Dapoxetine and the treatment of premature ejaculation

For missing data post-baseline, the last post-baseline

When Dapoxetine May Be Prescribed

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. In the pooled analysis, it was reported that there was no evidence of men feeling suicidal whilst taking dapoxetine treatment (no statistical analysis presented). The mean age of the population in the pooled analysis was 41 years.

Lifelong PE

(2009) found no effect on mood, or evidence of treatment-emergent anxiety or akathisia. 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. It also states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors (for example, sildenafil). 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.

Development of this evidence summary

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. 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. The summary of product characteristics states that patients should be advised not to use dapoxetine in combination with recreational drugs or alcohol. Dapoxetine has a number of potential drug interactions; these are similar to those which occur with other SSRIs. observation carried forward (LPOCF) method was used.

In this approach, regardless of when a patient left the

Counseling and Sex Therapy

Across the groups 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. An orthostatic test should be performed before initiating therapy (blood pressure and pulse rate, supine and standing).

Clinical studies of dapoxetine

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'. 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'.

Priligy side effects

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 vardenafil with dapoxetine tablets 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. No syncope events were reported in any of the men treated with dapoxetine during the study. trial (for example, after week 1, week 6 or week 12),

• Economic burden of PE includes impact on quality of life.
• Dapoxetine can be cost-effective compared to no treatment or therapy alone.
• Adherence improved by clear instructions on timing of intake.
• Missed opportunity: if taken too late, may not be effective.
• Food does not significantly affect absorption; can be taken with/without.
• Potential for mild withdrawal-like symptoms if used very frequently.
• No established benefit for other sexual dysfunctions.
• Research continues on new formulations or delivery methods.

the last available result for that patient was carried forward and

• 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.

analysed as though it were the result at the study end.

As stated in the summary of product characteristics, the

efficacy and safety of dapoxetine in men with both premature

Article history

For further information on contraindications, cautions and warnings please refer to the summary of product characteristics. The pooled analysis included data from 6081 men and reported results for both IELT and patient-reported outcomes such as perceived control over ejaculation. However, there are no RCTs that compare 'on demand' dapoxetine with an active comparator, such as daily use of a longer-acting SSRI (off-label use). The studies only included men aged 18 years and over who had been in a monogamous heterosexual relationship for at least 6 months and who met Diagnostic and Statistical Manual of Mental Health Disorders, 4th edition, text revision (DSM-IV-TR) criteria for premature ejaculation. In 4 of the RCTs included in the pooled analysis, participants also had to have an intravaginal ejaculatory latency time of 2 minutes or less, and this is reflected in the licensed indication.

Step 1 — Structured Intake and Sexual Health History

Only 3 of the studies included in the pooled analysis stated how frequently men were to try to attempt sexual intercourse; the other 2 included studies did not state this. The average age of men in the pooled analysis was 41 years. The efficacy and safety of dapoxetine have not been established in men aged 65 years and over. 2006) included in the pooled analysis, the method of allocation described suggests that this was concealed. However, in the other 2 RCTs (McMahon et al. ejaculation and erectile dysfunction treated

Associated data

2009) it is unclear if allocation was concealed. The efficacy outcomes were reported to be based on the intention-to-treat (ITT) population, classed as all randomised participants. However, in the pooled analysis, numbers of participants for whom data were available was also presented. It is unclear if the analysis was based on the ITT population or the population for whom data were available. Discontinuation rates were high in the studies but were similar for dapoxetine and placebo (31.1% of all participants in the dapoxetine groups and 28.9% of all participants in the placebo groups). with both dapoxetine and phosphodiesterase type 5 inhibitors (for example,

sildenafil) has not been established.

What do we need to know?

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. For both of these outcomes there were statistically significant reductions with dapoxetine 30 mg and 60 mg compared with placebo at 12 weeks.

Study selection

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. The CHMP concluded that a statistically significant efficacy difference in favour of 60 mg compared with 30 mg had been established.

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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. 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.