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Titolo:
A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction
Autore:
Meuleman, E; Cuzin, B; Opsomer, RJ; Hartmann, U; Bailey, MJ; Maytom, MC; Smith, MD; Osterloh, IH;
Indirizzi:
Acad Ziekenhuis, Dept Urol, NL-6500 HB Nijmegen, Netherlands Acad Ziekenhuis Nijmegen Netherlands NL-6500 HB HB Nijmegen, Netherlands Hop Edouard Herriot, Serv Urol, Lyon, France Hop Edouard Herriot Lyon France douard Herriot, Serv Urol, Lyon, France Clin Univ St Luc, Div Urol, B-1200 Brussels, Belgium Clin Univ St Luc Brussels Belgium B-1200 Urol, B-1200 Brussels, Belgium Med Hsch Hannover, Arbeitsbereich Klin Psychol, Hannover, Germany Med HschHannover Hannover Germany eich Klin Psychol, Hannover, Germany Epsom Gen Hosp, Surrey, England Epsom Gen Hosp Surrey EnglandEpsom Gen Hosp, Surrey, England Pfizer Inc, New York, NY 10016 USA Pfizer Inc New York NY USA 10016Pfizer Inc, New York, NY 10016 USA Pfizer Cent Res, Sandwich, Kent, England Pfizer Cent Res Sandwich Kent England Cent Res, Sandwich, Kent, England
Titolo Testata:
BJU INTERNATIONAL
fascicolo: 1, volume: 87, anno: 2001,
pagine: 75 - 81
SICI:
1464-4096(200101)87:1<75:ADSTAT>2.0.ZU;2-9
Fonte:
ISI
Lingua:
ENG
Soggetto:
VASOACTIVE INTESTINAL POLYPEPTIDE; ORAL SILDENAFIL; IMPOTENCE; PHENTOLAMINE; PHYSIOLOGY; PREVALENCE; INJECTION; FAILURE;
Keywords:
erectile dysfunction; sildenfil; dose-escalation study; efficacy;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
24
Recensione:
Indirizzi per estratti:
Indirizzo: Meuleman, E Acad Ziekenhuis, Dept Urol, Postbus 9101, NL-6500 HB Nijmegen,Netherlands Acad Ziekenhuis Postbus 9101 Nijmegen Netherlands NL-6500 HB
Citazione:
E. Meuleman et al., "A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction", BJU INT, 87(1), 2001, pp. 75-81

Abstract

Objective To assess the efficacy and safety of sildenafil citrate (Viagra(R), Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology. Patients and methods In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a historyof pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg andthen to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, anoverall efficacy question, and event-log data. Results After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafilsignificantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain. regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo. Conclusion Sildenafil is an effective and well-tolerated treatment for menwith erectile dysfunction of a broad spectrum of aetiology.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 22/01/20 alle ore 22:33:26