News Release

First study of Viagra(R) in black men demonstrates treatment as effective, well tolerated

Related data finds erectile dysfunction to be a common problem in black men

Peer-Reviewed Publication

Porter Novelli

ORLANDO, May 25, 2002 - In the first study to evaluate the efficacy and safety of Viagra® (sildenafil citrate) in black men with erectile dysfunction (ED), approximately eight out of 10 patients reported improvement in their erectile function and ability to have sexual intercourse after taking Viagra for six weeks, according to data scheduled to be presented at the annual meeting of the American Urological Association.

In this study of 246 black men, patients were randomly assigned to receive Viagra or placebo for six weeks, at which point they were given the choice to switch to the alternate treatment for another six weeks. At week six, a significantly larger percentage of Viagra-treated patients reported “improved erections” and “improved ability to have sexual intercourse” (79 percent and 81 percent) compared with placebo-treated patients (38 percent and 36 percent). Additionally, patient satisfaction was greater in the Viagra-treated group than in the placebo group.

Data also presented at the meeting by Culley Carson, M.D. of the University of North Carolina, Chapel Hill, examined the prevalence of ED in a nationally representative population sample of white, black and Hispanic American men, as defined by US census criteria, aged 40 and above. The study found that ED was a common problem among black men, with 24 percent of men reported to be only "sometimes" or "never" able to get and keep a satisfactory erection, compared to 22 percent of white and 20 percent of Hispanic men respectively.

“Cardiovascular disease, high blood pressure and diabetes are all highly prevalent among black men. Because ED is often associated with such conditions, it is especially important to screen and treat black men who are experiencing erection problems," said Jean Bonhomme, M.D., Founder, National Black Men's Health Network. "We have now confirmed that Viagra is an effective and well tolerated treatment option for these men."

The prevalence study, of over 2,000 men, found that ED was not only prevalent across a multi-cultural spectrum of men, but also confirmed that it was associated with hypertension, ischemic heart disease and diabetes.

“We need to be more proactive in studying and screening for ED as cultural influences make some of these men reluctant to seek treatment and/or limit their access to appropriate care," added Bonhomme. "The renewed interest in ED that was prompted by the introduction of Viagra has likely given physicians the opportunity to diagnose and treat the diseases associated with ED which otherwise may not have been identified."

In the study of black men, treatment with Viagra was well tolerated. No serious adverse effects directly related to treatment were observed and side effects were mild to moderate. No patients discontinued treatment due to adverse events.

Viagra (sildenafil citrate) should be prescribed with caution in patients with recent serious cardiovascular events, strokes, or hypotension or uncontrolled hypertension. As with all ED treatments, a patient’s cardiovascular status should be evaluated before beginning treatment. The most common side effects of Viagra are headaches, facial flushing and indigestion.

Viagra is a prescription medication available only from doctors and should always be used in accordance with its approved labeling. Viagra is contraindicated in patients who use nitrates in any form at any time.

Discovered and developed by Pfizer, Viagra is the breakthrough oral treatment for erectile dysfunction that has been found to be effective and well tolerated in over 100 completed and ongoing clinical studies. Viagra has been approved by regulatory authorities in 118 countries around the world and is among the most widely prescribed medications, with over 100 million prescriptions written for more than 16 million men.

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Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer products.

Please see full prescribing information for Viagra (25 mg, 50 mg, 100 mg) Tablets.


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