What is the treatment approach for a male patient with premature ejaculation (PE) using Dapoxetine (Priligy)?

Dapoxetine (Priligy) for Premature Ejaculation

Dapoxetine 30-60 mg taken on-demand (1-3 hours before intercourse) is an approved and effective first-line treatment option for premature ejaculation, producing a 2.5- to 3.0-fold increase in intravaginal ejaculatory latency time (IELT), with even greater efficacy (3.4- to 4.3-fold increase) in men with baseline IELT <30 seconds. 1

When to Use Dapoxetine

Dapoxetine is specifically indicated as first-line pharmacotherapy for lifelong PE and represents the only SSRI specifically designed and approved for on-demand PE treatment in many countries (excluding the USA). 1 The European Association of Urology recommends pharmacotherapy as first-line treatment for lifelong PE, with dapoxetine being one of two approved on-demand options alongside lidocaine/prilocaine spray. 1

Patient Selection Criteria

• Treat any coexisting erectile dysfunction first or concomitantly, as secondary PE may resolve when ED is effectively managed. 2, 3 Many men with ED develop secondary PE due to anxiety or need for intense stimulation to maintain erection. 3
• Dapoxetine is particularly suited for patients with infrequent sexual activity who prefer on-demand dosing over daily SSRI therapy. 2, 3
• For patients with frequent sexual activity, daily SSRI therapy (paroxetine 10-20 mg daily) provides substantially greater ejaculatory delay than on-demand dapoxetine. 2, 3

Dosing Protocol

Initial Dosing

• Start with dapoxetine 30 mg taken 1-3 hours before anticipated sexual activity. 1, 2 The medication is effective on the first dose. 4
• If response is inadequate after several attempts, increase to 60 mg. 1 The 60 mg dose produces a 3.0-fold IELT increase compared to 2.5-fold with 30 mg. 2

Special Populations

• In men with baseline IELT <30 seconds (severe PE), dapoxetine demonstrates enhanced efficacy: 30 mg produces a 3.4-fold increase and 60 mg produces a 4.3-fold increase in IELT. 1, 2

Expected Outcomes and Efficacy

Objective Measures

• Mean IELT increases from baseline 0.9 minutes to 2.78 minutes with 30 mg and 3.32 minutes with 60 mg at 12 weeks. 5, 4
• Geometric mean IELT increases from 0.7 minutes at baseline to 1.8 minutes with 30 mg and 2.3 minutes with 60 mg. 5

Patient-Reported Outcomes

• All Premature Ejaculation Profile (PEP) measures improve significantly versus placebo, including perceived control over ejaculation, satisfaction with intercourse, reduced ejaculation-related distress, and decreased interpersonal difficulties. 1, 6, 5
• These improvements are sustained through 9-12 months of treatment. 7

Side Effects and Safety Profile

Common Adverse Events (Dose-Dependent)

• Nausea (8.7% with 30 mg, 20.1% with 60 mg) 4
• Dizziness (3.0% with 30 mg, 6.2% with 60 mg) 4
• Diarrhea (3.9% with 30 mg, 6.8% with 60 mg) 4
• Headache (5.9% with 30 mg, 6.8% with 60 mg) 1, 4

Discontinuation and Tolerability

• Adverse events lead to discontinuation in only 3.9% of patients on 30 mg and 8.2% on 60 mg. 5
• However, treatment discontinuation rates reach 90% at 2 years, primarily due to cost (29.9%) and disappointment with the on-demand nature (25%), not side effects. 1

Reproductive Safety

• Dapoxetine has no documented adverse effects on sperm parameters, fertility, or testicular function based on clinical evidence from over 10,000 men. 8 No routine semen analysis is required. 8

Combination Therapy

With PDE5 Inhibitors

• Dapoxetine can be safely combined with PDE5 inhibitors for men with both PE and ED. 1, 2 This combination shows superior results to SSRI monotherapy and enhances confidence and sexual satisfaction. 1, 2
• Do not prescribe PDE5 inhibitors alone to men with PE and normal erectile function, as they do not significantly improve IELT. 2

With Other SSRIs

• Combination therapy of daily low-dose SSRI plus on-demand dapoxetine may be considered for patients with partial response to monotherapy. 2

Critical Safety Considerations

Absolute Contraindications

• Never prescribe dapoxetine (or any SSRI) to men with bipolar depression due to risk of triggering mania. 3
• Avoid combining with other serotonergic drugs due to risk of serotonin syndrome. 3

Diagnostic Requirements Before Treatment

Base the diagnosis and classification of PE on medical and sexual history, including assessment of self-estimated IELT, perceived control, distress, and interpersonal difficulty. 1

• Include physical examination to identify anatomical abnormalities associated with PE or other sexual dysfunctions, particularly ED. 1
• Do not perform routine laboratory or physiological tests unless directed by specific findings from history or physical examination. 1

Common Pitfalls to Avoid

• Do not use dapoxetine as first-line when daily SSRI therapy is feasible for patients with frequent sexual activity, as daily paroxetine provides an 8.8-fold IELT increase compared to dapoxetine's 2.5-3.0-fold increase. 2, 3
• Address patient expectations upfront regarding the on-demand nature and cost, as these are the primary reasons for long-term discontinuation, not efficacy or side effects. 1
• Ensure patient counseling emphasizes that patient and partner satisfaction is the primary target outcome, not just IELT improvement. 2