Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

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.

Assessment of Tacrolimus Neurotoxicity Measured by Retinal OCT.

BACKGROUND: Neurotoxicity secondary to anticalcineurinics is a prevalent side effect in transplant recipients. Optical coherence tomography (OCT) scans the central nervous system by direct access to the retina. OCT assesses central nervous system involvement by measuring the thickness of the retinal layers, especially the ganglion cell layer (GCL). The retinal scan divides the scanned area into affected and unaffected segments, which can be quantified for each eye. The aim of this study was to determine retinal GCL thickness by means of OCT, analyzing the proportion of affected segments in individuals exposed to tacrolimus compared with a control group. MATERIALS AND METHODS: We evaluated 20 renal transplant recipients exposed to tacrolimus for ≥6 months. The number of affected segments in the GCL of the retina was quantified by OCT. The control group was drawn from the general population attending routine ophthalmologic checkups. RESULTS: Patients exposed to tacrolimus had a pathologic examination in 50% of cases compared with 20% in the control group (P < .044). Furthermore, among patients with an exposure time to tacrolimus >5 years, the examination was pathologic in 80% (P < .005). Linear regression analysis showed the presence of GCL segments with decreased thickness to be associated with the duration of exposure to tacrolimus (P = .036) and the time in dialysis before kidney transplant (P = .030). CONCLUSION: Although this is a preliminary study, OCT scanning could serve to detect the neurotoxic effect of tacrolimus on the retinal GCL and central nervous system in renal transplant recipients.

Paternal safety of the use of mycophenolic acid in kidney transplant recipients. Results of the EMVARON study.

BACKGROUND: The use of mycophenolic acid (MPA) in women during pregnancy causes an increase in miscarriages and birth defects with a typical embryopathy profile. Although epidemiological data does not suggest a greater risk among the offspring of male kidney transplant recipients, the European Medicines Agency and The Spanish Agency of Medicines and Medical Devices introduced the recommendation of using contraceptive methods. METHODS: We conducted a national retrospective study in 15 Spanish Kidney Transplant Centers to evaluate the frequency of miscarriages and birth defects between the offspring from male kidney transplants recipients. We included 151 males who had fathered 239 offspring, 225 under MPA and 14 without MPA. RESULTS: The results of our study showed an incidence of miscarriages in the MPA group of 9.8%, and of birth defects of 4%. CONCLUSIONS: We observed an incidence of miscarriages between the offspring fathered by kidney transplant males under MPA lower than the general population. The incidence of birth defects was similar to the incidence described in other studies and the fact that we did not find the typical embryopathy profile makes it difficult to associate them to the use of MPA. Because of that, we urge the European and Spanish Agencies to reconsider their recommendations for males.

Esputo anaranjado en el contexto de neumonía por Legionella micdadeien un paciente trasplantado renal / Orange sputum in a kidney transplant patient with Legionella micdadei pneumonia

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