title: An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction.
abstract: OBJECTIVE
  Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes.
  
  
  METHODS
  This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; '100/200-mg' group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF).
  
  
  RESULTS
  Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13.6 to 22.2 (100-mg group) and from 11.9 to 22.7 (100/200-mg group). Avanafil was effective in some patients ≤ 15 min and > 6 h postdose. Sixty-five per cent (112/172) of 'nonresponders' to avanafil 100 mg responded to the 200-mg dose. The most common (≥ 2%) treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events.
  
  
  CONCLUSIONS
  The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.
authors.affiliation: Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA. belkoff.ucsepa@covad.net
authors.forename: L H
authors.initials: LH
authors.lastname: Belkoff
authors.forename: A
authors.initials: A
authors.lastname: McCullough
authors.forename: I
authors.initials: I
authors.lastname: Goldstein
authors.forename: L
authors.initials: L
authors.lastname: Jones
authors.forename: C H
authors.initials: CH
authors.lastname: Bowden
authors.forename: K
authors.initials: K
authors.lastname: DiDonato
authors.forename: B
authors.initials: B
authors.lastname: Trask
authors.forename: W W
authors.initials: WW
authors.lastname: Day
mesh_terms: D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; C553414:avanafil