Effect of the new 75-mg orodispersible film of sildenafil on erection and sexual quality of life: insights from an observational study

Andrea Sansone; Valeria Frangione; Arturo Lanzarotti; Andrea Cocci; Carlo Ceruti; Marco De Sio; Ciro Imbimbo; Vincenzo Mirone; Luigi Schips; Carlo Terrone; Emmanuele A Jannini

doi:10.1093/sexmed/qfac007

Effect of the new 75-mg orodispersible film of sildenafil on erection and sexual quality of life: insights from an observational study

Sex Med. 2023 Mar 1;11(2):qfac007. doi: 10.1093/sexmed/qfac007. eCollection 2023 Apr.

Authors

Affiliations

¹ Section of Endocrinology and Medical Sexology (ENDOSEX), University of Rome Tor Vergata, Rome, Italy.
² IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
³ Section of Urology, Careggi Hospital, University of Florence IBSA Institut Biochimique SA, Pambio-Noranco, Florence, Italy.
⁴ Division of Urology, University of Turin, Turin, Italy.
⁵ Urology Unit, University "Luigi Vanvitalli" of Naples, Naples, Italy.
⁶ Andrology Unit, University "Federico II" of Naples, Naples, Italy.
⁷ Urology Unit, University "Federico II" of Naples, Naples, Italy.
⁸ Department of Urology, SS Annunziata Hospital, University of Chieti, Chieti, Italy.
⁹ Department of Urology, IRCCS Ospedale Policlinico San Martino, University of Genova., Genova, Italy.

Abstract

Background: The newly devised orodispersible film (ODF) of sildenafil is the first phosphodiesterase type 5 inhibitor (PDE5i) available in a 75-mg dose. This intermediate dose and the particular properties of the ODF formulation can improve the clinical management of erectile dysfunction (ED) patients.

Aim: We investigated the effects of the sildenafil 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 study was a post hoc analysis of results from an observational, real-life study carried out in ED patients at 6 treatment centers in Italy. All subjects were asked to take the prescribed dose 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.

Outcomes: Erectile function, assessed by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain; sexual quality of life, measured using the sexual quality of life instrument for men (SQoL-M).

Results: Among the 36 subjects initially recruited for the 75-mg dose, 5 patients dropped out of the study (2 at visit 2 and 3 at visit 3), none of whom due to treatment inefficacy or serious adverse events. At visit 2, the mean (SD) 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 effects for age, BMI, previous use of PDE5i, presence of metabolic comorbidities, or smoking habits on study outcomes at both visits 2 and 3.

Clinical implication: The new 75-mg ODF sildenafil formulation is a safe and effective treatment for ED, significantly improving both erectile function and sexual quality of life in patients undergoing treatment.

Strengths and limitations: This is the first study assessing the efficacy of the sildenafil ODF 75-mg dose in a real-life setting. However, the small sample size, possible underlying cultural factors, and limited availability of clinically relevant data may have affected the reliability of our results.

Conclusion: The use of the 75 mg ODF formulation for sildenafil represents an effective and safe novel treatment option for ED patients.

Keywords: 75-mg; IIEF; erection; film; orodispersible; quality of life; sildenafil.