Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies)

Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies)
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DOI:
10.1097/tp.0b013e31820c10eb
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发表时间:
2011-05-15
期刊:
影响因子:
6.2
通讯作者:
Vincenti, Flavio
Vincenti, Flavio
中科院分区:
医学2区
文献类型:
--
作者:
Vanrenterghem, Yves;Bresnahan, Barbara;Vincenti, Flavio

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背景。心血管疾病是肾移植受者最常见的功能性移植物死亡原因,免疫抑制药物,特别是钙调磷酸酶抑制剂可加重心血管疾病。Belatacept是一种选择性共刺激阻断剂,可能比目前的免疫抑制剂提供更好的心血管/代谢风险概况。两项基于belataccept的肾移植受体方案的III期研究(BENEFIT和BENEFIT- ext)的心血管和代谢终点在第12个月进行评估。每项研究都评估了belataccept在高强度(MI)和低强度(LI)方案中与环孢素A (CsA)的对比。这些次要终点包括血压变化、血脂变化和移植后新发糖尿病(NODAT)的发生率。在两项研究中,共有1209名患者被随机移植。与CsA相比,心肌梗死组和LI组的平均收缩压降低6 ~ 9mmhg,平均舒张压降低3 ~ 4mmhg
Background. Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants.Methods. Cardiovascular and metabolic endpoints from two Phase III studies (BENEFIT and BENEFIT-EXT) of belatacept-based regimens in kidney transplant recipients were assessed at month 12. Each study assessed belatacept in more intensive (MI) and less intensive (LI) regimens versus cyclosporine A (CsA). These secondary endpoints included changes in blood pressure, changes in serum lipids, and the incidence of new-onset diabetes after transplant (NODAT).Results. A total of 1209 patients were randomized and transplanted across the two studies. Mean systolic blood pressure was 6 to 9 mm Hg lower and mean diastolic blood pressure was 3 to 4 mm Hg lower in the MI and LI groups versus CsA (P