Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation.

Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation.
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从头心脏移植后一年依维莫司与硫唑嘌呤的经济评估。

DOI:
10.1111/j.1399-0012.2004.00312.x
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发表时间:
2005
影响因子:
2.1
通讯作者:
Schulman,KevinA
Schulman,KevinA
中科院分区:
医学3区
文献类型:
--
作者:
Radeva,JasminaI;Reed,ShelbyD;Kalo,Zoltan;Kauf,TeresaL;Cantu3rd,Edward;Cretin,Nathalie;Schulman,KevinA

文献摘要

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摘要:背景:依维莫司可降低心脏移植术后急性排斥反应和同种异体移植血管病变。我们比较了随机分配到依维莫司1.5 mg/d (n = 209)、依维莫司3.0 mg/d (n = 211)或硫唑嘌呤(n = 214)组的新心脏移植患者1年随访期间的试验内成本和资源使用情况。患者和方法:前瞻性地收集了来自14个国家的634例患者的资源使用数据。我们使用非参数自举法来检验平均成本的差异,并估计成本-效益比的置信区间。结果:依维莫司患者疗效失败发生率低于硫唑嘌呤患者(41.6%,依维莫司1.5 mg; 32.2%,依维莫司3.0 mg; 52.8%,硫唑嘌呤)。与接受硫唑嘌呤治疗的患者相比,依维莫司组患者住院天数更长[依维莫司1.5 mg/d组为36.3 d (p = 0.21);依维莫司3.0 mg/d组38.4 d (p = 0.01);32.2 d为硫唑嘌呤]。除研究药物外,各治疗组的平均总成本无显著差异(依维莫司1.5 mg组为72065美元;依维莫司3.0 mg组为72631美元;硫唑嘌呤组为70815美元)。结论:在心脏移植后随访1年以上,依维莫司没有显著增加治疗费用(不包括研究药物的费用),同时减少了疗效失败。为了充分评估依维莫司与硫唑嘌呤在移植后维持中的成本-效果,需要更长的随访时间和依维莫司的成本。
Abstract:Background:Everolimus decreases acute rejection and cardiac allograft vasculopathy after heart transplantation. We compared within‐trial costs and resource use over 1 yr of follow‐up inde novoheart transplant patients randomized to everolimus 1.5 mg/d (n = 209), everolimus 3.0 mg/d (n = 211), or azathioprine (n = 214).Patients and methods:Resource use data were collected prospectively for 634 patients from 14 countries. We used the nonparametric bootstrap method to test for differences in mean costs and to estimate confidence intervals for cost‐effectiveness ratios.Results:Everolimus patients had lower incidence of efficacy failure compared with azathioprine patients (41.6%, everolimus 1.5 mg; 32.2%, everolimus 3.0 mg; 52.8%, azathioprine). Compared with patients receiving azathioprine, everolimus patients spent more days in the hospital [36.3 d for everolimus 1.5 mg/d (p = 0.21); 38.4 d for everolimus 3.0 mg/d (p = 0.01); 32.2 d for azathioprine]. Mean total costs, excluding the study medications, were not significantly different among treatment groups ($72 065 for everolimus 1.5 mg; $72 631 for everolimus 3.0 mg; $70 815 for azathioprine).Conclusions:Over 1 yr of follow‐up after heart transplantation, everolimus did not significantly increase treatment costs, excluding the costs of the study medications, while reducing efficacy failure. Longer follow‐up and the cost of everolimus are required to fully evaluate the cost‐effectiveness of everolimus vs. azathioprine in post‐transplant maintenance.