Comparison of Silodosin versus Tadalafil in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Treatment of non-metastatic castration-resistant prostate cancer: facing age-related comorbidities and drug–drug interactions
- The Efficacy of Flogofilm® in the Treatment of Chronic Bacterial Prostatitis as an Adjuvant to Antibiotic Therapy: A Randomized Prospective Trial
- Inhibition of growth and contraction in human prostate stromal cells by silencing of NUAK1 and -2, and by the presumed NUAK inhibitors HTH01-015 and WZ4003
- Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study
- Extract from Cucurbita pepo improves BPH symptoms without affecting sexual function: a 24-month noninterventional study
- Aquablation vs. holmium laser enucleation of the prostate for benign prostatic hyperplasia: a 150-patients prospective comparative multicenter study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.