On-demand dapoxetine safe, effective for premature ejaculation

The on-demand use of dapoxetine helps improve ejaculation control and sexual satisfaction without significant safety signals in men with premature ejaculation (PE), reports a recent China study.

Researchers conducted a real-world phase IV study on 1,244 PE patients (mean age, 32.61±7.12 years) who were given 30 mg dapoxetine. If participants reported no improvement, the dose was escalated to 60 mg, and the medication was given for 4 more weeks. A self-reported PE profile questionnaire was administered to assess condition severity and treatment safety and efficacy.

No deaths occurred. Almost a fifth of the patients (n=233; 18.6 percent) reported experiencing treatment-emergent adverse events (TEAEs), most of which were mild. Dizziness, nausea, and headache were the most common side effects, both in patients who stayed on the 30-mg dose and in those who needed escalation to 60 mg.

All TEAEs were considered related to the study drug. There were no episodes of syncope reported. Serious AEs included cholecystitis and salivary gland cysts, none of which were deemed related to dapoxetine.

After 4 weeks, 1,052 patients receiving only the 30-mg dose of dapoxetine had data available for effectiveness analysis. In 928 men in this subgroup, intervention was deemed successful, yielding an effectiveness rate of 88.2 percent. In the 192 patients whose doses were uptitrated to 60 mg, treatment was effective in 107 men, resulting in a rate of 55.7 percent. Overall, 83.2 percent of the participants responded to treatment regardless of dose.