Sansone Andrea, Guida Eugenia, Dolci Susanna, Frangione Valeria, Asso Amanda, Bellia Gilberto, Jannini Emmanuele A
Chair of Endocrinology and Medical Sexology (ENDOSEX), Dept. of Systems Medicine, University of Rome Tor Vergata, via Montpellier 1, Rome, 00133, Italy.
Chair of Anatomy, Dept. of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
Basic Clin Androl. 2025 Jan 27;35(1):3. doi: 10.1186/s12610-024-00245-y.
The serendipitous discovery that inhibiting type 5 phosphodiesterase (PDE5) using sildenafil, a potent PDE5 inhibitor (PDE5i) initially developed for cardioprotection, introduced the possibility of orally managing erectile dysfunction (ED) led to an increase in research data, which are currently considered groundbreaking for the new discipline of sexual medicine. Findings from a number of laboratories and clinics around the world unanimously demonstrated the following: (i) the major cause of ED is directly or indirectly related to cardiovascular disease (CVD); (ii) ED and CVDs share the same risk factors, which are related mainly to lifestyle choices; (iii) the first therapeutic approach to both ED and CVDs is to transform harmful lifestyles into virtuous lifestyles; and (iv) PDE5is in general, particularly sildenafil, are very safe, if not protective, for use in CVD patients. However, the use of PDE5is has faced several challenges. Many patients and some healthcare providers (HCPs) often share the misconception that using these drugs can increase the risk of CVD. Some patients might desire to fulfill the unmet need for privacy linked to the stigma of being treated for ED or might be enticed by the idea of buying drugs online, either because of shame or cheaper prices, without knowing the risks associated with counterfeit drugs. The aim of this narrative revision of the current literature is to demonstrate that (i) the orodispersible film of sildenafil is safe from a CV perspective; (ii) it is a discreet formulation that respects the need for privacy; and (iii) it is virtually the unique PDE5i formulation too expensive to produce outside the correct channels, making it impossible to be counterfeit.
偶然发现，使用西地那非抑制5型磷酸二酯酶（PDE5）——一种最初为心脏保护而研发的强效PDE5抑制剂（PDE5i）——带来了口服治疗勃起功能障碍（ED）的可能性，这导致了研究数据的增加，这些数据目前被认为是性医学新学科的开创性成果。世界各地许多实验室和诊所的研究结果一致表明：（i）ED的主要原因直接或间接与心血管疾病（CVD）相关；（ii）ED和CVD具有相同的风险因素，主要与生活方式选择有关；（iii）对ED和CVD的首要治疗方法都是将有害的生活方式转变为健康的生活方式；（iv）一般来说，PDE5i，尤其是西地那非，对CVD患者使用即使没有保护作用也是非常安全的。然而，PDE5i的使用面临一些挑战。许多患者和一些医疗保健提供者（HCP）常常有这样的误解，即使用这些药物会增加患CVD的风险。一些患者可能希望满足与因治疗ED而产生的耻辱感相关的未被满足的隐私需求，或者可能因羞耻或价格便宜而被网上购药的想法所吸引，却不知道假药的相关风险。本对当前文献的叙述性综述的目的是证明：（i）从心血管角度来看，西地那非口腔崩解膜是安全的；（ii）它是一种谨慎的剂型，尊重隐私需求；（iii）它几乎是唯一一种在正规渠道之外生产成本过高以至于不可能造假的PDE5i剂型。
