Sildenafil as orodispersible film may provide satisfaction to patients with in context of daily clinical practice: Study
Erectile dysfunction (ED) is defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. Recent European Association of Urology (EAU) guidelines established that ED is a frequent medical condition.
ED has a significant impact on patients’ quality of life (QoL) and their physical and psychosocial health. There is a growing body of scientific evidence demonstrating that ED is an early manifestation of peripheral vascular disease. ED should therefore be considered as a potential warning sign of cardiovascular disease, which is the leading cause of mortality.
The management of ED includes the control of risk factors (tobacco use, obesity, sedentary lifestyle, chronic alcohol use, comorbidities, and depression) and appropriate pharmacological therapy. The first-line treatment for ED is oral therapy with an inhibitor of cyclic guanosine monophosphate- (cGMP-) specific phosphodiesterase type 5 (PDE5-I). The PDE5-I results in intracellular accumulation of cGMP, which induces relaxation of smooth muscles and blood flow in the cavernous bodies of the penis. In this way, PDE5-I exerts a proerectile action helping to maintain the erection after sexual stimulation. Sildenafil is the first PDE5-I approved, and it represents an effective and safe oral drug treatment for ED. Xybilun® (IBSA Pharma SAS, France), a new orodispersible film formulation (sildenafil-ODF) available in four different dosage forms (25, 50, 75, and 100 mg), represents a valid alternative to the tablets.
Sildenafil ODF does not require the intake of a liquid; in comparison to coated-tablets, this mode of assumption is more subtle and unobtrusive. The 75 mg dose allows a fine-tuned modulation of the therapy. Pharmacokinetic studies demonstrated that the sublingual and supralingual exposure to sildenafil-ODF is comparable to that of conventional sildenafil coated-tablets.
The present multicentre observational study was aimed at collecting and comparing data in real-life setting use of sildenafil-ODF at different doses (50, 75, and 100 mg) in patients suffering from mild to severe ED during three months of treatment.
Patients aged ≥18 years with ED were included in four groups: Group 1 mild, Group 2 moderate, Group 3 severe ED, according to the International Index for Erectile Function (IIEF)-6 subscore, never treated with phosphodiesterase inhibitors (PDE)5-I; Group 4, patients previously treated with another PDE5-I. Patients were evaluated at baseline (V1), one (V2), and three (V3) months. The RR and satisfaction were assessed using the IIEF-6 subscore questionnaire, a 5-point Likert scale, and a Global Assessment Question (GAQ). The primary endpoint for Groups 1 to 3 was the RR according to Rosen criteria at V3 compared to V1. For Group 4, the primary endpoint was the RR, defined as the satisfaction compared with previous treatment. Secondary endpoints were the RR at V2 compared to V1, the evolution of IIEF-6 and IIEF-15 scores, dose adjustment, satisfaction, convenience, and safety. One hundred and five patients were enrolled, 83 analysed. The RR at V3 was 100% (Group 1); 75% (Group 2); 65.2% (Group 3); and 84.2% (Group 4). The overall RR was 78.3%. Secondary parameters confirmed the satisfaction with sildenafil-ODF, with 81.6% of patients very satisfied at V3. No Serious Adverse Events (SAEs) were observed.
In conclusion, this study confirms, in the context of daily clinical practice, the satisfaction of patients with sildenafil ODF. Data also suggest that the availability of the intermediate dose of 75 mg could add greater flexibility to the therapy.
Source: Stéphane Droupy 1 and Marie Hélène Colson; Hindawi International Journal of Reproductive Medicine Volume 2022, Article ID 9122099, 8 pages https://doi.org/10.1155/2022/9122099
