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Viagra Approval Information on the Internet
JAMA. 1998;279:1684.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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Sildenafil citrate (Viagra, Pfizer Pharmaceuticals, New York, NY) has been approved for marketing by the FDA as therapy for erectile dysfunction. The drug is a selective inhibitor of phosphodiesterase 5 and acts to enhance the effects of nitric oxide, causing smooth muscle relaxation and inflow of blood to the corpus cavernosum in the presence of sexual stimulation. The agency's detailed clinical review of the studies on the product, approval letter, professional labeling, and information for consumers may be found on the Internet at http://www.fda.gov/cder/consumerinfo/viagra/viagra.htm.
The studies that established the drug's benefit demonstrated improvements in success rates for sexual intercourse compared with placebo in numerous randomized trials involving more than 3000 men with varying degrees of impotence associated with diabetes, spinal cord injury, history of prostate surgery, and no identifiable organic cause. Patients also had a wide range of concomitant illnesses, including hypertension and coronary artery disease. Effectiveness was assessed . . . [Full Text of this Article]
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