Department of Drug Safety Information, Korea Institute of Drug Safety and Risk Management, Gyeonggi-do, Republic of Korea.
Department of Relief of Adverse Drug Reaction, Korea Institute of Drug Safety and Risk Management, Gyeonggi-do, Republic of Korea.
PLoS One. 2022 Mar 16;17(3):e0265169. doi: 10.1371/journal.pone.0265169. eCollection 2022.
One of the most prescribed treatments for benign prostatic hyperplasia (BPH) is 5α-reductase inhibitors (5ARI). Europe experienced recent safety issues involving 5ARI and depression symptoms, with similar findings being seen in Western countries. The South Korea has updated the drug label in accordance with European recommendations, but the relevant evidence was insufficient. This study compared the use of 5ARI versus α-blocker (AB) as a treatment for BPH and related risks of depression to provide evidence based on the Korean population.
This was a retrospective cohort study using South Korea's Health Insurance Review & Assessment Service claim data from 2011 to 2017. New patients diagnosed in men with BPH and taking medications that contained either 5ARI or AB between July 1, 2013, and June 30, 2015, were included (n = 1,461 5ARI; n = 18,650 AB). The primary outcome was depression defined per the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10: F32-34, F38, F412, F432). Logistic regression was used to implement 1:1 propensity score (PS) matching of patients taking 5ARI to those taking AB to adjust for confounding. Cox proportional hazard models were used to compare the risk of depression associated with 5ARI versus AB.
Balance in baseline characteristics between the treatment groups were achieved within PS matched pairs (1,461 pairs). Compared to the AB medication group, the 5ARI group had lower depression (HR: 0.69, 95% CI: [0.51-0.92]). However, we could not find a clinically relevant, statistical difference after PS matching (HR: 0.91, 95% CI: [0.61-1.36]).
The risk of depression associated with 5ARI was not meaningfully different from AB in Korea, which suggests that medical officials should provide the most appropriate medication for BPH patients by considering both treatment benefits and depression risk.
5α-还原酶抑制剂（5ARI）是治疗良性前列腺增生（BPH）最常用的方法之一。欧洲最近出现了涉及 5ARI 和抑郁症状的安全问题，西方国家也有类似的发现。韩国根据欧洲建议更新了药品标签，但相关证据不足。本研究比较了 5ARI 与 α-受体阻滞剂（AB）治疗 BPH 及相关抑郁风险的疗效，为韩国人群提供了基于证据的结果。
这是一项回顾性队列研究，使用了韩国 2011 年至 2017 年健康保险审查和评估服务的索赔数据。纳入 2013 年 7 月 1 日至 2015 年 6 月 30 日期间被诊断为 BPH 的男性患者，服用包含 5ARI 或 AB 的药物（n = 1461 例 5ARI；n = 18650 例 AB）。主要结局为根据国际疾病分类第 10 次修订版（ICD-10：F32-34、F38、F412、F432）定义的抑郁。采用 logistic 回归对服用 5ARI 的患者与服用 AB 的患者进行 1:1 倾向评分（PS）匹配，以调整混杂因素。采用 Cox 比例风险模型比较 5ARI 与 AB 相关的抑郁风险。
PS 匹配的治疗组间基线特征达到平衡（1461 对）。与 AB 药物组相比，5ARI 组的抑郁发生率较低（HR：0.69，95%CI：[0.51-0.92]）。但是，PS 匹配后，我们没有发现有临床意义的统计学差异（HR：0.91，95%CI：[0.61-1.36]）。
在韩国，与 5ARI 相关的抑郁风险与 AB 无显著差异，这表明医务人员应根据治疗获益和抑郁风险，为 BPH 患者提供最合适的药物。
