title: Efficacy and safety of the simultaneous administration of mirodenafil and an α-blocker in men with BPH-LUTS: a multicenter open-label prospective study.
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.
authors.affiliation: Department of Urology, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: W J
authors.initials: WJ
authors.lastname: Bang
authors.forename: C Y
authors.initials: CY
authors.lastname: Oh
authors.forename: C
authors.initials: C
authors.lastname: Yoo
authors.forename: J S
authors.initials: JS
authors.lastname: Cho
authors.forename: D Y
authors.initials: DY
authors.lastname: Yang
authors.forename: D H
authors.initials: DH
authors.lastname: Lee
authors.forename: S H
authors.initials: SH
authors.lastname: Lee
authors.forename: B H
authors.initials: BH
authors.lastname: Chung
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000317:Adrenergic alpha-Antagonists; D058986:Phosphodiesterase 5 Inhibitors; D011744:Pyrimidinones; D013449:Sulfonamides; C528396:mirodenafil