Comparative Efficacy Assessment of Tamsulosin vs. Tamsulosin Plus Tadalafil in the Treatment of LUTS/BPH. Pilot Study

Abstract

Introduction The high incidence of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) in aging men and the same pathophysiology make probable to treat both disorders with the same treatment. Numerous authors evaluated the actions of PDE5i in improving the LUTS/(benign prostate hyperplasia) BPH. Aim To assess the efficacy and safety of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day in patients with LUTS in a crossover design study. Main Outcomes Measures International Prostate Symptoms Score (IPSS), IPSS Quality of Life (IPSS-QOL), maximum flow rate (Qmax), post-void residual volume (PVR), International Index of Erectile Function-Erectile Function Domain (IIEF-EF), Global Assessment Quality (GAQ). For the statistical analysis, a Tukey-Kramer multicomparison test was used. Methods A randomized, double-blind, crossover study was conducted from September 2007 to February 2008 in one center. Thirty men, older than 50 years old, with a history of LUTS/BPH of at least 6 months, were randomized into two groups to receive tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus tadalafil 20 mg/day for 45 days, and then switched to the other treatment mode for other 45 days. Results Twenty-seven patients completed the study. Improvements of IPSS score and IPSS-QOL were significant with both treatments but greater with the drug combination. Both regimens similarly improved the Qmax and decreased the PVR volume from baseline (P < 0.001) with no significant differences between tamsulosin alone vs. tamsulosin and tadalafil (P > 0.05). The IIEF improved with tamsulosin plus tadalafil (P < 0.001) but not with tamsulosin alone (P > 0.05). The GAQ showed that all patients preferred the combination scheme. Both treatments were well tolerated. Conclusion Tamsulosin 0.4 mg/day plus tadalafil 20 mg/day was more effective than tamsulosin 0.4 mg/day alone to improve LUTS and erectile dysfunction and was also well tolerated. Large-scale, randomized, placebo-controlled studies are needed to further assess the long-term safety and effectiveness of these agents in treating LUTS/BPH with or without ED.

Efficacy and safety of combination therapy with mirodenafil and α1-blocker for benign prostatic hyperplasia-induced lower urinary tract symptoms accompanied by erectile dysfunction: a multicenter, open-label, prospective study

“…29 Supporting this is that the baseline Qmax of 14.54 ± 3.26 ml s À1 in the present study is high compared with those recorded in previous studies. [23][24][25][26] In comparison with Kaplan et al and Tuncel et al, the full dose of mirodenafil, which we used might result in similar outcomes of improvement for LUTS despite only two times per week. In addition, we investigated two groups to examine correlation on improvement of IIEF-5 and IPSS.…”

“…Alfuzosin alone also significantly improved the Qmax (11.7%, P ¼ 0.03) but the combination therapy was even better (21.1%, P ¼ 0.02). Another study on the efficacy of PDE5i/a 1 -blocker combination therapy for LUTS/BPH was that by Bechara et al, 24 who performed a study with 27 BPH patients who had had LUTS for X6 months to examine the efficacy of tamsulosin 0.4 mg OAD monotherapy and tamsulosin 0.4 mg and tadalafil 20 mg OAD combination therapy. The treatment started with the monotherapy or combination therapy for 45 days, after which the therapy was switched to the other regimen for another 45 days.…”

The Role of Tadalafil and Tamsulosin Alone and in Combination Therapy in Lower Ureteric Stone Expulsion

“…9 This combination had also been used for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia by Bechara et al and has shown significant improvements in pain by the relaxation of the bladder, urethra, and prostate and was the basis of this pilot study. 10 In another study conducted by Bos et al titled, 'update on medical expulsive therapy for distal ureteral stones: beyond alpha-blockers' concluded that corticosteroid therapy in adjunct to alpha-blocker therapy is effective in improving expulsion rates. PDE5 inhibitors did not show significantly higher expulsion rates compared to alpha-blockers and calcium channel blockers remain inferior to alpha-blockers.…”

Synthesis and Blocking Activities of a New Class of α1‐Adrenoceptor Antagonists

“…To date, several types of a 1 -AR antagonists have been reported, such as tamsulosin (4,5), BMY-7378 (3,6), prazosin (3,(7)(8)(9)(10) and spiperone (3) (Figure 1). These antagonists, albeit diverse in their structures, have two common structural features (11).…”