Abstract | BACKGROUND: OBJECTIVE: To assess efficacy, including onset, and safety of tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled, 12-week trial enrolled men ≥45 yr of age with BPH-LUTS for >6 mo, International Prostate Symptom Score (IPSS) ≥13, and maximum urine flow rate (Q(max)) ≥4 to ≤15 ml/s. INTERVENTION:
Tadalafil 5mg (n=161) or placebo (n=164), once daily. MEASUREMENTS: Analysis of covariance (ANCOVA) modeling evaluated change from baseline in continuous efficacy variables. Categoric efficacy variables were analyzed with the Cochran-Mantel-Haenszel test, and between-group differences in treatment-emergent adverse events (TEAEs) were assessed using the Fisher exact test. RESULTS AND LIMITATION: Tadalafil significantly improved IPSS results, from baseline to endpoint, compared to placebo (-5.6 vs -3.6; p=0.004). Reduction in IPSS results was apparent after 1 wk and significant after 4 wk ( tadalafil -5.3 vs placebo -3.5; p=0.003). The BPH Impact Index (BII) was not assessed at week 1; however, BII improvement was apparent at 4 wk ( tadalafil -1.8 vs placebo -1.2; p=0.029) and continued at 12 wk ( tadalafil -1.8 vs placebo -1.3; p=0.057). Tadalafil significantly improved the International Index of Erectile Function-Erectile Function score in sexually active men with erectile dysfunction (ED; 6.7 vs 2.0; p<0.001) at 12 wk (not assessed at week 1). Few subjects reported one TEAE or more (p=0.44). For tadalafil, the most common TEAEs were headache (3.7%) and back pain (3.1%). Tadalafil did not significantly improve Q(max) or reduce postvoid residual volume. CONCLUSIONS:
Tadalafil 5mg once daily for 12 wk resulted in a clinically meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS. The adverse event profile was consistent with that previously reported in men with ED. TRIAL REGISTRATION: This clinical trial is registered on the clinicaltrials.gov website (http://www.clinicaltrials.gov). The registration number is NCT00827242.
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Authors | Hartmut Porst, Edward D Kim, Adolfo R Casabé, Vincenzo Mirone, Roberta J Secrest, Lei Xu, David P Sundin, Lars Viktrup, LVHJ study team |
Journal | European urology
(Eur Urol)
Vol. 60
Issue 5
Pg. 1105-13
(Nov 2011)
ISSN: 1873-7560 [Electronic] Switzerland |
PMID | 21871706
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011. Published by Elsevier B.V. |
Chemical References |
- Carbolines
- Phosphodiesterase 5 Inhibitors
- Placebos
- Tadalafil
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Topics |
- Aged
- Analysis of Variance
- Argentina
- Carbolines
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Administration Schedule
- Europe
- Humans
- Lower Urinary Tract Symptoms
(drug therapy, etiology, physiopathology)
- Male
- Mexico
- Middle Aged
- Penile Erection
(drug effects)
- Phosphodiesterase 5 Inhibitors
(administration & dosage, adverse effects)
- Placebos
- Prostatic Hyperplasia
(complications, drug therapy, physiopathology)
- Tadalafil
- Time Factors
- Treatment Outcome
- United States
- Urination
(drug effects)
- Urodynamics
(drug effects)
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