Dapoxetine for premature ejaculation

No syncope events were reported in any of the men treated with dapoxetine during the study.

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2011), adverse events occurred in 35.1% of men in the placebo groups, 47.0% in the dapoxetine 30 mg 'on demand' groups and 60.3% in the dapoxetine 60 mg 'on demand' groups. Across the groups dapoxetine sildenafil online approximately 3% of men reported severe adverse events and 1% or less of men reported serious adverse events. Across all 5 RCTs, syncope (including loss of consciousness) occurred in 0.05% of men in the placebo groups, 0.06% of men in the dapoxetine 30 mg groups and 0.23% of men in the dapoxetine 60 mg groups (no statistical analysis presented). Orthostatic hypotension has been reported in clinical trials, and the summary of product characteristics includes recommendations to minimise this risk. This states that before treatment initiation, a careful medical examination including history of orthostatic events should be performed by the clinician.

Is there anything else I can try?

An orthostatic test should be performed before initiating therapy (blood pressure and pulse rate, supine and standing). The man should be counselled on the risk of prodromal symptoms such as light-headedness soon after standing and the risk of syncope. Treatment with dapoxetine should not be initiated with the 60 mg dose, and if a man has an orthostatic reaction on the 30 mg dose, the dose should not be increased to 60 mg. A 12-week open-label, prospective observational study (Mirone et al. 2014) assessed the safety profile of dapoxetine compared with 'alternative care'. However, the observational design of this study limits the conclusions that can be drawn. As highlighted in the dapoxetine summary of product characteristics, antidepressants (including SSRIs) increased the risk of suicidal thinking and suicidality compared with placebo in short-term studies in children and young people with major depressive disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults who are aged over 24.

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In the pooled analysis, it was reported that there was no evidence of men feeling suicidal whilst taking dapoxetine treatment (no statistical analysis presented).

Premature Ejaculation Medications

The percentage of men who reported that their premature ejaculation was 'better' or 'much better', and who reported 'good' or 'very good' satisfaction with sexual intercourse and 'good' or 'very good' perceived control over ejaculation was statistically significantly higher with dapoxetine 30 mg and 60 mg 'on demand' compared with placebo 'on demand' (all p<0.001, see table 1 for details). However, the differences between the 30 mg and 60 mg strengths were small (no statistical analysis reported). In addition, the majority of men in the dapoxetine groups (69.3% in the 30 mg group and 61.7% in the 60 mg group) did not report that their PE was 'better' or 'much better'. (2011) also presented pooled analyses from 2 of the included studies (Buvat et al. 2010) for the percentage of men reporting 'quite a bit' or 'extreme' ejaculation-related personal distress or ejaculation-related interpersonal difficulty.

New insights on premature ejaculation: a review of definition, classification, prevalence and treatment

For both of these outcomes there were statistically significant reductions with dapoxetine 30 mg and 60 mg compared with placebo at 12 weeks. For the percentage of men reporting 'quite a bit' or 'extreme' ejaculation-related personal distress, there was a reduction from 73.5% (545/742) to 39.0% (268/688) with placebo, from 71.3% (529/742) to 28.2% (194/689) with dapoxetine 30 mg and from 69.7% (519/745) to 22.2% (153/690) with dapoxetine 60 mg (p<0.001 for comparisons with placebo). For the percentage of men reporting 'quite a bit' or 'extreme' ejaculation-related interpersonal difficulty, there was a reduction from 38.5% (286/742) to 23.8% (164/688) with placebo, from 38.8% (288/742) to 16.0% (110/689) with dapoxetine 30 mg and from 36.1% (269/745) to 12.3% (85/690) with dapoxetine 60 mg (p<0.001 for comparisons with placebo). As part of the process of granting a UK marketing authorisation for dapoxetine, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence on the benefit/risk balance of the 60 mg dose. Concerns had been raised that the benefit of 60 mg compared with 30 mg was considered too modest to outweigh the potentially increased risk for severe events of syncope.

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The CHMP concluded that a statistically significant efficacy difference in favour of 60 mg compared with 30 mg had been established. However, the mean (or median) difference in IELT between the 30 mg and 60 mg dose appears marginal. The CHMP concluded that based on IELT data as well as patient- and partner-reported outcome measures, at least 12% more men respond to dapoxetine 30 mg compared with placebo and an additional 5–10% more men respond to the 60 mg dose compared with the 30 mg dose. The CHMP also recommended that additional changes were to be made to the summary of product characteristics to further optimise the benefit-risk ratio (see Safety and tolerability section). In the pooled analysis (McMahon et al. The mean age of the population in the pooled analysis was 41 years.

• Dapoxetine's effectiveness peaks when taken on an empty stomach.
• It is classified as a selective serotonin reuptake inhibitor (SSRI).
• The medication’s half-life is short, leading to quick clearance from the system.
• Dapoxetine does not cure premature ejaculation but manages symptoms temporarily.
• Possible temporary side effects include mild nausea and dizziness.
• Do not exceed the recommended dose to avoid adverse effects.

(2009) found no effect on mood, or evidence of treatment-emergent anxiety or akathisia.

