Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction.
OBJECTIVE
To compare the safety and efficacy of the daily erectogenic therapy, tadalafil, on lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) in men with or without comorbid erectile dysfunction (ED).


METHODS
Following a 4-week placebo run-in period, men with moderate-to-severe BPH-LUTS were randomized to placebo or tadalafil 2.5, 5, 10, or 20 mg once daily for 12 weeks. International Prostate Symptom Scores (IPSS), IPSS quality of life, and BPH Impact Index were measured every 4 weeks. Safety was mainly assessed via spontaneous reports of adverse events. Data from men with (n=716) or without (n=340) ED at baseline were compared in posthoc analyses.


RESULTS
Men with ED were older and had more frequent hypertension, hyperlipidemia, coronary artery disease, and diabetes at baseline compared with men without ED. After 12 weeks, changes in IPSS in men with ED (least squares mean change from baseline, placebo: -2.4; tadalafil 2.5, 5, 10, 20 mg: -4.3, -4.8, -5.3, -5.6) and without ED (-2.4, -3.2, -5.3, -5.1, -4.5) were not significantly different (subgroup/interaction P values: .352/.644). Similar effects were observed for IPSS quality of life (with ED: -0.6, -0.9, -0.9, -1.0, -1.1; without ED: -0.6, -0.7, -0.9, -0.8, -0.8; 0.090/0.773) and BPH Impact Index (with ED: -0.7, -0.9, -1.3, -1.3, -1.4; without ED: -1.0, -0.7, -1.3, -1.3, -1.2; 0.753/0.852). Tadalafil was generally well tolerated, and men with or without ED had similar tolerability profiles.


CONCLUSIONS
Changes in BPH-LUTS after 12 weeks of treatment with placebo or various doses of once daily tadalafil were similar in men with or without comorbid ED.
Broderick
Gregory A
GA
Mayo Clinic, Jacksonville, Florida 32224, USA. Broderick.Gregory@mayo.edu
Brock
Gerald B
GB
Roehrborn
Claus G
CG
Watts
Steven D
SD
Elion-Mboussa
Albert
A
Viktrup
Lars
L
D000368:Aged; D002243:Carbolines / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use; D011336:Probability; D011470:Prostatic Hyperplasia / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D053448:Prostatism / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D011788:Quality of Life; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D000068581:Tadalafil; D016896:Treatment Outcome; D014555:Urination Disorders / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D014563:Urodynamics
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil