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| |  Viagra Approved In Canada For Erectile Dysfunction KIRKLAND, QC -- March 9, 1999 -- Health Canada has approved Pfizer Canada Inc.’s oral therapy Viagra(TM) (sildenafil citrate) for the treatment of erectile dysfunction (ED). "Canadian couples will finally have access to this important medical advance, which has been proven safe and effective for millions of men with ED since its introduction in the U.S. in March 1998," said urologist Dr. Gerald Brock, of London, Ontario. Dr. Brock is also chair of the Canadian Male Sexual Health Council. "ED can have serious consequences: it can affect self-esteem, weaken the foundation of intimate relationships and has a direct impact on the quality of life of men and their partners," Brock said. "Viagra has helped people to recognise ED as a serious medical condition and now Canadian men will benefit from this first-line oral therapy." Viagra is the first in a new class of medications, known as phosphodiesterase type 5 (PDE 5) inhibitors, that improve blood flow to the penis. In clinical trials, Viagra has been demonstrated to safely restore sexual function in patients. Taken as a single tablet 30 minutes to one hour before anticipated sexual activity, Viagra restores normal erectile function, meaning that men taking it still need sexual stimulation to achieve an erection. ED is associated with a broad range of medical conditions, including diabetes, prostate cancer surgery, spinal cord injury, multiple sclerosis, cardiovascular diseases and depression. As a result, it is estimated that ED affects approximately three million Canadian men. ED is defined as the persistent inability to achieve and/or maintain an erection sufficient for satisfactory sexual activity. Traditionally, this condition has been called impotence, but the term ED is more precise because it refers specifically to the clinical problem of erection difficulties. The incidence of ED increases with age, although aging itself does not appear to be the cause. Rather, age-related illnesses such as diabetes and high blood pressure are reasons that ED is more prevalent and severe as men age. "In the clinical trials that I conducted, the direct impact that Viagra had on my patients' quality of life was obvious from their testimonials and from those of their partners," Dr. Brock explained. "There has not been an effective oral treatment for ED until now. Other approved treatments tend to be more complicated, so many Canadian men have been hesitant to use them and have been waiting for Viagra to be approved in Canada." Viagra was tested in more than 4,500 men, including 498 Canadians, participating in clinical trials since 1996 at 27 sites across Canada. In 21 global clinical trials, which included men with ED diagnosed as mild, moderate or complete, the mean age of patients was 55. Patients had a broad range of conditions associated with ED including high blood pressure, high cholesterol levels, diabetes, prostate surgery and spinal cord injury. Participants had experienced ED for an average of five years prior to entering the clinical trials. Viagra was shown to be effective in approximately seven out of 10 men regardless of the cause of ED. Trial results for patients and their partners were assessed using questionnaires designed with leading academic researchers. Viagra was well tolerated by patients in the clinical trials; the most common side effects, headache, facial flushing and indigestion, were reported as mild to moderate more than 90 per cent of the time. Very few patients actually stopped taking Viagra because of side effects, with a 2.5 per cent drop-out rate for those taking Viagra compared to 2.3 per cent for those taking placebo. Viagra is contraindicated in patients taking nitrates in any form, including the heart medication nitroglycerin. Since Viagra was introduced in the United States on March 27, 1998, approximately seven million Viagra prescriptions (60 million tablets) have been written by about 200,000 physicians for more than three million men with ED. This unprecedented level of prescribing provided a safety database after the first three months of Viagra availability that was equivalent to two years' safety reporting experience for other new medicines. In November 1998, following a comprehensive review of all post-marketing reports, the U.S. Food and Drug Administration again reaffirmed its position that Viagra is safe and effective when used according to the label. Health Canada has had access to information about the U.S. experience throughout its review and approval process. "Experience in past and ongoing clinical trials and for the past year in clinical practice around the world, has shown that Viagra is very safe when used appropriately," said Dr. Eldon Smith, cardiologist, University of Calgary. "There is no epidemiological evidence that Viagra adds to the cardiovascular risk inherent in sexual activity. "Viagra is contraindicated for men taking any form of nitrates. All patients should be aware of how to use Viagra appropriately. Sexual activity is a form of exercise which could pose a risk to men with severe cardiovascular disease. It is important therefore, that the safety of this level of exercise be established before Viagra or any other treatment for ED is utilised." Viagra will be available by prescription in Canada in three strengths (25 mg, 50 mg and 100 mg). To promote its responsible use, Viagra will be packaged in blister packs of four or eight tablets and a hologram will be printed on the outside of the box which will help healthcare professionals and patients recognise the authenticity of the product as being manufactured by Pfizer. Inside will be a patient information sheet so that patients and their partners directly receive information on the proper and responsible use of Viagra. Related Links: Viagra, Pfizer Inc.
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