Ecacy results and quality-of-life measures in men receiving sildena®l citrate for the treatment of erectile dysfunction FrancËois Giuliano 1 , Beatriz M. PenÄa 2 , Avanish Mishra 2 & Michael D. Smith 3 1 Department of Urology, CHU de BiceÃtre, AP-HP, Le Kremlin Bice Ãtre, France (E-mail: giuliano@cyber- sante.org); 2 P®zer Inc, New York, NY, USA; 3 P®zer Ltd, Sandwich, England Accepted in revised form 25 June 2001 Abstract The aim of the present study was to evaluate the ecacy of sildena®l citrate and its eects on quality of life (QoL) in men with erectile dysfunction (ED) using data from three multicenter, double-blind, placebo- controlled clinical trials. Ecacy was evaluated using a global ecacy question (improvement of erections) and questions from the International Index of Erectile Function (IIEF) addressing the ability to achieve and maintain erections. QoL directly related to ED was evaluated using questions 13 and 14 of the IIEF, several psychometric instruments, and a questionnaire addressing men's concerns about their erection problems. Ninety-seven percent of patients receiving sildena®l reported improved erections compared with 23% of patients receiving placebo (p < 0.0001); also reported were improvements in the ability to achieve and maintain erections with sildena®l but not with placebo (p < 0.0001). Improvements were also seen for other aspects of sexual function (overall satisfaction with sex life, sexual relationships with partners, concerns about erectile problems; p < 0.0001) and general mental health (well-being, self-control, satis- faction with relationship, health relative to 1 year ago, mental health; p O 0:05) following treatment with sildena®l. Thus, treatment of ED with sildena®l can signi®cantly improve key QoL parameters related to sexual dysfunction and general mental health. Key words: Erectile dysfunction, Quality of life, Sildena®l Abbreviations: ED ± Erectile dysfunction; GEQ ± Global ecacy question; IIEF ± International Index of Erectile Function; MOS ± Medical outcomes survey; PGWB ± Psychological general well-being; QoL ± Quality of life Introduction Erectile dysfunction (ED) is de®ned as the persis- tent inability to achieve and/or maintain an erec- tion sucient for satisfactory sexual performance [1]. In contrast to other forms of treatment for ED, sildena®l citrate (Viagra Ò , P®zer Inc) is the ®rst oral medication to be approved for the treatment of ED of mixed etiology. Taken before sexual ac- tivity, sildena®l enhances sexually stimulated pe- nile tumescence through selective inhibition of the phosphodiesterase type 5 enzyme and subsequent enhancement of the nitric oxide±cyclic guanosine monophosphate (cGMP) pathway in corpus caver- nosum smooth muscle [2, 3]. The drug has been proven to be eective and well tolerated in large- scale, controlled clinical trials [4, 5]. In one trial, 74% of patients with ED who received sildena®l reported improved erections compared with 16% of patients who received placebo [4, 5]. In an open- label trial conducted in 100 men with ED who were treated with sildena®l, test scores for the These studies were supported by P®zer Inc. Quality of Life Research 10: 359±369, 2001. Ó 2001 Kluwer Academic Publishers. Printed in the Netherlands. 359