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Titolo:
Efficacy and safety of fixed-dose and dose-optimization regimens of sublingual apomorphine versus placebo in men with erectile dysfunction
Autore:
Dula, E; Keating, W; Siami, PF; Edmonds, A; ONeil, J; Buttler, S;
Indirizzi:
W Coast Clin Res, Van Nuys, CA 91405 USA W Coast Clin Res Van Nuys CA USA91405 t Clin Res, Van Nuys, CA 91405 USA Scotland Family Med, Scotland, PA USA Scotland Family Med Scotland PA USA cotland Family Med, Scotland, PA USA Welborn Clin E, Evansville, IN USA Welborn Clin E Evansville IN USAWelborn Clin E, Evansville, IN USA TAP Holdings Inc, Deerfield, IL USA TAP Holdings Inc Deerfield IL USATAP Holdings Inc, Deerfield, IL USA
Titolo Testata:
UROLOGY
fascicolo: 1, volume: 56, anno: 2000,
pagine: 130 - 135
SICI:
0090-4295(200007)56:1<130:EASOFA>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
PENILE ERECTION; IMPOTENT PATIENTS; YOHIMBINE; RATS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
22
Recensione:
Indirizzi per estratti:
Indirizzo: Dula, E W Coast Clin Res, 15243 Van Owen St,Suite 306, Van Nuys, CA 91405 USA W Coast Clin Res 15243 Van Owen St,Suite 306 Van Nuys CA USA 91405
Citazione:
E. Dula et al., "Efficacy and safety of fixed-dose and dose-optimization regimens of sublingual apomorphine versus placebo in men with erectile dysfunction", UROLOGY, 56(1), 2000, pp. 130-135

Abstract

Objectives. A sublingual (SL) formulation of apomorphine has been developed and found effective in penile erectile dysfunction (ED). This study assessed the efficacy and safety of several doses of apomorphine SL in a dose-optimization schedule compared with placebo. Methods. In this 8-week, multicenter, double-blind clinical trial, 569 patients were randomized to four groups: a dose-optimization group in which patients began with 2 mg, increased or decreased the dosage as needed for 4 weeks, and thereafter maintained an optimal dose for 4 weeks; two fixed-dosegroups of either 5 or 6 mg; and a placebo group. Efficacy was assessed by patient and partner responses to home-use questionnaires about sexual function and activity and by responses to the International Index of Erectile Function and the Brief Sexual Function Inventory. Results. In all apomorphine SL groups, a significantly higher percentage of patients compared with the placebo group achieved and maintained an erection firm enough for intercourse (48% to 53% versus 35% for placebo, P less than or equal to 0.001) and a significantly higher percentage of attempts resulted in intercourse (45% to 51% versus 33%, P less than or equal to 0.001). The responses to the questionnaires completed by the patients and partners were similar. Apomorphine SL was well tolerated; nausea, the most common side effect, was dose related and diminished substantially during the second 4-week period at all doses. The dose-optimization schedule resulted in fewer adverse events without impacting efficacy. Conclusions. Apomorphine SL is an effective and safe treatment for ED, with 2 and 4 mg providing the most acceptable therapeutic index. UROLOGY 56: 130-135, 2000, (C) 2000, Elsevier Science Inc.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/01/20 alle ore 15:37:05