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Patients on Tadalafil See Relief of Erectile Dysfunction for 36 Hours: Presented at AUA

By Ed Susman

ORLANDO, FL -- May 27, 2002 -- One 20 mg dose of the experimental drug tadalafil allows men with erectile dysfunction to have sexual intercourse up to 36 hours later-sometimes even longer.

"About 60 percent of patients taking tadalafil were able to maintain an erection sufficient for sexual intercourse 36 hours after taking the pill," said Dr. Hartmut Porst, professor of urology at the University of Hamburg, Germany. About 30 percent of patients taking placebo were able to achieve the same results.

"Some of my patients tell me that they are still able to perform sexual intercourse three days after taking one pill," Dr. Porst said here Sunday at the annual meeting of the American Urological Association (AUA) in Orlando, Florida.

"The advantage tadalafil gives to couples," he said, "is that it will make sex with a partner more spontaneous, because a person doesn't have to take the pill just before having sex." He said that tadalafil could be taken daily because the chemicals that enhance sexual response reach a peak in the body and don't reach toxic levels.

"But just because one can take a pill each day doesn't mean he has to."

In the double-blind, placebo-controlled study, Dr. Porst and colleagues from 36 centers in Europe and the United States enrolled 348 men with mild to severe erectile dysfunction. Patients were randomised to tadalafil 20 mg or placebo and were asked to attempt intercourse on four occasions: twice approximately 24 hours after a dose and twice approximately 36 hours after a dose.

After analyzing the patients' self-reports of intercourse success, Dr. Porst determined that tadalafil significantly increased the percentage of successful intercourse attempts at 24 hours and 36 hours, compared with placebo. At 24 hours, 57.3 percent of intercourse attempts by tadalafil-treated men were successful versus 31.3 percent of attempts by placebo-treated men. He said the effect was maintained at 36 hours; 60.4 percent of intercourse attempts in the tadalafil-treated group were successful versus 29.9 percent in the placebo group. Both differences were highly statistically significant to the p<0.001 level.

Dr. Porst said secondary measures of efficacy such as penetration ability, hardness of erection, and overall satisfaction showed tadalafil to have greater efficacy than placebo at 24 and 36 hours.

Dyspepsia and headache were the most common treatment-emergent adverse events, he said, but those events were generally mild and decreased as the patients used the drugs.

The study was supported by Lilly ICOS.

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