麻豆传媒

CHICAGO -- The newest drug for erectile dysfunction (ED) may work in as little as 15 minutes after dosing, researchers said here.

A significantly larger proportion of patients had successful sexual encounters within 15 minutes of taking avanafil (Stendra) compared with placebo (P≤0.05), John Mulhall, MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues reported here at the World Meeting on Sexual Medicine.

"About half of attempts are successful in 15 minutes," Mulhall said.

Approved last April, avanafil is the first ED drug to be introduced to the market in nearly a decade. It's a highly specific phosphodiesterase type 5 (PDE5) inhibitor that is rapidly absorbed, typically within 30 to 45 minutes.

Patients in the four randomized, controlled trials of the drug were told to take a dose 30 minutes before sexual activity, but 277 patients (18.3% of the sample) recorded intercourse attempts within 15 minutes of dosing.

To evaluate their success rates, the researchers looked at responses to the Sexual Encounter Profile question 3 (SEP3). Patients took either placebo or one of three doses of the drug -- 50 mg, 100 mg, or 200 mg doses -- though most (75%) increased their dose to 200 mg.

The population included diabetics, non-diabetics, and men who'd had bilateral, nerve-sparing radical prostatectomy, and about a third of patients had severe ED.

Mulhall and colleagues found that significantly more men on the drug who attempted sex within 15 minutes were successful compared with those on placebo (P≤0.05).

For instance, 55% of those on 50 mg and 200 mg, as well as 57% of those on 100 mg, were successful, compared with 35% of those on placebo, he reported.

On a per-attempt basis, nearly 60% of diabetic and non-diabetic patients reported one or more successful attempts with avanafil, 15 minutes after dosing, compared with a little more than 27% of placebo patients (P<0.0001).

In post-prostatectomy patients, about 40% reported success with the drug compared with 4.5% in the placebo group (P<0.0005). Success rates were similar for men attempting sex within 16 to 30 minutes, and more than 30 minutes after dosing, they found.

Mulhall added that results were similar for patients with both mild or severe ED, noting that avanafil is "well suited for on-demand treatment of men with mild-to-severe ED."

Overall, the drug was well tolerated, with the most common adverse event being headache, and fewer than 2% of patients discontinued due to an adverse event. There were no serious adverse events, Mulhall added.

"A quick onset of action and favorable tolerability suggest that avanafil may be an attractive option for on-demand ED therapy in difficult-to-treat populations, as well as the general ED population," he concluded.

Mulhall added that the drug will be "on the shelves in December" in the U.S.

He also noted that there are data on sexual attempts within 15 minutes of dosing tadalafil (Viagra) and sildenafil (Cialis) but he did not have that available.

Laurence Levine, MD, of Rush University Medical Center and local chairman of the meeting, told 麻豆传媒 the results for avanafil are "exciting," though he estimated that other agents have similar activity, with about 30% of patients reporting an adequate response at 20 minutes.

Edgardo Becher, MD, PhD, president of the International Society of Sexual Medicine, agreed that the findings are similar to those seen with other PDE5 inhibitors, and noted that the avanafil studies were designed to look at patients attempting intercourse before 30 minutes.

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