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

Dapoxetin > sildenafil dapoxetine tablets


The combination of both drugs in cases who are not satisfied with monotherapy can be considered. No potential conflict of interest was reported by the author(s). Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction—DAP-SPEED study. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second international society for sexual medicine ad hoc committee for the definition of premature ejaculation. Desk reference to the diagnostic criteria from DSM-5-TR. Washington, DC: American Psychiatric Association Publishing,; 2022. p.

  • Sildenafil's patent expiration has increased availability of generics.
  • Dapoxetine is relatively newer, approved in the early 2000s.
  • Lifestyle factors like smoking can impact medication effectiveness.
  • Both medications have different mechanisms of action.
  • Dapoxetine's efficacy is confirmed through multiple clinical trials.
  • Sildenafil may cause temporary visual disturbances.
  • Proper dosage timing enhances effectiveness and safety.
  • Always discard expired medications safely to avoid misuse.

1. online resource. Shabsigh R, Rowland D.

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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 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).

CAS registry number (Chemical Abstracts Service)

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]. The diagnostic and Statistical manual of mental disorders, fourth edition, text revision as an appropriate diagnostic for premature ejaculation.

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doi: 10.1111/j.1743-6109.2007.00557.x Premature ejaculation-emerging concepts and a Novel classification. The premature ejaculation prevalence and attitudes (PEPA) survey: prevalence, comorbidities and professional help-seeking.

6.1 Clinical Trials Experience

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. The combination of dapoxetine and sildenafil had the greatest outcomes (p value < 0.001). Headache, nausea and flushing had been the most prevalent side impacts linked with the combination therapy [Citation22].

Therapeutic Categories

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. 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. 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. Help-seeking behaviour for sexual problems: the global study of sexual attitudes and behaviors.

  • 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.

Efficacy of PDE5Is and SSRIs in men with premature ejaculation: a new systematic review and five meta- analyses. Guidelines on male sexual dysfunction: Erectile dysfunction and premature ejaculation. doi: 10.1016/j.eururo.2010.02.020 Emerging treatments for premature ejaculation: dapoxetine sildenafil online Focus on dapoxetine.

  • Sildenafil is marketed globally under the brand Viagra.
  • Dapoxetine is marketed as Priligy in many regions.
  • Common side effects of sildenafil include headaches and flushing.
  • Dapoxetine may cause nausea, dizziness, or insomnia.
  • Taking sildenafil with nitrates can cause severe hypotension.
  • Dapoxetine should not be used with other antidepressants without doctor approval.
  • Both medications may cause dizziness, so caution is advised when driving.
  • Alcohol can reduce the effectiveness of sildenafil and dapoxetine.

Utility of selective serotonin reuptake inhibitors in premature ejaculation.

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

Phosphodiesterase 5 inhibitors in rapid ejaculation: potential use and possible mechanisms of action. Is there a role for phosphodiesterase type-5 inhibitors in the treatment of premature ejaculation? Development and evaluation of an abridged, 5-item version of the International Index of erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Short-term analysis of the effects of as needed use of sertraline at 5 pm for the treatment of premature ejaculation. doi: 10.1016/S0090-4295(99)00187-9 Gillman N, Gillman M. Premature ejaculation: Aetiology and treatment strategies. Comparison of dapoxetine/tadalafil and paroxetine/tadalafil combination therapies for the treatment of the premature ejaculation: a randomized clinical trial. Comparison between tadalafil plus paroxetine and paroxetine alone in the treatment of premature ejaculation. Dapoxetine for the treatment of premature ejaculation: a meta-analysis of randomized controlled trials with trial sequential analysis. A prospective randomized study comparing the efficacy and safety of sildenafil with dapoxetine in treatment of premature ejaculation. Which one is the best in premature ejaculation treatment?

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

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 dapoxetine tadalafil tablets 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].

Foreign Names

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. 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]. 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. Comparison of the clinical efficacy and safety of the on-demand use of paroxetine, dapoxetine, sildenafil and combined dapoxetine with sildenafil in treatment of patients with premature ejaculation: a randomised placebo-controlled clinical trial. Dr. Srishti Rastogi is a medical writer and healthcare professional dedicated to high-quality patient education and public health awareness. Leveraging her clinical background, she produces deeply researched, evidence-based content for digital health platforms and medical publications.

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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.

Dapoxetine sildenafil

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. Dr. Srishti’s unique dual perspective as a clinician and communicator allows her to craft content that builds trust and credibility with readers navigating sensitive health topics.

Focus Area Description Expected Outcomes
New Delivery Systems Development of fast-dissolving or transdermal patches Improved compliance and onset time
Combination Therapies Combining sildenafil with other agents for enhanced effects Broader treatment spectrum
Reduced Side Effects Formulations aiming to minimize adverse reactions Better patient tolerability
Personalized Medicine Genetic-based dosing and predictions More precise and safe therapy

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