title: Safety and efficacy of the simultaneous administration of udenafil and an alpha-blocker in men with erectile dysfunction concomitant with BPH/LUTS.
abstract: We evaluated the clinical efficacy and safety of administering udenafil (5-[2-propyloxy-5-(1-methyl-2-pyrollidinylethylamidosulphonyl)phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo(4,3-d)-pyrimidin-7-one) in patients with comorbid benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). One hundred and twenty patients who had been undergoing stable alpha-blocker therapy for BPH were enrolled in this trial and they were administered 100 mg udenafil for 8 weeks. Changes in blood pressure (BP), heart rate (HR), the international prostatic symptom score (IPSS) and the international index of ED (IIEF-5) were evaluated every 4 weeks. At end point, there was no significant change in BP and HR, whereas the lower urinary tract symptoms (LUTS) and ED improved significantly compared with baseline (IPSS 14.3-11.5, IIEF-5 11.95-18.32, P<0.05). Most patients were tolerant to the treatment and there was no evidence of additional side effects related to coadministration. The coadministration of udenafil and an alpha-blocker in patients with comorbid BPH and ED was safe and gave significant improvements in both LUTS and ED.
authors.affiliation: Department of Urology, Yonsei University Health System, Seoul, Korea.
authors.forename: B H
authors.initials: BH
authors.lastname: Chung
authors.forename: J Y
authors.initials: JY
authors.lastname: Lee
authors.forename: S H
authors.initials: SH
authors.lastname: Lee
authors.forename: S J
authors.initials: SJ
authors.lastname: Yoo
authors.forename: S W
authors.initials: SW
authors.lastname: Lee
authors.forename: C Y
authors.initials: CY
authors.lastname: Oh
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D054706:Cyclic Nucleotide Phosphodiesterases, Type 5 / Q000378:metabolism; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000150:complications* / Q000188:drug therapy*; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides; D014570:Urologic Diseases / Q000150:complications*; D000096926:Benzenesulfonamides
chemical_list: D000317:Adrenergic alpha-Antagonists; D054706:Cyclic Nucleotide Phosphodiesterases, Type 5; D010726:Phosphodiesterase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides