Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial

• Published in: European urology Vol. 61; no. 5; pp. 917 - 925
• Main Authors: Oelke, Matthias, Giuliano, François, Mirone, Vincenzo, Xu, Lei, Cox, David, Viktrup, Lars
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 01.05.2012; Elsevier
• Subjects: Adrenergic alpha-1 Receptor Antagonists - therapeutic use; Aged; Aged, 80 and over; Benign prostatic hyperplasia; Biological and medical sciences; Carbolines - therapeutic use; Erectile dysfunction; Erectile Dysfunction - drug therapy; Humans; Lower urinary tract symptoms; Lower Urinary Tract Symptoms - drug therapy; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Patient Satisfaction; Phosphodiesterase type 5 inhibitors; Prostatic Hyperplasia - drug therapy; Screening; Sulfonamides - therapeutic use; Symptoms; Tadalafil; Tamsulosin; Treatment Outcome; Tumors of the urinary system; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urology; Vasodilator Agents - therapeutic use; Tadalafil; Benign prostatic hyperplasia; Tamsulosin; Erectile dysfunction; Lower urinary tract symptoms; Phosphodiesterase type 5 inhibitors; inhibitors; Nephrology; Vasodilator agent; Prostate disease; 3',5'-Cyclic-GMP phosphodiesterase; Impotence; Sexual dysfunction; Phosphodiesterase type 5; α1-Adrenergic receptor; Esterases; Phosphoric diester hydrolases; Urology; Voiding dysfunction; Alpha blocking agent; Clinical trial; Antagonist; Benign neoplasm; Male genital diseases; International; Urinary system disease; 3',5'-Cyclic-nucleotide phosphodiesterase; Erection disorders; Enzyme; Enzyme inhibitor; Urinary tract disease; Randomized controlled trial; Phosphodiesterase inhibitor; Phosphodiesterase 5 inhibitor; Carboline derivatives; Sulfonamides; Placebo; Hydrolases
• ISSN: 0302-2838; 1873-7560; 1873-7560
• DOI: 10.1016/j.eururo.2012.01.013

Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study. Assess tadalafil or tamsulosin versus placebo for LUTS/BPH. A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Qmax) ≥4 to ≤15ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo (n=172), tadalafil 5mg (n=171), or tamsulosin 0.4mg (n=168) once daily for 12 wk. Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables). IPSS significantly improved versus placebo through 12 wk with tadalafil (−2.1; p=0.001; primary efficacy outcome) and tamsulosin (−1.5; p=0.023) and as early as 1 wk (tadalafil and tamsulosin both −1.5; p<0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (−0.8; p<0.001) and tamsulosin (−0.9; p<0.001) and through 12 wk (tadalafil −0.8, p=0.003; tamsulosin −0.6, p=0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale–BPH improved significantly versus placebo with tadalafil (both p<0.05) but not with tamsulosin (both p>0.1). The International Index of Erectile Function–Erectile Function domain improved versus placebo with tadalafil (4.0; p<0.001) but not tamsulosin (−0.4; p=0.699). Qmax increased significantly versus placebo with both tadalafil (2.4ml/s; p=0.009) and tamsulosin (2.2ml/s; p=0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare tadalafil versus tamsulosin. Monotherapy with tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Qmax. However, only tadalafil improved erectile dysfunction. Clinicaltrials.gov ID NCT00970632 Monotherapy with tadalafil or tamsulosin for 12 wk resulted in similar, significant improvements versus placebo in lower urinary tract symptoms suggestive of benign prostatic hyperplasia and maximum flow rate. However, only tadalafil significantly improved measures of treatment satisfaction and erectile dysfunction. Adverse events and related discontinuations were few.