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Comparison of Silodosin versus Tadalafil in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
- Source :
- LUTS: Lower Urinary Tract Symptoms. 9:176-186
- Publication Year :
- 2017
- Publisher :
- Wiley, 2017.
-
Abstract
- Objectives To compare the efficacy and safety of silodosin versus tadalafil for treating lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Methods After informed consent, patients with LUTS/BPH were randomized in a 1:1 ratio to receive silodosin 8 mg/day or tadalafil 5 mg/day for 8 weeks (Period 1). Patients treated with tadalafil entered an exploratory phase and received silodosin or tadalafil for another 8 weeks. The primary efficacy endpoint was the change in the total International Prostate Symptom Score (IPSS) with Period 1 treatment. Results Both silodosin and tadalafil demonstrated statistically significant improvement in IPSS total symptom score, with a mean ± standard deviation change of −10.1 ± 6.4 (P < 0.0001) and −8.0 ± 6.3 (P < 0.0001), respectively. The former reduction was significantly greater than the latter (P = 0.0277). Adverse drug reactions occurred at a rate of 23.4% with silodosin and 8.4% with tadalafil. No serious adverse drug reactions were documented, suggesting that both drugs were well tolerated. Moreover, results of Period 2 showed that switching to silodosin from tadalafil achieved a faster onset of improvements in IPSS Quality of Life Index score and total Overactive Bladder Symptom Score. Conclusions Silodosin achieved significantly greater improvement than tadalafil, with a higher incidence of adverse drug reactions. The risk-benefit profiles obtained in this study will provide useful information for optimal pharmacological treatment of LUTS/BPH. Our results suggest that silodosin can be one of the first-line therapies for rapid and efficient relief in patients with LUTS/BPH.
- Subjects :
- medicine.medical_specialty
business.industry
Urology
Incidence (epidemiology)
030232 urology & nephrology
Hyperplasia
Silodosin
medicine.disease
Tadalafil
law.invention
03 medical and health sciences
0302 clinical medicine
Neurology
Overactive bladder
Randomized controlled trial
Lower urinary tract symptoms
law
030220 oncology & carcinogenesis
medicine
International Prostate Symptom Score
business
medicine.drug
Subjects
Details
- ISSN :
- 17575664
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- LUTS: Lower Urinary Tract Symptoms
- Accession number :
- edsair.doi...........f426e5cf29029f8ad5a9cc40d3794516