Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.

Abstract

INTRODUCTION:

Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS.

AIMS:

This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy.

METHODS:

Men were ≥ 45 years old, sexually active, and experiencing ED for ≥ 3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation).

MAIN OUTCOME MEASURES:

The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed.

RESULTS:

Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo -3.8 ± 0.5, tadalafil 2.5 mg -4.6 ± 0.4, and 5 mg -6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters.

CONCLUSIONS:

Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.

• Authors: Russell Blair Egerdie, Stephen Auerbach, Claus G Roehrborn, Pierre Costa, Martin Sanchez Garza, Anne L Esler, David G Wong, Roberta J Secrest
• Journal: The journal of sexual medicine (J Sex Med) Vol. 9 Issue 1 Pg. 271-81 (Jan 2012) ISSN: 1743-6109 [Electronic] Netherlands
• PMID: 21981682 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2011 International Society for Sexual Medicine.

Chemical References

• Carbolines
• Phosphodiesterase 5 Inhibitors
• Tadalafil

Topics

• Aged
• Aged, 80 and over
• Carbolines (administration & dosage, therapeutic use)
• Double-Blind Method
• Erectile Dysfunction (complications, drug therapy)
• Humans
• Male
• Middle Aged
• Phosphodiesterase 5 Inhibitors (administration & dosage, therapeutic use)
• Prostatic Hyperplasia (complications, drug therapy)
• Surveys and Questionnaires
• Tadalafil
• Treatment Outcome