Diabetees & Erectile Dysfunction

[eric1000]

Diabetic Men Are at Greater Risk for Developing Erectile Dysfunction (ED)

New Data Analysis Show Success with LEVITRA® (vardenafil HCl)

In Diabetic Men Who Were Previously Unsuccessful With Other Treatment

WEST HAVEN, Conn., and PHILADELPHIA, June 7 /PRNewswire/ -- Men being

treated for diabetes are three times more likely to have erectile dysfunction

(ED) than men in the general population.(1) In addition, more than 50

percent of diabetic men develop ED within 10 years of being diagnosed with

diabetes(2), and ED tends to be difficult to treat in diabetic men.

Study results presented at the American Diabetes Association (ADA) 64th

Scientific Session in Orlando are encouraging for men with ED and diabetes.

Results showed that men with diabetes and ED who were previously unsuccessful

by history with Viagra® (sildenafil citrate)+ were able to obtain an

erection sufficient for successful intercourse on 33 percent of attempts with

Levitra compared with 13 percent of attempts with placebo. In addition, 58

percent of diabetic men in the study experienced improved erections with

Levitra compared with placebo.(3) The results of the study, referred to as the

PROVEN (Patient RespOnse with VardENafil in Sildenafil Non-Responders) trial

evaluated Levitra in men with ED who were historically unresponsive to

Viagra® (as identified by six criteria)++.

"Many men with diabetes don't realize that they are at greater risk of

developing ED," said Alan J. Garber, M.D., Ph.D., professor of medicine,

Biochemistry and Molecular Biology, and Molecular and Cellular Biology, Baylor

College of Medicine. "Because half of all diabetic men will ultimately

develop ED, it is important to educate these men about this condition. This

study is important because it shows that vardenafil is a successful treatment

option for ED in the difficult-to-treat diabetic population, in whom other

treatments often have not been successful."

"Results from the PROVEN study clearly demonstrated that Levitra was

effective in many diabetic men who reported lack of success with Viagra," said

Culley C. Carson, III, M.D., lead study investigator and chief of urology at

the University of North Carolina Hospitals, Chapel Hill, and Rhodes

distinguished professor of urology. "These findings provide hope to men with

both ED and diabetes as they may be able to successfully treat their ED with

Levitra."

About the Study

Results discussed in this news release are taken from post-hoc analyses of

PROVEN trial data to evaluate the improvement of erectile function in a subset

of 138 men with diabetes and ED and a history of unresponsiveness to Viagra.

Patients were classified as having diabetes based on medical history,

laboratory values (HbA1c>8%), and medication data. The PROVEN study was a

prospective, multicenter, double-blind, flexible-dose trial studying men with

ED who had a documented history of non-response to Viagra.

Unresponsiveness to Viagra was defined by patient reported history and

they were not re-challenged with Viagra. All study participants met rigorous

criteria, including failing at least four of the last six attempts at

successful intercourse with Viagra and having at least one unsuccessful

attempt with the highest available dose of Viagra (100 mg).(3b)++ These men

were considered to be unresponsive to Viagra in the medical opinion of the

study physician. A total of 463 men with moderate to severe ED were

randomized to Levitra 10 mg or placebo for four weeks. At weeks four and

eight of the trial, physicians could adjust the starting dose of Levitra 10 mg

up to 20 mg, or down to 5 mg, based on the efficacy and tolerability of the

drug.

All endpoints showed clinically significant improvements compared with

placebo. Among Viagra non-responders, results showed that after 12 weeks:

* In men with diabetes (n=138), treatment with Levitra almost doubled

mean EF domain scores from 8.3 (severe ED) to 14.9 (moderate ED).(3c)

* Men with diabetes were able to obtain an erection sufficient for

successful intercourse on 33 percent of attempts with Levitra,

compared with only 6 percent of attempts before treatment, a more than

5-fold increase.(5)

In the clinical trial, the most commonly reported adverse events were

generally mild to moderate and included upset stomach, flushing, nasal

congestion, headache, and upper respiratory tract infection.(3d) Three

patients receiving placebo and five patients receiving Levitra withdrew from

treatment due to adverse events. (3e)

Diabetes and ED

While 50 percent of men over the age of 50 will experience a decline in

their erectile function, ED occurs even earlier in men with diabetes.(5) In

fact, the onset of ED may occur 10 to 15 years earlier in men with diabetes

than in the general population.(5b)

There are many factors that contribute to ED in the diabetic population.

The most common are physical problems such as blood vessel and nerve

damage.(6) In diabetes, glucose (blood sugar) builds up in the blood, causing

damage to the blood vessels and nerves.(6b) If the nerves to the penis are

damaged, they may not be able to send signals that lead to an erection. Nerve

damage also can limit blood flow, which can prevent an erection.(6c)

Other factors may lead to the development of ED in men with diabetes. Low

testosterone levels are a risk factor for ED in diabetic men, and men with

diabetes may have lower intracavernosal levels of nitric oxide synthase.(5c)

Both of these play a role in the maintenance of an erection. In addition, some

medications that men with diabetes may take such as those for high blood

pressure, anxiety and ulcers, can contribute to ED.(7)

ED and Levitra

ED -- the consistent or recurrent inability of a man to attain and/or

maintain a penile erection sufficient for sexual performance(8) -- 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(9)

-- 152 million men worldwide(10) and 30 million men in the United States

alone.(11)

Despite the high prevalence of sexual problems, nine out of 10 men in the

U.S. have not yet sought treatment from a physician.(12)

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

were headache, flushing, and stuffy or runny nose. Levitra is available in

2.5 mg, 5 mg, 10 mg, and 20 mg tablets.

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 83

countries. Levitra was approved by the U.S. Food and Drug Administration for

the treatment of ED on August 19, 2003.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com) is part of

the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer

HealthCare is one of the world's leading innovators in the health care and

medical products industry. Bayer HealthCare combines the global activities of

the business groups of Bayer AG in the fields of Animal Health, Biological

Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000

employees support the worldwide operations of Bayer HealthCare.

Our work at Bayer HealthCare is to discover and manufacture innovative

products for the purpose of improving human and animal health worldwide. Our

products enhance well-being and quality of life by diagnosing, preventing and

treating disease.

This news release contains forward-looking statements based on current

assumptions and forecasts made by Bayer Group 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 our public reports filed with the Frankfurt

Stock Exchange and with the U.S. Securities and Exchange Commission (including

our Form 20-F). The company assumes no liability whatsoever to update these

forward-looking statements or to conform them to future events or

developments.

About GSK

GlaxoSmithKline -- one of the world's leading research-based

pharmaceutical and healthcare companies -- is committed to improving the

quality of human life by enabling people to do more, feel better and live

longer.

Under the safe harbor provisions of the U.S. Private Securities Litigation

Reform Act of 1995, the company cautions investors that any forward-looking

statements or projections made by the company, including those made in this

Announcement, are subject to risks and uncertainties that may cause actual

results to differ materially from those projected. Factors that may affect

the Group's operations are describe under 'Risk Factors' in the Operating and

Financial Review and Prospects in the company's Annual Report on Form 20-F for

2003.

REFERENCES

(1) 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.

(2) Vinik A, Richardson D. Diabetes Review 1998;6:16-33.

(3) Carson C, Murdoch M, Aliotta P, Hatzichristou D, Auerbach S,

Carrier S, Lording D, Lyngdorf P for the Vardenafil Study Group.

Vardenafil Significantly Improves Erectile Function in Diabetics

Who Are Sildenafil Nonresponders by History: PROVEN Trial Results.

To be presented at the 64th Annual Scientific Sessions of the

American Diabetes Association (ADA), June 4-8 Orlando, Florida.

(4) Carson C, Murdoch M, Aliotta P, Hatzichristou D, Auerbach S,

Carrier S, Lording D, Lyngdorf P for the Vardenafil Study Group.

Vardenafil Significantly Improves Intercourse Success Rates in

Diabetics Who Are Sildenafil Nonresponders By History: PROVEN Trial

Results. To be presented at the 64th Annual Scientific Sessions of

the American Diabetes Association (ADA), June 4-8 Orlando, Florida.

(5) Chu NV, Edelman S. Diabetes and erectile dysfunction. Clinical

Diabetes 2001;19:45-47.

(6) American Diabetes Association (ADA) - http://www.diabetes.org.

May 22, 2002.

(7) Clinical Diabetes Journals, February 2001 -

http://clinical.diabetesjournals.org/cgi/reprint/19/1/48.pdf

May 22, 2002.

(8) 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.

(9) 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.

(10) 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.

(11) 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).

(12) Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United

States: prevalence and predictors. JAMA 1999;281:537-544.

+ Viagra® (sildenafil citrate) is a registered trademark of

Pfizer Inc.

++ All study participants had a documented history of non-response to

Viagra and met all six of the following rigorous criteria:

1. Must have previously made at least six attempts at intercourse with

Viagra, administering each dose in accordance with the dosing

recommendations outlined in the Viagra package insert, AND

[KevinN]

Do not know about that,but I do know that I have got a lot stronger as I have got older,,used to be that I couldn't bend it with 2 hands,,and now I can bend it with one,,wonder how much stronger I will get before I die?