Comparative efficacy assessment of tamsulosin vs. tamsulosin plus tadalafil in the treatment of LUTS/BPH. Pilot study.
BACKGROUND
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.


OBJECTIVE
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.


METHODS
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.
Bechara
Amado
A
División Urología, Hospital Durand, Buenos Aires, Argentina. amadobechara@fibertel.com.ar
Romano
Salomon
S
Casabé
Adolfo
A
Haime
Sergio
S
Dedola
Pablo
P
Hernández
Cecilia
C
Rey
Horacio
H
D000368:Aged; D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D000068581:Tadalafil; D000077409:Tamsulosin; D016896:Treatment Outcome; D001748:Urinary Bladder Neck Obstruction / Q000188:drug therapy*; D016055:Urinary Retention / Q000188:drug therapy*
D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors; D013449:Sulfonamides; D000068581:Tadalafil; D000077409:Tamsulosin