Comprehensive Overview of Priligy (Dapoxetine): Uses, Mechanism, and Clinical Considerations

The unique pharmacokinetic characteristics might be the reason why dapoxetine is the on-demand treatment of choice for PE.

• For missed dose: if less than 1 hour before sex, take as soon as remembered; otherwise skip.
• Do not double the dose to compensate for a missed one; stay within 24-hour limit.
• Combining with food that is high in fat may delay absorption slightly, but not significantly reduce effect.

Safety and efficacy data have demonstrated that dapoxetine use produces

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The present findings agree with the results of previous clinical trials that reported similar low incidence rates of side effects. Dapoxetine is a short-acting SSRI and doses of 30 mg and 60 mg have been evaluated through our meta-analysis. Peak plasma concentrations of dapoxetine were observed within 1.01–1.27 hours after oral administration24. The elimination half-life time is 1.3–1.4 hours and there appears to be very little accumulation24. Dapoxetine undergoes rapid absorption, elimination and dose-dependent pharmacokinetics, which are unaffected by multiple dosing. acceptable improvement in the IELT and PGIC with on-demand use.

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Thus, we also believe it is probably better suited as an on-demand treatment option for PE26.

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Our systematic review and meta-analysis has many drawbacks, the

6. Real-World Applications and Clinical Efficacy

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.

Drug-related adverse effects (AEs)

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. Ultimately, seven RCTs met the inclusion criteria for the present meta-analysis. To our knowledge, this is the most recent systematic review and meta-analysis comparing oral dapoxetine on-demand with placebo and comparing dapoxetine dosages (60 mg versus 30 mg) for the treatment of patients with PE. primary one being that this was a heterogeneous trial.

• Alcohol consumption during dapoxetine use may increase sedation, dizziness, and fainting risk.
• Patients should avoid driving or operating heavy machinery if they experience dizziness or somnolence.
• Grapefruit juice may modestly increase dapoxetine exposure; limited clinical relevance.

In an attempt to reduce the high heterogeneity, we carried out a subgroup

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The present meta-analysis for IELT demonstrated that on-demand oral treatment with dapoxetine had an advantage over placebo despite the different dosages (30 mg and 60 mg) used. It demonstrated that on-demand oral dapoxetine was an effective treatment for PE. In addition, our meta-analysis comparing dapoxetine 60 mg with 30 mg on-demand orally proved that there was a statistically significant difference in IELT between the both groups; thus, 60 mg dapoxetine had a longer IELT than 30 mg on-demand for PE. The present findings are in agreement with the results of previous clinical trials that have reported significant improvement in the IELT with the use of dapoxetine9,10,11,12,13,14,15,16,17,18,19,20,21. Mean IELT was also significantly increased in all the studies not included in this meta-analysis.

Statistical analysis

Mirone et al22 performed non-RCT trials in 2014 that compared dapoxetine 30–60 mg with alternative care/nondapoxetine, the results revealed that dapoxetine for treatment of PE had a longer mean IELT. The integrated analysis from five trials by McMahon et al19 also showed dapoxetine 30 and 60 mg on-demand significantly increased mean IELT compared with placebo (1.9 minutes for placebo, 3.1 and 3.6 minutes for dapoxetine 30 mg and 60 mg, respectively). Our statistical results and subgroup analysis dapoxetine sildenafil online of PGIC demonstrated that dapoxetine was associated with a major improvement in PGIC. As shown in Figure 5, the overall RR was 2.14 (95% CI = 1.90–2.24) between dapoxetine and placebo, 2.01(95% CI = 1.69–2.38) between the dapoxetine 30 mg subgroup and placebo and 2.26 (95% CI = 1.91–2.67) between the dapoxetine 60 mg subgroup and placebo, respectively. Additionally, the present meta-analysis also demonstrated significant improvement in PGIC with 60 mg over 30 mg dapoxetine on-demand alone. analysis among studies involving the drug dosage used (30 mg versus 60 mg groups).

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Pryor et al9 thought that the PGIC condition as a study endpoint is informative with respect to men's perception to minor detectable changes in IELT. In other words, there is a positive relationship between the participants' PGIC ratings and mean change in IELT values. The present findings agree with the results of previous clinical trials that reported a similar improvement in PGIC with dapoxetine versus placebo or comparing 60 mg versus 30 mg dapoxetine9,10,11,12,13,16,17,18,19,20,21. This analysis revealed the incidence of total AEs was more frequent with dapoxetine than with placebo and more common with dapoxetine 60 mg than 30 mg. However, from a review of all the studies reported in the literature, AEs of dapoxetine are generally tolerable.

Chemical Names

In the integrated analysis of the McMahon et al16 study, total AEs occurred in 35.1%, 47.0%, 60.3% subjects with placebo, dapoxetine 30 mg and dapoxetine 60 mg on-demand orally, respectively. In Figure 7, the total number of AEs occurred in 49.1% (2601/5293) and 20.7% (1040/5017) of subjects treated with dapoxetine and placebo, respectively. In Figure 8, the total number of AEs occurring with dapoxetine 60 mg or 30 mg were 58.2% (1421/2441) and 36.6% (907/2476), respectively. The most frequently reported AEs were nausea, dizziness, headache, diarrhea and insomnia22,23. Fortunately, the most common AEs with dapoxetine were mild or moderate in nature and were transient symptoms9,10,11,12,13,15,16,17,18,19,20,21,24,25. The heterogeneity was significantly decreased when comparing dapoxetine with placebo in the IELT by subgroup analysis.

Study Overview

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).

Therapeutic Categories

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. However, this heterogeneity of data still exists in the PGIC and AEs analyses, which we were unable to improve.

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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).

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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).