WEST HAVEN, Conn., and PHILADELPHIA, March 24 /PRNewswire-FirstCall/ -- A new study being presented today at the 19th Congress of the European Association of Urology (EAU) in Vienna may give hope to men with erectile dysfunction (ED) who also have depressive symptoms.
The first clinical study to evaluate LEVITRA(R) (vardenafil HCl) in men with both ED and untreated mild to moderate major depressive disorder (MDD), showed that Levitra significantly improved all measures of erectile function (EF) that were studied compared with placebo.(1) Men with ED taking Levitra were nearly three times more likely to report improved erections than men taking placebo.(1) In addition, some improvements in depression and self-esteem were seen with Levitra compared with placebo. Results from the study, referred to as the DRIVER (Depression Related Improvement with Vardenafil for Erectile Response) trial, are being presented for the first time at EAU.
Research has shown that ED and depression are strongly associated.(2) ED can be a consequence of depression, or ED may result in depression.(3) According to a study of men's attitudes towards life events and sexuality, 25 percent of men with ED reported symptoms of depression or anxiety.(4)
"We know that many men with ED also suffer from depression, and it is likely that ED can be a causative factor for depression," said Raymond Rosen, M.D., study investigator and professor of Psychiatry and director of the Human Sexuality Program at the University of Medicine and Dentistry of New Jersey (UMDNJ) - Robert Wood Johnson Medical School in New Brunswick, N.J. "These findings reinforce the importance of rapid and reliable diagnosis and treatment of ED if the wider well-being of men is to be supported."
The multicenter, double-blind, flexible-dose trial studied men with ED and untreated mild to moderate MDD.* A total of 280 men with a history of ED for longer than six months were randomized to receive Levitra 10 mg or placebo for four weeks. At weeks four and eight, physicians could adjust the dose of Levitra based on the efficacy and tolerability of the drug. Patients either remained on their previous dose of Levitra or placebo, or the dose was increased or decreased by one step according to the three applicable dosage strengths (5 mg, 10 mg or 20mg). The total duration of treatment was 12 weeks.
All efficacy measures related to ED significantly improved with Levitra compared with placebo.(1) After 12 weeks, results showed that:
-- EF domain scores (a measure of ED severity) improved from moderate to
mild (13.2 to 22.9) among men taking Levitra but remained at moderate
(13.6 to 14.9) among men taking placebo (p<0.0001).(1)
-- Men taking Levitra were nearly three times more likely to report
improved erections than men taking placebo(a) (83 percent vs. 30
percent, p<0.0001).(1)
-- The magnitude of improvement in the HAM-D17 score was greater in men
treated with Levitra than in those treated with placebo (p=0.0001).(1)
In the clinical trial, the most commonly reported adverse events were generally mild to moderate and included headache, flushing and nasal congestion.(1)
ED and Levitra
ED -- the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance(5) -- is a common health condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 40(6) -- 152 million men worldwide(7) and 30 million men in the United States alone.(8)
Despite the high prevalence of sexual problems, nine out of 10 men in the U.S. have not yet sought treatment from a physician.(9)
Bayer and GlaxoSmithKline signed a worldwide co-promotion and co-development agreement for Levitra in November 2001. To date, Levitra has received regulatory approval for the treatment of ED in more than 63 countries. Levitra was approved by the U.S. Food and Drug Administration for the treatment of ED on August 19, 2003, providing American men with their first new ED treatment choice in five years.
Levitra is a prescription medicine that is used to treat erectile dysfunction (ED). Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take Levitra. Men who use alpha-blockers, sometimes prescribed for high blood pressure or prostate problems, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. You should not take Levitra if your doctor determines that sexual activity poses a health risk for you. Men who experience an erection for more than four hours should seek immediate medical attention. Levitra does not protect against sexually transmitted diseases. The starting dose of Levitra is 10 mg taken no more than once per day. Your doctor will decide the dose that is right for you. In patients taking certain medications such as ritonavir, indinavir, ketoconazole, itraconazole, and erythromycin, lower doses of Levitra are recommended, and time between doses of Levitra may need to be extended. In clinical trials, the most commonly reported side effects are headache, flushing, and stuffy or runny nose. Levitra is available in 2.5 mg, 5 mg, 10 mg and 20 mg tablets. Individual patient results may vary.
About Bayer Pharmaceuticals Corporation
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REFERENCES
1. Rosen R, Montorsi F, Assalian P, et al. Efficacy and tolerability of
vardenafil in men with mild depressive disorder and erectile
dysfunction: the Depression Related Improvement with Vardenafil for
Erectile Response (DRIVER) study. To be presented at the 19th Congress
of the European Association of Urology (EAU), March 26, 2004.
2. Araujo AB, Durante R, Feldman HA et al. The relationship between
depressive symptoms and male erectile dysfunction: cross-sectional
results from the Massachusetts Male Aging Study. Psychosom Med
1998;60:458-65.
3. Radl, J.M. Recent Developments in the Treatment of Erectile
Dysfunction. Journal of the Pharmacy Society of Wisconsin
1988;May/June:26-31.
4. Rosen R, Fisher W, Eardley I, Niederberger C, Nadel A, Sand M. The
Multinational Men's Attitudes to Life Events and Sexuality (MALES)
Study: I. Prevalence of Erectile Dysfunction and Related Health
Concerns in the General Population. Curr Med Res Opin 2004;20:607-617.
5. Jardin A, Wagner G, Khoury S, et al. Recommendations of the 1st
International Consultation on Erectile Dysfunction. Co-sponsored by
the World Health Organization (WHO), International Consultation on
Urological Diseases (ICUD) and Societe Internationale d'Urologie (SIU)
and held July 1-3, 1999, Paris. 2000, p. 713.
6. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its
medical and psychosocial correlates: results of the Massachusetts Male
Aging Study. J Urol 1994;151:54-61.
7. Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of
erectile dysfunction between 1995 and 2025 and some possible policy
consequences. BJU Int 1999;84:50-56.
8. National Institutes of Health, Consensus Development Conference
Statement, December 7-9, 1992. Online data:
http://odp.od.nih.gov/consensus/cons/091/091_statement.htm. (accessed
8/26/02).
9. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States:
prevalence and predictors. JAMA 1999;281:537-544.
* As assessed by DSM IV and HAM-D17. DSM, the Diagnostic and Statistical
Manual of Mental Disorders, is the standard classification of mental
disorders used by health professionals. DSM IV refers to the Diagnostic
and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV),
which is published by the American Psychiatric Association, Washington
D.C., 1994. It provides a list of diagnostic criteria for the most
common mental disorders and includes description, diagnosis, treatment
and research findings. HAM-D, the 17-item Hamilton Depression Rating
Scale, is a widely used clinician-rated checklist designed to aid
examiners in assessing a broad spectrum of depression symptoms and to
track changes in symptom severity during the course of treatment.
a) Based on the Global Assessment Question (GAQ), a widely accepted
measure to evaluate ED treatment efficacy.
Bayer Pharmaceuticals Corporation; GlaxoSmithKline