Govorov Alexander, Kasyan George, Priymak Diana, Pushkar Dmitry, Sorsaburu Sebastian
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Department of Urology, Moscow, Russia.
Eli Lilly Vostok S.A.
Cent European J Urol. 2014;67(2):167-77. doi: 10.5173/ceju.2014.02.art10. Epub 2014 Jun 23.
Strong epidemiologic evidence supports correlation between lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) and erectile dysfunction (ED). The link has biologic plausibility given phosphodiesterase type 5 (PDE5) expression in pelvic structures. PDE5 inhibitors target pathophysiologic processes implicated in LUTS/BPH.
This review highlights the efficacy and safety of the daily use of a PDE5 inhibitor tadalafil in LUTS/BPH, with a focus on LUTS/BPH medical management in Russia.
Alpha-blockers and phytotherapy are major components of the current LUTS/BPH therapy in Russia. Russian regulatory authorities granted approval for once-daily tadalafil for treatment of LUTS/BPH in January 2012. In a pivotal study, tadalafil 5 mg once-daily significantly improved International Prostate Symptom Score (IPSS) over 12 weeks vs. placebo (P = .004) regardless of baseline ED severity. IPSS improvement was maintained at 12 weeks. Integrated analysis of randomized studies showed that tadalafil 5 mg once-daily resulted in significant symptom improvements across a range of men with LUTS/BPH. Relief of LUTS due to tadalafil was independent of improvement in ED; improvements in IPSS and erectile function were only weakly correlated (r = -0.229). Another pooled analysis found similar improvement in LUTS/BPH between men with or without ED, with non-significant P values for treatment-by-ED-status interactions for total IPSS ( P = .73). Non-registration studies of tadalafil and alpha-blocker co-therapy in LUTS/BPH suggest an additive effect, but co-therapy is not recommended in current tadalafil prescribing instructions.
Tadalafil results in symptom improvements across a range of men with LUTS/BPH and represents a new treatment option for patients in Russia with LUTS/BPH.
强有力的流行病学证据支持良性前列腺增生所致下尿路症状（LUTS/BPH）与勃起功能障碍（ED）之间存在关联。鉴于5型磷酸二酯酶（PDE5）在盆腔结构中的表达，这种联系具有生物学合理性。PDE5抑制剂针对LUTS/BPH所涉及的病理生理过程。
本综述重点介绍了每日使用PDE5抑制剂他达拉非治疗LUTS/BPH的疗效和安全性，特别关注俄罗斯LUTS/BPH的药物治疗。
α受体阻滞剂和植物疗法是俄罗斯目前LUTS/BPH治疗的主要组成部分。俄罗斯监管机构于2012年1月批准他达拉非每日一次用于治疗LUTS/BPH。在一项关键研究中，无论基线ED严重程度如何，每日一次服用5mg他达拉非在12周内与安慰剂相比显著改善了国际前列腺症状评分（IPSS）（P = 0.004）。IPSS的改善在12周时得以维持。随机研究的综合分析表明，每日一次服用5mg他达拉非可使一系列LUTS/BPH男性患者的症状得到显著改善。他达拉非所致LUTS的缓解与ED的改善无关；IPSS和勃起功能的改善仅呈弱相关（r = -0.229）。另一项汇总分析发现，有或无ED的男性在LUTS/BPH方面有相似改善，总IPSS的ED状态治疗交互作用的P值无统计学意义（P = 0.73）。他达拉非与α受体阻滞剂联合治疗LUTS/BPH的非注册研究提示有相加作用，但目前他达拉非的处方说明中不推荐联合治疗。
他达拉非可使一系列LUTS/BPH男性患者的症状得到改善，是俄罗斯LUTS/BPH患者的一种新治疗选择。
