Efficacy of the Orally Disintegrating Strip Sildenafil for the Treatment of Erectile Dysfunction: A Prospective, Randomized Trial
| Autor: | Yada Phengsalae, Wachira Kochakarn, Kun Sirisopana, Panuwat Lertsithichai, Wisoot Kongchareonsombat, Wijittra Matang, Premsant Sangkum, Chinnakhet Ketsuwan |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Sildenafil
Urology Endocrinology Diabetes and Metabolism Crossover Study Dermatology law.invention Behavioral Neuroscience chemistry.chemical_compound Other systems of medicine Endocrinology Randomized controlled trial Erectile Dysfunction law Medicine Adverse effect Orally Disintegrating Strip Original Research business.industry Incidence (epidemiology) medicine.disease Crossover study Pharmacotherapy Psychiatry and Mental health Erectile dysfunction Reproductive Medicine chemistry cGMP-specific phosphodiesterase type 5 Anesthesia Onset of action business RZ201-999 |
| Zdroj: | Sexual Medicine, Vol 9, Iss 6, Pp 100453-(2021) Sexual Medicine |
| ISSN: | 2050-1161 |
| Popis: | Introduction Phosphodiesterase 5 inhibitors are the predominant treatment option for erectile dysfunction. Aim This study evaluates the efficacy and safety of sildenafil orally disintegrating strips for the treatment of erectile dysfunction. Methods One hundred twenty erectile dysfunction patients were enrolled in a prospective, randomized, controlled crossover study and allocated into 2 groups of 60 participants. Patients were either treated with sildenafil strips or tablets for 8 weeks after which they crossed over into the alternate treatment formulation for another 8 weeks following a 4-week wash-out period. Each participant was assessed 8 times throughout the study period and their formulation preference registered at the end of the study. Main outcomes and measures Changes in the abridged International Index of Erectile Function (IIEF-5) score and Erection Hardness Score (EHS) resulting from sildenafil orally disintegrating strip or tablet treatments were the primary end points, with differences in onset of action, duration of action, and incidence of adverse events between the 2 formulations included as secondary end points. Results Both sildenafil formulations were effective in treating patients with erectile dysfunction. There was significant improvement of erectile function in term of IIEF-5 score and EHS from both formulations. The number and type of adverse events were also comparable. Likewise, there were no statistically significant differences between the earliest onset of action times and longest duration of action times. However, the results showed a 7.1-minute earlier onset of action time for orally disintegrating strips that may be considered as clinically meaningful by some patients. Conclusion Sildenafil orally disintegrating strips are a safe and effective alternative to the conventional tablet formulation for the treatment of erectile dysfunction. |
| Databáze: | OpenAIRE |
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