Effectiveness and patient satisfaction with the new sildenafil oral suspension formulation compared to sildenafil oro-dispersible film: a real-life study.

Abstract

Sildenafil is one of the most used phosphodiesterase type 5 inhibitor (PDE5i) for the treatment of erectile dysfunction (ED) in clinical practice. A new oral suspension formulation (OSF) of sildenafil has been introduced to overcome the drawbacks of previous formulations. We assess the efficacy and patients' experience with sildenafil 50 mg OSF in men with ED who were taking the sildenafil oro-dispersible film (ODF). Demographics and clinical data from 70 consecutive men with mild-moderate ED were analysed. Patients were treated with sildenafil 50 mg ODF for 12 weeks (follow-up 1), then, after 2-week washout, were administered sildenafil 50 mg OSF for 12 weeks (follow-up 2). At each follow-up, patients completed the International Index of Erectile Function (IIEF), the Patient Global Impression of Improvement (PGI-I), and the Psychological and Interpersonal Relationship Scales-Short Form (PAIRS-SF) questionnaires. Descriptive statistics described the whole cohort. The Wilcoxon Signed Rank Test assessed potential differences in psychometric scores at different follow-up assessments. Logistic regression analyses tested the associations between study variables and satisfaction after sildenafil OSF treatment. Overall, median age was 56 (51-62) years, and median IIEF-EF score was 14 (12-17). Compared to baseline, IIEF-EF scores significantly improved after sildenafil ODF and OSF treatment (all p < 0.01) with no differences between the two formulations. IIEF-overall satisfaction (OS) was higher after sildenafil OSF than ODF (p < 0.001). Similarly, median PGI-I score were better after sildenafil OSF than ODF (p < 0.001). The PAIRS-SF spontaneity scores were significantly higher after OSF than ODF (p < 0.01). At multivariable logistic regression analysis, younger age (p = 0.02) and lower baseline IIEF-EF scores (p = 0.01) were independent predictors of improved satisfaction with OSF compared to ODF. The sildenafil OSF and ODF had similar efficacy, however the new OSF provides higher satisfaction and spontaneity scores compared to the oro-dispersible film.