Background: Gastrointestinal (GI) complications may affect up to 64% of kidney transplant recipients, with a higher incidence of symptoms in patients receiving tacrolimus-based immunosuppression. Tacrolimus extended release once-daily (OD) formulation offers the benefit of OD administration over standard tacrolimus, with a similar rate of GI complications when compared with the standard tacrolimus. We hypothesized that patients with tacrolimus-based immunosuppressive regimen with posttransplant gastrointestinal symptoms may benefit from a conversion to a tacrolimus OD regimen.
Methods: In this pilot study, 27 kidney transplant recipients with tacrolimus-related GI complications were converted to a tacrolimus OD regimen (group 1). This group was compared with a historical cohort of 30 patients on standard tacrolimus therapy with GI symptoms (group 2). Patients were followed up for 1 year after initial enrollment.
Results: Patients in group 1 reported a significant improvement in GI symptoms, as expressed by the change in the Gastrointestinal Symptom Rating Scale scores (1.7±0.3 vs. 1.2±0.2, P<0.001) and GI-specific health-related quality of life scores (87±26.3 vs. 97±24.6, P<0.05). After comparing changes in Gastrointestinal Symptom Rating Scale total scores and subscale scores at 12 months, patients in Group 1 scored better than patients in Group 2 in total scores (-0.5 vs. -0.12, P<0.0001), abdominal pain (P<0.001), diarrhea (P<0.001), and reflux (P=0.013).
Conclusions: Preliminary results from this study demonstrate that kidney transplant recipients experiencing tacrolimus-induced GI symptoms may benefit from a conversion to a tacrolimus OD regimen.