يوجد فقط 14 صفحة متاحة للعرض العام
SUMMARY AND CONCLUSION
enign prostatic hyperplasia (BPH) is a disorder histologically characterized as the nonmalignant hyperplasia of prostatic cells most of patients with benign prostate hyperplasia present with lower urinary tract symptoms(LUTS). Erectile dysfunction (ED) is defined as the persistent or recurrent inability to achieve & maintain an erection sufficient for satisfactory sexual performance. Lower urinary tract symptoms (LUTS), benign prostate hyperplasia (BPH), and erectile dysfunction (ED) are highly prevalent entities in aging men.
Considering the high incidence of ED and BPH in aging men and the same pathophysiology and the probability to treat both disorders with the same treatment (alpha blockers and/or phosphodiesterase type 5 [PDE5] inhibitors.
In our analysis the aim of our study to assess the efficacy and safety of fixed-dose combinations therapy of Tamsulosin 0.4 mg plus Tadalafil 5mg versus Tadalafil 5mg alone once daily in treatment for BPH patient with lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). In this prospective randomized clinical study Fifty patients >45 years old complaining of LUTS due to BPH and erectile dysfunction were randomaly divided into two groups.
Twenty Five patients received fixed-dose combinations of Tamsulosin 0.4mg/day and Tadalafil 5mg /day for 45 days (groupA) and Twenty Five patients received Tadalafil 5mg /day for 45 days (group B).
The study showed that the fixed-dose combinations of Tamsulosin and Tadalafil significantly improve IPSS score and Qmax more than with Tadalafil 5 mg/day alone. Furthermore, PVRU significantly decreased with the fixed-dose combinations of Tamsulosin and Tadalafil more than with Tadalafil alone. Fixed-dose combinations of Tamsulosin 0.4 mg plus Tadalafil 5 mg were determined to be safe, efficacious, and well tolerated in the subjects investigated, which suggests the new fixed-dose combinations therapy can offer clinically relevant benefits for patients with LUTS complaints and desiring amelioration for comorbid ED complaints.
The study shows that the fixed- dose combination of Tamsulosin 0.4 mg/day and Tadalafil 5 mg/day are significantly superior to Tadalafil 5 mg/day alone for the treatment of BPH patients with LUTS and non-inferiority in treatment of ED Without showing any clinically significant safety issues, supporting favorable benefit-risk balance of the fixed-dose combinations of therapy for the treatment of BPH patients with LUTS and ED because of its synergistic effects, well tolera¬tion and its safety.