Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1-year, open-label extension study.
OBJECTIVE
• To evaluate the 1-year safety of 5 mg of tadalafil once daily in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS); efficacy measures were included to evaluate the maintenance of efficacy after an additional year of treatment.


METHODS
• In total, 427 men who completed a 12-week, placebo-controlled, dose- finding study assessing once-daily tadalafil (2.5, 5, 10 or 20 mg) or placebo elected to continue into the open-label extension period. Safety and efficacy parameters were assessed after 1 month and every 3 months.


RESULTS
• In total, 299 patients (69.9%) completed the 1-year, open-label extension period. Treatment-emergent adverse events (TEAEs) were reported by 57.6% of patients, with most TEAEs being mild (44%) or moderate (45%) in severity; the most common TEAEs (≥ 2%) were dyspepsia, gastro-oesophageal reflux disease, back pain, headache, sinusitis, hypertension and cough. Twenty-two patients (5.2%) discontinued as a result of AEs. During the open-label extension period, mean prostate-specific antigen increased from 1.6 ± 1.3 ng/mL to 1.8 ± 1.4 ng/mL. • Mean post-void residual volume was 61.1 ± 60.4 mL at study entry and 42.2 ± 64.1 mL after the open-label extension period. Changes in the total International Prostate Symptom Score (IPSS), IPSS irritative and obstructive subscores, IPSS health-related quality of life and BPH Impact Index were maintained after 1 year. In sexually-active patients with erectile dysfunction, improvements in the International Index of Erectile Function-Erectile Function domain were maintained after 1 year.


CONCLUSIONS
• In men with BPH-LUTS, 5 mg of tadalafil once daily during 1 year of treatment was well tolerated and efficacy changes were maintained.
Department of Surgery, Division of Urology, Duke University, Durham, NC, USA.
Craig F
CF
Donatucci
Gerald B
GB
Brock
Evan R
ER
Goldfischer
Peter J
PJ
Pommerville
Albert
A
Elion-Mboussa
Jay D
JD
Kissel
Lars
L
Viktrup
D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil