USRF Research

Update on Male Erectile Dysfundtion (MED):
Sildenafil (Viagra), Part II

Leonard S. Marks, M.D.


Director, USRF

Fall, 1998 -FDA approval of sildenafil (Viagra) for the treatment of male erectile dysfunction (MED) was announced on March 27, 1998, and for the estimated 10 - 15 million men with this disorder, "the whole world changed." For the first time, an effective oral agent is now available. Demand for the new drug has been overwhelming: In the first four months following approval (through 8/7/98), U.S. physicians have written more than 3.8 million prescriptions for more than 2.5 million men, totalling more than 31 million doses (source: Pfizer Marketing Division).

Much information is available on sildenafil (see links on USRF homepage), and a number of issues have been raised:

  • Is there a safety concern in certain men?
  • Should third party payors cover the cost?
  • Is there an abuse potential?
  • What about it's direct use in women?
  • What about the other oral agents currently in development?
  • How effective is sildenafil in clinical practice, ie, outside of clinical trials?
  • What do the partners think about this new alternative?

Answers to these important questions will soon be forthcoming. With regard to the last two questions, USRF has conducted a study of the first 100 men to receive sildenafil in a clinical practice setting and also obtained information from the partners. The results of this study, now in preparation for publication, show clearly that sildenafil is an effective treatment of MED, according to partner-validated questionnaire responses; and the results of treatment are predictable with a simple ED Severity Classification system.

While awaiting definitive answers to the above questions, the best available medical information on sildenafil should be regarded as the clinical trial data published in the New England Journal of Medicine.

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