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Sildenafil: two decades of benefits or risks?

Abstract Sildenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). A patent was registered for this drug in 1990, which expired in 2010. Since expiration, the drug has been marketed under various trade names or as generic drugs. Numerous clinical trials have been conducted addressing the effectiveness of the drug for erectile dysfunction (ED) and its safety regarding the presence or absence of specific comorbidities. After over 20 years in the market, we need to ask: has the scientific community reached a general consensus as to the overall efficacy and safety of the drug? Can we firmly state that the benefits of the drug outweigh its risks? This review suggests that sildenafil is an effective and easily manageable treatment for erectile dysfunction, both in the absence and in the presence of comorbidities. After two decades of the emergence of sildenafil as a drug of choice for the treatment of ED (and the numerous studies and clinical trials undertaken during this time span), it is now possible to state that the benefits of the drug do outweigh the risks, and represent an significant improvement in the quality of life in men with ED.