vardenafil 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
Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. vardenafil, 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 vardenafil 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.
Conclusions: vardenafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.
© 2011 International Society for Sexual Medicine.
Comment in
Jones JS. Jones JS. Nat Rev Urol. 2011 Oct 25;8(12):651-2. doi: 10.1038/nrurol.2011.162. Nat Rev Urol. 2011. PMID: 22025171 No abstract available.
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vardenafil 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
Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. vardenafil, 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 vardenafil 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.
Conclusions: vardenafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.
© 2011 International Society for Sexual Medicine.
Wang Y, Bao Y, Liu J, Duan L, Cui Y. Wang Y, et al. Low Urin Tract Symptoms. 2018 Jan;10(1):84-92. doi: 10.1111/luts.12144. Epub 2016 Nov 5. Low Urin Tract Symptoms. 2018. PMID: 29341503 Review.
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PMID 24341303 Review.
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