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Over-the-counter use of PDE-5 inhibitors – focus on safety issues

Lew-Starowicz, M1

1: Institute of Psychiatry and Neurology, Warsaw, Poland

Objectives: PDE-5 inhibitors are broadly accepted as a first-line treatment for men with erectile dysfunction. Recently, discussion arise according to the change of sildenafil availability category from “on prescription” to “over-the-counter” (OTC). Poland is the first country in the EU that legalized OTC sildenafil use. Supporters raised arguments of improved accessibility of safe and effective medication and limiting the influence of pharmaceutical black market. Opponents are drawing attention into safety concerns, possible negative impact on early detection of underlying cardiovascular disease and recreational drug use. The aim of this study was to address the safety issues, specifically, (1) if patients searching for the treatment of erectile dysfunction are able to make a safe decision on starting with the medication with sildenafil OTC supported by a dedicated self-administered questionnaire and (2) to compare patients self-assessment with evaluation made by physician.

Material and Methods: 147 male patients referring for the first consultation of erectile dysfunction have completed a self-assessment questionnaire (SAQ) intended to facilitate the assessment of potential medical contraindications to engage in sexual activity supported with sildenafil. Answers “yes” or “don’t know” were indicating a need for consultation with physician before starting the medication. Subsequently, all patients were examined by a qualified physician who stratified the cardiovascular risk of sexual activity according to the 3rd Princeton Consensus Recommendations and indications/contraindications for the use of sildenafil. Results of both assessments were compared.

Results: The diagnosis of erectile dysfunction was confirmed in 97,3% of patients. Based on responses in the SAQ, 58,5% of patients were advised to see a physician before starting the medication with sildenafil. Cardiovascular risk of engaging in sexual activity was assessed by the physicians as low in 84,4% of patients, intermediate in 10,9% and high in 4,8%. None of the patients refrained by a physician from using sildenafil has received a positive indication to start the medication based on SAQ.

Conclusions: The use of a SAQ proved to be an effective solution for patient self-assessment before starting medication with sildenafil OTC. However, there are still several pros and cons of the OTC use of sildenafil that have to be further investigated.


Work supported by industry: yes, by PPF Hasco Lek S.A. (industry funding only - investigator initiated and executed study).

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