Glina Sidney, Roehrborn Claus G, Esen Adil, Plekhanov Alexey, Sorsaburu Sebastian, Henneges Carsten, Büttner Hartwig, Viktrup Lars
Instituto H. Ellis, São Paulo, Brazil; Department of Urology, Ipiranga Hospital, São Paulo, Brazil.
J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.
Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described.
Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED).
A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks.
International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs).
Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders.
TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.
他达拉非（TAD）5毫克与非那雄胺（FIN）5毫克联合使用可显著改善良性前列腺增生（BPH）和前列腺肿大男性的下尿路症状（LUTS）。然而，其对勃起/性功能的影响尚未得到充分描述。
评估TAD/FIN联合用药（与安慰剂[PBO]/FIN相比）对患有LUTS且继发于BPH伴或不伴基线合并勃起功能障碍（ED）的性活跃男性勃起和性功能的影响。
在13个国家的70个地点对695名男性进行了一项随机、双盲、PBO对照研究（610名性活跃；450名有基线ED；404名性活跃且有基线ED）。TAD 5毫克或PBO每日一次与FIN 5毫克每日一次联合使用，持续26周。
国际勃起功能指数（IIEF）领域和单项评分；在IIEF勃起功能领域评分（IIEF-EF；最小临床重要差异[MCID]定义为改善≥4分）中显示出最小临床重要差异的患者比例；以及性功能障碍不良事件（AE）。
与PBO/FIN相比，TAD/FIN使基线ED患者（所有测量指标P≤0.002）和无基线ED患者（所有测量指标P≤0.041）中评估的所有IIEF领域和单项评分均有所改善。与PBO/FIN相比，接受TAD/FIN治疗的有基线ED的性活跃男性在治疗4、12和26周后达到IIEF-EF MCID的百分比显著更高（在所有3个基线后时间点，TAD/FIN与PBO/FIN的优势比比较P<0.001）。性AE的发生率较低：5名TAD/FIN患者和7名PBO/FIN患者报告了性AE，包括ED、性欲减退/丧失和射精障碍。
TAD/FIN联合用药治疗继发于BPH的LUTS和前列腺肿大男性，无论治疗开始时是否存在ED，均可在统计学上显著改善勃起/性功能，且耐受性良好。
