The clinician must take into account factors that affect duration of the excitement phase, such as age, novelty of the sexual partner or situation, and recent frequency of sexual activity '. The major point of debate between the DSM-IV-TR definition of premature ejaculation and other definitions is quantifying the time to ejaculation, which is usually described as the intravaginal ejaculatory latency time IELT.
Premature ejaculation is classified as 'lifelong' primary or 'acquired' secondary. Lifelong premature ejaculation is characterised by onset from the first sexual experience and remaining during life with ejaculation occurring too fast before vaginal penetration or less than 1 to 2 minutes after.
Acquired premature ejaculation is characterised by a gradual or sudden onset - after previous normal ejaculation experiences; time to ejaculation is short but usually not as short as in lifelong premature ejaculation. The European guidelines recommend that the diagnosis and classification of premature ejaculation is based on medical and sexual history and that it should include assessment of IELT, perceived control, distress and interpersonal difficulty.
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It is important to distinguish premature ejaculation from erectile dysfunction. Erectile dysfunction or other sexual dysfunction or genitourinary infection for example, prostatitis should be treated first. The European guidelines state that in men for whom premature ejaculation causes few if any problems treatment should be limited to psychosexual counselling and education.
Before beginning treatment the guidelines recommend that it is essential to discuss expectations of treatment thoroughly. Various behavioural techniques have demonstrated benefit in treating premature ejaculation and are indicated for men uncomfortable with pharmacological therapy. In lifelong premature ejaculation, the European guidelines state that pharmacological treatment should be the first-line option; behavioural techniques are not recommended as first-line treatment because they are time-intensive, require the support of a partner and can be difficult to do.
The guidelines recommend that pharmacological treatment options include 'on demand' dapoxetine, daily use of a longer-acting selective serotonin reuptake inhibitor off-label use , daily use of clomipramine off-label use , 'on demand' use of topical local anaesthetic agents off-label use , or 'on demand' tramadol off-label use.
Dapoxetine Priligy is the first pharmacological treatment to be licensed in the UK for the treatment of premature ejaculation.
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Dapoxetine is a short-acting selective serotonin-reuptake inhibitor SSRI. The time to maximum plasma concentration is about 1 to 2 hours after intake. Human ejaculation is primarily mediated by the sympathetic nervous system. The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre- and postsynaptic receptors Priligy summary of product characteristics.
Dapoxetine Priligy was launched in the UK in November It is licensed for the treatment of premature ejaculation in adult men aged 18 to 64 years.
Dapoxetine should only be prescribed to men who meet all the following criteria:. Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and. Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and. A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Dapoxetine should be administered only as on demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with premature ejaculation. Dapoxetine must not be taken more frequently than once every 24 hours Priligy summary of product characteristics.
Dapoxetine is available at 2 different strengths: 30 mg and 60 mg.
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The recommended starting dose for all men is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment should not be initiated with the 60 mg dose. If the individual response to 30 mg is insufficient and the man has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed approximately 1 to 3 hours prior to sexual activity.
The incidence and severity of adverse events is higher with the 60 mg dose.
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Data regarding the efficacy and safety of dapoxetine beyond 24 weeks are limited. Dapoxetine Priligy is available in packs of 3 and 6 tablets. All 5 of the studies were conducted in heterosexual men aged 18 years and over who had been in a monogamous relationship for at least 6 months and who met the DSM-IV-TR criteria for premature ejaculation.
The pooled analysis provides pooled data from these 4 studies for the mean average IELT at week The 5 th study compared dapoxetine 60 mg once daily, dapoxetine 60 mg 'on demand' and placebo over a 9-week period.
McMahon et al.
Dapoxetine - Wikipedia
Intervention and comparison: in 4 studies Pryor et al. In Kaufman et al.
Outcomes: 4 studies Pryor et al. Secondary outcome measures in these 4 studies included patient-reported outcomes such as the clinical global impression of change in premature ejaculation where participants were asked to rate their premature ejaculation as 'much worse', 'worse', 'slightly worse', 'no change', 'slightly better', 'better' or 'much better' and items from the Premature Ejaculation Profile PEP , a validated tool that includes measures of perceived control over ejaculation.
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Missing post-baseline data were substituted with the last post-baseline observation carried forward. Three of the included studies Pryor et al.
Premature ejaculation: dapoxetine
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.
No statistical analysis was presented for the safety outcomes.
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These participants took placebo once daily and placebo 'on demand'. 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.
One of the included studies Buvat et al. 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. In the pooled analysis, the improvement in mean 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 week IELT was 1. 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.
However, the differences between the 30 mg and 60 mg strengths were small no statistical analysis reported.
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In addition, the majority of men in the dapoxetine groups 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 For the percentage of men reporting 'quite a bit' or 'extreme' ejaculation-related interpersonal difficulty, there was a reduction from 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 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.
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In the pooled analysis McMahon et al. Across all 5 RCTs, syncope including loss of consciousness occurred in 0. 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.
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 week open-label, prospective observational study Mirone et al.
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A total of men mean age 40 years were assessed: were treated with dapoxetine 30 mg or 60 mg 'on demand' and 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 The most common treatment-emergent adverse events were nausea, headache and vertigo, with a higher incidence in the dapoxetine group 3. 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.
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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.
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Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults who are aged over 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. Analysis of data from Buvat et al.
It also states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors for example, sildenafil.
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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.
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.
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Common between 1 in 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.
For further information on contraindications, cautions and warnings please refer to the summary of product characteristics. The pooled analysis included data from 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, 4 th 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. 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.