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Levitra effective on demand

The study involved 87 centers across Europe, the United States, Canada and South Africa between December 2004 and September 2007. A total of 423 patients completed the study. The inclusion of the on-demand dosing regimen enabled comparison of the currently recommended guidelines for the use of PDE5 inhibitors with a proposed nightly dosing regimen. The results clearly show that nightly dosing with vardenafil does not have any effect beyond that of on-demand use. The study, published in European Urology, shows that on-demand use of vardenafil during the treatment period was associated with significantly greater erectile function and sexual intercourse completion rates compared to placebo. The success rates for the vardenafil on-demand group were also higher than for the nightly group.

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Levitra (vardenafil HCl), a PDE5 inhibitor, is effective in treating erectile dysfunction (ED) in men receiving one or more medications for the treatment of hypertension (high blood pressure),(1) according to data published in a recent issue of The Journal of Sexual Medicine. In this double-blind, placebo-controlled clinical trial, patients treated with LEVITRA experienced an 83% overall success rate in erectile function while also receiving one or more anti-hypertensive medications.

“This study demonstrated that LEVITRA was well-tolerated when used concomitantly with anti-hypertensive medications in patients not previously treated with PDE5 inhibitors,” said study author Dr. Hermann van Ahlen, University of Muenster, Germany.

Hypertension, a major risk factor for ED, affects 29.4 million men in the United States(2). It is one of the most common medical conditions, along with diabetes and high cholesterol, associated with ED. In addition many blood-pressure-lowering medications, particularly beta-blockers and diuretics, may adversely affect erectile function.

“As a primary care physician, I know that my male patients are often concerned about taking anti-hypertensive drugs for fear of the potential sexual side effects,” said Dr. Matthew Rosenberg, medical director at Mid-Michigan Health Centers in Jackson, MI. “This study gives me support to tell patients that I can treat hypertension and also prescribe an effective medication to treat ED. The fact that LEVITRA improved erectile function in patients taking multiple anti-hypertensive medications is a testimony to its efficacy.”

About the study

Study investigators carried out a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of flexible-dose LEVITRA in men with treated hypertension and ED who had not previously used LEVITRA or other PDE5 inhibitors. In this study, use of alpha blockers was not permitted. The study, conducted at 98 primary care sites in Germany, involved 354 patients over age 18 who had experienced ED for more than 6 months. Participants received either placebo or LEVITRA, in a dose ranging from 5 mg to 20 mg, for 12 weeks. To measure the drug’s efficacy, the patients kept diaries of their responses to standardized questions regarding their erectile function.

LEVITRA was well-tolerated and effective at improving all ED efficacy parameters. There was no significant difference in the frequency of adverse events when patients were grouped according to the type of anti-hypertensive medications being received. Compared with placebo, LEVITRA significantly improved patients’ ability to successfully have intercourse. The success rate was 83% for men treated with LEVITRA vs 58% for placebo (P < 0.0001). Success rates for LEVITRA were unaffected by the concomitant use of one or more antihypertensive medications including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. When compared to baseline or placebo, there were no clinically significant differences in ECG findings, supine (or at rest) systolic and diastolic blood pressure readings, or heart rate in LEVITRA-treated patients during clinic visits. The most common reported adverse events were headache and flushing.

Background: Erectile dysfunction

Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. ED can be a total inability to achieve an erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. It is estimated that some degree of ED affects up to 30 million men in the United States.

Some of the most common treatments for ED include adjustments to lifestyle and better control of concomitant medical conditions as well as the use of oral medications or other forms of therapy. Treating related health conditions or reducing stress may help maintain erectile function. LEVITRA belongs to a class of medications called oral phosphodiesterase type 5 (PDE5) inhibitors, which are among the most successful treatments for ED. There are currently three FDA-approved oral PDE5 inhibitors available.

About LEVITRA

LEVITRA is an FDA-approved oral prescription medication for the treatment of erectile dysfunction (ED) in men. It belongs to a class of medications commonly referred to as oral phosphodiesterase type 5 (PDE5) inhibitors, the most commonly prescribed treatments for men with ED. LEVITRA helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity.

LEVITRA, developed by Bayer Healthcare and GlaxoSmithKline (GSK), is jointly promoted in the U.S. by GSK and Schering-Plough Corporation.

Important Safety and Dosing Information

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. Such combinations could cause blood pressure to drop to an unsafe level.

As with all ED drugs, there is a rare risk of an erection lasting longer than four hours. To avoid long-term injury, seek immediate medical attention. LEVITRA does not protect against sexually transmitted diseases. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicine, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away.

Discuss your medical conditions, including heart problems, and medications, including alpha blockers prescribed for prostate problems or high blood pressure, with your doctor to ensure LEVITRA is right for you and that you are healthy enough for sexual activity.

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 alpha blockers, your doctor may start you on a lower dose of LEVITRA. 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 were headache, flushing, and stuffy or runny nose. LEVITRA is available in 2.5-mg, 5-mg, 10-mg, and 20-mg tablets.

For Prescribing Information please visit http://www.LEVITRA.com.

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

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