PMID- 17087804
OWN - NLM
STAT- MEDLINE
DCOM- 20070518
LR  - 20220409
IS  - 1743-6095 (Print)
IS  - 1743-6095 (Linking)
VI  - 4
IP  - 2
DP  - 2007 Mar
TI  - Real-life safety and efficacy of vardenafil in the treatment of erectile 
      dysfunction-results from 30,010 U.S. patients.
PG  - 432-9
AB  - INTRODUCTION: Clinical trials show that vardenafil produces effective and 
      satisfactory first-dose success rates and reliability for erection and 
      intercourse in men with erectile dysfunction (ED). AIM: This study was conducted 
      to evaluate real-life efficacy, safety, and acceptance of vardenafil in men with 
      ED. METHODS: This open-label, prospective study, conducted in 6,740 U.S. centers, 
      included an initial visit and one or two follow-up visits within a 2-month period 
      of the first vardenafil dose. Vardenafil was administered in 5-20 mg doses. MAIN 
      OUTCOME MEASURES: Efficacy variables included first-dose success rates for 
      vaginal penetration, maintenance of erection, and satisfaction based on physician 
      and patient assessments. Safety was assessed by adverse events (AEs). RESULTS: A 
      total of 30,010 men were included in the safety/intent-to-treat (S/ITT) analysis, 
      with 26,043 men in the adjusted S/ITT population. Vardenafil improved erectile 
      function in 78% of men, with 75% rating overall efficacy as "satisfying" or "very 
      satisfying." The overall rates of successful penetration and maintenance with 
      vardenafil following the first dose were 78% and 68%, respectively. For men with 
      mild and moderate ED, first-dose success rates for penetration were 89% and 82%, 
      respectively, and for maintenance, 82% and 71%, respectively. First-dose 
      penetration and maintenance of erection rates were 76% and 66%, respectively, for 
      men with self-reported hypertension, and 70% and 60%, respectively, for men with 
      diabetes mellitus. At study end, 67% of patients preferred to continue using 
      vardenafil. The most frequently reported AEs were headache (4%) and flushing 
      (2%). Vardenafil was well tolerated, with a "satisfied/very satisfied" 
      tolerability rating in 75% of cases as assessed by the physician. CONCLUSIONS: 
      This observational study demonstrated the tolerability and efficacy of vardenafil 
      in men with ED and comorbidities. Vardenafil provided a high rate of first-dose 
      intercourse success and a favorable safety profile in patients with and without 
      comorbid disease.
FAU - Cheng, Eric
AU  - Cheng E
AD  - Department of Family Medicine, State University of New York, Health Science 
      Center, Brooklyn, New York, USA. mrspeakerz@earthlink.net
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20061106
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
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  - *Coitus
MH  - Dose-Response Relationship, Drug
MH  - Erectile Dysfunction/*drug therapy/epidemiology
MH  - Humans
MH  - Imidazoles/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction/*statistics & numerical data
MH  - Penile Erection/drug effects
MH  - Phosphodiesterase Inhibitors/*administration & dosage/adverse effects
MH  - Piperazines/*administration & dosage/adverse effects
MH  - Quality of Life
MH  - Sulfones/administration & dosage/adverse effects
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Triazines/administration & dosage/adverse effects
MH  - United States/epidemiology
MH  - Vardenafil Dihydrochloride
EDAT- 2006/11/08 09:00
MHDA- 2007/05/19 09:00
CRDT- 2006/11/08 09:00
PHST- 2006/11/08 09:00 [pubmed]
PHST- 2007/05/19 09:00 [medline]
PHST- 2006/11/08 09:00 [entrez]
AID - S1743-6095(15)31547-2 [pii]
AID - 10.1111/j.1743-6109.2006.00383.x [doi]
PST - ppublish
SO  - J Sex Med. 2007 Mar;4(2):432-9. doi: 10.1111/j.1743-6109.2006.00383.x. Epub 2006 
      Nov 6.