Study Confirms that Levitra(R) on-demand is Effective in Patients with Erectile Dysfunction (ED) after nerve-sparing Prostatectomy



    - World's largest landmark study of its kind presented first in Canada -

    TORONTO, Aug. 19 /CNW/ - An international study published in the August
issue of the European Urology journal and presented first in Canada at the
Canadian Urology Association's annual meeting in June demonstrates that
Levitra(R) (vardenafil HCI), taken on-demand, is highly effective in men with
erectile dysfunction (ED) in the months after a radical nerve-sparing
prostatectomy.
    In Canada, one in seven men will develop prostate cancer, with an
estimated 24,700 men being diagnosed this year.(1) For patients with localized
prostate cancer, a nerve-sparing prostatectomy is the gold standard of
treatment - unfortunately, ED commonly occurs in many men following the
procedure, who were sexually active before the surgery.(2)
    The landmark study Recovery of Erections: Intervention with Vardenafil
Early Nightly Therapy (REINVENT), is the largest double-blind, randomized,
placebo-controlled multicentre parallel group study, that investigated the
tolerability and efficacy of Levitra taken once nightly as a prophylactic
treatment versus Levitra pro re nata (PRN) (i.e., taken on-demand, when
needed) versus placebo in patients who have ED after undergoing a bilateral,
nerve-sparing, radical retropubic prostatectomy (BNSRRP).
    "After men have undergone a nerve-sparing prostatectomy, helping them
regain their erectile function when they desire is extremely important for
their quality of life," said Dr. Jay Lee, a Urologist with the Rockyview
General Hospital in Calgary.
    The study was done in three phases. Within 14 days of surgery, subjects
were randomized 1:1:1 to receive double-blind for nine months, either nightly
vardenafil, on-demand vardenafil, or placebo. At the end of nine months, all
patients were given two months of treatment with placebo (in a single-blind
population), and then all were given two months of treatment with vardenafil,
taken on-demand (as an open label).
    In the first phase of the study, men experienced excellent results with
the PRN Levitra. Thirty-six per cent of men taking Levitra PRN (PRN vs.
placebo p=0.0003), 20 per cent taking Levitra nightly and 17 per cent of men
on placebo reported normal erectile function (represented by an International
Index of Erectile Function - Erectile Function (IIEF-EF) score of greater than
or equal to 26) measured at Last Observation Carried Forward (LOCF). Over the
entire double-blind period the mean per-patient success rates for successful
intercourse were 46 per cent for Levitra on-demand (vs. placebo p less than
0.0001), 35 per cent for Levitra nightly, and 25 per cent on placebo as
measured by the SEP 3 question of the diary-based Sexual Encounter Profile
(SEP). The study does not support its primary endpoint, the concept of
restoring erectile function by an early intervention with nightly dosing of
Levitra in patients after a nerve-sparing prostatectomy.
    These new study data confirms the well-established efficacy of Levitra in
patients with ED after a radical prostatectomy(3) and reassure doctors and
patients that Levitra taken on-demand, i.e., when sexual intercourse is
planned, is the optimal treatment for this condition and that a daily/nightly
use of PDE5 (phosodiesterase type 5) inhibitors is not indicated. The study
was conducted at 87 centres in Canada, the USA, Europe and South Africa and
investigated 423 males aged 18 to 64 years for up to 13 months.
    "The results conclude that Levitra taken on-demand shows a considerable
and immediate benefit in patients with ED after a nerve-sparing
prostatectomy," said Dr. Gerald Brock, Professor of Surgery, Division of
Urology, at the University of Western Ontario. "Seeing the outcome for
successful intercourse around 46 per cent with Levitra is quite significant in
this patient population, helping to pave the way for the most efficient
approach in treating with PDE5 inhibitors after this type of surgery."

    About Erectile Dysfunction

    Erectile dysfunction (ED) is defined as the consistent or recurrent
inability of a man to attain and/or maintain a penile erection sufficient for
sexual performance.(4) It is estimated that ED affects one-in-three men over
40 years of age and half of men over 50.(5) Approximately 152 million men
worldwide(6) and three-to-four million Canadian men suffer from ED.(7) The
number of men with ED is expected to more than double to 322 million men
worldwide by 2025.(8) Despite the high prevalence of sexual dysfunction,
experts estimate that only 15 to 20 per cent of men with ED are currently
treated.(9)
    Levitra has shown in many studies to be effective in men with a wide
range of underlying conditions such as hypertension,(10) diabetes,(11) obesity
and dyslipidemia.(12,13) It provides a rapid and effective solution to ED in a
broad patient population and enables both partners to achieve sexual
satisfaction.(14) Levitra is a potent PDE5 inhibitor, which has shown high
levels of efficacy and tolerability in patients with ED, including those with
ED as a result of nerve-sparing radical-prostatectomy.(15)

    About Bayer Inc.

    Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international
research-based group with core businesses in health care, crop science, and
innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates
the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer
Crop Science Inc., headquartered in Calgary, Alberta operates as a separate
legal entity in Canada. Together, the companies play a vital role in improving
the quality of life for Canadians - producing products that fight diseases,
protecting crops and animals, and developing high-performance materials for
applications in numerous areas of daily life. Canadian Bayer facilities
include the Toronto headquarters and offices in Ottawa and Calgary.
    Bayer Inc. has approximately 1,000 employees across Canada and had sales
of over $986 million CDN in 2007. Globally, the Bayer Group had sales of over
32 billion Euro in 2007. Bayer Inc. invested approximately $45 million CDN in
research and development in 2007. Worldwide, the Bayer Group spent the
equivalent of over 2.5 billion Euro in 2007 in R&D.

    Forward-looking Statements

    This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management. Various
known and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial situation,
development or performance of the company and the estimates given here. These
factors include those discussed in Bayer's public reports which are available
on the Bayer website at www.bayer.com. The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.

    
    References:

    -------------------------
    (1)  2007 Canadian Cancer Society; Prostate Cancer Stats, cited on
         July 23, 2008.
    (2)  McCullough A.R. et al. Return of nocturnal erections and erectile
         function after bilateral nerve-sparing radical prostatectomy in men
         treated nightly with sildenafil citrate: subanalysis of a
         longitudinal randomized double-blind placebo-controlled trial. J Sex
         Med 2008;5:476-84.
    (3)  Brock G et al. Safety and efficacy of vardenafil for the treatment
         of men with erectile dysfunction after radical retropubic
         prostatectomy. J Urol 2003; 170:1278-83.
    (4)  Jardin A, Wagner G, Khory S et al. Recommendations of the 1st
         International Consultation on Erectile Dysfunction. Co-sponsored by
         the World Health Organisation (WHO), International Consultation on
         Urological Diseases (ICUD) and Societé Internationale D'Urologie
         (SIU). p.713.
    (5)  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.
    (6)  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.
    (7)  Barkin J, Carrier S, Gajewski J, Brock G. Erectile function and male
         sexual satisfaction: A national survey. J Sex Reprod Med 2003;
         3:10B-14B.
    (8)  Aytac IA, McKinlay JB, Krane RJ: The likely world increase in
         erectile dysfunction between 1995 and 2065 and some possible policy
         consequences. BJU International 1999; 84:50-56.
    (9)  Southgate J: New rivals to Viagra expand the market. Scrip World
         Pharmaceutical News, 2002.
    (10) Shabsigh R. et al. Efficacy of vardenafil for the treatment of
         erectile dysfunction in men with hypertension: a meta-analysis of
         clinical trial data. Curr Med Res Opin 2007;23:2453-60.
    (11) Goldstein I. et al. Vardenafil, a new phosphodiesterase type 5
         inhibitor, in the treatment of erectile dysfunction in men with
         diabetes: a multicenter double-blind placebo-controlled fixed-dose
         study. Diabetes Care 2003; 26: 777-83.
    (12) Levitra(R) Product Monograph. Bayer Inc., April 15, 2008.
    (13) Miner M. et al. Vardenafil in Men with Stable Statin Therapy and
         Dyslipidemia; J Sex Med 2008;5:1455 -1467.
    (14) Rosen R. et al. The Treatment Satisfaction Scale (TSS) is a
         sensitive measure of treatment effectiveness for both patients and
         partners: results of a randomized controlled trial with vardenafil.
         J Sex Med 2007; 4: 1009-21.
    (15) Nehra A. et al. Vardenafil improved patient satisfaction with
         erectile hardness, orgasmic function and sexual experience in men
         with erectile dysfunction following nerve sparing radical
         prostatectomy. J Urol 2005;173:2067-71.
    




For further information:

For further information: Jennifer Runza, Manning, Selvage & Lee (MS&L),
(416) 847-1329; Laura Colpitts, Bayer Inc., (416) 240-5466

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