title: Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt.
abstract: BACKGROUND
  Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy.
  
  
  OBJECTIVE
  Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED.
  
  
  METHODS
  Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg).
  
  
  METHODS
  Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg.
  
  
  RESULTS
  Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose.
  
  
  CONCLUSIONS
  Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose.
authors.affiliation: Department of Urology, Russian Medical Academy of Postgraduate Education, 2nd Botkinsky Street, 5 Moscow Russian Federation 125101, Moscow, Russia. urosurfer@mail.ru
authors.forename: Oleg B
authors.initials: OB
authors.lastname: Loran
authors.forename: Peter
authors.initials: P
authors.lastname: Ströberg
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Lee
authors.forename: Nam Cheol
authors.initials: NC
authors.lastname: Park
authors.forename: Soo-Woong
authors.initials: SW
authors.lastname: Kim
authors.forename: Li-Jung
authors.initials: LJ
authors.lastname: Tseng
authors.forename: Suzanne
authors.initials: S
authors.lastname: Collins
authors.forename: Vera J
authors.initials: VJ
authors.lastname: Stecher
mesh_terms: D000328:Adult; D000368:Aged; D001007:Anxiety / Q000188:drug therapy / Q000209:etiology; D003075:Coitus / Q000523:psychology; D016001:Confidence Intervals; D004311:Double-Blind Method; D006305:Health Status Indicators; D006801:Humans; D018783:Impotence, Vasculogenic / Q000188:drug therapy* / Q000523:psychology; D038622:Internationality; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D017060:Patient Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011687:Purines / Q000008:administration & dosage / Q000627:therapeutic use; D000068677:Sildenafil Citrate; D013223:Statistics as Topic; D013450:Sulfones / Q000008:administration & dosage / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate