Dale: Dr. Tom Lue is one of the most respected ED investigators in the world. He has studied both MUSE vivus.com and Viagra.
During the 1996 and 1997 AUA meetings, Dr. Lue expressed his thoughts about Viagra to the media. Moreover, during the 1997 meeting he presented the results of a Viagra study on 416 patients conducted at 22 sites. Listed below are summaries of Dr. Lue's comments.
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Safety and Efficacy Data Presented on Pfizer Oral Drug for Impotence
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NEW YORK, May 6, 1996-- According to data presented today at the
American Urological Association annual meeting, a new oral medicine
helped the majority of men with male erectile dysfunction (MED), or
impotence, in three clinical trials.
Impotence affects an estimated 140 million men worldwide, although it is believed that this condition is vastly underreported. Over half of all
impotence cases are believed to have physical causes such as diabetes, or circulatory, neurological, or urological conditions. Current
impotence therapies include implants and injections.
International experts including Pfizer scientists at the AUA meeting
reported data on Viagra, (sildenafil), Pfizer's novel oral drug in
late-stage development, from three double-blind, randomized, controlled studies involving men with MED of no known cause. Among the highlights of their findings are:
-- The drug was well tolerated in a four-week dose-controlled trial of
351 men. Of the patients who received Viagra in this study, 65 percent, 79 percent, and 88 percent reported improved erections on respective doses of 10mg, 25mg, and 50mg, compared with 39 percent of the patients who received the placebo.
-- In a 28-day study of 43 patients, Viagra improved the quality of
erections of 92 percent of patients taking the drug. When the same
patients received a placebo, only 27 percent responded;
-- In another study, ten out of 12 MED patients given Viagra over the
course of 7 days reported an improvement in erections. When the same patients took placebo, two of twelve responded.
The researchers additionally presented data on Viagra's mechanism of
action. The drug enhances the natural response to sexual stimulation by blocking the effect of an enzyme, phosphodiesterase-5, effectively
increasing blood flow to the penis. Blood flow to the penis is necessary
for an erection.
"Impotence has a major, and sometimes devastating, psychological and social impact on patients and their partners," said George M. Milne, president of Pfizer Central Research. "Effective drugs currently
available involve injections and for that reason have not been widely
accepted. Viagra, because it is a pill and enhances the normal sexual
response, offers advantages to these patients in terms of both
convenience and safety."
"This is one of the most exciting new developments in the clinical
research for erectile dysfunction," said Tom F. Lue, M.D., Professor or
Urology at The University of California, San Francisco. "If further
clinical trials prove its efficacy and safety, it may be a dream come
true for many patients who are looking for a magic pill to improve their
erection."
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Barrons 2/24/97: Investors are hot about impotence treatments; will new techniques cool their ardor?"At a conclave of the American Urological Association starting April 12 in New Orleans, Dr. Tom Lue, a urology professor at the University of California at San Francisco, will report on the Phase III trial of sildenafil, a pill Pfizer hopes to market under the name Viagra.
The drug will be as revolutionary as was the birth control pill, predicts Padma-Nathan: ''It may put me out of business.'' Taken 20 minutes before intercourse, sildenafil selectively relaxes the blood vessels of the penis, producing a rigid erection.
European studies found it worked in 80%-90% of patients with psychological impotence.Padma-Nathan has tested the pill on diabetics, prostate surgery patients and patients with vascular disease. He's seen it work in up to 70% of those organically impotent patients. Side effects appear milder than with either Caverject or Muse. Dr. Pierre Wicker, at Pfizer, says that about 4,300 men will have been tested on it when Pfizer submits a new-drug application later this year. Approval times are unpredictable, but the FDA approved Muse just eight months after submission."
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Dr. Tom Lue of San Francisco presented efficacy, safety, and toleration data on 416 patients from 22 sites during an 8 week double-blinded study at the 1997 AUA meeting.
The study tested 4 strengths of sildenafil vs placebo given 1 hr before anticipated sexual activity. The erectile dysfunction of the men were assessed as 73% organic, 9% psychogenic, and 18% mixed.
Efficacy was assessed by a self-administered questionnaire at week 8. Safety and toleration were evaluated by routine lab tests and recording of adverse events.
The following results are highly statistically significant with a p value of <0.0001
Sildenafil
question....... placebo.........5mg ......... 25mg..........50mg.........100mg
GAQ (%yes).... 27.7............ 47.7......... 60.9........... 72.9 ......... 77.8
Q3 (mean)...... 2.00........... 2.69.......... 2.93........... 3.28 ......... 3.69
Q4 (mean)...... 2.05............ 2.40.......... 2.95........... 3.32........ 3.60
GAQ = Global Assessment Score: "Did treatment improve your erections?"
Q3 : ability to achieve erection (1 to 5)
Q4: ability to maintain erection satisfactory for sexual intercourse (1 to 5)
Responses to Q3 and Q4 were graded on a scale from 1 (almost never or never) to 5 (almost always or always). The mean responses are listed in the table above.
Responses to other questionnaire questions showed "similar dose-response relationships for other aspects of erectile and sexual functioning".
The most common adverse effects were headache (2.4-11%), vasodilation (0-8.5%), dyspepsia (0-8.5%), and diarrhea (0-4.9%). These ae's were predominantly of mild severity.
"CONCLUSION: The results indicate that sildenafil is an effective, well-tolerated oral treatment for patients with erectile dysfunction associated with a broad range of etiologies."
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Dr. Lue was interviewed by WLS (ABC) television in Chicago (shown on May 5, 1997) and commented:
"It's remarkable because we didn't really think a pill would actually work for this problem. Because normally, you take a pill, it goes to all parts of the body. And this particular one actually works on the penis.
"If this medication works, like it shows so far, with minimal side effects, it's going to make most of the men with impotence or erection problems, much, much better." |
