When it comes to Sildenafil, many people immediately think of treating male erectile dysfunction.
Indeed, Sildenafil citrate (commonly known as Sildenafil) is a commonly used oral medication for treating male erectile dysfunction. It works by inhibiting the activity of phosphodiesterase to increase cyclic guanosine monophosphate in tissues, causing relaxation of the smooth muscles in the penile corpus cavernosum and penile arterioles, increasing local tissue blood flow, and achieving the purpose of treating male erectile dysfunction.
Currently, the indications in the Sildenafil package insert are limited to the treatment of male erectile dysfunction. However, the original intention of the earliest research on Sildenafil was not to treat male diseases.
Sildenafil was a “surprise”
Pfizer initially developed Sildenafil to treat cardiovascular diseases, but the results of clinical trials were not very ideal. The pharmaceutical company planned to retrieve the remaining trial medication from the participants, but no one wanted to return it. It was then discovered that this drug could improve the quality of users’ sexual life, giving birth to the well-known “Viagra.”
Sildenafil not only treats “sex” but also saves “lives”
Last year, the news of a young girl buying “Viagra” at a pharmacy may have been heard by many. The incident was shocking and also felt helpless. The girl had pulmonary arterial hypertension, a type of disease with a poor prognosis that is difficult to cure once diagnosed, requiring lifelong treatment.
In addition to treating male erectile dysfunction, Sildenafil is recommended as a first-line medication for pulmonary arterial hypertension in European and American pulmonary arterial hypertension treatment guidelines. However, it has not been documented in the domestic package insert, making it an off-label use for treating pulmonary arterial hypertension.
The main drugs approved in our country for treating pulmonary arterial hypertension are bosentan and ambrisentan, but they are quite expensive. To alleviate the heavy economic burden on patients, the slightly cheaper Sildenafil is chosen out of necessity.
However, for children, since the Sildenafil available on the market is mainly in dosages and formulations for treating male diseases, careful evaluation and consideration are required for pediatric use. The National Health Commission has issued a notice on the approval of the third batch of children’s drug list for research and development, which includes Sildenafil oral suspension. It is believed that good news will soon be brought to patients.
Off-label use of Sildenafil
With the increasing clinical application of Sildenafil, more and more research reports indicate that Sildenafil can also be used to treat infertility, delayed endometrial development and premature delivery, ischemia-reperfusion injury, myocardial infarction, heart failure, and other diseases. Currently, off-label use of Sildenafil is common, especially among women of childbearing age and newborns. As this group constitutes special populations, caution must be exercised in off-label use. Due to the adverse reactions of Sildenafil, if used in special populations, further clinical trials are recommended to clarify the safety and effectiveness of off-label use of Sildenafil, ensuring the safety of off-label use and avoiding related medical risks, thus being responsible for patients.
Reference:
[1] Deng GH, Yang L, Chen XK, He JH, Zhang L. A retrospective investigation of off-label use of Sildenafil. Chin J Pharmacoepidemiol. 2017, 36(01): 44-47.
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