title: Combined tadalafil and α-blocker therapy for benign prostatic hyperplasia in patients with erectile dysfunction: a multicenter, prospective study.
abstract: This prospective study evaluated the safety of tadalafil 5 mg taken once a  day in terms of hypotensive side effects and whether it improves lower urinary  tract symptoms (LUTS) and restores sexual function in patients with erectile  dysfunction who are receiving concomitant α-blocker (AB) therapy for  benign prostatic hyperplasia (BPH). A total of 158 LUTS/BPH patients receiving  AB therapy for ≥3 months were given tadalafil 5 mg once a day. Before  treatment with tadalafil (V1), and 4 weeks (V2) and 12 weeks (V3) after  starting tadalafil, blood pressure, heart rate, International Prostate Symptom  Score (IPSS), maximal urine flow rate (Qmax), postvoiding residual urine  volume, and International Index of Erectile Function (IIEF-5) score were  measured. Of the 158 LUTS/BPH patients, a total of 119 completed the trial.  Blood pressure (systolic and diastolic) and heart rate did not change. IPSS  and IIEF-5 scores improved significantly, but Qmax and postvoiding residual  urine volume did not; however, in the 39 men with a low baseline Qmax (≤10  mL/s), Qmax rose significantly from 7.97 ± 1.44 mL/s (baseline) to 8.91  ± 1.60 mL/s (V3; P = .012). The remaining patients (baseline  Qmax >10 mL/s) did not change. At V2 and V3, adverse side effects were  observed in 10 men (7.30%) and 6 men (5.04%), respectively. Facial flushing  was the most common adverse side effect (6 men at V2 and 4 men at V3),  followed by headache (2 men each at V2 and V3) and dizziness (2 men at V2).  Two patients dropped out of the study because of adverse side effects. In  conclusion, tadalafil 5 mg once a day in combination with AB appeared to have  few adverse effects on hypotensive events and can improve LUTS and restore  sexual function.
authors.affiliation: Department of Urology, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Joo Yong
authors.initials: JY
authors.lastname: Lee
authors.forename: Sung Yul
authors.initials: SY
authors.lastname: Park
authors.forename: Tae Yoong
authors.initials: TY
authors.lastname: Jeong
authors.forename: Hong Sang
authors.initials: HS
authors.lastname: Moon
authors.forename: Yong Tae
authors.initials: YT
authors.lastname: Kim
authors.forename: Tag Keun
authors.initials: TK
authors.lastname: Yoo
authors.forename: Hong Yong
authors.initials: HY
authors.lastname: Choi
authors.forename: Hae Young
authors.initials: HY
authors.lastname: Park
authors.forename: Seung Wook
authors.initials: SW
authors.lastname: Lee
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D004359:Drug Therapy, Combination / Q000009:adverse effects; D007172:Erectile Dysfunction / Q000188:drug therapy*; D005483:Flushing / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011467:Prostate / Q000187:drug effects; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D000068581:Tadalafil; D016896:Treatment Outcome
chemical_list: D000317:Adrenergic alpha-Antagonists; D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil