Efficacy of Low Daily Dose of Tadalafil as Mono-Therapy for Diabetic Patients With Lower Urinary Tract Symptoms Suggestive of Benign Enlargement of Prostate
Abstract
Objective: To assess efficacy of tadalafil or tamsulosin versus placebo for LUTS/BEP.
Methods: This was a triple blind randomized control trial (RCT). This study was done on 150 cases of well controlled diabetic patients with LUTS/BEP after screening. The patients were >45 years of age, international prostate symptom score (IPSS) > 13, maximum urine flow rate (Qmax) 10-15 ml/sec. Selected patients were randomized in to 1:1:1 ratio to once-daily tadalafil 5 mg, tamsulosin 0.4 mg, or placebo for 12 weeks. Efficacy measures were assessed by IPSS, Qmax, post-voidal residue (PVR) in ultra-sonogram.
Results: IPSS significantly improved versus placebo through 12 wk with tadalafil (-4.81; p<0.001) and tamsulosin (-4.03; p<0.001) and as early as 1 wk (tadalafil -2.04; p=0.001 and tamsulosin -2.14; p < 0.001). The IPSS Quality-of-Life Index improved significantly versus placebo with tadalafil (p<0.001) and with tamsulosin (p<0.001) but outcome was better with tadalafil. Qmax increased significantly versus placebo with both tadalafil (6.52 ml/s; p<0.001) and tamsulosin (6.64 ml/s; p<0.001). Adverse event profiles were consistent with previous reports.
Conclusion: Monotherapy with 5 mg daily tadalafil or 0.4 mg daily tamsulosin resulted in significant and similar improvements versus placebo in IPSS+QOL in diabetic patients with LUTS/BEP staring from week one and maintained throughout the week 12. It However, Tadalafil also significantly improve Qmax. The adverse event profile was…
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
- Antioxidant efficacy and the upregulation of Nrf2-mediated HO-1 expression by (+)-lariciresinol, a lignan isolated from Rubia philippinensis, through the activation of p38
- Anti-influenza virus activity of green tea by-products in vitro and efficacy against influenza virus infection in chickens
- Therapeutic Potential of Mesenchymal Stem Cells (MSCs) and MSC-Derived Extracellular Vesicles for the Treatment of Spinal Cord Injury
- The intratumoral administration of ferucarbotran conjugated with doxorubicin improved therapeutic effect by magnetic hyperthermia combined with pharmacotherapy in a hepatocellular carcinoma model
- Enhanced anticancer efficacy of TRAIL-conjugated and odanacatib-loaded PLGA nanoparticles in TRAIL resistant cancer
- In vivo tracking of bioorthogonally labeled T-cells for predicting therapeutic efficacy of adoptive T-cell therapy
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.