(182) THE EFFECT OF THE NEW 75 MG ORODISPERSIBLE FILM OF SILDENAFIL ON ERECTION AND SEXUAL QUALITY OF LIFE: INSIGHTS FROM AN OBSERVATIONAL STUDY.

Abstract Objectives We investigated the effects of the sildenafil orodispersible film (ODF) 75 mg dose on both sexual quality of life and erectile function based on the results from an observational study in daily practice in Italy. Methods This was a post-hoc analysis of results from an observational, real-life study carried out in six centers in Italy on ED patients. All subjects were asked to take the prescribed dosage of Sildenafil ODF at inclusion (Visit 1) and to return for a control visit (Visit 2) to confirm or adapt the prescribed dose after a minimum of 4 weeks. An End of study Control visit (Visit 3) was performed after additional 4 weeks. Erectile function was assessed by the International Index of Erectile Function – Erectile Function Domain (IIEF-EF); sexual quality of life was measured using the sexual QoL instrument for men (SQoL-M). Results Among the 36 subjects initially recruited for the 75 mg dose, five patients dropped out of the study (2 at visit 2 and 3 at visit 3), none of which due to treatment inefficacy or serious adverse events. At visit 2, the mean IIEF-EF scores significantly increased (∆ = 7.97±4.71, p <0.0001) as SQoL-M scores also did (∆ = 10.76±10.46, p <0.0001). At visit 3, IIEF-EF and SQoL-M scores were still significantly improved compared to baseline (∆ = 10.64±7.01, p <0.0001 and ∆ = 18.15±12.32, p <0.0001, respectively). By ANCOVA, we found no significant effect for age, BMI, previous use of PDE5i, presence of metabolic comorbidities, and smoking habits on study outcomes at both visits 2 and 3. Conclusions The use of the ODF formulation for sildenafil represents an effective and safe novel opportunity to take care of ED patients, significantly improving both erectile function and sexual quality of life in patients undergoing treatment. Conflicts of Interest AS has been a consultant for Menarini. EAJ is/has been a consultant and/or paid speaker for Bayer, IBSA, Menarini, Merck-Serono, Otsuka, Pfizer Inc, Shionogi, and Viatris. VF and AL are full-time employees of IBSA. AC has no conflicts of interest. CC has been a consultant and/or paid speaker for Dompè Primary, Menarini, Takeda, Alphremev, SOFAR. MDS is/has been paid speaker for Janssen, Astellas, Leonardo Medica. CI has no conflicts of interest. VM has been a consultant and/or paid speaker for SR, Recordati, Janssen. LS has no conflicts of interest. CT has no conflicts of interest.