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The Annals of Pharmacotherapy: Vol. 38, No. 1, pp. 77-85. DOI 10.1345/aph.1D019
© 2004 Harvey Whitney Books Company.
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NEW DRUG APPROVALS

Vardenafil Treatment for Erectile Dysfunction

Susan M Crowe, PharmD

Pharmacy Practice Resident, Department of Pharmacy Services, University of Michigan Health System; Clinical Instructor, College of Pharmacy, University of Michigan, Ann Arbor, MI

Daniel S Streetman, PharmD

Clinical Pharmacist, Department of Pharmacy Services, University of Michigan Health System; Clinical Assistant Professor, College of Pharmacy, University of Michigan

Reprints: Daniel S Streetman PharmD, UHB2D301/Box 0008, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-0008, fax 734/936-7027, danstr{at}umich.edu

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical trial data, and adverse effects of vardenafil in the treatment of erectile dysfunction (ED).

DATA SOURCES: Literature searches were performed using the MEDLINE database (referenced citations through December 2002), and the references of all identified articles were scanned for additional publications of interest. Unpublished information provided by the manufacturer and proceedings of professional meetings were also evaluated.

STUDY SELECTION AND DATA EXTRACTION: All available studies were utilized to obtain information regarding pharmacology. Only human studies were used to gather pharmacokinetic, drug interaction, efficacy, and safety data.

DATA SYNTHESIS: Vardenafil is a potent and selective inhibitor of the phosphodiesterase 5 (PDE5) enzyme that has been shown to improve erectile function in several populations of men with ED. Vardenafil has a rapid onset of action, is hepatically metabolized, and has a half-life of 4–6 hours. Clinical trials in otherwise healthy men with ED, men with ED and diabetes, and men with ED and a history of prostatectomy have demonstrated vardenafil's efficacy. Adverse effects appear to be relatively mild in intensity and dose dependent, with 22–61% of subjects reporting adverse effects.

CONCLUSIONS: Vardenafil is a safe and effective oral agent for the treatment of ED. Its greater potency and PDE5 selectivity compared with sildenafil appear to confer a lower risk of vision-related adverse effects, but other clinical consequences of these differences are currently unclear.

Key Words: erectile dysfunction, phosphodiesterase, vardenafil

Published Online, December 5, 2003. www.theannals.com, DOI 10.1345/aph.1D019

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER
: 407-000-04-001-H01


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