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UK Registered Pharmacy The MHRA regulates medicines and medical devices in the UK.
The MHRA regulates medicines and medical devices in the UK. GPhC Regulated Pharmacy The GPhC regulates pharmacists, pharmacy technicians and pharmacies in Great Britain. The GPhC regulates pharmacists, pharmacy technicians and pharmacies in Great Britain. PCI DSS Compliant PCI DSS is an information security standard for organisations that handle credit card payments. PCI DSS is an information security standard for organisations that handle credit card payments. ICO Registered Website The UK's independent authority set up to uphold information rights in the public interest. The UK's independent authority set up to uphold information rights in the public interest. Premature ejaculation (PE) is the most common male sexual dysfunction. Dapoxetine hydrochloride, belonging to a class of drugs known as selective serotonin reuptake inhibitors or, was the first drug originally approved for the on-demand treatment of men with PE. We aimed to compare the intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGIC) and adverse effect (AE) incidence associated with the use of dapoxetine (30 mg and 60 mg) versus placebo and evaluate the differences in administering 60 mg versus 30 mg as on-demand medical oral therapy for the treatment of PE via a literature review and meta-analysis.
We conclude that dapoxetine (particularly the 60 mg dosage) may be considered a safe and effective drug for patients with PE. Premature ejaculation (PE) is the most common male sexual dysfunction with a prevalence of between 20% and 40%1,2. Recently, the International Society for Sexual Medicine has proposed the following evidence-based definition: “PE is a male sexual dysfunction characterized by ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration; inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy”3,4. In addition, PE affects numerous aspects of a man's life, including sexual confidence, interpersonal relationships and the sexual satisfaction of both partners5. The role of PE on the individual and the sexual relationship is very significant.
Thus, it is important to treat patients with PE in order to improve quality of life. At present, treatment of PE includes mainly psychotherapy, drug therapy and surgical treatment6. Drug therapy is not only likely to be the most receptive approach for patients, but it is also the most commonly used method. Selective serotonin reuptake inhibitors (SSRIs) have become the most widely used medicine in the world7. Dapoxetine hydrochloride, belonging to the class of SSRIs, was the first drug originally approved for the on-demand treatment of men with PE by seven European countries in 20088.
Unfortunately, the efficacy and safety of dapoxetine (30 mg and 60 mg on-demand) has never been comprehensively studied in men with PE. Most data derived from clinical studies in men with PE are available. The objective of this study was to not only evaluate the efficacy and safety of dapoxetine when used at either 30 mg or 60 mg as compared with the placebo as an oral on-demand treatment in men with PE in routine clinical practice by performing a meta-analytic synthesis of studies, but also to assess whether there are differences in efficacy and safety for PE treatment using either 30 mg or 60 mg dapoxetine. The electronic and manual searches of PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases resulted in 106 references, of which 88 were clearly not relevant to our study. Of the remaining 18 references, 11 were excluded after reading the full text. Relevant randomized controlled trials (RCTs) were identified from PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases. Ultimately, a total of seven RCTs with 8039 patients were included.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Levitra Original | 20mg | 120 + 8 Pills | 528.19€ 503.04€ | |
| Viagra Generic | 100mg | 60 + 4 Pills | 96.36€ 91.77€ | |
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Kamagra Effervescent Tablets | 100 mg | 14 Pills | 51.61€ 49.15€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ |
Our meta-analysis demonstrated that dapoxetine (in the 30 mg and 60 mg subgroup) resulted in significantly higher IELT, PGIC and AE incidence relative to the placebo, with higher proportions observed for 60 mg versus 30 mg of dapoxetine administration.
Pooled analysis indicated that when compared to the placebo group, there was a significantly higher proportion of PGIC in the dapoxetine group. The overall risk ratio (RR) was 2.14 (95% CI = 1.90–2.42; P < 0.00001). The subgroup analysis indicated a statistically significant difference between the dapoxetine (for both 30 mg and 60 mg groups) and the placebo group in PGIC (RR = 2.01, 95% CI = 1.69–2.38, P < 0.00001; and RR = 2.26, 95% CI = 1.91–2.67, P < 0.00001, respectively; Figure 5). In addition, data from three9,12,13 studies reporting PGIC compared dapoxetine dosages (60 mg versus 30 mg). These count data were extracted to perform a forest plot analysis, which showed that the use of dapoxetine 60 mg was associated with a significantly greater improvement in PGIC than when dapoxetine 30 mg was used (RR = 1.17, 95% CI = 1.09–1.25; P < 0.00001, Figure 6).
