Efficacy and safety of tadalafil in men with erectile dysfunction with a high prevalence of comorbid conditions: results from MOMENTUS: multiple observations in men with erectile dysfunction in National Tadalafil Study in the US.
BACKGROUND
Limited efficacy and safety data exist from open-label clinical trials of phosphodiesterase 5 inhibitors in men with erectile dysfunction (ED) and multiple comorbid (MCM) conditions, historically a difficult group to treat.


OBJECTIVE
A multicenter study (Multiple Observations in Men with Erectile Dysfunction in National Tadalafil Study in the US) assessed efficacy and safety of tadalafil in men with ED and MCM conditions.


METHODS
The primary end point was change from baseline in the erectile function (EF) domain of the International Index of Erectile Function. Secondary end points included the Sexual Encounter Profile, Global Assessment Questions, and Sexual Self-Confidence and Spontaneity Domains of the Psychological and Interpersonal Relationship Scales.


METHODS
This was an open-label, multicenter study in men with ED. Tadalafil 20 mg was administered as needed prior to sexual activity, up to once/day, for 12 weeks following a 4-week ED-treatment-free period. The MCM group was 155 of 1,911 men enrolled in this study. Men in the MCM group met eligibility criteria but could not be included in other predefined groups: (i) Caucasian; (ii) Black American; (iii) Hispanic (groups 1-3, < or =65 years, no diabetes or depression); (iv) depression, < or =65 years, no diabetes; (v) diabetes, < or =65 years, no depression; (vi) >65 years, no diabetes or depression; and (vii) ED subsequent to traumatic spinal cord injury.


RESULTS
Mean baseline EF domain score in MCM (mean age 65 +/- 9 years) was 12.2 +/- 6.5; 52% of subjects had severe ED; 72% diabetes mellitus; 67% cardiovascular disease (including hypertension); 49% hyperlipidemia; 38% depression; 84% had two or more comorbidities. At end point, there was a significant (P < 0.001) mean change of 7.6 from baseline in mean EF domain score. Among men with severe ED, 22% achieved an EF domain score > or =26. Most common adverse events were headache 5.2%; flushing 3.9% and nasal congestion 3.2%; 3% discontinued use because of an adverse event.


CONCLUSIONS
In this open-label clinical trial of older men with ED and MCMs, tadalafil 20 mg significantly increased all efficacy end points and was well-tolerated.
Goldstein
Irwin
I
Milton, MA, USA;. Electronic address: irwingoldstein@comcast.net.
Kim
Edward
E
University of Tennessee, Knoxville, TN, USA.
Steers
William D
WD
University of Virginia, Charlottesville, VA, USA.
Pryor
Jon L
JL
University of Minnesota, Minneapolis, MN, USA.
Wilde
Dixon W
DW
ICOS Corporation, Bothell, WA, USA.
Natanegara
Fanni
F
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Wong
David G
DG
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Ahuja
Sanjeev
S
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
D017677:Age Distribution; D000368:Aged; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D003863:Depression / Q000453:epidemiology; D003920:Diabetes Mellitus / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010410:Penile Erection; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015995:Prevalence; D000068581:Tadalafil; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil