Roehrborn Claus G, Casabé Adolfo, Glina Sidney, Sorsaburu Sebastian, Henneges Carsten, Viktrup Lars
University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Instituto Médico Especializado, Buenos Aires, Argentina.
Int J Urol. 2015 Jun;22(6):582-7. doi: 10.1111/iju.12741. Epub 2015 Mar 31.
To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5 mg with finasteride 5 mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia.
An international, randomized, double-blind, parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26 weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization.
Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week 4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week 12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week 26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week 26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P = 0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P ≥ 0.371).
Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.
在一项随机研究中报告治疗满意度的二次分析以及具有临床意义的改善情况，该研究比较了5毫克他达拉非与5毫克非那雄胺联合用药与单独使用非那雄胺治疗良性前列腺增生继发前列腺肿大的男性患者的疗效。
对年龄≥45岁、未使用过5-α还原酶抑制剂、国际前列腺症状评分≥13且前列腺体积≥30毫升的男性进行了一项国际、随机、双盲、平行研究；350名男性接受安慰剂/非那雄胺治疗，345名男性接受他达拉非/非那雄胺治疗，为期26周。按照方案使用良性前列腺增生治疗满意度量表评估治疗满意度。事后分析的反应者临界值为国际前列腺症状评分从随机分组起改善≥3分或≥25%。
反应者和非反应者的基线患者特征总体上具有可比性。在第4周时，他达拉非/非那雄胺组和安慰剂/非那雄胺组国际前列腺症状评分改善≥3分的患者比例分别为57.0%和47.9%（比值比1.45，95%置信区间1.07 - 1.97），在第12周时分别为68.8%和60.7%（比值比1.48，95%置信区间1.07 - 2.05），在第26周时分别为71.4%和70.2%（比值比1.14，95%置信区间0.81 - 1.61）；对于国际前列腺症状评分变化≥25%，相应比例分别为44.8%和32.9%（比值比1.66，95%置信区间1.21 - 2.28），55.5%和51.9%（比值比1.18，95%置信区间0.87 - 1.62），以及62.0%和58.3%（比值比1.23，95%置信区间0.89 - 1.70）。在第26周时，他达拉非/非那雄胺组在总体治疗满意度量表评分（P = 0.031）和疗效子评分满意度（P = 0.025）方面的治疗满意度显著高于安慰剂/非那雄胺组；在给药满意度或副作用满意度方面，两组评分无显著差异（P均≥0.371）。
与安慰剂/非那雄胺相比，他达拉非/非那雄胺可使更多患者在早期实现具有临床意义的症状改善，并具有更高的治疗满意度。
