Long-term efficacy and safety of sildenafil was assessed in 1008 patients with erectile dysfunction (ED) enrolled in four flexible-dose (25 - 100 mg), open-label, 36- or 52-week extension studies. After 36 and 52 weeks, 92% and 89% of patients felt that treatment with sildenafil had improved their erections. Responses to a Sexual Function Questionnaire indicated that 52 weeks of sildenafil treatment resulted in clinically significant improvements in the duration and firmness of erections, overall satisfaction with sex life, and the frequency of stimulated erections. Commonly reported adverse events (AEs) were headache, flushing, dyspepsia, and rhinitis, which were generally mild to moderate. Reports of abnormal vision were consistent with previous clinical trials. The occurrence of treatment-related cardiovascular AEs, such as hypertension, tachycardia, and palpitation, was <1%. Discontinuations due to treatment-related AEs were low (2%). Long-term therapy does not diminish the efficacy of sildenafil in patients with ED and remains well tolerated.

中文翻译：

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长期治疗期间勃起功能障碍男性中伟哥（枸sil酸西地那非）的疗效和安全性评估。

西地那非的长期疗效和安全性在100例勃起功能障碍（ED）的患者中进行了评估，该患者参加了4项弹性剂量（25-100 mg），开放标签，36周或52周扩展研究。在36和52周后，有92％和89％的患者认为西地那非治疗可改善勃起。对性功能问卷的回答表明，西地那非治疗52周可以使勃起的持续时间和牢固性，对性生活的总体满意度以及刺激的勃起频率在临床上得到显着改善。常见的不良事件（AE）为头痛，潮红，消化不良和鼻炎，通常为轻度至中度。视力异常的报告与以前的临床试验一致。与治疗有关的心血管AE的发生，例如高血压，心动过速和心pa <1％。与治疗相关的不良事件引起的停药率较低（2％）。长期治疗不会降低西地那非对ED患者的疗效，并且仍具有良好的耐受性。