PMID- 17073835
OWN - NLM
STAT- MEDLINE
DCOM- 20070227
LR  - 20231024
IS  - 1368-5031 (Print)
IS  - 1368-5031 (Linking)
VI  - 60
IP  - 11
DP  - 2006 Nov
TI  - First-dose success with vardenafil in men with erectile dysfunction and 
      associated comorbidities: RELY-I.
PG  - 1378-85
AB  - First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely 
      affected in patients with comorbidities. This article reports first-dose success 
      rates for vardenafil 10 mg in men with erectile dysfunction (ED) and associated 
      comorbidities who participated in the challenge phase of the 
      Reliability--Vardenafil for Erectile Dysfunction I study. This study involved an 
      open-label, single-dose, 1-week challenge period where patients who achieved 
      SEP-2 (penetration) success were randomised to vardenafil 10 mg or placebo for 12 
      weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 
      (maintenance of erection to completion of intercourse) were stratified according 
      to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who 
      received a single 10 mg dose of vardenafil, 32% had hypertension, 16% had 
      diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall 
      effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients 
      with and without specific comorbidities. Initial overall success rates for SEP-2 
      and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose 
      SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 
      191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men 
      with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the 
      most frequently reported flushing (3.5%), were mild to moderate in intensity. 
      Vardenafil 10 mg is generally well tolerated and efficacious, providing 
      first-dose success with a consistently high rate of reliability of penetration 
      and maintenance of erection in men with ED and associated comorbidities.
FAU - Valiquette, L
AU  - Valiquette L
AD  - Department of Urology, Hopital St-Luc du CHUM, Montreal, Quebec, Canada. 
      lucval@videotron.ca
FAU - Montorsi, F
AU  - Montorsi F
FAU - Auerbach, S
AU  - Auerbach S
CN  - Vardenafil Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Imidazoles)
RN  - 0 (Phosphodiesterase Inhibitors)
RN  - 0 (Piperazines)
RN  - 0 (Sulfones)
RN  - 0 (Triazines)
RN  - 5O8R96XMH7 (Vardenafil Dihydrochloride)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Diabetic Angiopathies/complications/*drug therapy
MH  - Double-Blind Method
MH  - Dyslipidemias/complications
MH  - Humans
MH  - Hypertension/complications
MH  - Imidazoles/*administration & dosage/adverse effects
MH  - Impotence, Vasculogenic/complications/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Phosphodiesterase Inhibitors/*administration & dosage/adverse effects
MH  - Piperazines/*administration & dosage/adverse effects
MH  - Sulfones/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Triazines/administration & dosage/adverse effects
MH  - Vardenafil Dihydrochloride
EDAT- 2006/11/01 09:00
MHDA- 2007/02/28 09:00
CRDT- 2006/11/01 09:00
PHST- 2006/11/01 09:00 [pubmed]
PHST- 2007/02/28 09:00 [medline]
PHST- 2006/11/01 09:00 [entrez]
AID - IJCP1170 [pii]
AID - 10.1111/j.1742-1241.2006.01170.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2006 Nov;60(11):1378-85. doi: 10.1111/j.1742-1241.2006.01170.x.