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 - PubMed
Clinical Trial
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
Russell Blair Egerdie et al. J Sex Med. 2012 Jan.
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, making it essential to understand its dual efficacy in alleviating both ED and BPH-related symptoms.
Aims: This multinational Phase 3 study aimed to comprehensively assess the effects of tadalafil 2.5 or 5 mg administered once daily over a period of 12 weeks on the conditions of erectile dysfunction and benign prostatic hyperplasia-related lower urinary tract symptoms in men presenting both conditions.
Methods: Subjects included men aged 45 years and older who were sexually active and had been experiencing erectile dysfunction for at least 3 months alongside BPH-related lower urinary tract symptoms for greater than 6 months. The trial commenced with a 4-week period during which participants received a placebo before randomization, allowing for a clearer assessment of tadalafil's effects. Subsequent analyses compared changes from baseline between the tadalafil and placebo groups, employing rigorous statistical techniques, including analysis of covariance, to evaluate treatment effectiveness. Employing a gatekeeping procedure, the trial strictly controlled for multiple comparisons involving both co-primary and key secondary outcome measures at the study's endpoint, which was defined as the last observation following the baseline.
Main outcome measures: The principal co-primary measures analyzed were the International Index of Erectile Function-erectile function (IIEF-EF) domain and the International Prostate Symptom Score (IPSS) score. Key secondary measures included the Sexual Encounter Profile Question 3 (SEP Q3) and the BPH Impact Index (BII). Additionally, the study meticulously tracked treatment-emergent adverse events, serious adverse events, and changes in orthostatic vital signs, as well as clinical laboratory parameters and uroflowmetry outcomes, including postvoid residual volume assessments. This comprehensive approach aimed to ensure a thorough understanding of tadalafil's safety and efficacy profile.
Results: The findings revealed that both the 2.5 mg (N = 198) and 5 mg (N = 208) dosages of tadalafil led to significant improvements in IIEF-EF domain scores (both P < 0.001) when compared to placebo (N = 200) at the endpoint of the study. In terms of the IPSS, notable improvements were observed with the 5 mg dosage of tadalafil (P < 0.001), while the 2.5 mg dosage did not show significant changes across the observations from 2 weeks through to the endpoint (least-squares mean ± standard error change from baseline at endpoint: placebo -3.8 ± 0.5; tadalafil 2.5 mg -4.6 ± 0.4; tadalafil 5 mg -6.1 ± 0.4). Furthermore, tadalafil 5 mg also demonstrated significant advancements in SEP Q3 and BII (P < 0.001). Overall, tadalafil was shown to be well tolerated, with no clinically significant adverse changes recorded in orthostatic vital signs or uroflowmetry parameters during the trial.
Conclusions: In conclusion, the administration of tadalafil 5 mg resulted in statistically significant improvements in both erectile dysfunction and benign prostatic hyperplasia-related outcomes over the course of the 12-week study period, and the treatment was found to be well tolerated among participants. This study reinforces the potential of tadalafil not only as an effective treatment for erectile dysfunction but also as a viable option for men suffering from benign prostatic hyperplasia symptoms, thereby providing a dual therapeutic benefit.
© 2011 International Society for Sexual Medicine.
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Prostate cancer: The optimal number and location of cores for repeat biopsy.
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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