Deciphering erectile dysfunction drug trials Journal Article


Author: Mulhall, J. P.
Article Title: Deciphering erectile dysfunction drug trials
Abstract: Purpose: Erectile dysfunction affects more than 20 million men in the United States. Currently, there are at least 10 novel erectogenic agents in development. It is incumbent on clinicians and especially urologists to be facile in interpreting data from drug trials investigating such medications. Materials and Methods: A comprehensive review of the literature addressing novel Food and Drug Administration approved erectogenic drugs was conducted using MEDLINE to highlight the key points in the analysis of data arising from these trials. Results: The major points for analysis include trial design, patient population studied, end points used and adverse event profile. The patients enrolled in erectile dysfunction drug trials should be representative of the general erectile dysfunction population. Assessment of the population includes defining baseline erectile dysfunction severity, co-morbidity profiles and concomitant medication use. Defining clinically meaningful end points is difficult. Several validated questionnaire instruments are available, the most commonly used being the International Index of Erectile Function. Much of the data gathered are based on this self-report inventory. Factors relating to adverse events include frequency of events-per patient and per administration rates-and severity and duration of side effects. Conclusions: Several key factors in trial design, patient enrollment and outcome analysis need to be assessed to interpret accurately the data generated from erectile dysfunction drug trials.
Keywords: treatment outcome; satisfaction; safety; epidemiology; drug therapy; sildenafil; impotence; clinical trials; efficacy; men; blockade; international index; alprostadil
Journal Title: Journal of Urology
Volume: 170
Issue: 2 Pt.1
ISSN: 0022-5347
Publisher: Elsevier Science, Inc.  
Date Published: 2003-08-01
Start Page: 353
End Page: 358
Language: English
ACCESSION: WOS:000184134100001
DOI: 10.1097/01.ju.0000063377.12281.57
PROVIDER: wos
PUBMED: 12853774
Notes: Review -- 1 -- Source: Wos
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  1. John P Mulhall
    603 Mulhall