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Effectiveness and safety of orodispersible Sildenafil in a new film formulation for the treatment of erectile dysfunction: comparison between Sildenafil 100 mg film-coated tablet (FCT) vs 75 mg orodispersible film (ODF)

Cocci, A1; Capece, M2; Cito, G1; Russo, GI3; Falcone, M4; Timpano, M4; Rizzo, M5; Della Camera, PA1; Cacciamani, G6; Minervini, A1; Gacci, M1; Mondaini, N7; Polloni, G8; Serni, S1; Natali, A1

1: Careggi Hospital, Florence, Italy; 2: University of Naples, Naples, Italy; 3: University of Catania, Catania, Italy; 4: University of Turin, Turin, Italy; 5: University of Trieste, Trieste, Italy; 6: University of Verona, Verona, Italy; 7: Santa Maria Annunciata Hospital, Florence, Italy; 8: Psycho-sexologist, Como, Italy

Objectives: A new orodispersible film (ODF) formulation of Sildenafil has been developed for treatment of erectile dysfunction (ED),in order to overcome the drawbacks that some patients experience when taking the old conventional film-coated tablet (FCT).The aim is to assess the effectiveness and safety of Sildenafil ODF formulation in a group of patients with ED, who were using FCT.

Materials & Methods: Between May-July 2017, 139 patients with ED were enrolled. A penile color-duplex ultrasound, medical history, hormonal evaluation and patient self-administered questionnaires were collected. All patients were administered Sildenafil 100 mg FCT for 4 weeks. Thereafter, they underwent a 2-week wash-out period and subsequently took Sildenafil 75 mg ODF for 4 weeks.IIEF-15, Hospital Anxiety and Depression Scale (HADS), Patient Global Impressions of Improvement (PGI-I) and Clinician Global Impressions of Improvement (CGI-I) questionnaires were administered.

Results: Differences of IIEF-EF, IIEF-OF, IIEF-SD and IIEF-IS mean were significantly in favor of Sildenafil 100 mg FCT, while IIEF-OS was in favor of Sildenafil 75 mg ODF. (Figure1) Significant difference in HADS changes was found in the period between wash-out to final follow-up(mean difference:-0.19;p<0.01). According to the ODF formulation, median CGI-I was 3.5(IQR:2.5-4.5)and median PGI-I was 3.0(IQR:2-0-4.0). Median action time was 20.0 minutes (IQR:15.0-30.0) and the median mouth time 60.0(IQR:30.0-120.0).Table 1:baseline characteristics

Conclusions: The new ODF formulation is as efficient and safe as the oral tablets and offers a new choice of treatment to specialists for a more precisely tailored therapy.

Table 1: Baseline characteristics of the population


N= 139

Age, years, median (IQR)

66.6 (63.3-69.0)

BMI, kg/m2, median (IQR)

14.0 (12.0-16.0)

IIEF-EF, median (IQR)

14.0 (12.0-17.0)

IIEF-OF, median (IQR)

3.0 (2.0-5.0)

IIEF-SD, median (IQR)

3.0 (2.0-3.0)

IIEF-IS, median (IQR)

4.0 (3.0-6.0)

IIEF-OS, median (IQR)

6.0 (4.0-7.0)

Classification of ED, n (%)

Ø  Severe

19 (13.7)

Ø  Moderate

65 (46.8)

Ø  Mild

55 (39.6)

HADS, median (IQR)

5.0 (5.0-6.0)

Hypertension, n (%)

81 (58.3)

Diabetes, n (%)

31 (22.3)

Hyperlipidaemia, n (%)

46 (33.1)

Hearth disease, n (%)

23 (16.5)

Smoking, n (%)

Ø  No

29 (20.9)

Ø  Former

82 (59.0)

Ø  Current

28 (20.1)

Alcohol, n (%)

Ø  Abstinent

84 (60.4)

Ø  Light

55 (39.6)

Previous penile surgery, n (%)

16 (11.5)

Duration of erectile dysfunction, n (%)

24.0 (12.0-48.0)

FSH, IU/L, median (IQR)

5.0 (1.9-8.0)

LH, IU/L, median (IQR)

5.6 (1.2-11)

TT, ng/ml, median (IQR)

7.7 (3-15)

TSH, mIU/L, median (IQR)

2.5 (0.8-5.2)

PRL, ng/ml, median (IQR)

6.6 ( 4-16)


Work supported by industry: no.

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