Abstract Introduction Vasculogenic erectile dysfunction (ED) is a prevalent condition frequently treated with phosphodiesterase type 5 inhibitors (PDE5Is). However, standard fixed-dose regimens can limit patient adherence due to tolerability issues, and therapeutic adherence may be affected by the formulation. This study evaluates a novel oral suspension formulation of sildenafil, focusing on its efficacy, safety, and impact on treatment compliance, with particular emphasis on patients’ ability to individually adjust the dose based on clinical outcomes. Objective To evaluate a novel formulation of sildenafil via oral suspension, focusing on: A-the treatment efficacy and tolerability, B-the compliance with the treatment, and C-the patients’ propensity to revise autonomously the ingested dose. Methods Data from a cohort of 27 phosphodiesterase type 5 inhibitor (PDE5I) -naive patients being diagnosed with moderate or severe vasculogenic erectile dysfunction (ED) were collected prospectively. Patients were instructed to ingest eight puffs (e.g., 100mg) of the sildenafil suspension about one hour prior to sexual intercourse and were encouraged to reduce autonomously or under medical supervision the ingested dose according to the clinical response and/or the appearance of any side effect. All of the patients were informed about both the possible side effects of the treatment and the off-label nature of this prescription. The International Index of Erectile Function (IIEF-5) questionnaire was administered at baseline and at a 12-month follow-up consultation. The ED-severity was classified according to Cappelleri’s criteria. Results Three out of 27 patients were lost to follow-up. The median age was 65 years old (interquartile range (IQR) 61–72 years). Median baseline IIEF-5 was 9 (IQR 7-10). Eight out 24 patients discontinued the treatment or switched the formulation or the PDE5I-molecule at the 12-month follow-up. A significant IIEF-5 median score increase of 7 (IQR 7–8) points was identified at the 12-month followup among the treatment-compliant patients (p 0.01). Nine out of 16 patients reduced their dosage of up to 50% of the initially suggested dose, due to a satisfactory response even with a reduced dose, and/or the occurrence of minor adverse drug reactions (ADRs) including facial flushing and headache. Conclusions Despite the inherent limitations of this experience, these initial data seem to suggest that this novel PDE5I-formulation via oral suspension may be effective and safe even for moderate-to-severe ED patients, and even when the sildenafil dose exceeds the maximal threshold suggested for this specific formulation. The ability to adjust autonomously and/or under medical supervision the dosage within certain limits may provide a theoretical advantage in the compliance with the treatment, as a dose-reduction may come with better tolerability and lower costs, along with similar levels of efficacy. Patients should always be instructed not to exceed the 100mg dose threshold, and about the off-label nature of the initial prescription. Disclosure No
Coschignano et al. (Mon,) studied this question.