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) are two common issues that often coexist in aging men, leading to significant quality of life concerns. In recent years, tadalafil, a phosphodiesterase type 5 inhibitor that is FDA-approved for the treatment of erectile dysfunction, has gained attention for its potential to also alleviate symptoms associated with benign prostatic hyperplasia. The current study aims to explore this potential dual benefit of tadalafil therapy in men who present with both ED and BPH-related symptoms and the efficacy of different dosing regimens.
Aims: The objective of this multinational Phase 3 study was to rigorously assess the effects of daily tadalafil administration, at dosages of either 2.5 mg or 5 mg, over a period of 12 weeks on the symptoms of erectile dysfunction and BPH-LUTS in men diagnosed with both conditions. We aimed to statistically compare the efficacy between the tadalafil groups and placebo to clearly define the therapeutic advantages.
Methods: Eligible participants were men aged 45 years or older who were sexually active, experiencing erectile dysfunction for a minimum of 3 months, and had been dealing with BPH-LUTS symptoms for over 6 months. Participants underwent randomization after a 4-week placebo lead-in phase, with subsequent assessments of changes from baseline conducted through analysis of covariance, comparing results against those in the placebo group. A meticulous gatekeeping procedure was employed to control for multiple comparisons among primary and key secondary variables at the final endpoint, ensuring robust results.
Main outcome measures: The primary outcomes of interest were derived from the International Index of Erectile Function-erectile function (IIEF-EF) domain and the International Prostate Symptom Score (IPSS); secondary measures consisted of the Sexual Encounter Profile Question 3 (SEP Q3) as well as the BPH Impact Index (BII). The study also closely monitored treatment-emergent adverse events, serious adverse events, any significant changes in orthostatic vital signs, clinical laboratory results, uroflowmetry parameters, and the postvoid residual urine volume, ensuring comprehensive safety evaluations.
Results: The findings indicated that tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) groups demonstrated significant improvements in IIEF-EF domain scores (both P < 0.001) when compared to the placebo cohort (N = 200) at the conclusion of the study. Notably, the IPSS scores showed substantial improvement with the 5 mg dosage (P < 0.001), whereas the 2.5 mg dosage did not yield significant results at various time points from 2 weeks through the endpoint. The least-squares mean ± standard error changes from baseline at endpoint showed that placebo had a score change of -3.8 ± 0.5, the 2.5 mg group had -4.6 ± 0.4, and the 5 mg group had an impressive -6.1 ± 0.4. Moreover, tadalafil 5 mg notably enhanced the SEP Q3 and BII scores (P < 0.001). Importantly, the overall tolerability of tadalafil was confirmed, with no clinically significant alterations in orthostatic vital signs or notable changes in uroflowmetry parameters.
Conclusions: The results indicated that tadalafil at a dosage of 5 mg significantly enhanced both erectile dysfunction and BPH-related outcomes throughout the 12-week period, showcasing its potential as a dual-action therapeutic agent, and was generally well tolerated among participants. This supports the viability of using tadalafil as an effective option in the management of men suffering from both erectile dysfunction and benign prostatic hyperplasia symptoms.
© 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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