title: Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus.
abstract: OBJECTIVE
  To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus.
  
  
  METHODS
  This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score.
  
  
  RESULTS
  Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion.
  
  
  CONCLUSIONS
  Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier NCT00809471.
authors.affiliation: San Diego Sexual Medicine, Alvarado Hospital, CA 92120, USA. dr.irwingoldstein@gmail.com
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.forename: LeRoy A
authors.initials: LA
authors.lastname: Jones
authors.forename: Laurence H
authors.initials: LH
authors.lastname: Belkoff
authors.forename: Gary S
authors.initials: GS
authors.lastname: Karlin
authors.forename: Charles H
authors.initials: CH
authors.lastname: Bowden
authors.forename: Craig A
authors.initials: CA
authors.lastname: Peterson
authors.forename: Brenda A
authors.initials: BA
authors.lastname: Trask
authors.forename: Wesley W
authors.initials: WW
authors.lastname: Day
mesh_terms: D003920:Diabetes Mellitus; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects; D010919:Placebos; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D011743:Pyrimidines; C553414:avanafil