Albuquerque Denilson C, Miziara Lineu J, Saraiva Jose F K, Rodrigues Ulisses S, Ribeiro Artur B, Wajngarten Mauricio
Department of Cardiology, State University of Rio de Janeiro, RJ, Brazil.
Int Braz J Urol. 2005 Jul-Aug;31(4):342-53; discussion 354-5. doi: 10.1590/s1677-55382005000400008.
To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs.
One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED) lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity). During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications.
The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively). In the assessment of global efficacy, 87% of the patients treated with sildenafil reported improved erections, as compared with 37% of patients given placebos (p < 0.0001). The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4%), vasodilation (11.4%) and dyspepsia (6.5%). There were no significant changes in blood pressure measurements in both groups.
Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.
评估西地那非在接受联合抗高血压药物治疗的巴西高血压患者中的疗效、安全性和耐受性。
120名年龄在30至81岁之间、正在接受两种或更多种抗高血压药物治疗且患有持续至少6个月勃起功能障碍（ED）的男性高血压患者在巴西的7个研究中心入组。患者被随机分为两组，一组在性交前1小时服用西地那非，另一组服用安慰剂（初始剂量为50毫克，根据疗效和毒性调整为25毫克或100毫克）。在接下来的8周内，对患者的生命体征、不良事件、治疗效果、对治疗的满意度以及同时使用的药物进行评估。
基于国际勃起功能指数第3和第4个问题的回答进行的疗效初步评估显示，西地那非治疗组有显著差异（p分别为0.0002和p<0.0001）。在总体疗效评估中，87%接受西地那非治疗的患者报告勃起功能有所改善，而服用安慰剂的患者中这一比例为37%（p<0.0001）。其他次要评估也支持西地那非更具优势的结果。接受西地那非治疗的患者中最常见的不良事件是头痛（11.4%）、血管扩张（11.4%）和消化不良（6.5%）。两组的血压测量值均无显著变化。
对于接受联合抗高血压药物治疗且患有ED的高血压患者，西地那非治疗有效且安全。
