MEDICINE - UP TO THE MINUTE

by

Charles A. Bertrand, M.D., FACP, DIM-CD (Ret.)
Associate Clinical Professor of Medicine at New York Medical College
and at the Medical University of South Carolina

THE AGE OF VIAGRA

If you haven't heard of Viagra by now, you're possibly a hermit, a permanent resident of Sky Lab, or dead. This new medication, billed as a cure for impotence, has replaced O.J. Simpson as the Most Talked About Topic of the Nineties.

Television commentators have called it a "miracle drug." All major newspapers have carried in-depth stories about its rejuvenating properties. Time has featured the pill on its cover.

As a consequence of such widespread publicity, Viagra is in great demand despite its high cost, which varies from seven to twelve dollars per tablet. Doctors' phones are ringing off the hook. A mind-boggling number of prescriptions have been filled... for women as well as for men, despite the fact that no one yet knows whether or not women can benefit from this medication; some buy it for their husbands. Meanwhile, stockholders of Pfizer Pharmaceutical Company... the people who developed the drug... have seen the value of their holdings soar.

Needless to say, jokesters and comics are having a field day:

  • The pill is now being called the "Pfizer Riser."
  • Jay Leno speaks of the "Viagra cafe latte... keeps you up all night."
  • One wit reports that the name of Sun City has been changed to "Viagra Falls."
  • And even poets have been inspired:
    "Heading for Niagara?
    Take along Viagra!"

After the hype and the jokes and the public interest, the first scientific study of the drug has finally appeared. Published in the New England Journal of Medicine(May 14, 1998, Volume 338, Number 20, pp.1397-1404), authors Irwin Goodwin, M.D., et al. echo the good news reported in the press: The stuff really works.

The same issue also contains a companion editorial, "A Pill for Impotence," written by Dr. Robert D. Utiger. Both articles emphasize facts, and both are useful.

Goodwin et al. conducted their study at 37 centers throughout the United States. They evaluated 861 men, 18 years of age and older, with a clinical diagnosis of erectile dysfunction (ED). In order to enroll in the study, the individual had to be in a stable relationship with a female partner for at least six months. The group was divided into three categories of ED: "psychogenic," "organic," and "mixed."

The Pfizer Company provided Viagra and identical placebos for the group in what is called a "double blind placebo controlled study." 532 were randomly assigned to take a placebo or Viagra in doses of 25, 50, and 100 milligrams.

A second group of 329 men participated in a "flexible dose association study." Here the dose could be adjusted... doubled or reduced by 50 percent on the basis of the patient's response.

The international index of erectile dysfunction was used as one of the methods for evaluating the subjects' responses, and this index was applied throughout the study.

Considering the fact that these were sufferers from ED, the results were highly impressive: 69 percent of all attempts at sexual intercourse in men taking Viagra were successful, as opposed to 22 percent for those receiving a placebo. The average number of successful attempts per month as 5.9 for those receiving Viagra as opposed to 1.5 for those receiving a placebo... approximately a four-fold difference.

Ninety-two percent of the subjects completed the study. A few dropped out, mostly in the placebo group. Interestingly, in the last four weeks of treatment, those receiving an increased dose of medication had greater effectiveness... 72 percent for those who took 25 milligram tablets, 80 percent for those who took 50 milligram tablets, and 85 percent for those who took 100 milligram tablets.

Transient changes in perception of color or brightness were reported by some, but these side effects were mild and generally lasted for a few minutes to a few hours only. One patient complained of nausea and vomiting, another of leg pains and backache, still another of intermittent headache and dyspepsis. A very few noted transient headache and flushing.

Patients should not be taking a nitrate preparation and Viagra at the same time because blood pressure may drop a lot and cause problems. No one in the study, however, was on both medications.

Several deaths occurred during the course of the study. The incidence did not seem unusual for this age group. However, the deaths are under investigation to see if they were Viagra-related. So far they appear to be unrelated.

The researchers concluded that Viagra improves erectile function significantly and quadrupled the success of intercourse. This effectiveness was maintained for at least six months.

The female partners of the men in the study were also questioned. Their reports corroborated what the men had said. Unfortunately, only 25 percent of the partners completed the questionnaire.

The editorial is likewise instructive. It speaks of the different treatments available to combat impotence and also focuses on the biochemical reactions brought about by Viagra. In general, Dr. Utiger, in his commentary, supported the study. The availability of Sildanafil (Ulegra) as an effective and safe oral therapy for men with erectile dysfunction means many more will seek help. There are pitfalls in that men with such a disorder may undergo little or no evaluation before treatment is initiated, and secondly, man may seek treatment in hope it will enhance their own sexual performance, even though they do not have this disorder.

He concludes that the results are promising and notes that the drug has been widely hailed in the media since its approval by the FDA on MArch 27. However, he closes by wondering whether or not this promise will be fulfilled after many more men have been treated and the drug has been taken repeatedly for long periods of time.

So the news is good, but questions remain. Will side effects develop with prolonged use? Will the drug remain effective over a long period of time? Will it work for women? Most of these questions will be answered in the next one or two years. Meanwhile, Viagra is clearly a medication that is likely to enhance the lifestyle of millions of men... and women.



The advice provided on this website is intended to be general in nature and should not be relied upon for specific treatment. If you need personal medical attention please contact your physician.

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