Data from four9,11,12,13 and five9,10,11,12,13 studies reported AEs with sufficient data to generate a subgroup forest plot for dapoxetine 30 mg versus placebo and dapoxetine 60 mg versus placebo, respectively. Our pooled result of the meta-analysis showed that the number of AEs of patients in the dapoxetine (30 mg and 60 mg) group were significantly higher than those reported by patients in the placebo group (RR = 2.23; 95% CI = 1.66–3.01; P < 0.00001). The subgroup analysis indicated a statistically significant difference between treatment, with regards to 30 mg or 60 mg dapoxetine versus the placebo group in number of AEs reported (RR = 1.91, 95% CI = 1.36–2.70, P = 0.0002; and RR = 2.52, 95% CI = 1.58–4.02, P = 0.0001, respectively; Figure 7). Furthermore, AEs were assessed in six studies9,11,12,13,14,15 comparing two dapoxetine dosages (60 mg vs. 30 mg). The most common AEs were mild and tolerable. We conclude that dapoxetine (particularly the 60 mg dosage) may be considered a safe and effective drug for patients with PE. Premature ejaculation (PE) is the most common male sexual dysfunction with a prevalence of between 20% and 40%1,2. Recently, the International Society for Sexual Medicine has proposed the following evidence-based definition: “PE is a male sexual dysfunction characterized by ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration; inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy”3,4. In addition, PE affects numerous aspects of a man's life, including sexual confidence, interpersonal relationships and the sexual satisfaction of both partners5. The role of PE on the individual and the sexual relationship is very significant. Thus, it is important to treat patients with PE in order to improve quality of life. At present, treatment of PE includes mainly psychotherapy, drug therapy and surgical treatment6. Drug therapy is not only likely to be the most receptive approach for patients, but it is also the most commonly used method. Selective serotonin reuptake inhibitors (SSRIs) have become the most widely used medicine in the world7. Dapoxetine hydrochloride, belonging to the class of SSRIs, was the first drug originally approved for the on-demand treatment of men with PE by seven European countries in 20088. Unfortunately, the efficacy and safety of dapoxetine (30 mg and 60 mg on-demand) has never been comprehensively studied in men with PE. Most data derived from clinical studies in men with PE are available. The objective of this study was to not only evaluate the efficacy and safety of dapoxetine when used at either 30 mg or 60 mg as compared with the placebo as an oral on-demand treatment in men with PE in routine clinical practice by performing a meta-analytic synthesis of studies, but also to assess whether there are differences in efficacy and safety for PE treatment using either 30 mg or 60 mg dapoxetine. The electronic and manual searches of PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases resulted in 106 references, of which 88 were clearly not relevant to our study. Of the remaining 18 references, 11 were excluded after reading the full text.
UK Registered Pharmacy The MHRA regulates medicines and medical devices in the UK. The MHRA regulates medicines and medical devices in the UK. GPhC Regulated Pharmacy The GPhC regulates pharmacists, pharmacy technicians and pharmacies in Great Britain. The GPhC regulates pharmacists, pharmacy technicians and pharmacies in Great Britain. PCI DSS Compliant PCI DSS is an information security standard for organisations that handle credit card payments.
PCI DSS is an information security standard for organisations that handle credit card payments. ICO Registered Website The UK's independent authority set up to uphold information rights in the public interest. The UK's independent authority set up to uphold information rights in the public interest. Premature ejaculation (PE) is the most common male sexual dysfunction. Dapoxetine hydrochloride, belonging to a class of drugs known as selective serotonin reuptake inhibitors or, was the first drug originally approved for the on-demand treatment of men with PE.
We aimed to compare the intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGIC) and adverse effect (AE) incidence associated with the use of dapoxetine (30 mg and 60 mg) versus placebo and evaluate the differences in administering 60 mg versus 30 mg as on-demand medical oral therapy for the treatment of PE via a literature review and meta-analysis. Relevant randomized controlled trials (RCTs) were identified from PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases. Ultimately, a total of seven RCTs with 8039 patients were included. Our meta-analysis demonstrated that dapoxetine (in the 30 mg and 60 mg subgroup) resulted in significantly higher IELT, PGIC and AE incidence relative to the placebo, with higher proportions observed for 60 mg versus 30 mg of dapoxetine administration. The most common AEs were mild and tolerable. After a quality validation, only seven studies9,10,11,12,13,14,15 were selected from the literature search.
| Medication | Dosage | Onset Time | Duration | Side Effects | Purchase Ease |
|---|---|---|---|---|---|
| Dapoxetine 60 mg | 60 mg | 1-3 hrs | 24 hrs | Mild to moderate | Easy online |
| Sildenafil | 50-100 mg | 30-60 mins | 4-6 hrs | Possible headache | Moderate |
| Tadalafil | 10-20 mg | 1 hr | Up to 36 hrs | Flushing, head ache | Moderate |
The flow chart of the evidence acquisition process is summarized in Figure 1 and the methodological quality of the included studies is reported in Figure 2. Seven randomized controlled trials (RCTs) involving 8039 PE patients met sildenafil dapoxetine tablets the inclusion criteria. Of these, 2478, 2932 and 2629 patients received 30 mg dapoxetine, 60 mg dapoxetine, or the placebo, respectively. The study included patients aged 18 years or older and the patients were randomized for dapoxetine 30 mg or dapoxetine 60 mg or placebo administration on-demand (1–3 hours prior to anticipated sexual activity).
After a quality validation, only seven studies9,10,11,12,13,14,15 were selected from the literature search. The flow chart of the evidence acquisition process is summarized in Figure 1 and the methodological quality of the included studies is reported in Figure 2. Seven randomized controlled trials (RCTs) involving 8039 PE patients met sildenafil dapoxetine tablets the inclusion criteria. Of these, 2478, 2932 and 2629 patients received 30 mg dapoxetine, 60 mg dapoxetine, or the placebo, respectively. The study included patients aged 18 years or older and the patients were randomized for dapoxetine 30 mg or dapoxetine 60 mg or placebo administration on-demand (1–3 hours prior to anticipated sexual activity).
The basic characteristics of the included studies are summarized in Table 1. Three of the RCTs selected9,12,13 evaluating dapoxetine versus placebo for PE reported IELT as the primary outcome. Our pooled analysis showed that PE in patients in the dapoxetine group showed a significant improvement in IELT when compared to patients in the placebo group (mean difference [MD] = 1.39; 95% confidence interval [95% CI] = 1.24–1.55; P < 0.00001). Among these studies, we carried out a subgroup analysis based on PE patients treated with dapoxetine 30 mg and 60 mg on-demand oral administration. A statistically significant difference was found in the subgroup treated with 30 mg dapoxetine compared with the placebo-treated group (MD = 1.16; 95% CI = 0.94–1.38; P < 0.00001).
The subgroup analysis of the dapoxetine group treated with 60 mg compared with placebo also reporting IELT also revealed a statistically significant difference in patient response (MD = 1.63; 95% CI = 1.41–1.84; P < 0.00001). In addition, five studies9,12,13,14,15 including a total of 3346 patients, we pooled to compare IELT; patients were divided into two groups treated with either 60 mg or 30 mg dapoxetine. In the fixed-effect model meta-analysis of the five studies, the pooled estimates were statistically significantly different between the dapoxetine 60 mg and 30 mg groups (MD = 0.39; 95% CI = 0.23–0.56; P < 0.00001; Figure 4). This pooled analysis indicated that the dapoxetine 60 mg group was associated with a markedly longer IELT than the dapoxetine 30 mg group. Three studies9,12,13 including 2950 patients compared the PGIC in dapoxetine 30 mg and placebo subgroups and four studies9,10,12,13 including 3567 patients compared PGIC in dapoxetine 60 mg and a placebo subgroup. The basic characteristics of the included studies are summarized in Table 1.
However, no valid conclusions from these studies comparing 60 mg versus 30 mg dapoxetine could be obtained since these lacked strong statistical evidence. In this meta-analysis, in order to obtain a reliable and scientifically sound comparison of dapoxetine (30 and 60 mg) versus placebo and dapoxetine 60 mg versus dapoxetine 30 mg as on-demand oral treatment for PE, a precise search strategy was performed to include all relevant RCTs. Therefore, studies of patients with erectile dysfunction18, non-RCTs19 and studies including patients with chronic, daily oral treatment with dapoxetine20,21 were excluded from the analysis of patients with PE. Three of the RCTs selected9,12,13 evaluating dapoxetine versus placebo for PE reported IELT as the primary outcome. Our pooled analysis showed that PE in patients in the dapoxetine group showed a significant improvement in IELT when compared to patients in the placebo group (mean difference [MD] = 1.39; 95% confidence interval [95% CI] = 1.24–1.55; P < 0.00001). Among these studies, we carried out a subgroup analysis based on PE patients treated with dapoxetine 30 mg and 60 mg on-demand oral administration. A statistically significant difference was found in the subgroup treated with 30 mg dapoxetine compared with the placebo-treated group (MD = 1.16; 95% CI = 0.94–1.38; P < 0.00001). The subgroup analysis of the dapoxetine group treated with 60 mg compared with placebo also reporting IELT also revealed a statistically significant difference in patient response (MD = 1.63; 95% CI = 1.41–1.84; P < 0.00001). In addition, five studies9,12,13,14,15 including a total of 3346 patients, we pooled to compare IELT; patients were divided into two groups treated with either 60 mg or 30 mg dapoxetine. In the fixed-effect model meta-analysis of the five studies, the pooled estimates were statistically significantly different between the dapoxetine 60 mg and 30 mg groups (MD = 0.39; 95% CI = 0.23–0.56; P < 0.00001; Figure 4). This pooled analysis indicated that the dapoxetine 60 mg group was associated with a markedly longer IELT than the dapoxetine 30 mg group.
Three studies9,12,13 including 2950 patients compared the PGIC in dapoxetine 30 mg and placebo subgroups and four studies9,10,12,13 including 3567 patients compared PGIC in dapoxetine 60 mg and a placebo subgroup. Pooled analysis indicated that when compared to the placebo group, there was a significantly higher proportion of PGIC in the dapoxetine group. The overall risk ratio (RR) was 2.14 (95% CI = 1.90–2.42; P < 0.00001).
The subgroup analysis indicated a statistically significant difference between the dapoxetine (for both 30 mg and 60 mg groups) and the placebo group in PGIC (RR = 2.01, 95% CI = 1.69–2.38, P < 0.00001; and RR = 2.26, 95% CI = 1.91–2.67, P < 0.00001, respectively; Figure 5). In addition, data from three9,12,13 studies reporting PGIC compared dapoxetine dosages (60 mg versus 30 mg). These count data were extracted to perform a forest plot analysis, which showed that the use of dapoxetine 60 mg was associated with a significantly greater improvement in PGIC than when dapoxetine 30 mg was used (RR = 1.17, 95% CI = 1.09–1.25; P < 0.00001, Figure 6). Data from four9,11,12,13 and five9,10,11,12,13 studies reported AEs with sufficient data to generate a subgroup forest plot for dapoxetine 30 mg versus placebo and dapoxetine 60 mg versus placebo, respectively. Our pooled result of the meta-analysis showed that the number of AEs of patients in the dapoxetine (30 mg and 60 mg) group were significantly higher than those reported by patients in the placebo group (RR = 2.23; 95% CI = 1.66–3.01; P < 0.00001). The subgroup analysis indicated a statistically significant difference between treatment, with regards to 30 mg or 60 mg dapoxetine versus the placebo group in number of AEs reported (RR = 1.91, 95% CI = 1.36–2.70, P = 0.0002; and RR = 2.52, 95% CI = 1.58–4.02, P = 0.0001, respectively; Figure 7). Furthermore, AEs were assessed in six studies9,11,12,13,14,15 comparing two dapoxetine dosages (60 mg vs. 30 mg). This present plot demonstrated that a statistically significant difference existed between the 60 mg and 30 mg group in terms of the incidence of AEs (RR = 1.57; 95% CI = 1.31–1.89; P < 0.00001; Figure 8). Dapoxetine hydrochloride was the first drug originally approved for the on-demand treatment of patients with PE in 2008. Since then, it has received marketing authorization in 59 countries worldwide7,8. In 2011, McMahon et al.16 published an integrated analysis of results from five phase 3 trials attempting to explore the efficacy and safety of dapoxetine for treatment of PE and they proposed that dapoxetine significantly improved all aspects of PE and was generally well tolerated. In 2012, McCarty et al17 published a systematic descriptive review and analyzed whether dapoxetine could be considered an efficacious and tolerable treatment for PE. However, no valid conclusions from these studies comparing 60 mg versus 30 mg dapoxetine could be obtained since these lacked strong statistical evidence. In this meta-analysis, in order to obtain a reliable and scientifically sound comparison of dapoxetine (30 and 60 mg) versus placebo and dapoxetine 60 mg versus dapoxetine 30 mg as on-demand oral treatment for PE, a precise search strategy was performed to include all relevant RCTs.
This present plot demonstrated that a statistically significant difference existed between the 60 mg and 30 mg group in terms of the incidence of AEs (RR = 1.57; 95% CI = 1.31–1.89; P < 0.00001; Figure 8). Dapoxetine hydrochloride was the first drug originally approved for the on-demand treatment of patients with PE in 2008. Since then, it has received marketing authorization in 59 countries worldwide7,8. In 2011, McMahon et al.16 published an integrated analysis of results from five phase 3 trials attempting to explore the efficacy and safety of dapoxetine for treatment of PE and they proposed that dapoxetine significantly improved all aspects of PE and was generally well tolerated. In 2012, McCarty et al17 published a systematic descriptive review and analyzed whether dapoxetine could be considered an efficacious and tolerable treatment for PE. Therefore, studies of patients with erectile dysfunction18, non-RCTs19 and studies including patients with chronic, daily oral treatment with dapoxetine20,21 were excluded from the analysis of patients with PE.