ABSTRACT
Multicenter, prospective, observational study to compare the relative bioavailability of once-daily tacrolimus formulations in de novo kidney transplant recipients. De novo kidney transplant recipients who started a tacrolimus-based regimen were included 14 days post-transplant and followed up for 6 months. Data from 218 participants were evaluated: 129 in the LCPT group (Envarsus) and 89 in the PR-Tac (Advagraf) group. Patients in the LCPT group exhibited higher relative bioavailability (Cmin /total daily dose [TDD]) vs. PR-Tac (61% increase; P < .001) with similar Cmin and 30% lower TDD levels (P < .0001). The incidence of treatment failure was 3.9% in the LCPT group and 9.0% in the PR-Tac group (P = .117). Study discontinuation rates were 6.2% in the LCPT group and 12.4% in the PR-Tac group (P = .113). Adverse events, renal function and other complications were comparable between groups. The median accumulated dose of tacrolimus in the LCPT group from day 14 to month 6 was 889 mg. Compared to PR-Tac, LCPT showed higher relative bioavailability, similar effectiveness at preventing allograft rejection, comparable effect on renal function, safety, adherence, treatment failure and premature discontinuation rates.
Subject(s)
Kidney Transplantation , Tacrolimus , Biological Availability , Drug Administration Schedule , Graft Rejection/drug therapy , Graft Rejection/etiology , Graft Rejection/prevention & control , Humans , Immunosuppressive Agents/therapeutic use , Kidney Transplantation/adverse effects , Prospective Studies , Tacrolimus/therapeutic use , Transplant RecipientsABSTRACT
We found chronic pneumoperitoneum in two continuous ambulatory peritoneal dialysis patients from two different hospitals. Both patients used the Stay.Safe® system and bicaVera solution, whose extension tubing is not primed with fluid but air-filled, unlike that of the conventional solution bags. This fact, together with a handling fault common to both patients, resulted in the inflow of the air in the tubing of bicaVera bags into the peritoneal cavity during every exchange. We warn of this complication, which must be specifically pointed out during training, and we recommend providing the system with a mechanic device to prevent this handling fault.