PMID- 22788525
OWN - NLM
STAT- MEDLINE
DCOM- 20130311
LR  - 20130117
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 111
IP  - 1
DP  - 2013 Jan
TI  - A phase II, single-blind, randomized, crossover evaluation of the safety and 
      efficacy of avanafil using visual sexual stimulation in patients with mild to 
      moderate erectile dysfunction.
PG  - 137-47
LID - 10.1111/j.1464-410X.2012.11267.x [doi]
AB  - OBJECTIVE: To evaluate the safety, efficacy and time course of three doses of 
      avanafil (50 mg, 100 mg and 200 mg) compared with sildenafil 50 mg or placebo, 
      given in conjunction with visual sexual stimulation (VSS) videos in men with mild 
      to moderate erectile dysfunction (ED). PATIENTS AND METHODS: Male patients, 35-70 
      years of age, with mild to moderate ED of >/=6 months duration, were included in 
      the study. During the course of the study, each patient received placebo, active 
      control (sildenafil 50 mg), and one dose of avanafil (50 mg, 100 mg or 200 mg), 
      all administered in random order at least 72 h apart. RigiScan(R) (Dacomed Corp., 
      Minneapolis, MN, USA) monitoring was used in conjunction with 20-min VSS videos 
      (20, 60, and 100 min after dosing) to determine the duration of and time to >/=60% 
      penile rigidity, maximum rigidity, tumescent activity units (TAUs), rigidity 
      activity units (RAUs), and responses to the five-point Erection Assessment Scale. 
      Safety assessments included adverse events (AEs), vital sign changes in response 
      to dosing, laboratory results (complete blood counts, chemistry panel, 
      prostate-specific antigen, serum testosterone, prothrombin time and urine 
      analysis) and physical examination findings. RESULTS: Eighty-three patients were 
      randomized and received at least one dose of study medication; 82 patients 
      completed the study. Peak response to avanafil occurred in the early interval 
      (20-40 min after dosing), while peak response to sildenafil occurred either in 
      the middle (60-80 min) or late (100-120 min) intervals after dosing. Results were 
      qualitatively similar for all other efficacy endpoints. During the 20-40-min 
      interval, the majority of values for TAUs and RAUs with the avanafil 50-mg, 
      100-mg and 200-mg treatments were significantly superior to placebo (P < 0.05). 
      Avanafil treatment was generally well tolerated; facial flushing (7-15%) was the 
      most commonly observed AE, and no visual disturbances were reported. CONCLUSION: 
      A favourable safety profile and improvement in sexual function, coupled with 
      rapid onset of action and durability of effect, make avanafil an attractive 
      option for males with ED, especially in the setting of on-demand treatment.
CI  - (c) 2012 BJU International.
FAU - Hellstrom, Wayne J G
AU  - Hellstrom WJ
AD  - Department of Urology, Tulane University Medical Center, New Orleans, LA 70112, 
      USA. whellst@tulane.edu
FAU - Freier, Matthew T
AU  - Freier MT
FAU - Serefoglu, Ege Can
AU  - Serefoglu EC
FAU - Lewis, Ronald W
AU  - Lewis RW
FAU - DiDonato, Karen
AU  - DiDonato K
FAU - Peterson, Craig A
AU  - Peterson CA
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120712
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Pyrimidines)
RN  - DR5S136IVO (avanafil)
RN  - EC 3.1.4.35 (Cyclic Nucleotide Phosphodiesterases, Type 5)
SB  - IM
CIN - Nat Rev Urol. 2012 Sep;9(9):477. PMID: 22847547
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - Cyclic Nucleotide Phosphodiesterases, Type 5/*administration & dosage/adverse 
      effects
MH  - Drug Administration Schedule
MH  - Erectile Dysfunction/*drug therapy/physiopathology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penile Erection/drug effects
MH  - Photic Stimulation
MH  - Pyrimidines/*administration & dosage/adverse effects
MH  - Single-Blind Method
MH  - Treatment Outcome
EDAT- 2012/07/14 06:00
MHDA- 2013/03/12 06:00
CRDT- 2012/07/14 06:00
PHST- 2012/07/14 06:00 [entrez]
PHST- 2012/07/14 06:00 [pubmed]
PHST- 2013/03/12 06:00 [medline]
AID - 10.1111/j.1464-410X.2012.11267.x [doi]
PST - ppublish
SO  - BJU Int. 2013 Jan;111(1):137-47. doi: 10.1111/j.1464-410X.2012.11267.x. Epub 2012 
      Jul 12.