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ESSIR: New Study Of Viagra's (Sildenafil Citrate) Onset Of Action Finds Majority Of Men Respond Within 20 Minutes

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256C830055C2ED

December 2, 2002
Hamburg, Germany

A new study of men with erectile dysfunction (ED) found that 51 percent taking Viagra® (sildenafil citrate) achieved an erection that resulted in successful sexual intercourse within 20 minutes, according to data presented today at the European Society for Sexual and Impotence Research (ESSIR).

(NOTE: The first study published in 1998 reported that sildenafil (Viagra) was shown to improve erections in 77% to 84% of patients.(1) Since then, numerous studies have confirmed this range of efficacy.)

In the double-blind study, 228 men successfully treated for ED for at least two months were randomly assigned to receive either Viagra or placebo for four weeks. Study participants averaged 60 years of age, had ED for an average of seven years, and a majority had moderate to severe dysfunction. Patients recorded the time needed to obtain an erection sufficient for sexual intercourse after taking their pill a minimum of two hours after eating.

Results showed that within 14 minutes of taking Viagra, 35 percent of men achieved at least one erection that resulted in successful sexual intercourse. A majority of men (51 percent) achieved this response within 20 minutes.

Viagra was well tolerated, with no patients discontinuing treatment because of side effects.

"These results demonstrate that Viagra offers ED sufferers greater flexibility than what is currently perceived," said Dr. Harin Padma Nathan, clinical professor of urology at the University of Southern California Keck School of Medicine. "Indeed, as results of a new survey of the sexual habits of men and their partners in the United Kingdom demonstrates, Viagra's onset is well-suited to meet the needs of this population."

The survey of more than 1,000 men and women in Britain found that men with ED spend an average of 53 minutes from thinking about engaging in sexual activity to initiation of intercourse. The survey also found 87 percent of men with ED had intercourse only once in 24 hours. The survey was conducted to better understand how men aged 40-69 with and without erectile dysfunction approach intimacy and was also presented at the ESSIR annual meeting.

When asked about the importance of engaging in sexual intercourse more than once in a 24-hour period, only 19 percent of men and 11 percent of women felt it was very or extremely important. These findings are consistent with a similar U.S. survey of more than 1,000 men and women conducted last year.

"These results demonstrate that Viagra's unique clinical profile of a rapid onset and duration of at least four hours with minimal side effects, clearly meets the needs of real world ED patients," said Dr. Mike Sweeney, senior medical director, urology group leader of Pfizer.

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. 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 118 countries around the world and is among the most widely prescribed medications, with over 120 million prescriptions written for more than 20 million men.

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

Reference:
(1) - Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. (1998) N Engl J Med 338: 1397-1404.

SOURCE: Pfizer Canada Inc.
 

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