Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia.
BACKGROUND
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED).


OBJECTIVE
To evaluate the effects of once-daily tadalafil on erectile function in men with ED and BPH-LUTS.


METHODS
Post hoc analysis of a phase 2-3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate.


METHODS
Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or tadalafil 2.5, 5, 10, or 20 mg for 12 wk.


METHODS
International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Q(max)), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior alpha-blocker use, and prior ED therapy.


CONCLUSIONS
Overall, 581 men were included (placebo, n=115; tadalafil 2.5 mg, n=113; tadalafil 5 mg, n=117; tadalafil 10 mg, n=120; tadalafil 20 mg, n=116). IIEF-EF domain score improvements from baseline to end point with tadalafil were 5.4 (2.5 mg), 6.8 (5 mg), 7.9 (10 mg), and 8.2 (20 mg) versus 2.0 with placebo (least-squares means; all p values <0.001). IIEF-EF domain score improvements were observed with tadalafil for all subgroup analyses, with no significant differences between subgroup or subgroup-by-treatment interaction terms. IPSS improvements from baseline to end point were significantly greater for all tadalafil doses versus placebo (all p values <0.05). Changes in Q(max) and PVR were small and not clinically meaningful.


CONCLUSIONS
These data support the use of once-daily tadalafil in men with ED and BPH-LUTS.


BACKGROUND
http://www.clinicaltrials.gov: NCT00384930.
Porst
Hartmut
H
porst20354@aol.com
McVary
Kevin T
KT
Montorsi
Francesco
F
Sutherland
Peter
P
Elion-Mboussa
Albert
A
Wolka
Anne M
AM
Viktrup
Lars
L
D000368:Aged; D002243:Carbolines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000175:diagnosis; D000068581:Tadalafil
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil