However, in the pooled analysis, numbers of participants for whom data were available was also presented.
- Priligy is not approved for women; mainly for men.
- Viagra is also used off-label for pulmonary hypertension.
- Using both drugs together can cause blood pressure drops.
It is unclear if the analysis was based on the ITT population or the population for whom data were available.
- Priligy should be avoided with SSRIs due to serotonin syndrome risk.
- Viagra should not be taken with nitrate medications.
- Always inform your doctor about other medications.
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).
How can I reduce the risk of side effects of dapoxetine (Priligy)?
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. 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 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. 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.
Authors and Affiliations
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 viagra gel 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. For missing data post-baseline, the last post-baseline observation carried forward (LPOCF) method was used.
| Aspect | Priligy (Dapoxetine) | Viagra (Sildenafil) | Combined Use Effectiveness |
|---|---|---|---|
| Effectiveness in delaying ejaculation | High (80-90%) | Not relevant | Variable, depends on individual response |
| Improvement in erectile function | No | Yes | Yes, when used with ED indication |
| Satisfaction rate in users | 70-80% | 75-85% | Enhanced with proper management |
| Onset of noticeable effects | 1-3 hours | 30-60 mins | Typically within 30 minutes to 2 hours |
In this approach, regardless of when a patient left the trial (for example, after week 1, week 6 or week 12), the last available result for that patient was carried forward and analysed as though it were the result at the study end.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Viagra Super Active | 100mg | 10 Pills | 28.76€ 27.39€ | |
| Viagra Original | 100mg | 22 + 2 Pills | 120.71€ 114.96€ | |
| Viagra Super Active | 100mg | 360 + 30 Pills | 470.93€ 448.50€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Generic | 200mg | 270 + 10 Pills | 379.76€ 361.68€ | |
| Viagra Soft Tabs | 100mg | 180 + 10 Pills | 314.95€ 299.95€ | |
| Viagra Original | 100mg | 64 + 4 Pills | 264.15€ 251.57€ | |
| Viagra Oral Jelly | 100mg | 90 + 8 Sachets | 258.02€ 245.73€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Viagra Super Active | 100mg | 90 + 10 Pills | 165.61€ 157.72€ | |
| Viagra Soft Tabs | 100mg | 90 + 6 Pills | 205.31€ 195.53€ | |
| Viagra Professional | 100mg | 180 + 4 Pills | 337.30€ 321.24€ | |
| Viagra Generic | 100mg | 30 + 4 Pills | 60.91€ 58.01€ | |
| Viagra Professional | 100mg | 90 + 2 Pills | 207.09€ 197.23€ | |
| Viagra Generic | 25mg | 90 + 6 Pills | 105.03€ 100.03€ |
As stated in the summary of product characteristics, the efficacy and safety of dapoxetine in men with both premature ejaculation and erectile dysfunction treated with both dapoxetine and phosphodiesterase type 5 inhibitors (for example, sildenafil) has not been established.
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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. 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. The summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors.
- Priligy (Dapoxetine) is used to treat premature ejaculation.
- Viagra (Sildenafil) enhances blood flow for erectile dysfunction.
- Both are prescription medications for male sexual health.
There are limited data available on the safety and efficacy of dapoxetine 'on demand' for longer than 24 weeks.
| Medication | Typical Dose | Maximum Dose | Frequency | Special Instructions |
|---|---|---|---|---|
| Priligy | 30 mg or 60 mg | 60 mg | As needed, 1-3 hours before intercourse | Do not exceed 1 tablet per day |
| Viagra | 50 mg or 100 mg | 100 mg | As needed, 30-60 mins before activity | Take on an empty stomach for faster effect |
| Cialis | 10 mg or 20 mg | 20 mg | As needed, 30 mins before sex or daily low dose | Can be taken daily or as-needed |
The European Association of Urology 2014 guidelines on male sexual dysfunction recommend that pharmacological treatment options include 'on demand' dapoxetine, daily use of a longer-acting selective serotonin reuptake inhibitor (SSRI) [off-label use], daily use of clomipramine (off-label use), 'on demand' topical local anaesthetic agents (off-label use) and 'on demand' tramadol (off-label use).
- Priligy is generally well-tolerated in healthy males.
- Viagra carries contraindications in certain health conditions.
- Combining prescribed medications requires medical guidance.
Because longer-acting SSRIs such as citalopram, fluoxetine or paroxetine have a longer onset of action than the shorter-acting dapoxetine they need to be taken on a daily basis and cannot be used as an 'on demand' treatment.
About this article
A 12-week open-label, prospective viagra red 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'. 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.
Conflict of interest
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. No syncope events were reported in any of the men treated with dapoxetine during the study. 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 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 viagra tablet sex 41 years. (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. The European Association of Urology 2014 guidelines on male sexual dysfunction states that in men for whom premature ejaculation causes few if any problems treatment should be limited to psychosexual counselling and education. The guidelines recommend that before beginning treatment, it is essential to discuss the expectations of treatment thoroughly.
Important information about all medicines
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. 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.
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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. 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).
What Is the Role of Ejaculation Latency in the Diagnosis of Premature Ejaculation and Does the Ejaculation Latency Threshold Matter?
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. Various behavioural techniques have demonstrated benefit in treating premature ejaculation and are indicated for men who are uncomfortable with pharmacological therapy.