Pfizer Inc. said today that men with erectile dysfunction (ED) who have been prescribed Viagra (sildenafil citrate) do not have an increased risk of heart attack or death from ischemic heart disease, according to results from the first phase of a large-scale, observational study of Viagra presented at the annual meeting of the American College of Cardiology (ACC).
The study of 5,601 men in the United Kingdom found that the risk of these
cardiovascular events for Viagra users were comparable to U.K. national health
data in the general population of men of the same age. Men in the study were
prescribed Viagra in the general practice setting and their doctors provided
responses on all adverse events an average of five months after the first
prescription. Viagra was effective in 85 percent of patients, according to
reports from physicians who provided an opinion for the study.
"More than 10 million men have taken Viagra since its approval and this
study provides additional 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).
The average age of men in the study was 57 years (range 18-90); 64 percent
of men studied were between the ages of 50 and 69. 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.
Dr. Saad Shakir, FACP, FFPM, MRCGP, Director of the Drug Safety Research
Unit (DSRU) at Southampton University, UK, presented the results of the study
at the ACC annual meeting. These results were also published in the March 16
issue of the British Medical Journal.
Pfizer said that 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. These trials involved men of
different ages, backgrounds and health status, including men with pre-existing
Viagra is an oral treatment for erectile dysfunction that was approved by the US 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. Viagra is a widely prescribed medication, with over 25 million prescriptions written for over 10 million men. More than 300 million tablets have been dispensed worldwide.
Viagra is a prescription medication 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
uncontrolled hypotension or 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.
The DSRU is an independent academic unit at Southampton University that
conducts observational cohort studies (called Prescription Event Monitoring
studies) on many new drugs when they first become available by prescription in
the United Kingdom. The DRSU receives charitable funds from many
pharmaceutical companies including Pfizer to fund its independent research