Padma-nathan Harin, Eardley Ian, Kloner Robert A, Laties Alan M, Montorsi Francesco
The Male Clinic, Keck School of Medicine at the University of Southern California School of Medicine, Beverly Hills, California, USA.
Urology. 2002 Sep;60(2 Suppl 2):67-90. doi: 10.1016/s0090-4295(02)01752-1.
Clinical studies have demonstrated that sildenafil citrate (Viagra) is an effective and well-tolerated oral treatment for erectile dysfunction. Despite its established safety profile, concern about its cardiovascular safety persists among some physicians and the general public. This concern has stemmed primarily from sporadic reports of adverse events published in the literature and sensationalized by the media. However, the only absolute contraindication for sildenafil is concurrent use of nitrates. Because sildenafil has been on the market for 4 years and under clinical investigation for even longer, we can now evaluate its long-term safety in men who have been taking the drug for several years. We review this issue from 3 perspectives. First, we reassess the overall safety profile of sildenafil by reviewing the initial controlled clinical trials and open-label studies. We present new data from patients who have been exposed to sildenafil for up to 4.5 years. We also evaluate the results from independent postmarketing studies. Second, we review the cardiovascular-specific results from the clinical trials, long-term extension, and postmarketing studies. Lastly, we review the specific effects on the visual system based on findings from studies conducted during drug development and post marketing.
临床研究表明，枸橼酸西地那非（万艾可）是一种治疗勃起功能障碍的有效且耐受性良好的口服药物。尽管其安全性已得到确立，但一些医生和普通公众仍对其心血管安全性存在担忧。这种担忧主要源于文献中零星报道的不良事件，并被媒体炒作。然而，西地那非唯一绝对的禁忌证是与硝酸盐类药物同时使用。由于西地那非已上市4年，且进行临床研究的时间更长，我们现在可以评估服用该药物数年的男性的长期安全性。我们从三个角度审视这个问题。首先，我们通过回顾最初的对照临床试验和开放标签研究，重新评估西地那非的总体安全性。我们展示了接触西地那非长达4.5年的患者的新数据。我们还评估了独立的上市后研究结果。其次，我们回顾临床试验、长期扩展研究和上市后研究中针对心血管方面的结果。最后，我们根据药物研发期间和上市后进行的研究结果，回顾对视觉系统的具体影响。
