Efficacy and Safety of Tadalafil Monotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Meta-Analysis

Abstract

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 results. Results: Eight studies were identified and analyzed. Compared with placebo, tadalafil was associated with significant improvements in the International Prostate Symptom Score (IPSS) (mean difference = -2.19, p < 0.00001) and the International Index of Erectile Function (IIEF) score (mean difference = +4.66, p < 0.00001), despite the concomitant presence of erectile dysfunction. Significant differences were also observed in the IPSS irritative and obstructive subscores, IPSS quality of life index and BPH impact index. After pooling four doses (2.5, 5, 10 and 20 mg), tadalafil failed to produce a significant outcome in maximal urinary flow rate (Q_max) (mean difference = +0.26 ml/s, p = 0.14), but 5 mg of tadalafil significantly improved Q_max (mean difference = +0.63 ml/s, p = 0.04). No significant difference was detected in the incidence of serious adverse events (risk ratio = 1.00, p = 1.00) after tadalafil treatment. Conclusions: Tadalafil showed good efficacy and safety for improving LUTS and erectile dysfunction in men with BPH, and 5 mg of tadalafil significantly improved Q_max.

Tadalafil Monotherapy for Benign Prostatic Hyperplasia

“…The interesting article by Dong et al [1] confirmed our data in a systematic appraisal that included exclusively randomized controlled trials based on the high quality of the Jadad score and funnel plot for biases analyses.…”

“…The results of the review by Dong et al [1] seem to confirm that aging, metabolic syndrome and hypogonadism could be determinants for the response to daily treatment with tadalafil in men with LUTS due to BPH.…”

“…Dong et al [1] evaluated the safety and efficacy of tadalafil monotherapy for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) in a comprehensive analysis of randomized controlled trials assessed by meta-analytical techniques. Tadalafil was significantly effective in ameliorating irritative and obstructive LUTS, increasing sexual function and improving overall quality of life.…”

Effects of Pumpkin Seed in Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in the One-Year, Randomized, Placebo-Controlled GRANU Study

“…The responders had an IPSS improvement by ≥5 points, and so they unequivocally experienced a clinically significant symptom relief. According to previous symptom evaluations, a minimum improvement of 3 points is necessary for a patient to perceive a clinical benefit [18,19]. …”

Management options for the treatment of benign prostatic hyperplasia with or without erectile dysfunction: a focus on tadalafil and patient considerations

“…Several clinical trials have been conducted to investigate the role of PDE5-Is in the LUTS/ED population 9,24–26. The main outcomes of these trials have included the effect of therapy on the International Prostate Symptom Score (IPSS) and BPH Impact Index, used to track BPH symptomatology; International Index of Erectile Function (IIEF), reflecting male sexual function; and maximum urinary flow rate (Qmax).…”