Sildenafil-orodispersible film benefits patients irrespective of severity of Erectile dysfunction
Erectile dysfunction (ED) is defined by "The National Institutes of Health Consensus Development Conference on Impotence" as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. 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.
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.
A 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.
The results of secondary endpoints indicate that, even if the first effects occur at one month, the peak of efficacy is reached probably around the third month of treatment. The increase of effectiveness at three months could be due, at least partially, to the dose adjustment, especially in those with the most severe symptoms. Effects were similar in patients previously treated for ED and in those who just started treatment. Consistently, with the primary endpoint, the improvement of the symptoms defined by the IIEF-6 score RR is higher in mild/moderate groups.
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 and Marie Hélène Colson; Hindawi International Journal of Reproductive Medicine https://doi.org/10.1155/2022/9122099
