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Earlier Apomorphine Treatment Achieves Better Response for Erectile Dysfunction: Presented at AUA

By Ed Susman

ORLANDO, FL -- May 30, 2002 -- The longer men wait to get treatment for erectile dysfunction, the more difficult it appears to be for them to get benefits from drugs to treat the conditions, researchers reported.

In an analysis of responses to the centrally-acting dopamine receptor antagonist, apomorphine, doctors found that the best responses occurred among men who had erectile dysfunction for less than two years.

"These results show that patients should not delay seeking therapy for erectile dysfunction," said Darryl Sleep, MD, associate medical director for Abbott Laboratories, in Abbott Park, Illinois. Dr. Sleep presented results of pooled studies at a late-breaker session here Wednesday at the 97^th annual scientific meeting of the American Urological Association (AUA).

Dr. Sleep and colleagues analyzed the results of studies using the 2 mg and 3 mg doses of apomorphine among 558 patients with erectile dysfunction were analyzed to determine how duration of erectile dysfunction affected outcome.

They found that in men who had erectile dysfunction for less than two years and were treated with apomorphine -- a drug being marketed in Europe but not yet approved in the United States -- 68.6 percent of the attempts at intercourse were successful compared to 41.3 percent of successful attempts by patients taking placebo.

However, if the men had erectile dysfunction for two to four years, the number of successful attempts fell to 48.3 percent for those on apomorphine compared to 39.9 percent success with placebo, Dr. Sleep said. The success rate dropped further to 39.2 percent with apomorphine if they had erectile dysfunction for more than four years compared to 25.1 percent with placebo.

Led by Dr. Claude Shulman, professor of urology at the University of Brussels in Belgium, Dr. Sleep and colleagues found that 22 percent of the men had erectile dysfunction for less than two years; 27 percent had the condition for two to four years, and 51 percent were affected for more than four years. According to validated instruments that measure severity of erectile dysfunction, 35 percent of the patients in the study had severe illness.

In the study, sponsored by Abbott, patients received 2 mg or 3 mg of apomorphine or placebo. Dr. Sleep suggested that the 3 mg dose would be the one most likely to be prescribed for treatment. The company is expected to file for approval of apomorphine in the United States later this year.

"The duration of erectile dysfunction is a predictor of outcome," commented John Mulhall, MD, associate professor of urology at Weill Medical College of Cornell University/New York Hospital, in New York. He said the studies with apomorphine confirm the "longer you have erectile dysfunction the less likely the person will be responsive to medicine."

Apomorphine is taken sublingually, and therefore gets into the blood system rapidly. Under conditions of sexual stimulation, it can result in an erection in 10 to 15 minutes, said Dr. Mulhall, who did not participate in the study. The agent could have advantages over other oral drugs -- sildenafil, vardenafil and tadalafil -- in that it has an "excellent cardiovascular safety profile", avoids gastrointestinal absorption considerations, has no food interactions, and does not require up to a hour to become effective, he said.

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