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A total of 9443 men (mean age 40 years) were assessed: 6128 were treated with dapoxetine 30 mg or 60 mg 'on demand' and 3315 were treated with 'alternative care'. In the alternative care group, men were treated in a variety of ways including oral treatment with longer-acting SSRIs such as paroxetine or sertraline, topical treatment or behavioural counselling. Treatment-emergent adverse events were reported by 12.0% of the dapoxetine group compared with 8.9% of the alternative care group. The most common treatment-emergent adverse events were nausea, headache and vertigo, with a higher incidence in the dapoxetine group (3.1%, 2.6% and 1.0% respectively) than in men who were taking oral treatment in the alternative care group (2.3%, 1.3% and 0.9% respectively). Men in the dapoxetine group had an orthostatic test at baseline: 70 men had an orthostatic reaction and 60 of these men took dapoxetine and were included in the safety analysis. The summary of product characteristics states that contraindications to the use of dapoxetine include significant pathological cardiac conditions such as heart failure, significant ischaemic heart disease or history of syncope; a history of mania or severe depression; and concomitant treatment with thioridazine, monoamine oxidase inhibitors, SSRIs, tricyclic antidepressants or other herbal/medicinal products with serotonergic effects and potent CYP3A4 inhibitors.

• Some men may experience mood changes or irritability with dapoxetine.
• Alcohol use can increase the risk of side effects when taking dapoxetine.
• Dapoxetine is not approved for use in women or children.
• Store dapoxetine in a cool, dry place away from children.
• Always report any unusual or severe side effects to your doctor.
• It is important to get a medical assessment before starting dapoxetine.

It also states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors (for example, sildenafil).

• Dapoxetine has been shown to significantly increase ejaculatory latency time.
• It is not intended to treat all aspects of sexual dysfunction.
• Use of dapoxetine may require dose adjustments based on side effects.
• The medication should be stored safely out of children's reach.
• Monitoring response and side effects enhances safe use of dapoxetine.
• Dapoxetine should be used only as part of a broader treatment plan.

Dapoxetine should be used with caution in men with mild or moderate renal impairment, and is not recommended for use in men with severe renal impairment. It is contraindicated in men with moderate and severe hepatic impairment.

Safety Screening: Why Medication Review Matters

Safety outcomes included pooled data from all 5 studies for adverse events and safety observations of well-recognised selective serotonin reuptake inhibitor (SSRI)-related effects concerning mood, akathisia, anxiety, suicidality or SSRI discontinuation syndrome reported separately from each study. Table 1 Summary of pooled analysis McMahon et al. The pooled analysis of results from 4 phase III studies showed that there was an increase from baseline in mean IELT at 12 weeks with all 3 groups, including the placebo group. There was a statistically significantly greater increase from baseline in mean IELT at 12 weeks with both dapoxetine 30 mg and 60 mg 'on demand' compared with placebo 'on demand' (from 0.9 minutes in all groups to 1.9, 3.1 and 3.6 minutes respectively for placebo, dapoxetine 30 mg and dapoxetine 60 mg; p<0.001 for comparisons with placebo). The RCTs that contributed to the pooled analysis also individually showed statistically significantly greater increases of similar magnitude in mean IELT at 12 weeks with both strengths of dapoxetine compared with placebo (p<0.001).

How Dapoxetine works

One of the included studies (Buvat et al. 2009) was continued for 24 weeks and the statistically significant increase in mean IELT with dapoxetine 30 mg and 60 mg 'on demand' compared with placebo 'on demand' was still maintained at this time point (p<0.001). (2011) also presented exploratory analyses of geometric means (a measure of central tendency) for the 12-week IELT. Because IELT may be influenced by several factors and it is not expected to be normally distributed, it has been previously suggested that geometric mean may be preferred over average mean to correct for this skewed distribution. The increase from baseline in geometric mean values for IELT was also statistically significantly greater for dapoxetine 30 mg and 60 mg 'on demand' compared with placebo 'on demand' (p<0.001).

Not recommended for primary or secondary care prescribing

Whilst there is no generally agreed minimum clinically important change in IELT, Pryor et al. (2006) concluded that it was about 1 minute, based on a correlation of global impression of change scores with mean changes in IELT. In the pooled analysis, the improvement in mean 12-week IELT from baseline for the placebo group was 1 minute. In the pooled analysis, the difference between placebo and dapoxetine 30 mg for the improvement in mean 12-week IELT was 1.2 minutes. In both the pooled analysis and the individual studies, the difference between dapoxetine 30 mg and 60 mg 'on demand' for the mean IELT at 12 weeks was less than 1 minute (0.5 minutes for the pooled analysis; no statistical analysis reported). The efficacy and safety of dapoxetine have not been established in men aged 65 years and over (summary of product characteristics). Very common (greater than 1 in 10 men) adverse reactions reported in the summary of product characteristics are dizziness, headache and nausea.

• Men should be aware of potential allergic reactions such as rash or swelling.
• Dapoxetine does not affect sexual desire directly.
• It is important to report any persistent or worsening side effects.
• Use caution when scaling doses up, only as advised by a healthcare professional.
• Avoid taking dapoxetine with other medications that affect serotonin levels.
• Stay informed about new research and updates on dapoxetine therapy.

Common (between 1 in 100 and 1 in 10 men) adverse reactions reported include anxiety, agitation, insomnia, somnolence, abnormal dreams, tremor, paraesthesia, blurred vision, tinnitus, erectile dysfunction, decreased libido, increased blood pressure, hyperhidrosis and gastrointestinal disorders.

Country	Approval Status	Notes
USA	Approved by FDA for PE	Prescription required
European Union	Approved in several countries	Prescription essential
Australia	Approved for PE	Sold under brand names
India	Available OTC in some pharmacies	Consult healthcare provider before use
Canada	Approved with prescription	Used for PE treatment