Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study.

BMC Clinical Pharmacology Pub Date : 2008-03-31 DOI:10.1186/1472-6904-8-2

Andrew Spencer, Andrew Roberts, Nola Kennedy, Christina Ravera, Serge Cremers, Sanela Bilic, Terry Neeman, Michael Copeman, Horst Schran, Kevin Lynch

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引用次数: 8

Abstract

Background: Cases of impaired renal function have been reported in patients who had been treated with both zoledronic acid and thalidomide for myeloma. Hence, we conducted a safety study of zoledronic acid and thalidomide in myeloma patients participating in a trial of maintenance therapy.

Methods: Twenty-four patients who were enrolled in a large randomized trial of thalidomide vs no thalidomide maintenance therapy for myeloma, in which all patients also received zoledronic acid, were recruited to a pharmacokinetic and renal safety sub-study, and followed for up to 16 months.

Results: No significant differences by Wilcoxon rank-sum statistic were found in zoledronic acid pharmacokinetics or renal safety for up to 16 months in patients randomized to thalidomide or not.

Conclusion: In myeloma patients receiving maintenance therapy, the combination of zoledronic acid and thalidomide appears to confer no additional renal safety risks over zoledronic acid alone.

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唑来膦酸联合沙利度胺治疗骨髓瘤患者的肾脏安全性:一项药代动力学和安全性亚研究。

背景:在同时使用唑来膦酸和沙利度胺治疗骨髓瘤的患者中有肾功能受损的病例报道。因此，我们对参与维持治疗试验的骨髓瘤患者进行了唑来膦酸和沙利度胺的安全性研究。方法:24名患者参加了沙利度胺与非沙利度胺维持治疗骨髓瘤的大型随机试验，其中所有患者也接受了唑来膦酸治疗，他们被招募到一个药代动力学和肾脏安全性亚研究中，随访长达16个月。结果:根据Wilcoxon秩和统计，在长达16个月的时间里，唑来膦酸药代动力学和肾脏安全性在随机分配到沙利度胺组和未分配到沙利度胺组的患者中没有发现显著差异。结论:在接受维持治疗的骨髓瘤患者中，唑来膦酸和沙利度胺联合使用似乎没有比单独使用唑来膦酸带来额外的肾脏安全风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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BMC Clinical Pharmacology

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