Universidade do Estado do Rio de Janeiro, Departamento de Clinica Medica, Hospital Universitario Pedro Ernesto, State University of Rio de Janeiro, Brazil.
Urology. 2012 Oct;80(4):858-64. doi: 10.1016/j.urology.2012.06.042. Epub 2012 Aug 22.
To evaluate whether the response to on-demand vardenafil could be improved by its daily usage in hypertensive men with erectile dysfunction (ED) who previously did not answer to on-demand regime.
Our main efficacy criterion was per patient percentage of positive answers on the Sexual Encounter Profile question 3 (SEP3). Carotid intima-media thickness (IMT), flow-mediated dilation (FMD), and nitrate-mediated dilation on brachial artery were considered as vascular parameters. A total of 74 hypertensive men with ED aged 50 to 70 years with no major cardiovascular disease were selected from 284 patients initially referred. After vardenafil on-demand usage during 4 weeks, patients with more than 50% of positive answers on the SEP3, or 50% and more than 6 points on the International Index of Erectile Function-Erection Function Domain (IIEF-EF) basal score or positive answer to global evaluation question were considered "responders." "Nonresponders" (n = 35) were randomized to daily vardenafil 10 mg or placebo during 5 weeks along with open 10 mg of vardenafil before intercourse.
In the active group, 38.8% of patients became responders to vardenafil (P < .05). Clinical response to continuous vardenafil correlated with sexual frequency (r = .68, P < .01), Framingham risk score (r = -.65, P < .01), carotid IMT (r = -.61, P = .01) and low-density lipoprotein (LDL)-cholesterol (r = -.64, P < .01).
Daily vardenafil during 5 weeks rescued response to on-demand regime among ED hypertensive men with no major cardiovascular disease. Further clinical trials and cost-effectiveness studies are necessary to confirm these findings.
评估按需使用伐地那非对先前对按需治疗方案无反应的高血压伴勃起功能障碍（ED）男性的日常使用是否能改善其反应。
我们的主要疗效标准是每位患者在性遭遇调查问卷 3（SEP3）上的阳性回答百分比。颈动脉内膜中层厚度（IMT）、血流介导的扩张（FMD）和肱动脉硝酸盐介导的扩张被认为是血管参数。从最初转诊的 284 名患者中选择了 74 名年龄在 50 至 70 岁之间、无重大心血管疾病的高血压 ED 男性。在按需使用伐地那非 4 周后，SEP3 阳性回答率超过 50%，或 IIEF-EF 基础评分中 50%以上且超过 6 分，或全球评估问题阳性回答的患者被认为是“应答者”。“无应答者”（n=35）被随机分为连续 5 周接受伐地那非 10mg 或安慰剂治疗组，同时在性交前开放接受 10mg 伐地那非治疗。
在活性组中，38.8%的患者对伐地那非有反应（P<.05）。连续使用伐地那非的临床反应与性频率（r=0.68，P<.01）、弗雷明汉风险评分（r=0.65，P<.01）、颈动脉 IMT（r=0.61，P=0.01）和低密度脂蛋白胆固醇（LDL-C）（r=0.64，P<.01）相关。
在无重大心血管疾病的高血压 ED 男性中，连续 5 周使用伐地那非可挽救对按需治疗方案的反应。需要进一步的临床试验和成本效益研究来证实这些发现。
