Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA.
Oak Ridge Institute of Science and Education Fellowship, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
Sci Rep. 2021 Dec 14;11(1):23956. doi: 10.1038/s41598-021-03214-x.
Osteoporosis affects over 10 million Americans over 50. Bisphosphonate therapy, mainly alendronate, is amongst the most prescribed treatments for the disease. The use of alendronate and other bisphosphonates has been associated with depressive symptoms in recent case reports. In this study we quantified this association by analyzing over 100,000 adverse events reports from the Food and Drug Administration Adverse Events Reporting System (FAERS) and the World Health Organization's (WHO) global database for adverse drug reactions, ADRs, VigiAccess. We found that alendronate therapy is significantly associated with depression and anxiety when compared to other first-line osteoporosis treatments. The reported risk of depressive ADRs was found to be over 14-fold greater in patients taking alendronate under the age of 65 and over fourfold greater for patients over 65 compared to the control. Several hypotheses concerning the molecular mechanism of the observed association of alendronate and depressive symptoms were discussed.
骨质疏松症影响了超过 1000 万 50 岁以上的美国人。双磷酸盐治疗,主要是阿仑膦酸钠,是该疾病最常开的治疗方法之一。最近的病例报告显示,阿仑膦酸钠和其他双磷酸盐的使用与抑郁症状有关。在这项研究中,我们通过分析来自美国食品和药物管理局不良事件报告系统(FAERS)和世界卫生组织(WHO)全球药物不良反应数据库,VigiAccess 的超过 100000 份不良事件报告来量化这种关联。我们发现,与其他一线骨质疏松症治疗方法相比,阿仑膦酸钠治疗与抑郁和焦虑显著相关。与对照组相比,年龄在 65 岁以下接受阿仑膦酸钠治疗的患者发生抑郁性不良反应的风险高出 14 倍以上,65 岁以上患者的风险高出 4 倍以上。我们讨论了几个关于观察到的阿仑膦酸钠与抑郁症状之间关联的分子机制的假设。