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.
BACKGROUND
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.


OBJECTIVE
Assess tadalafil or tamsulosin versus placebo for LUTS/BPH.


METHODS
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 (Q(max)) ≥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.


METHODS
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).


CONCLUSIONS
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). Q(max) 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.


CONCLUSIONS
Monotherapy with tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max). However, only tadalafil improved erectile dysfunction.


BACKGROUND
Clinicaltrials.gov ID NCT00970632.
Department of Urology, Hannover Medical School, Hannover, Germany. oelke.matthias@mh-hannover.de
Matthias
M
Oelke
François
F
Giuliano
Vincenzo
V
Mirone
Lei
L
Xu
David
D
Cox
Lars
L
Viktrup
D058668:Adrenergic alpha-1 Receptor Antagonists / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000188:drug therapy; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D013449:Sulfonamides / Q000627:therapeutic use*; D000068581:Tadalafil; D000077409:Tamsulosin; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
D058668:Adrenergic alpha-1 Receptor Antagonists; D002243:Carbolines; D013449:Sulfonamides; D014665:Vasodilator Agents; D000068581:Tadalafil; D000077409:Tamsulosin