Viagra significantly effective, well-tolerated for men taking multiple blood pressure treatments

May 15, 2002

NEW YORK, May 15, 2002 -- More than 80 percent of men taking two or more drugs for their high blood pressure reported improvement in their erections and their ability to have sexual intercourse after taking Viagra® (sildenafil citrate) for 12 weeks to treat their erectile dysfunction (ED), according to data scheduled to be presented at the American Society of Hypertension 17th Annual Scientific Meeting.

The 12-week, study involved 562 men taking two or more antihypertensives drugs. The first six weeks of double-blind treatment was followed by an additional six weeks of open-label treatment with Viagra. After six weeks, Viagra significantly improved erections for 71 percent of the men versus 18 percent taking placebo. In addition, the Viagra group had significantly more successful intercourse attempts, 62 percent, compared to 26 percent on placebo. During the open label extension, more than 80 percent of men who received Viagra had improved erections and intercourse.

"This study showed that Viagra is both well-tolerated and effective when used in conjunction with high blood pressure medications which is good news for men who are often forced to choose between treating their hypertension and staying sexually active," said Dr. Thomas G. Pickering of the Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai School of Medicine in New York.

Investigators did not observe any serious adverse events related to Viagra treatment. The majority of side effects were mild to moderate and short-lived, with the most common including headache, facial flushing, indigestion, dizziness, nasal congestion and abnormal vision. Less than 2 percent of Viagra- and placebo-treated patients discontinued the study due to side effects.

"For many men, ED is often an underlying symptom signaling that there may be another significant health issue such as hypertension," said Dr. Pickering.

On average, the study participants had high blood pressure for 11.7 years, with 307 men taking two and 222 men taking three or more antihypertensive medications including, diuretics, beta-blockers, alpha-blockers, angiotensin converting enzyme inhibitors and calcium channel blockers. In addition, the men in the study experienced ED for an average of 4.5 years. Researchers measured the efficacy of Viagra by querying patients using the International Index of Erectile Function, two global efficacy assessment questions and the Erectile Dysfunction Inventory of Treatment Satisfaction, all standard measures.

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.

Viagra should be prescribed with caution in patients with recent serious cardiovascular events, strokes, or hypotension or uncontrolled hypertension or retinitis pigmentosa. Before treating ED, physicians should consider whether the mild and transient vasodilatory effects of Viagra on blood pressure could adversely affect patients with underlying cardiovascular disease or other more unusual conditions, especially in combination with the impact of resuming sexual activity.

When the alpha blocker doxazosin (4 mg) and Viagra (25 mg) were administered to patients with benign prostatic hyperplasia, mean additional reductions of supine blood pressure of 7 mm Hg systolic and 7 mm Hg diastolic were observed, and the combination of agents was well tolerated. When higher doses of Viagra and doxazosin (4 mg) were administered simultaneously, there were infrequent reports of patients who experienced symptomatic postural hypotension within 1 to 4 hours of dosing. Simultaneous administration of a PDE5 inhibitor to patients taking alpha-blocker therapy may lead to symptomatic hypotension in some patients.Patients on multiple antihypertensive medications were included in the clinical trials for Viagra. In a separate controlled interaction study of Viagra and amlodipine, the mean additional reduction in supine blood pressure was 8 mm Hg systolic and 7 mm Hg diastolic.

The most common side effects of Viagra are headaches, facial flushing and indigestion.

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 over 115 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.

Porter Novelli

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