protocol population. Among ITT population, overall 95 (59.4%) had a variety type of adverse event (AE), and twenty eight patients (17.5%) had serious adverse event. Six months after introduction of the simplified immunosuppressive regimen, the patients demonstrated the significant improvements of treatment satisfaction (P<0.001).

Conclusion. This study demonstrated that the kidney recipients who were taking once-daily immunosuppressive regimen expressed the statistically significant improvement of satisfaction without the additional risks of adverse effect of the regimen.

CITATION INFORMATION: Oh C.-K, Kim S.-J, Huh K, Kim S, Cho H, Lee S. Clinical Outcomes of Simplified Once-Daily Immunosuppressive Regimen for Kidney Recipients. Am J Transplant. 2016;16 (suppl 3).

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