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.
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.
Loran
Oleg B
OB
Department of Urology, Russian Medical Academy of Postgraduate Education, 2nd Botkinsky Street, 5 Moscow Russian Federation 125101, Moscow, Russia. urosurfer@mail.ru
Ströberg
Peter
P
Lee
Sung Won
SW
Park
Nam Cheol
NC
Kim
Soo-Woong
SW
Tseng
Li-Jung
LJ
Collins
Suzanne
S
Stecher
Vera J
VJ
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
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate