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Back To Vidyya Viagra ® - As Safe In General Medical Practice As In Clinical Trials

Antiretrovirals and Immune-Based Therapies

Yesterday, Pfizer announced that results from the first stage of a large-scale, post-marketing study of Viagra (sildenafil citrate) in men with erectile dysfunction (ED) confirmed the safety profile established by the extensive clinical trials program.

The independently-conducted observational study of 5,391 men in the UK found no evidence of increased risk of heart attack or death from ischemic heart disease. The data were comparable to UK national health data of the general population of men of the same age. Men in the study had been prescribed Viagra in the general practice setting and had been taking the medicine for an average of five months. Among physicians who provided an opinion on effectiveness, Viagra was reported to be effective in 85 percent of patients. The study did not identify any safety issues.

"With availability of Viagra now having passed the two-year mark, this study provides important confirmation that Viagra has an excellent safety profile and is well tolerated in the wide variety of men who suffer from ED," said Joe Feczko, M.D., Senior Vice President for Medical and Regulatory Operations for the Pfizer Pharmaceuticals Group (PPG).

Among the men taking Viagra in the study, the combined incidence of fatal and non-fatal heart attacks was 7.2 per 1000 person-years and incidence of mortality due to ischemic heart disease was 3.2 per 1000 person-years. The mean age of men in the study was 57 years (range 18-89); sixty four percent of men studied were between the ages of 50 and 69. The study found that when compared to UK national health data, the incidence of these findings were similar to that occurring in the general population of men of the same age. In addition, the study also found there were no cases of heart attack, stroke or death reported during the first month after treatment was prescribed.

"Our interim results are reassuring and did not produce any surprises," said Saad Shakir, FACP, FFPM, MRCGP, Director of the Drug Safety Research Unit (DSRU) at Southampton University, UK, who recently presented the interim results of the study at the annual meeting of the European Society of Pharmacovigilance, in Verona, Italy.

These findings are consistent with data used to support the approval of Viagra worldwide. The database of clinical trials currently includes 36 double-blind placebo-controlled trials, including 4,500 men taking Viagra and over 3,000 men taking placebo. The trials involved men of different ages, backgrounds and health status, including men with pre-existing cardiovascular disease.

Viagra is is Pfizer's treatment for erectile dysfunction that was approved by the U.S. Food and Drug Administration in March 1998 and by the European Commission in September 1998. The medicine has since been approved by regulatory authorities in over 100 countries around the world. Over 25 million prescriptions have been written for Viagra for over 10 million men. More than 300 million tablets have been dispensed worldwide.

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

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Editor: Susan K. Boyer, RN
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