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Erectile Dysfunction Drug Tadalafil Appears Effective in Men with Mild to Moderate Disease: Presented at ESC

By Ed Susman

BERLIN, GERMANY -- September 3, 2002 -- Researchers looking at five studies involving the investigational drug tadalafil concluded that the selective phosphodiesterase-type-5 inhibitor effectively treats erectile dysfunction.

The analysis included four studies that followed patients for 12 weeks and one study that described results after 24 weeks of treatment, said Serge Carrier, MD, assistant professor of urology at Jewish General Hospital, McGill University Health Center, in Montreal, Canada. He presented the five-study analysis here September 3^rd at the 24^th annual congress of the European Society of Cardiology.

The studies were conducted with researchers in Sydney, Australia, Taipei, Taiwan, with Eli Lilly & Company, in Indianapolis, and ICOS, in Bothell, Washington, United States. Tadalafil was administered at doses of 2.5 to 20 mg as needed up to once daily to 1,112 men.

Dr. Carrier said that compared with placebo, tadalafil significantly improved all primary and secondary end points, including the ability of men with erectile dysfunction to achieve an erection with sufficient rigidity to perform sexual intercourse.

"Among the 972 patients who were taking tadalafil in the four 12-week studies, as many as 81 percent reported improved erections," Dr. Carrier said. "The mean percentage of successful intercourse attempts improved to up to 75 percent."

He said the long 17-18 hour half-life of the drug could allow it to be used two or three times a week to permit a patient with erectile dysfunction to have intercourse more spontaneously. As with other drugs in its class, tadalafil only is effective when used in conjunction with sexual stimulation.

"Some men report that one dose of tadalafil is still effective after 36 hours," Dr. Carrier said. "However, the only reason that person would not use the drug daily would be the cost issue, not any physiological reason."

The studies scrutinised tadalfil's effectiveness in mild-to-severe erectile dysfunction with psychogenic, organic, or mixed aetiology. Erectile dysfunction often occurs in men with heart disease.
Participants had an average age of 58 years. They were free to choose the time of sexual attempts after dosing and had no restrictions on food and alcohol intake.

Dr. Carrier said that adverse events reported with tadalafil were generally mild-to-moderate in intensity, were transient, and attenuated with continued dosing. Discontinuation rates were similarly low in tadalafil- and placebo-treated patients. Headache, dyspepsia and back pain were the most commonly reported -- those that were mentioned by at least 5 percent of the patients -- across the studies.

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