Vardenafil in the Treatment of Erectile Dysfunction in Outpatients With Chronic Schizophrenia: A Flexible-Dose, Open-Label Study
J Clin Psychiatry 2008;69(2):206-212
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: The aim of this study was to evaluate the safety
and efficacy of vardenafil in outpatients with chronic schizophrenia and
erectile dysfunction and to investigate any effect on quality of life in this
Method: In this 12-week, open-label, flexible-dose study, 25
outpatients with chronic schizophrenia (DSM-IV criteria) and erectile
dysfunction received vardenafil 10 mg as needed (at a maximum of 1 dose per
day) with the option to maintain current dose or to titrate to 5 mg or 20 mg at
4 and 8 weeks. Assessment was performed with the International Index of
Erectile Function (IIEF) at base line and at weeks 4, 8, and 12. The Quality of
Life Scale (QLS) was administered at baseline and at week 12. The study was
carried out at the Psychiatric Hospital of Athens, Greece, between October 2005
and November 2006.
Results: Vardenafil produced a statistically significant
improvement in all IIEF domains [erectile function (p < .001), orgasmic
function (p < .05), sexual desire (p < .05), intercourse satisfaction (p <
.01), and overall satisfaction (p < .001)] and QLS (p < .003). Results were
similar for the intention-to-treat (N = 25) and completer (N = 21, 84%) groups.
Adverse events were infrequent and decreased in incidence over the course of
Conclusion: Vardenafil was generally well tolerated and highly
effective in outpatients with chronic schizophrenia and erectile dysfunction.
The response to vardenafil was not influenced by certain patient
characteristics, such as erectile dysfunction severity or serum prolactin
levels. Improvement in sexual function was correlated with improvement in the
quality of life.