Why wasn't dapoxetine (Selective Serotonin Reuptake Inhibitor) mentioned as a treatment option for premature ejaculation?

Dapoxetine as a First-Line Treatment Option for Premature Ejaculation

Dapoxetine is specifically mentioned in current guidelines as a first-line treatment option for premature ejaculation where available, and should be considered alongside daily SSRIs and topical anesthetics for the management of this condition. 1

Why Dapoxetine is Recommended

Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) that has been specifically developed and approved for on-demand treatment of premature ejaculation in many countries (though not in the USA). 1 It offers several advantages:

• Specifically designed for PE: Unlike other SSRIs used off-label, dapoxetine was developed specifically for this indication
• On-demand dosing: Can be taken 1-3 hours before anticipated sexual activity
• Proven efficacy: Increases intravaginal ejaculatory latency time (IELT) by 2.5-3.0 fold at 30mg and 60mg doses respectively 1, 2
• Rapid onset of action: Effective from the first dose 3

Efficacy of Dapoxetine

Integrated analysis of five phase 3 trials has demonstrated that dapoxetine significantly improves all aspects of premature ejaculation: 2

• Increases average IELT from baseline (0.9 minutes) to 3.1 minutes (30mg) and 3.6 minutes (60mg)
• Geometric mean fold increase of 2.5 (30mg) and 3.0 (60mg) vs 1.6 for placebo
• Significant improvements in Premature Ejaculation Profile (PEP) items and Clinical Global Impression of Change (CGIC)

Dosing and Administration

• Available in 30mg and 60mg doses
• Taken on-demand 1-3 hours before anticipated sexual activity
• For patients with baseline IELT <30 seconds, efficacy increases to 3.4-fold (30mg) and 4.3-fold (60mg) 1

Safety Profile

Dapoxetine is generally well-tolerated: 2, 3, 4

• Most common side effects are dose-dependent and include:

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

• No evidence of anxiety, akathisia, suicidality, or mood changes

• No discontinuation syndrome following abrupt withdrawal

• Can be safely combined with PDE5 inhibitors 1

Treatment Algorithm for Premature Ejaculation

1. First-line pharmacotherapy options:

   • Dapoxetine (30-60mg) on-demand where available
   • Daily off-label SSRIs (paroxetine 10-40mg, sertraline 50-200mg, fluoxetine 20-40mg, citalopram 20-40mg)
   • On-demand clomipramine (12.5-50mg)
   • Topical anesthetics (lidocaine/prilocaine)

2. Special considerations:

   • If PE is secondary to erectile dysfunction, treat ED first or concomitantly
   • Avoid SSRIs in men with bipolar depression due to risk of mania 1
   • Be cautious with SSRIs in adolescents and men with comorbid depressive disorders with suicidal ideation 1

Limitations and Challenges

Despite its efficacy, dapoxetine has high discontinuation rates:

• Up to 90% at 2 years 1
• Main reasons include cost (29.9%) and disappointment with the on-demand nature of the medication (25%) 1

Conclusion

When discussing treatment options for premature ejaculation, dapoxetine should be included as a first-line option where available, alongside daily SSRIs and topical anesthetics. Its specific development for PE, on-demand dosing, and proven efficacy make it an important treatment consideration for appropriate patients.