Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study

Participants in group 1 were given tadalafil 5 mg and participants in group 2 were given a combination therapy of dapoxetine 30 mg with tadalafil 5 mg.

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The means of pretreatment IELT were 1.49 ± 0.51 and 1.47 ± 0.57 minutes in group 1 and 2 respectively. The means of post-treatment IELT were 7.35 ± 4.31 and 9.07 ± 4.2 minutes in groups 1 and 2, respectively, with statistically significant improvements in group 2 (P = 0.045) [Citation21].

Ingredient	Quantity per Tablet	Function	Notes
Sildenafil Citrate	100 mg	Erectile dysfunction treatment	Active ingredient
Dapoxetine Hydrochloride	60 mg	Premature ejaculation relief	Active ingredient
Microcrystalline Cellulose	50 mg	Binder	Inactive excipient
Magnesium Stearate	5 mg	Lubricant	Inactive excipient
Lactose Monohydrate	20 mg	Filler	Inactive excipient

Abu El-Hamd M and Abdelhamed A evaluated 150 patients with PE without erectile dysfunction. Five groups of participants, each with 30 patients, were randomly allocated. For a six-week period, participants in each group received an on-demand placebo, paroxetine (30 mg), dapoxetine (30 mg), sildenafil (50 mg), and a combination of dapoxetine (30 mg) with sildenafil citrate (50 mg). Each participant was told to record his IELT results. The means of pretreatment IELT were 40.33 ± 8.6, 38.66 ± 9.9, 38.86 ± 10.35, 38.66 ± 9.9, and 38.33 ± 10.02 and the means of posttreatment IELT were 41.33 ± 8.3, 173.86 ± 19.8, 171.83 ± 20.7, 175.5 ± 22.4, 266 ± 36.6 in groups 1, 2, 3, 4, 5, respectively.

Condition	Details	Rationale
Temperature	15-30°C (59-86°F)	Maintain drug stability
Humidity	Keep dry	Prevent degradation
Light Exposure	Store in dark place	Avoid photodegradation
Beyond Expiry Date	Do not use	Risk of reduced efficacy

The combination of dapoxetine and sildenafil had the greatest outcomes (p value < 0.001).

Limitations of the study

When comparing group C with either group A and group B, highly statistically substantial variations were found in the mean IELT at 4, 8, and 12 months posttreatment in favor of group C (P = < 0.001), also highly statistically substantial variations were found in the mean Δ IELT in favor of group C (P < 0.001; ). Post hoc tests at 4, 8, and 12 weeks posttreatment revealed no statistically substantial variations in the mean IELT (P = 0.346, P = 0.508, P = 0.442 respectively) or Δ IELT (P = 0.340) among group A and group B. Highly statistically substantial variations were found among group A and group C and among group B and group C regarding IELT and Δ IELT in favor of group C (P < 0.001; ). When comparing satisfaction scores before treatment and at the end of treatment (12 weeks posttreatment), there were highly statistically substantial variations in group A (1 ± 0.6 vs 3 ± 0.6; p < 0.001), group B (1 ± 0.7 vs 3.2 ± 0.6; p < 0.001), and group C (1.1 ± 0.8 vs 4.1 ± 0.8; p < 0.001) (). When comparing group C with either group A and group B, no significant variation was found (P = 0.821) in the mean pretreatment satisfaction scores (group A: 1 ± 0.6; group B: 1 ± 0.7; and group C: 1.1 ± 0.8; ).

Foreign Names

When comparing group C with either group A and group B, highly statistically substantial variations were found in the mean satisfaction scores at 4, 8, and 12 months posttreatment in favor of group C (P = < 0.001), also a highly statistically substantial variations were found in the mean Δ satisfaction scores in favor of group C (P < 0.001; ). Post hoc tests at 4, 8, and 12 weeks post-treatment revealed no statistically substantial variations in the mean satisfaction scores (P = 0.71, P = 1, P = 0.353 respectively) or Δ satisfaction scores (P = 0.011) among group A and group B. Highly statistically substantial variations were found among group A and group C and among group B and group C regarding satisfaction scores and Δ satisfaction in favor of group C (P < 0.001; ). No statistically substantial variations were found among groups regarding the side effects except for headache and flushing which were more prominent in group C (P = 0.036 and P < 0.001, respectively; ). Premature ejaculation leads to negative consequences on the partner’s life.

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Although the importance of this area of male sexual health, it is usually neglected [Citation16]. Our results showed that on-demand administration of tadalafil 5 mg or dapoxetine 30 mg was beneficial for treating PE, but improvement was better with a combination of both drugs. Patients were randomly assigned into 4 groups: dapoxetine was given to the first group, paroxetine to the second, and tadalafil with dapoxetine to the third, and the fourth received paroxetine combined with tadalafil for one month. The mean pretreatment and posttreatment IELT among groups were 57.8 ± 34.2 vs 204.4 ± 82 in group 1, 59.4 ± 32 vs 208.8 ± 65.1 in group 2, 56.1 ± 31 vs 269.9 ± 100.4 in group 3, and 54.6 ± 30.9 vs 259.3 ± 83.4 in group 4. They concluded that combination therapy (tadalafil with dapoxetine or paroxetine) was associated with better improvement in the IELT than mono-therapy. Headache, nausea and flushing had been the most prevalent side impacts linked with the combination therapy [Citation22].

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In this study, the mean IELT was lower than in other studies as most of our patients did not seek medical advice except if PE is severe and responsible for major negative personal and partnership consequences.

• Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor.
• Dapoxetine is a selective serotonin reuptake inhibitor (SSRI).
• Both medications can be part of a comprehensive ED or PE treatment plan.
• Overdose symptoms include persistent erections or severe dizziness.
• Avoid using these tablets if you have recent cardiovascular events.
• Alcohol consumption should be minimized when using these medications.
• Patients should monitor for any unusual or severe side effects.
• Regular medical check-ups are recommended during treatment.

In this study headache and flushing, as adverse effects of treatment, were more pronounced in group 3 with a statistically significant variation (P = 0.036, < 0.001). For clinical implications, we recommend to start with a single drug and shift to the combination therapy in patients who are not improved by monotherapy. This work had some limitations including short follow-up period, after therapy was stopped, individuals were not observed, and it was not placebo controlled.

Patients and methods

Nonparametric data were compared using a Chi-squared (x2) test. When contrasting more than two means, a one-way analysis of variance (ANOVA) was utilized if the data was normally distributed and Kruskal Wallis (KW) test was utilized if the data was not normally distributed. P values were considered statistically significant at P < 0.05. To determine the sample size using the G*Power Version 3.1.9.4, we used the IELT to detect a 60-second (1-minute) variation among groups A, B, and C (based on the previous studies). A standard deviation of 150 seconds (2.5 minutes) was used for the sample size calculation.

Dosage for erectile dysfunction (ED)

The Cohen’s d effect size was approximately estimated to be 0.4. Therefore, with an alpha of 0.05 using the ANOVA test, the enrollment of a total of 84 patients in each group will provide 90% power. The sample size was increased to compensate for any attrition bias. We evaluated the eligibility of 385 patients for this research. After exclusions, 92 patients were included in group A and received tadalafil (5 mg) for 12-weeks period, 91 patients were included in Group B and received dapoxetine (30 mg) for 12-weeks period, and 89 patients were included in Group C and received tadalafil (5 mg) and dapoxetine (30 mg) together for 12-weeks period ().

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All patients reported the medication intake in their files with no dropouts but the needed time for drug intake (two hours before sexual intercourse) was not regularly respected by the patients. No statistically substantial variations were found before treatment among the three groups as regard age, BMI, smoking, fasting blood sugar, FSH, LH, testosterone, E2, and prolactin levels (). The mean of IELT in all the studied patients was 39.3 ± 10.5 seconds, median was 37 (31.25–46) seconds with minimum IELT of 25 seconds and maximum IELT of 65 seconds. When comparing IELT before treatment and at the end of treatment (12 weeks posttreatment), there were highly statistically substantial variations in group A (39.4 ± 10 sec. When comparing group C with either group A and group B, no significant variation was found (P = 0.580) for the mean pretreatment IELT measurements (group A: 39.4 ± 10 sec; group B: 40.8 ± 11.2 sec; and group C: 37.9 ± 10.9 sec; ). Both tadalafil and dapoxetine are effective in the treatment of PE as a single drug, but the combination of both gives more pronounced improvement, however with a slightly increased incidence of side effects. The combination of both drugs in cases who are not satisfied with monotherapy can be considered.

• Sildenafil can cause a drop in blood pressure in some users.
• Dapoxetine's adverse effects are usually mild and transient.
• Patients on medication for heart disease should consult a doctor first.
• Sexual activity itself can pose risks for some health conditions.
• Combining sildenafil with other ED medications is not recommended.
• Dapoxetine may interact with other serotonergic drugs.
• Use caution when operating machinery after taking these drugs.
• Always inform your doctor about other medications being used.

No potential conflict of interest was reported by the author(s).

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No significant differences were detected between the groups regarding the side effects except for headache and flushing which were significantly higher in the groups who received a combination therapy [Citation17]. In the management of PE, Moudi sildenafil and dapoxetine et al. 100 patients with PE were randomly allocated into two groups. In group 1, patients were given paroxetine 10 mg daily and in group 2, patients received paroxetine 10 mg plus tadalafil 10 mg daily. At the 3rd month follow-up, the mean IELT in groups 1 and 2 were 4.5 ± 1.5 and 5 ± 2.4 minutes, respectively (P = 0.285) and at the 6th month follow-up, the mean IELT were 4.8 ± 1 and 5.3 ± 2 minutes, respectively (P = 0.278).

Chemical Names

The authors concluded that tadalafil can increase the mean IELT and can be used for treatment of PE in combination with paroxetine. Flushing episodes, as a side effect, were more obvious in group 2 (P = 0.000) [Citation18]. performed a meta-analysis involving 17 trials with 5,739 participants. Seven single medications (paroxetine, fluoxetine, dapoxetine, sertraline, sildenafil, tadalafil and placebo) and five combination therapies were included (tadalafil with sildenafil, tadalafil with fluoxetine, paroxetine with sildenafil, dapoxetine with mirodenafil, and sildenafil with fluoxetine). They concluded that the combination of phosphodiesterase-5 inhibitors and SSRIs were more effective than monotherapy [Citation19]. Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction—DAP-SPEED study.

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Elbakary and colleagues evaluated the effectiveness of sildenafil combined with dapoxetine for treating PE. Eighty patients with PE without erectile dysfunction were allocated into 2 groups. The 1st group (40 patients) were given on- demand dapoxetine 30 mg for three months, the 2nd group (40 patients) received an on-demand combination of dapoxetine 30 mg and sildenafil 50 mg for three months. The means of pretreatment and posttreatment IELT among groups were 51.72 ± 12.53 vs 322 ± 24.62 in group 1 and 56.6 ± 10.93 vs 352.5 ± 29.33 in group 2 (P < 0.001). They concluded that combination therapy was associated with better improvement than mono-therapy [Citation20].

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