van Grootheest A C, Straus S M, Heeringa M
Stichting Landelijke Registratie Evaluatie Bijwerkingen (LAREB), Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch.
Ned Tijdschr Geneeskd. 2001 Mar 17;145(11):526-9.
Sildenafil has been registered for the treatment of erectile dysfunction since 1998. World wide a large number of patients were reported, dying of acute heart disease after using sildenafil. Therefore the patient instruction text was adapted. Simultaneous use of sildenafil and nitrates is contraindicated because of serious decrease of the blood pressure. The use of sildenafil can lead to physical stress in patients with a history of heart disease and a treadmill test assessment is advisable. In two years 38 adverse reactions were seen in 25 Dutch patients. The Dutch reports (three cardiovascular deaths since the introduction) also show the dilemmas in the assessment of the safety of sildenafil: is it the underlying disease or is it the drug that causes death? Further research into the adverse reactions has to be done, therefore reporting suspected side effects of sildenafil is important.
自1998年以来，西地那非已被注册用于治疗勃起功能障碍。在全球范围内，有大量患者在使用西地那非后死于急性心脏病的报告。因此，对患者说明书进行了修改。由于会严重降低血压，西地那非与硝酸盐类药物同时使用是禁忌的。有心脏病史的患者使用西地那非可能会导致身体应激反应，建议进行跑步机测试评估。在两年内，25名荷兰患者出现了38例不良反应。荷兰的报告（自引入该药物以来有3例心血管死亡）也显示了评估西地那非安全性时的两难境地：是潜在疾病还是药物导致了死亡？必须对不良反应进行进一步研究，因此报告西地那非的疑似副作用很重要。
