ORIGINAL RESEARCH—ERECTILE DYSFUNCTION Effectiveness of Tadalafil 5 mg Once Daily in the Treatment of Men with Lower Urinary Tract Symptoms Suggestive to Benign Prostatic Hyperplasia With or Without Erectile Dysfunction: Results from Naturalistic Observational TadaLutsEd Study
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چکیده
Introduction. Naturalistic clinical trials provide data on the effectiveness of drugs in nonexperimental and everyday situations and are extremely helpful for decision-making purposes and for confirming experimental findings in clinical trials. No data have been published from naturalistic studies performed in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) with or without erectile dysfunction (ED) and treated with phosphodiesterase type 5 inhibitors. Aim. The aim of this study (TadaLutsEd Study) was to assess, in the context of medical practice, the effectiveness of tadalafil 5 mg once daily in patients with LUTS/BPH with or without erectile dysfunction. Methods. The study was a 6-week uncontrolled, prospective, open-label, multicentric, observational study. The patient population involved sexually active males aged ≥50 years, diagnosed with LUTS/BPHwith or without concomitant ED, and treated with tadalafil 5 mg daily in accordance with standard urological practice. Main Outcome Measures. Effectiveness was assessed through the self-administered International Prostate Symptom Score (IPSS) questionnaire; quality of life was evaluated through the IPSS quality of life section (IPSS-QoL). The patients were also evaluated with the International Index of Erectile Function (IIEF-5). Adverse events were recorded. Statistical analyses using paired data samples was applied (Wilcoxon signed-ranks test). Results. Sixty-two patients (mean age 62.2 years) completed the treatment, of whom 85.5% showed improvement in their urinary symptoms. Preand post-treatment differences in the IPSS, IPSS-QoL, and IIEF-5 scores were statistically significant at 4.4, 1, and 5.4 points, respectively (P < 0.0001). Tadalafil was well tolerated, and adverse events were mild, with a discontinuation rate of 1.6%. Conclusion. According to study results, the use of tadalafil 5 mg once daily in a nonselected patient population with LUTS/BPH with or without ED led to improvements in terms of symptoms and quality of life and exhibited a safety profile similar to that obtained in controlled tadalafil clinical trials. Bechara A, Casabe A, Rodriguez Baigorri G, and Cobreros C. Effectiveness of tadalafil 5 mg once daily in the treatment of men with lower urinary tract symptoms suggestive to benign prostatic hyperplasia with or without erectile dysfunction: Results from naturalistic observational TadaLutsEd Study. J Sex Med 2014;11:498–505.
منابع مشابه
Survey of the Literature for March 2015 Issue of Sexual Medicine Journal
Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. A Casabé, CG Roehrborn, LF Da Pozzo, S Zepeda, RJ Henderson, S Sorsaburu, C Henneges, DG Wong, L Viktrup. J Urol 2014;191:727–33. Editorial Comment: Since the launch of the 5-alpha reductas...
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A strong and independent association between lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and erectile dysfunction (ED) has been widely evidenced in several clinical epidemiologic studies. Preclinical animal models have provided a great deal of information on potential common pathogenic mechanisms underlying these two clinical identities. Although the effic...
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متن کاملTadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia
INTRODUCTION Strong epidemiologic evidence supports correlation between lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) and erectile dysfunction (ED). The link has biologic plausibility given phosphodiesterase type 5 (PDE5) expression in pelvic structures. PDE5 inhibitors target pathophysiologic processes implicated in LUTS/BPH. MATERIAL AND METHODS This review hig...
متن کاملEfficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a meta-analysis.
OBJECTIVE To evaluate the efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). METHODS A comprehensive search was done to identify randomized controlled trials comparing the efficacy and safety of tadalafil for LUTS/BPH with placebos. Meta-analytical techniques were applied to evaluate the differences in the study ...
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تاریخ انتشار 2014