枸橼酸西地那非用于接受多种抗高血压药物治疗的男性勃起功能障碍：一项随机对照试验。

Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial.

作者信息

Pickering Thomas G, Shepherd Alexander M M, Puddey Ian, Glasser Dale B, Orazem John, Sherman Nancy, Mancia Giuseppe

机构信息

Columbia University Medical College, New York, New York 10032, USA.

出版信息

Am J Hypertens. 2004 Dec;17(12 Pt 1):1135-42. doi: 10.1016/j.amjhyper.2004.07.004.

DOI:10.1016/j.amjhyper.2004.07.004

PMID:15607620

Abstract

BACKGROUND

Erectile dysfunction (ED) is common among men taking antihypertensive drugs to control blood pressure. We evaluated the safety and efficacy of sildenafil citrate for treating ED in men taking multiple antihypertensive medications in a randomized, double-blind, placebo-controlled trial.

METHODS

A total of 568 men (> or =18 years) with ED and hypertension who were taking two or more antihypertensives were randomized to sildenafil (n = 281) or matching placebo (n = 287) for a 6-week double-blind trial followed by a 6-week open-label phase during which all patients received sildenafil. Primary efficacy variables were questions (Q) 3 and 4 (frequency of erections and penetration) of the International Index of Erectile Function (IIEF), and secondary efficacy variables were two global efficacy assessment (GEA) questions regarding improvement in erections and intercourse.

RESULTS

A total of 562 men (mean age, 59 years) took > or =1 dose of study drug. At week 6, mean scores on both Q3 and Q4 improved significantly among sildenafil-treated compared with placebo-treated patients. In regard to Q3 and Q4 there were no differences between patients taking two and those taking three or more antihypertensive agents. In all, 71% and 69% of sildenafil-treated patients reported improved erections (GEA1) and intercourse (GEA2) compared with 18% and 20% of placebo-treated patients, respectively. By week 12, >80% of all patients (regardless of initial treatment group) had improved erections and intercourse. During double-blind treatment, 40% of sildenafil-treated and 25% of placebo-treated patients experienced adverse events; fewer than 2% in each group discontinued because of adverse events.

CONCLUSIONS

Sildenafil was an effective and well tolerated treatment for ED in men receiving multiple antihypertensives. The results suggest that there were no additional safety risks associated with the use of sildenafil in these patients.

摘要

背景

勃起功能障碍（ED）在服用抗高血压药物控制血压的男性中很常见。我们在一项随机、双盲、安慰剂对照试验中评估了枸橼酸西地那非治疗服用多种抗高血压药物男性的ED的安全性和有效性。

方法

共有568名年龄≥18岁、患有ED和高血压且正在服用两种或更多种抗高血压药物的男性被随机分为西地那非组（n = 281）或匹配的安慰剂组（n = 287），进行为期6周的双盲试验，随后是为期6周的开放标签阶段，在此期间所有患者均接受西地那非治疗。主要疗效变量是国际勃起功能指数（IIEF）的问题3和问题4（勃起频率和插入频率），次要疗效变量是关于勃起和性交改善情况的两个总体疗效评估（GEA）问题。

结果

共有562名男性（平均年龄59岁）服用了≥1剂研究药物。在第6周时，与安慰剂治疗的患者相比，西地那非治疗的患者在问题3和问题4上的平均得分显著提高。在问题3和问题4方面，服用两种抗高血压药物的患者与服用三种或更多种抗高血压药物的患者之间没有差异。总体而言，分别有71%和69%的西地那非治疗患者报告勃起（GEA1）和性交（GEA2）有所改善，而安慰剂治疗患者的这一比例分别为18%和20%。到第12周时，所有患者（无论初始治疗组如何）中超过80%的患者勃起和性交情况得到改善。在双盲治疗期间，40%的西地那非治疗患者和25%的安慰剂治疗患者经历了不良事件；每组因不良事件停药的患者少于2%。