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Efficacy and safety of the simultaneous administration of mirodenafil and an α-blocker in men with BPH-LUTS: a multicenter open-label prospective study.
MedLine Citation:
PMID:  23303333     Owner:  NLM     Status:  Publisher    
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 (Q(max)) 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, Q(max) 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.International Journal of Impotence Research advance online publication, 10 January 2013; doi:10.1038/ijir.2012.44.
W J Bang; C Y Oh; C Yoo; J S Cho; D Y Yang; D H Lee; S H Lee; B H Chung
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-10
Journal Detail:
Title:  International journal of impotence research     Volume:  -     ISSN:  1476-5489     ISO Abbreviation:  Int. J. Impot. Res.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9007383     Medline TA:  Int J Impot Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Department of Urology, Hallym University College of Medicine, Chuncheon, Korea.
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