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Q Does vardenafil improve erectile dysfunction and mild major depressive disorder in men with both disorders?
METHODS
Design:
Randomised controlled trial.
Allocation:
Not stated.
Blinding:
Double blind.
Follow up period:
12 weeks.
Setting:
44 centres in the USA, Canada, France, Spain and Italy; December 2002 to November 2003.
Patients:
280 men aged 18 and over with erectile dysfunction for longer than 6 months (National Institutes of Health criteria) and untreated depressive disorder (a score of 13–23 (later modified to 11–17) on the Hamilton Depression Rating Scale and >13 on Center for Epidemiologic Studies Depression Scale) who had been in a heterosexual relationship for >6 months at study entry. Exclusions: serious risk of homicide or suicide; history of psychotic disorders, panic disorder, post-traumatic stress disorder or personality disorder; substance abuse; unstable medical condition; sildenafil non-responder; erectile dysfunction due to spinal cord injury; primary hypoactive sexual desire; penile anatomical abnormalities, retinitis pigmentosa and radical prostatectomy.
Intervention:
Vardenafil (10 mg for first 4 weeks, titrated to 20 mg or 5 mg at 4 week intervals as needed in consultation with treating physician; n = 137) or placebo (n = 143).
Outcomes:
Erectile function (International Index of Erectile Dysfunction (IIEF): erectile function domain, score change of 5 points considered clinically significant), depressive symptoms (Hamilton Depression Rating Scale, score change of 3.5 points considered clinically significant).
Patient follow up:
86% vardenafil; 78% placebo.
MAIN RESULTS
Compared with placebo, vardenafil improved erectile function (mean improvement in IIEF erectile function domain score: 10 with vardenafil v 2 with placebo, p<0.0001); and improved depressive symptoms (mean Hamilton Depression Rating Scale score: 7.9 for vardenafil v 10.1 for placebo, p = 0.0001) at 12 weeks.
CONCLUSION
Vardenafil improves comorbid erectile dysfunction and mild major depressive disorder.
Commentary
Both erectile dysfunction (ED) and major depressive disorder are common.1,2 The incidence of ED is increased in men with depression.3 The nature of this association and the direction of any causality is complex. Such a common clinical problem is worthy of study and effective interventions are welcome.
Phosphodiesterase-5 (PDE-5) inhibitors (sildenafil and related drugs) are effective in treating ED in men who are depressed and this improvement in erectile function may be associated with improved mood.4 This pharmaceutical company funded study investigated the effect of treatment with vardenafil on mood and erectile function in men with ED known to be responsive to sildenafil and comorbid untreated mild depression. The results describe improved erectile function and decreased depressive symptoms in the active treatment group.
Depression was rated using the Hamilton Depression Rating Scale (HAM-D) with a primary endpoint of least squares mean HAM-D. The clinical significance of an improvement between treatment and placebo of 2.2 on this endpoint is not clear. HAM-D includes a genital symptoms element (score 0–2) and this may partly account for the decreased HAM-D scores in the treatment group.
The mild severity of depressive symptoms and exclusion of psychiatric comorbidity in this trial limit its applicability to those working in secondary care psychiatric services in the UK. For those working in primary care, vardenafil is not available on NHS prescription and tadalafil is available only to specific groups.5 Current National Institute of Health and Clinical Excellence guidelines for the treatment of mild depression do not specifically include addressing ED.6 Recommended interventions include exercise, which can improve both mood and ED.7
Footnotes
For correspondence: Dr Raymond Rosen, Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School, 675 Hoes Lane, Piscataway, NJ 08854, USA; rosen{at}umdnj.edu
Sources of funding: Bayer Healthcare Pharmaceuticals and GlaxoSmithKline.