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.

Contraindication	Explanation	Precautionary Measures
Severe hepatic impairment	Impaired drug metabolism	Dose adjustment or avoid use
Concurrent use with MAO inhibitors	Risk of serotonin syndrome	Discontinue MAO inhibitors before use
Heart problems	Potential cardiovascular side effects	Consult physician before use
Allergies to dapoxetine or excipients	Possible allergic reactions	Discontinue and seek medical advice

However, from a review of all the studies reported in the literature, AEs of dapoxetine are generally tolerable.

Dapoxetine 60 mg showed no effect on semen parameters or male fertility in preclinical studies.
Long-term safety beyond 24 weeks is not well established; periodic reassessment is advised.
Post-marketing reports include rare cases of angioedema, anaphylaxis, and Steven-Johnson syndrome.

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.

Patient Profile	Recommended Dose	Frequency	Special Considerations
Adult Men with PE	60 mg taken 1-3 hours before sexual activity	As needed, max once daily	Do not exceed once daily
Men with Liver Impairment	Dose adjustment or avoid use	Under medical supervision	Liver function tests recommended
Elderly Men	Same as standard dose	Monitor for side effects	Increased sensitivity possible

The most frequently reported AEs were nausea, dizziness, headache, diarrhea and insomnia22,23.

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Our statistical results and subgroup analysis 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. 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. 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.

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The present findings agree with the results of previous clinical trials that reported similar low incidence rates of side effects.

Tên thương mại

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).

Drug-related adverse effects (AEs)

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.

Priligy dapoxetine review

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. 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 60 mg is supplied in tablet form, easy to swallow with water.
Any sudden allergic reactions such as rash, swelling, or difficulty breathing require emergency care.
This medication is part of a treatment plan that may include counseling or therapy.
Dapoxetine is generally well-tolerated but requires medical evaluation before use.
Use cautiously if you have a history of fainting or low blood pressure.
The medication should not be used more than once within 24 hours.
Discuss any past incidents of mood changes or depression with your doctor.
Always confirm the authenticity of the medication before purchase to avoid counterfeit drugs.

Dapoxetine undergoes rapid absorption, elimination and dose-dependent pharmacokinetics, which are unaffected by multiple dosing.

Can premature ejaculation be caused by anxiety or stress?

Seven randomized controlled trials (RCTs) involving 8039 PE patients met 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.

Chemical Names

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.

3.2 Dosage and Administration

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

An toàn và dung nạp

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. 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.

Brand Names

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 dapoxetine tadalafil tablets studies not included in this meta-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). Safety and efficacy data have demonstrated that dapoxetine use produces acceptable improvement in the IELT and PGIC with on-demand use.

Active Ingredient	Dosage	Form	Manufacturer	Approval Status
Dapoxetine Hydrochloride	60 mg	Tablet	Pfizer	Approved in many countries
Route of Administration	Oral	Packaging	Various pharmaceutical companies	Approved for premature ejaculation
Storage Conditions	Room temperature	Shelf life	Approved by regulatory agencies	Keep away from moisture and heat

Thus, we also believe it is probably better suited as an on-demand treatment option for PE26. Our systematic review and meta-analysis has many drawbacks, the primary one being that this was a heterogeneous trial.

Overdose may present with serotonin syndrome: agitation, hyperthermia, tremor, and clonus.
Management is supportive; no specific antidote exists; seek immediate medical attention.
Dialysis is unlikely to remove dapoxetine effectively due to high protein binding.