Early everolimus (EVR) introduction and tacrolimus (TAC) minimization after liver transplantation may represent a novel immunosuppressant approach. This phase 2, multicenter, randomized, open-label trial evaluated the safety and efficacy of early EVR initiation. Patients treated with corticosteroids, TAC, and basiliximab were randomized (2:1) to receive EVR (1.5 mg twice daily) on day 8 and to gradually minimize or withdraw TAC when EVR was stable at >5 ng/mL or to continue TAC at 6-12 ng/mL. The primary endpoint was the proportion of treated biopsy-proven acute rejection (tBPAR)-free patients at 3 months after transplant. As secondary endpoints, composite tBPAR plus graft/patient loss rate, renal function, TAC discontinuation rate, and adverse events were assessed. A total of 93 patients were treated with EVR, and 47 were controls. After 3 months from transplantation, 87.1% of patients with EVR and 95.7% of controls were tBPAR-free (P = 0.09); composite endpoint-free patients with EVR were 85% (versus 94%; P = 0.15). Also at 3 months, 37.6% patients were in monotherapy with EVR, and the tBPAR rate was 11.4%. Estimated glomerular filtration rate was significantly higher with EVR, as early as 2 weeks after randomization. In the study group, higher rates of dyslipidemia (15% versus 6.4%), wound complication (18.32% versus 0%), and incisional hernia (25.8% versus 6.4%) were observed, whereas neurological disorders were more frequent in the control group (13.9% versus 31.9%; P < 0.05). In conclusion, an early EVR introduction and TAC minimization may represent a suitable approach when immediate preservation of renal function is crucial.
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http://dx.doi.org/10.1002/lt.25400 | DOI Listing |
Objective: To investigate perceived task privacy in 2022 associated with short (1-3 days) self-certified sickness absence (SA) in 2023.
Methods: A prospective cohort of 1400 Finnish office workers with survey data in 2022 about e.g.
Arch Bronconeumol
November 2024
University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, The Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, The Netherlands. Electronic address:
Heart Vessels
December 2024
Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan.
Urgent revascularization should be performed to patients with acute limb ischemia (ALI) unless the ischemia is irreversible. In patients with severe ALI and multiple morbidities, surgical revascularization is not feasible; however, endovascular revascularization (EVR) may be an option. This study aimed to examine 1-year clinical outcomes of EVR in patients with ALI and determine prognostic factors.
View Article and Find Full Text PDFTransplant Proc
December 2024
Henry Ford Hospital, Detroit, Michigan.
Clin Transplant
November 2024
Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Background: Calcineurin inhibitors (CNIs) are associated with long-term complications after heart transplantation (HTx). Everolimus (EVR)-based immunosuppression allows for CNI withdrawal. We used data from The Scandinavian heart transplant everolimus de novo study with early CNI avoidance (SCHEDULE) trial to assess whether health-related quality of life (HRQoL) differed between patients on long-term treatment with EVR versus a CNI-based regimen.
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