Cardiovascular Risk Following Conversion to Belatacept From a Calcineurin Inhibitor in Kidney Transplant Recipients: A Randomized Clinical Trial.

Autor:	Bredewold OW; Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands., Chan J; Department of Renal Medicine, Akershus University Hospital, Lørenskog, Norway., Svensson M; Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark., Bruchfeld A; Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.; Department of Renal Medicine, Karolinska University Hospital and CLINTEC Karolinska Institutet, Stockholm, Sweden., de Fijter JW; Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands., Furuland H; Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden., Grinyo JM; Department of Clinical Sciences, Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain., Hartmann A; Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway., Holdaas H; Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway., Hellberg O; Department of Internal Medicine, School of Medical Sciences, Örebro University, Örebro, Sweden., Jardine A; Department of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK., Mjörnstedt L; Division of Transplantation, Department of Surgery, Sahlgrenska University Hospital, Göteborg, Sweden., Skov K; Department of Renal Medicine, Aarhus University Hospital, Denmark., Smerud KT; Smerud Medical Research International AS, Oslo, Norway., Soveri I; Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden., Sørensen SS; Department of Nephrology, Copenhagen University Hospital, Copenhagen, Denmark., Zonneveld AV; Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands., Fellström B; Department of Medical Science, Renal Unit, University Hospital, Uppsala, Sweden.
Jazyk:	angličtina
Zdroj:	Kidney medicine [Kidney Med] 2022 Nov 18; Vol. 5 (1), pp. 100574. Date of Electronic Publication: 2022 Nov 18 (Print Publication: 2023).
DOI:	10.1016/j.xkme.2022.100574
Abstrakt:	Rationale & Objective: In kidney transplant recipients (KTRs), a belatacept-based immunosuppressive regimen is associated with beneficial effects on cardiovascular (CV) risk factors compared with calcineurin inhibitor (CNI)-based regimens. Our objective was to compare the calculated CV risk between belatacept and CNI (predominantly tacrolimus) treatments using a validated model developed for KTRs. Study Design: Prospective, randomized, open-label, parallel-group, investigator-initiated, international multicenter trial. Setting & Participants: KTRs aged 18-80 years with a stable graft function (estimated glomerular filtration rate > 20 mL/min/1.73 m 2 ), 3-60 months after transplantation, treated with tacrolimus or cyclosporine A, were eligible for inclusion. Intervention: Continuation with a CNI-based regimen or switch to belatacept for 12 months. Outcomes: Comparison of the change in the estimated 7-year risk of major adverse CV events and all-cause mortality, changes in traditional markers of CV health, as well as measures of arterial stiffness. Results: Among the 105 KTRs randomized, we found no differences between the treatment groups in the predicted risk for major adverse CV events or mortality. Diastolic blood pressure, measured both centrally by using a SphygmoCor device and peripherally, was lower after the belatacept treatment than after the CNI treatment. The mean changes in traditional cardiovascular (CV) risk factors, including kidney transplant function, were otherwise similar in both the treatment groups. The belatacept group had 4 acute rejection episodes; 2 were severe rejections, of which 1 led to graft loss. Limitations: The heterogeneous baseline estimated glomerular filtration rate and time from transplantation to trial enrollment in the participants. A limited study duration of 1 year. Conclusions: We found no effects on the calculated CV risk by switching to the belatacept treatment. Participants in the belatacept group had not only lower central and peripheral diastolic blood pressure but also a higher rejection rate. Funding: The trial has received a financial grant from Bristol-Myers Squibb. Trial Registration: EudraCT no. 2013-001178-20. (© 2022 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu