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What sets dapoxetine apart from other SSRIs currently used off-label to treat PE is its pharmacokinetic profile.15,16 Briefly, the pharmacology of dapoxetine may be summarized as follows: Dapoxetine is rapidly absorbed following oral administration, whereas other SSRIs take several days or even weeks to reach steady-state concentrations14 Dapoxetine is rapidly absorbed following oral administration, whereas other SSRIs take several days or even weeks to reach steady-state concentrations14 Peak plasma levels of dapoxetine are reached in approximately 1 hour following a dose of 30 mg or 60 mg15,16 Peak plasma levels of dapoxetine are reached in approximately 1 hour following a dose of 30 mg or 60 mg15,16 Dapoxetine is rapidly eliminated; its initial half-life is approximately 1.4 hours for both doses, compared with 21 hours to 4 days for other SSRIs14 Dapoxetine is rapidly eliminated; its initial half-life is approximately 1.4 hours for both doses, compared with 21 hours to 4 days for other SSRIs14 Dapoxetine has a terminal half-life of 18.7 hours for the 30 mg dose and 21.9 hours for the 60 mg dose15 Dapoxetine has a terminal half-life of 18.7 hours for the 30 mg dose and 21.9 hours for the 60 mg dose15 Even with multiple dosing, the pharmacokinetics of dapoxetine are unchanged, and it does not appear to accumulate significantly.15 Even with multiple dosing, the pharmacokinetics of dapoxetine are unchanged, and it does not appear to accumulate significantly.15 These pharmacokinetic characteristics make dapoxetine ideal for on-demand dosing, which reduces the probability of unwanted side effects.15,40 Previous Phase II studies identified the optimal dose to be 30 mg initially, with an increase to 60 mg (the maximum recommended dose) if required. Pharmacodynamic studies identified the optimal dose administration time to be 1–3 hours before sexual intercourse.41 From the literature searches, nine publications were identified for inclusion in the following evaluation of the clinical evidence for dapoxetine in the treatment of PE. These comprised three integrated analyses, six randomized placebo-controlled studies (two studies of identical design are only available as an integrated analysis), one subanalysis of two studies, and one long-term extension study. In the following discussion, to aid critical analysis of the studies included for assessment, each publication has been assigned a “quality of evidence” rating based on the criteria shown in Table 1. Due to the nature of PE, a change in IELT is the only disease-orientated outcome that is regularly measured and reported. Other frequently reported outcomes are necessarily patient-reported outcomes, and these are discussed later. Table 2 provides a summary of the identified studies reporting changes in IELT with dapoxetine and the quality of evidence supporting these changes.

Medication	Main Active Ingredient	Uses	Typical Dose	Side Effects	Price Range (per pill)
Viagra + Dapoxetine	Sildenafil + Dapoxetine	ED + PE combined	50-100mg + 30-60mg	Headache, dizziness, nausea	$2 - $10
Cialis + Dapoxetine	Tadalafil + Dapoxetine	Long-term ED and PE support	10-20mg + 30-60mg	Muscle pain, flushing	$3 - $12
Levitra + Dapoxetine	Vardenafil + Dapoxetine	Similar to Viagra	5-20mg + 30-60mg	Vision disturbances	$3 - $11

All of these studies were carried out before the recent definition of lifelong PE was published by the International Society for Sexual Medicine,8 so the recruitment criteria are based on the definition given by the DSM-IV-TR,6 with the added criterion of IELT ≤2 minutes in at least 75% of sexual events (at least 90% of sexual events in Safarinejad43). In the studies listed in Table 2, IELT was measured using a stopwatch held by the partner during episodes of sexual intercourse and averaged over the specified baseline and treatment periods. Notes: Only data for patients without erectile dysfunction are shown for consistency with other studies; P < 0.0001 vs 30 mg dapoxetine; P value is based on fold-increase from baseline, not difference from placebo as stated for the other studies. Abbreviations: RCT, randomized controlled trial; SE, standard error; SD, standard deviation; PBO, placebo; DPX, dapoxetine; PE, premature ejaculation. Stopwatch-measured IELT was reported in seven publications listed in Table 2, with the duration of these studies ranging from 9 to 24 weeks.

• Some users report improved stamina and control during intercourse.
• Enhanced satisfaction for both partners is a common benefit.
• Reduced anxiety about performance can boost mental well-being.
• Relationship intimacy often improves with successful treatment.
• Avoid unrealistic expectations; results vary per individual.
• Patience is key as full benefits may take several uses.
• Track progress with a journal to discuss with your doctor.
• Combine with foreplay and communication for best experience.
• Celebrate small victories to maintain positive outlook on therapy.

Mean average IELT was significantly increased in all cases following treatment with dapoxetine 30 mg or 60 mg, with end-of-study values being significantly greater than those for placebo, indicating an improvement in PE. The RCT by McMahon et al demonstrated significant increases from baseline in mean (± standard deviation) IELT after just one dose of dapoxetine, ie, 30 mg (1.1 [0.45]–2.7 [2.68] minutes), 60 mg (1.1 [0.48]– 3.0 [3.19] minutes), and placebo (1.0 [0.47]–1.8 [1.71]; P < 0.001) for both doses of dapoxetine vs placebo.44 This significant difference from placebo was evident at all time points to the end of the study. Of the seven studies in Table 2, four reported arithmetic and geometric means of average IELT, while three reported only one or the other. Geometric means give more conservative results that are less affected by data outliers, thus the values tend to be lower than those for arithmetic means.

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Where both geometric and arithmetic means were presented, the results for average IELT were similar for priligy and viagra both methods.

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For example, in the integrated analysis of five Phase III studies, geometric mean IELT increased from 0.8 minutes at baseline in all groups to 2.0 and 2.3 minutes in those taking dapoxetine 30 mg and 60 mg, respectively, compared with 1.3 minutes for those taking placebo (both P < 0.001).45 The corresponding arithmetic means increased from 0.9 minutes at baseline to 3.1, 3.6, and 1.9 minutes, respectively (both P < 0.001 vs placebo, Table 2).

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Even in more extreme cases of PE, in which baseline IELT was very short, treatment with dapoxetine effectively increased IELT. In the integrated analysis of two Phase III studies by Pryor et al,46 increases from baseline in average IELT at 12 weeks were significantly greater for either dose of dapoxetine (30 mg or 60 mg) than for placebo in the subgroups of patients with baseline average IELTs ≤1 minute and ≤30 seconds.

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What sets dapoxetine apart from other SSRIs currently used off-label to treat PE is its pharmacokinetic profile.15,16 Briefly, the pharmacology of dapoxetine may be summarized as follows: Dapoxetine is rapidly absorbed following oral administration, whereas other SSRIs take several days or even weeks to reach steady-state concentrations14 Dapoxetine is rapidly absorbed following oral administration, whereas other SSRIs take several days or even weeks to reach steady-state concentrations14 Peak plasma levels of dapoxetine are reached in approximately 1 hour following a dose of 30 mg or 60 mg15,16 Peak plasma levels of dapoxetine are reached in approximately 1 hour following a dose of 30 mg or 60 mg15,16 Dapoxetine is rapidly eliminated; its initial half-life is approximately 1.4 hours for both doses, compared with 21 hours to 4 days for other SSRIs14 Dapoxetine is rapidly eliminated; its initial half-life is approximately 1.4 hours for both doses, compared with 21 hours to 4 days for other SSRIs14 Dapoxetine has a terminal half-life of 18.7 hours for the 30 mg dose and 21.9 hours for the 60 mg dose15 Dapoxetine has a terminal half-life of 18.7 hours for the 30 mg dose and 21.9 hours for the 60 mg dose15 Even with multiple dosing, the pharmacokinetics of dapoxetine are unchanged, and it does not appear to accumulate significantly.15 Even with multiple dosing, the pharmacokinetics of dapoxetine are unchanged, and it does not appear to accumulate significantly.15 These pharmacokinetic characteristics make dapoxetine ideal for on-demand dosing, which reduces the probability of unwanted side effects.15,40 Previous Phase II studies identified the optimal dose to be 30 mg initially, with an increase to 60 mg (the maximum recommended dose) if required. Pharmacodynamic studies identified the optimal dose administration time to be 1–3 hours before sexual intercourse.41 From the literature searches, nine publications were identified for inclusion in the following evaluation of the clinical evidence for dapoxetine in the treatment of PE. These comprised three integrated analyses, six randomized placebo-controlled studies (two studies of identical design are only available as an integrated analysis), one subanalysis of two studies, and one long-term extension study. In the following discussion, to aid critical analysis of the studies included for assessment, each publication has been assigned a “quality of evidence” rating based on the criteria shown in Table 1. Due to the nature of PE, a change in IELT is the only disease-orientated outcome that is regularly measured and reported.

Redefining a sexual medicine paradigm: subclinical premature ejaculation as a new taxonomic entity

Other frequently reported outcomes are necessarily patient-reported outcomes, and these are discussed later. Table 2 provides a summary of the identified studies reporting changes in IELT with dapoxetine and the quality of evidence supporting these changes. All of these studies were carried out before the recent definition of lifelong PE was published by the International Society for Sexual Medicine,8 so the recruitment criteria are based on the definition given by the DSM-IV-TR,6 with the added criterion of IELT ≤2 minutes in at least 75% of sexual events (at least 90% of sexual events in Safarinejad43). In the studies listed in Table 2, IELT was measured using a stopwatch held by the partner during episodes of sexual intercourse and averaged over the specified baseline and treatment periods. Notes: Only data for patients without erectile dysfunction are shown for consistency with other studies; P < 0.0001 vs 30 mg dapoxetine; P value is based on fold-increase from baseline, not difference from placebo as stated for the other studies.

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Abbreviations: RCT, randomized controlled trial; SE, standard error; SD, standard deviation; PBO, placebo; DPX, dapoxetine; PE, premature ejaculation. Stopwatch-measured IELT was reported in seven publications listed in Table 2, with the duration of these studies ranging from 9 to 24 weeks. Mean average IELT was significantly increased in all cases following treatment with dapoxetine 30 mg or 60 mg, with end-of-study values being significantly greater than those for placebo, indicating an improvement in PE. The RCT by McMahon et al demonstrated significant increases from baseline in mean (± standard deviation) IELT after just one dose of dapoxetine, ie, 30 mg (1.1 [0.45]–2.7 [2.68] minutes), 60 mg (1.1 [0.48]– 3.0 [3.19] minutes), and placebo (1.0 [0.47]–1.8 [1.71]; P < 0.001) for both doses of dapoxetine vs placebo.44 This significant difference from placebo was evident at all time points to the end of the study. Of the seven studies in Table 2, four reported arithmetic and geometric means of average IELT, while three reported only one or the other. The subanalysis of these studies by Shabsigh et al49 highlighted the importance of perceived control over ejaculation for achieving increases in IELT.

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Geometric means give more conservative results that are less affected by data outliers, thus the values tend to be lower than those for arithmetic means. Where both geometric and arithmetic means were presented, the results for average IELT were similar for priligy and viagra both methods. For example, in the integrated analysis of five Phase III studies, geometric mean IELT increased from 0.8 minutes at baseline in all groups to 2.0 and 2.3 minutes in those taking dapoxetine 30 mg and 60 mg, respectively, compared with 1.3 minutes for those taking placebo (both P < 0.001).45 The corresponding arithmetic means increased from 0.9 minutes at baseline to 3.1, 3.6, and 1.9 minutes, respectively (both P < 0.001 vs placebo, Table 2). Even in more extreme cases of PE, in which baseline IELT was very short, treatment with dapoxetine effectively increased IELT. In the integrated analysis of two Phase III studies by Pryor et al,46 increases from baseline in average IELT at 12 weeks were significantly greater for either dose of dapoxetine (30 mg or 60 mg) than for placebo in the subgroups of patients with baseline average IELTs ≤1 minute and ≤30 seconds.

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The subanalysis of these studies by Shabsigh et al49 highlighted the importance of perceived control over ejaculation for achieving increases in IELT. Patients who reported at least a two-category improvement in control after 12 weeks of dapoxetine therapy recorded a mean change in IELT of 3.8 (0.9–4.7) minutes, whereas those who reported less than a two-category improvement in control recorded a mean change in IELT of 0.8 (0.9–1.7) minutes (Table 2). Overall, the consistent nature of the results from the studies identified indicates substantial evidence for a significant increase in IELT with dapoxetine 30 mg and 60 mg, compared with placebo, in adult patients with PE. In studies of PE, patient-reported outcomes form an important part of the evidence base because of the many ways in which PE can affect psychological wellbeing and quality of life, both for the patient and their sexual partner. The most frequently applied instrument in studies of PE is the Premature Ejaculation Profile, which is a validated tool designed to investigate various domains in PE and assess treatment efficacy.

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It comprises four self-reported items, each scored on a five-point scale, ie, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation.50 In addition, the Clinical Global Impression (CGI) of change is a validated instrument often used to give a measurement of overall perceived change in PE following treatment. The CGI (also called the patient-reported global impression of change in some studies) comprises just one item, ie, “Compared to the start of the study, how would you describe your premature ejaculation now?” Patients rate their response on a seven-point scale (−3 to +3) as: much worse, worse, slightly worse, no change, slightly better, better, or much better.51 Studies reporting patient responses to items on the Premature Ejaculation Profile and the CGI of change are listed in Table 2, with quality of evidence indications. Each of the patient-reported outcomes is assessed individually below. Changes from baseline in perceived control over ejaculation are reported for eight studies (Table 3). All three integrated analyses found significant improvements in control over ejaculation at study endpoint. Patients who reported at least a two-category improvement in control after 12 weeks of dapoxetine therapy recorded a mean change in IELT of 3.8 (0.9–4.7) minutes, whereas those who reported less than a two-category improvement in control recorded a mean change in IELT of 0.8 (0.9–1.7) minutes (Table 2). Overall, the consistent nature of the results from the studies identified indicates substantial evidence for a significant increase in IELT with dapoxetine 30 mg and 60 mg, compared with placebo, in adult patients with PE.

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In studies of PE, patient-reported outcomes form an important part of the evidence base because of the many ways in which PE can affect psychological wellbeing and quality of life, both for the patient and their sexual partner. The most frequently applied instrument in studies of PE is the Premature Ejaculation Profile, which is a validated tool designed to investigate various domains in PE and assess treatment efficacy.

Reviewer	Effectiveness	Side Effects	Satisfaction Level	Comments
User A	Very effective	Mild headache	5/5	Works well for both ED and PE
User B	Moderately effective	Dizziness	4/5	Slight dizziness but manageable
User C	Less effective	None reported	3/5	Needs higher dose for better results
User D	Effective	Nausea at start	4/5	Side effects decrease over time

It comprises four self-reported items, each scored on a five-point scale, ie, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation.50 In addition, the Clinical Global Impression (CGI) of change is a validated instrument often used to give a measurement of overall perceived change in PE following treatment.

• Lifestyle changes can enhance effectiveness of Viagra with Dapoxetine.
• Regular exercise improves blood flow and sexual performance.
• Healthy diet supports overall cardiovascular health and libido.
• Reducing stress through meditation may improve treatment outcomes.
• Limit smoking and excessive alcohol for better results.
• Get adequate sleep to maintain hormonal balance and energy.
• Communicate openly with partner about sexual health concerns.
• Follow up with doctor for dosage adjustments if needed.
• Combine with therapy for long-term management of PE or ED.

The CGI (also called the patient-reported global impression of change in some studies) comprises just one item, ie, “Compared to the start of the study, how would you describe your premature ejaculation now?” Patients rate their response on a seven-point scale (−3 to +3) as: much worse, worse, slightly worse, no change, slightly better, better, or much better.51 Studies reporting patient responses to items on the Premature Ejaculation Profile and the CGI of change are listed in Table 2, with quality of evidence indications. Each of the patient-reported outcomes is assessed individually below. Changes from baseline in perceived control over ejaculation are reported for eight studies (Table 3).

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In McMahon et al, in which the results from five RCTs were integrated, the proportion of patients who reported at least “good” control after 12 weeks of dapoxetine therapy increased from a baseline of 0.6% to 26.2% with dapoxetine 30 mg, and from 0.5% to 30.2% with dapoxetine 60 mg, compared with 0.3% to 11.2% with placebo (P < 0.001 for both dapoxetine doses vs placebo).45 Note: Only data for patients without erectile dysfunction are shown for consistency with other studies. Abbreviations: CGI, Clinical Global Impression; NR, not reported; RCT, randomized, placebo-controlled trial; PBO, placebo; DPX, dapoxetine. The integrated analysis by Porst et al of two studies showed no differences in control over ejaculation between those with lifelong or acquired PE (and no erectile dysfunction), suggesting that the etiology of the two forms may be similar, given that dapoxetine treatment was equally effective.47 The proportions of patients reporting at least “good” control at baseline and end-of-study were as follows: Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Significant improvement in ejaculatory control with dapoxetine 30 mg or 60 mg, as compared with placebo, was found in all RCTs in Table 3. These improvements were noted not only at the end-of-study but at all time points in between.44,47,52 The long-term use of on-demand dapoxetine has been addressed in just one study (see Table 3), ie, a 9-month extension study of the two 12-week trials described by Pryor et al.47 All of the 1774 men enrolled in the extension study received on-demand dapoxetine 60 mg, regardless of prior treatment group in the original studies (dapoxetine 30 mg, 60 mg, or placebo).

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All three integrated analyses found significant improvements in control over ejaculation at study endpoint. In McMahon et al, in which the results from five RCTs were integrated, the proportion of patients who reported at least “good” control after 12 weeks of dapoxetine therapy increased from a baseline of 0.6% to 26.2% with dapoxetine 30 mg, and from 0.5% to 30.2% with dapoxetine 60 mg, compared with 0.3% to 11.2% with placebo (P < 0.001 for both dapoxetine doses vs placebo).45 Note: Only data for patients without erectile dysfunction are shown for consistency with other studies. Abbreviations: CGI, Clinical Global Impression; NR, not reported; RCT, randomized, placebo-controlled trial; PBO, placebo; DPX, dapoxetine.

• Viagra with Dapoxetine is not recommended for women or children.
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• Those with retinitis pigmentosa may face increased vision risks.
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The integrated analysis by Porst et al of two studies showed no differences in control over ejaculation between those with lifelong or acquired PE (and no erectile dysfunction), suggesting that the etiology of the two forms may be similar, given that dapoxetine treatment was equally effective.47 The proportions of patients reporting at least “good” control at baseline and end-of-study were as follows: Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Acquired PE, 1% at baseline to 32% at end-of-study (dapoxetine 30 mg); 1% to 35% (dapoxetine 60 mg), and 1% to 19% (placebo) Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Lifelong PE, 0.5% at baseline to 29% at end-of-study (dapoxetine 30 mg); 0.5% to 28% (dapoxetine 60 mg), and 0.5% to 12% (placebo)47 Significant improvement in ejaculatory control with dapoxetine 30 mg or 60 mg, as compared with placebo, was found in all RCTs in Table 3. These improvements were noted not only at the end-of-study but at all time points in between.44,47,52 The long-term use of on-demand dapoxetine has been addressed in just one study (see Table 3), ie, a 9-month extension study of the two 12-week trials described by Pryor et al.47 All of the 1774 men enrolled in the extension study received on-demand dapoxetine 60 mg, regardless of prior treatment group in the original studies (dapoxetine 30 mg, 60 mg, or placebo).