New Study Showed LEVITRA(R) (vardenafil HCl) Improved Erectile Function While Reducing Depressive Symptoms in Men Treated for Er

New Study Showed LEVITRA(R) (vardenafil HCl) Improved Erectile Function While
Reducing Depressive Symptoms in Men Treated for Erectile Dysfunction (ED) 


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 thedrug.  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