Kaminetsky Jed C, Stecher Vera, Tseng Li-Jung
University Urology Associates, New York, NY, USA.
Pfizer Inc., New York, NY, USA.
Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.
The aim of this study was to assess erection quality with sildenafil vs placebo and adverse events (AEs) according to age (≤45, 46-55 and ≥56 years) in 997 men with erectile dysfunction (ED) using pooled data from four randomized, double-blind, placebo-controlled, flexible-dose trials.
The trials included 6- to 10-week treatment periods. The starting sildenafil dose was 50 mg, taken ~1 hour before sexual activity but not more than once daily, with subsequent adjustment to 100 or 25 mg based on efficacy and safety. Exclusion criteria included blood pressure <90/50 or >170/110 mmHg, taking nitrate therapy or nitric oxide donors, severe cardiac failure/unstable angina or recent stroke or myocardial infarction. Changes from baseline in Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were analysed.
Improvements in QEQ scores with sildenafil vs placebo were significant (P<.0001) for the overall sample (33.7 sildenafil; 8.1 placebo) and each age group (≤45 years: 38.5 sildenafil, 13.9 placebo; 46-55 years: 34.9 sildenafil, 5.8 placebo; ≥56 years: 26.9 sildenafil, 4.9 placebo). IIEF Erectile Function domain (P<.0001), question 3 (achieving erection; P<.003), and question 4 (maintaining erection; P<.001) scores also improved significantly for the overall sample and each age group. Treatment satisfaction was significantly greater (P<.0001) with sildenafil vs placebo for the overall sample and each age group. The most common AEs with sildenafil were headache, flushing and nasal congestion in all age groups.
Sildenafil significantly improved erection quality across all age groups of men with ED. Efficacy improvements with sildenafil were consistent with the QEQ, IIEF, and EDITS. AEs were comparable across age groups. ClinicalTrials.gov ID: NCT00159900, NCT00147628, NCT00301262, NCT00343200.
本研究旨在利用四项随机、双盲、安慰剂对照、灵活剂量试验的汇总数据，评估997名勃起功能障碍（ED）男性使用西地那非与安慰剂相比的勃起质量以及按年龄（≤45岁、46 - 55岁和≥56岁）划分的不良事件（AE）。
试验包括6至10周的治疗期。西地那非起始剂量为50毫克，在性活动前约1小时服用，但每日不超过一次，随后根据疗效和安全性调整为100毫克或25毫克。排除标准包括血压<90/50或>170/110毫米汞柱、正在接受硝酸盐治疗或使用一氧化氮供体、严重心力衰竭/不稳定型心绞痛或近期中风或心肌梗死。分析了勃起质量问卷（QEQ）、国际勃起功能指数（IIEF）和治疗满意度勃起功能障碍量表（EDITS）得分相对于基线的变化。
对于总体样本（西地那非组为33.7，安慰剂组为8.1）以及各年龄组（≤45岁：西地那非组为38.5，安慰剂组为13.9；46 - 55岁：西地那非组为34.9，安慰剂组为5.8；≥56岁：西地那非组为26.9，安慰剂组为4.9），西地那非组与安慰剂组相比，QEQ得分的改善具有显著性（P<.0001）。总体样本和各年龄组的IIEF勃起功能领域（P<.0001）、问题3（实现勃起；P<.003）和问题4（维持勃起；P<.001）得分也有显著改善。总体样本和各年龄组中，西地那非组的治疗满意度显著高于安慰剂组（P<.0001）。西地那非在所有年龄组中最常见AE为头痛、面部潮红和鼻塞。
西地那非显著改善了所有年龄组ED男性的勃起质量。西地那非的疗效改善与QEQ、IIEF和EDITS一致。各年龄组的AE具有可比性。ClinicalTrials.gov标识符：NCT00159900、NCT00147628、NCT00301262、NCT00343200。
