Andrew Spencer, Andrew Roberts, Nola Kennedy, Christina Ravera, Serge Cremers, Sanela Bilic, Terry Neeman, Michael Copeman, Horst Schran, Kevin Lynch
{"title":"Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study.","authors":"Andrew Spencer, Andrew Roberts, Nola Kennedy, Christina Ravera, Serge Cremers, Sanela Bilic, Terry Neeman, Michael Copeman, Horst Schran, Kevin Lynch","doi":"10.1186/1472-6904-8-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":9196,"journal":{"name":"BMC Clinical Pharmacology","volume":"8 ","pages":"2"},"PeriodicalIF":0.0000,"publicationDate":"2008-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/1472-6904-8-2","citationCount":"8","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Clinical Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/1472-6904-8-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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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