ArticleInternational journal of impotence research
Efficacy and safety of the simultaneous administration of mirodenafil and an α-blocker in men with BPH-LUTS: a multicenter open-label prospective study.
Article in International journal of impotence research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia.The Cochrane database of systematic reviews · 2018Pooled it
- A review of the efficacy and safety of mirodenafil in the management of erectile dysfunction.Therapeutic advances in urology · 2016Review
- The efficacy of mirodenafil for chronic prostatitis/chronic pelvic pain syndrome in middle-aged males.The world journal of men's health · 2014Article
- Management of benign prostatic hyperplasia: role of phosphodiesterase-5 inhibitors.Drugs & aging · 2014Review
- Mirodenafil for the treatment of erectile dysfunction: a systematic review of the literature.The world journal of men's health · 2014Review
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We evaluated the clinical efficacy and safety of the coadministration of a PDE5 inhibitor and an α-adrenergic blocker in patients with both benign prostatic hyperplasia/lower urinary tract symptoms (BPH-LUTS) and ED using mirodenafil 50 mg (Mvixx) once daily (OD) in patients already receiving stable α-blocker therapy. This study was a prospective, multicenter, open-label trial. We selected 147 patients undergoing stable (longer than 4 weeks) α-blocker therapy for BPH-LUTS as recipients of the additive mirodenafil 50 mg OD for 8 weeks. The coprimary measures were the International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF-5). The key secondary measures were peak flow rate (Qmax) and postvoiding residual (PVR) volume. Safety was assessed by evaluating cardiovascular parameters and the participant-reported treatment-emergent adverse events (TEAEs). The additional administration of mirodenafil 50 mg OD significantly improved IPSS results (18.70-14.30 at 4 weeks and 18.70-13.72 at 8 weeks; P<0.001). The IIEF-5 score was improved at 8 weeks (10.94-16.16; P<0.001). There was no significant change in systolic blood pressure/diastolic blood pressure (124.8 mm Hg/78.6 mm Hg-122.0 mm Hg/79.6 mm Hg; P=0.638) and heart rates (78.8 per min to 80.2 per min; P=0.452). The most common TEAEs were hot flashes (10.9%) and headache (8.1%). The combination of mirodenafil with an α-blocker did not significantly improve PVR; however, Qmax was improved at 8 weeks (14.51-16.80 ml s(-1); P=0.026). Mirodenafil 50 mg OD in combination with an α-blocker appeared to have few adverse effects, to improve BPH-LUTS and restore sexual function.
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