Tarapués Mónica, Cereza Gloria, Figueras Albert
1Pharmacology, Therapeutics and Toxicology Department, Universitat Autònoma de Barcelona , E-08193 Bellaterra (Cerdanyola del Vallès), Barcelona , Spain
Expert Opin Drug Saf. 2015 Jun;14(6):807-13. doi: 10.1517/14740338.2015.1036857. Epub 2015 May 12.
Renal impairment associated with dronedarone use is hardly known. Our aim is to describe the characteristics of spontaneous reports involving renal adverse reactions with use of dronedarone.
In the Spanish Pharmacovigilance database, reports with renal reactions and dronedarone until May 2014 were retrieved and analyzed. Also, a review of case reports of renal failure and dronedarone was conducted in MEDLINE.
Dronedarone was found as a suspected drug in 192 reports, 10 (5.2%) of these reports described renal reactions. Renal reactions appeared until 3 months after the onset of dronedarone treatment. In 5 out of 10 cases, dronedarone was withdrawn and the patient recovered. The Reporting Odds Ratio was 2.88 [95% CI 1.52 - 5.46; p < 0.05]. Additionally, eight cases were found in the medical literature. In five of them, the patient outcome was described as recovered. One patient had to undergo hemodialysis for the treatment of their renal impairment.
The effect of dronedarone on the renal function is supported by limited information; therefore, the cases from spontaneous reporting system and those from the medical literature could give relevant additional information. Our analysis shows a potential relationship between dronedarone use and renal impairment. Further studies are needed to confirm these findings.
与使用决奈达隆相关的肾功能损害鲜为人知。我们的目的是描述涉及决奈达隆使用导致肾脏不良反应的自发报告的特征。
在西班牙药物警戒数据库中，检索并分析了截至2014年5月的有关肾脏反应和决奈达隆的报告。此外，还在医学文献数据库中对决奈达隆导致肾衰竭的病例报告进行了综述。
在192份报告中发现决奈达隆为可疑药物，其中10份（5.2%）报告描述了肾脏反应。肾脏反应出现在决奈达隆治疗开始后的3个月内。10例中有5例停用了决奈达隆，患者康复。报告比值比为2.88[95%可信区间1.52 - 5.46；p < 0.05]。此外，在医学文献中发现了8例。其中5例患者的结局被描述为康复。1例患者因肾功能损害不得不接受血液透析治疗。
关于决奈达隆对肾功能影响的信息有限；因此，自发报告系统的病例和医学文献中的病例可能会提供相关的补充信息。我们的分析显示了决奈达隆使用与肾功能损害之间的潜在关系。需要进一步研究来证实这些发现。
