Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers.
OBJECTIVE
To determine the efficacy, safety, and treatment satisfaction of tadalafil 20 mg for erectile dysfunction (ED) in patients evaluated at tertiary-care academic centers.


METHODS
In this randomized, double-blind, placebo-controlled trial, patients were randomly allocated to receive fixed-dose tadalafil 20 mg (n = 146) or placebo (n = 49) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ); patient and partner treatment satisfaction by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and SEP; and safety by adverse events, laboratory values, and vital signs.


RESULTS
Mean baseline IIEF erectile function (EF) domain was 12.98. Fifty-one percent of enrolled patients had severe baseline ED, and 82% had organic ED. Pre-existing, ED-associated comorbid conditions were common. When compared with patients treated with placebo, those receiving tadalafil reported significant improvement from baseline in the IIEF EF domain (P <0.001), successful penetration attempts (SEP question 2; P <0.001), successful intercourse (SEP question 3; P <0.001), and all secondary efficacy outcomes (P <0.001). Patients and their sexual partners were also significantly more satisfied with tadalafil treatment (P <0.001), including overall satisfaction (P <0.001) and length of time the treatment worked (P <0.001). Mild or moderate headache, dyspepsia, and myalgia were the most frequent treatment-emergent adverse events reported.


CONCLUSIONS
Tadalafil significantly improved erectile function and patient and partner satisfaction and was well tolerated. These results were observed in a tertiary-care, academic center population with a high incidence of severe, organic ED, and comorbid medical conditions, factors known to compromise erectile function and treatment outcome.
Carson
Culley
C
Division of Urology, University of North Carolina, Chapel Hill, North Carolina 27599-7235, USA.
Shabsigh
Ridwan
R
Segal
Scott
S
Murphy
Aileen
A
Fredlund
Paul
P
Kuepfer
Christine
C
D000368:Aged; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000150:complications; D015897:Comorbidity; D048909:Diabetes Complications / Q000188:drug therapy; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications; D008297:Male; D008875:Middle Aged; D010549:Personal Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy; D011468:Prostatectomy; D012747:Sexual Partners / Q000523:psychology; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D014665:Vasodilator Agents; D000068581:Tadalafil