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Vardenafil May Improve Both Erectile Dysfunction and Mild Depression

  • Authors: News Author: Laurie Barclay, MD
    CME Author: Charles Vega, MD, FAAFP
  • CME Released: 1/18/2006
  • Valid for credit through: 1/18/2007
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Target Audience and Goal Statement

This article is intended for primary care clinicians, urologists, psychiatrists, and other specialists who care for men with erectile dysfunction and depression.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Describe the relationship between erectile dysfunction and depression.
  • List outcomes improved with vardenafil vs placebo among patients with erectile dysfunction and mild depression.


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  • Laurie Barclay, MD

    Laurie Barclay is a freelance reviewer and writer for Medscape.


    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.


  • Gary Vogin, MD

    Senior Medical Editor, Medscape


    Disclosure: Gary Vogin, MD, has disclosed no relevant financial relationships.

CME Author(s)

  • Charles P Vega, MD

    Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine


    Disclosure: Charles Vega, MD, FAAFP, has disclosed that he has received grants for educational activities from Pfizer.

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Vardenafil May Improve Both Erectile Dysfunction and Mild Depression

Authors: News Author: Laurie Barclay, MD CME Author: Charles Vega, MD, FAAFPFaculty and Disclosures

CME Released: 1/18/2006

Valid for credit through: 1/18/2007



Jan. 18, 2006 — Vardenafil improves both erectile dysfunction and mild depression, according to the results of a randomized, multicenter study reported in the January issue of the American Journal of Psychiatry.

"Erectile dysfunction and depression are highly associated," write Raymond Rosen, PhD, from the University of Medicine and Dentistry of New Jersey in Piscataway, and colleagues from the Vardenafil Study Site Investigators. "Previous studies have shown benefits of phosphodiesterase-5 [PDE-5] inhibitor treatment for erectile dysfunction associated with antidepressant therapy or subsyndromal depression.... Vardenafil is a potent selective PDE-5 inhibitor that has been shown to be highly efficacious in men with erectile dysfunction, irrespective of severity or disease classification (organic, psychogenic, or mixed) or underlying etiology."

In this 12-week, parallel-group, double-blind study, 280 men with erectile dysfunction for at least 6 months and untreated mild major depression were randomized to placebo or vardenafil, 10 mg/day, for 4 weeks. After each of 2 consecutive 4-week intervals, investigators had the option to titrate vardenafil to 5 mg/day or 20 mg/day. Outcome measures included the erectile function domain of the International Index of Erectile Function and 17-item Hamilton Depression Rating Scale (HAM-D) scores.

Compared with placebo, vardenafil was associated with statistically significant and clinically meaningful improvement in all erectile function parameters. The erectile function domain score was 22.9 vs 14.9, and the HAM-D score was 7.9 vs 10.1. Treatment with vardenafil was the best predictor of return to normal erectile function, and improvement in International Index of Erectile Function erectile function domain score was the best predictor of remission in depressive symptoms.

"Vardenafil was well tolerated and highly efficacious in men with erectile dysfunction and untreated mild major depression," the authors write. "Significant improvements in erectile function and depression were observed in patients treated with vardenafil versus placebo. Erectile dysfunction treatment should be considered a component of therapy for men with depression and erectile dysfunction."

Study limitations include the relatively short duration of treatment, lack of generalizability to patients with more severe depression, and failure to determine the causal relationship between symptoms of erectile dysfunction and depression.

"It is highly unlikely that vardenafil exerts direct antidepressant effects because it is not known to penetrate the blood-brain barrier," the authors conclude. "Improvement in symptoms of depression is more likely attributable to increased self-esteem and quality of life associated with improved sexual function and satisfaction with the partner, family, and relationship. This reinforces the concept that treatment of physical symptoms in depression can enhance treatment outcomes and overall quality of life and reduce the risk of relapse."

Bayer Healthcare Pharmaceuticals and GlaxoSmithKline funded this study.

Am J Psychiatry. 2006;163:79-87