Combodart

Highlights:1

• First study to prospectively assess domains of sexual function in Benign Prostatic Hyperplasia (BPH) using validated Male Sexual Health Questionnaire (MSHQ) scores*
• The decrease in mean total MSHQ score was greater in the DUT-TAM FDC group vs placebo from baseline to month 12 (p<0.001)
• The study findings suggest the erection domain may not be a significant contributor to sexual dysfunction associated with dutasteride-tamsulosin fixed dose combination (DUT-TAM FDC) therapy (p value not signifcant compared to placebo)
• The data from this study suggest that the impact on ejaculatory (p<0.001 compared to placebo at all post-baseline visits) and satisfaction (p<0.05 compared to placebo at all post-baseline visits) domains of the MSHQ are the main drivers of sexual dysfunction associated with DUT-TAM FDC therapy
• Number of unresolved cases of ED six months after DUT-TAM FDC treatment discontinuation (13/243 vs 12/246 in placebo) is small and comparable between treatment groups suggesting persistent ED has not been observed in this study
• Number of unresolved cases of EjD decreased in 6 month follow up period but remained higher in DUT-TAM FDC compared to placebo (23/243 vs 5/246)
• The clinically relevant impact of EjD AEs and their potential correlation to semen volume reduction, as previously reported with 5-alpha reductase inhibitors, are to be evaluated further
• DUT-TAM FDC safety profile was similar to previous RCTs and consistent with current labelling2

ED: erectile dysfunction, EjD: ejaculation dysfunction, AEs: adverse events, RCTs: Randomised Controlled Trial

Study design: This European and Australian double-blind, placebo-controlled, parallel-group study was conducted at 51 centres. Inclusion criteria: age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen 1.5–10 ng/mL. Patients were randomised 1:1 to DUT-TAM FDC therapy (n=243) or placebo (n=246) for 12 months. Patients with unresolved sexual AEs at the end of study were followed up for additional 6 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains.

*16 questions; range: 7–80; higher scores indicate better sexual function. Erection, questions 1–3; range: 0–15; ejaculation, questions 5–11; range 1–35; satisfaction questions 13–18; range 6–30.