PMID- 16728966
OWN - NLM
STAT- MEDLINE
DCOM- 20070306
LR  - 20221207
IS  - 0955-9930 (Print)
IS  - 0955-9930 (Linking)
VI  - 19
IP  - 1
DP  - 2007 Jan-Feb
TI  - Tadalafil is efficacious in Black American and Hispanic men with erectile 
      dysfunction: results from multiple observations in men with erectile dysfunction 
      in national tadalafil study in the US (MOMENTUS).
PG  - 76-83
AB  - To show that tadalafil is efficacious in Black American and Hispanic men with 
      erectile dysfunction (ED) and efficacy is noninferior to that in Caucasian men. 
      Multiple observations in men with ED in national tadalafil study in the US, a 
      multicenter, open-label study, assessed the efficacy of tadalafil 20 mg taken as 
      needed (maximum one dose/day before sexual activity) for 12 weeks by patients 
      with ED in various populations. This analysis focuses on three groups: Caucasian 
      (Reference group), Black American, and Hispanic men. Primary measurement of 
      efficacy was change from baseline in erectile function (EF) domain of the 
      International Index of Erectile Function (IIEF) and the primary analysis was 
      whether efficacy in Black American and Hispanic groups was noninferior to 
      efficacy in the Caucasian group. Secondary efficacy measures included sexual 
      encounter profile (SEP), IIEF intercourse satisfaction (IS) and overall 
      satisfaction (OS) domains, Global Assessment Question (GAQ), and Psychological 
      and Interpersonal Relationship Scale (PAIRS). Safety was assessed from adverse 
      events (AEs) reported by all enrolled patients. The increase in IIEF EF domain 
      score (>or=9.5) from baseline for each group was statistically significant 
      (P<0.001) and clinically relevant. Efficacy of tadalafil in Black American and 
      Hispanic patients was noninferior to the Caucasian group. IS and OS domains of 
      IIEF had a statistically significant increase from baseline (P<0.001). Change 
      from baseline in positive responses to SEP questions for each group was 
      significant (P<0.001). At least 77% of intercourse attempts were successful over 
      various time intervals up to 36 h postdose. At least 88% of patients in the 
      various groups had a positive response to GAQ1. Improvement from baseline in 
      Sexual Self-Confidence and Spontaneity domains of PAIRS was statistically 
      significant (P<0.001). A low number of AEs and a low AE-related discontinuation 
      rate (2.3%) were reported in all groups. Tadalafil 20 mg was as efficacious in 
      Black American and Hispanic men with ED as in Caucasian patients and was well 
      tolerated.
FAU - Gomery, P
AU  - Gomery P
AD  - Department of Urology, Massachusetts General Hospital, Boston, MA 02114, USA. 
      pgomery@partners.org
FAU - Bullock, A
AU  - Bullock A
FAU - McGettigan, J
AU  - McGettigan J
FAU - Munarriz, R
AU  - Munarriz R
FAU - Natanegara, F
AU  - Natanegara F
FAU - Hague, J
AU  - Hague J
FAU - Kuepfer, C
AU  - Kuepfer C
FAU - Ahuja, S
AU  - Ahuja S
FAU - Wong, D
AU  - Wong D
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20060518
PL  - England
TA  - Int J Impot Res
JT  - International journal of impotence research
JID - 9007383
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
EIN - Int J Impot Res. 2007 May-Jun;19(3):339. Abuja, S [corrected to Ahuja, S]
MH  - Adult
MH  - Aged
MH  - *Black People
MH  - Carbolines/adverse effects/*therapeutic use
MH  - Coitus
MH  - Erectile Dysfunction/*drug therapy
MH  - *Hispanic or Latino
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Phosphodiesterase Inhibitors/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Tadalafil
MH  - Treatment Outcome
MH  - White People
EDAT- 2006/05/27 09:00
MHDA- 2007/03/07 09:00
CRDT- 2006/05/27 09:00
PHST- 2006/05/27 09:00 [pubmed]
PHST- 2007/03/07 09:00 [medline]
PHST- 2006/05/27 09:00 [entrez]
AID - 3901484 [pii]
AID - 10.1038/sj.ijir.3901484 [doi]
PST - ppublish
SO  - Int J Impot Res. 2007 Jan-Feb;19(1):76-83. doi: 10.1038/sj.ijir.3901484. Epub 
      2006 May 18.