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

Eligible patients attended our andrology clinic with premature ejaculation were randomly allocated into three groups: group A (92 participants) received on-demand tadalafil, 5 mg; group B (91 participants) were given on-demand dapoxetine, 30 mg; and group C (89 participants) received on-demand combination of tadalafil, 5 mg, and dapoxetine, 30 mg. We assessed the changes in the intravaginal ejaculatory latency time (IELT) and the satisfaction scores 1, 2, and 3 months after treatment.

8.1 Pregnancy

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Take the tablet orally with water, preferably during or after a meal to reduce stomach upset. Swallow the tablet whole; do not crush or chew it. Follow the dosage prescribed by your doctor based on your condition and body weight. Pregnant or breastfeeding women should consult their doctor before taking Praziquantel. The doctor will weigh the benefits and risks before prescribing it. Highly statistically significant improvements were found in the mean IELT and satisfaction scores 1, 2, and 3 months post-treatment in all groups (P = <0.001). Post hoc analysis suggested this improvement was more pronounced in group C (P < 0.001).

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Both tadalafil and dapoxetine are effective in the treatment of patients with premature ejaculation, but the combination of both drugs gives better results. Premature ejaculation (PE) is a male sexual disorder characterized by a brief intra-vaginal ejaculatory latency time (IELT) and lack of ability to properly control ejaculation which has detrimental personal effects [Citation1]. There is no priligy dapoxetine canada global definition for PE.

• 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.

PE is defined according to the International Society for Sexual Medicine (ISSM) guidelines as ejaculation that always happens in fewer than 1 minute following vaginal penetrating from the initial sexual encounter (lifelong PE), or a decrease in IELT, less than 3 min (acquired PE) with inability to delay ejaculation on all or nearly all vaginal penetrations and negative personal consequences, such as distress, frustration, bother and/or avoidance of sexual intimacy [Citation2].

Country/Region	Status	Regulatory Notes	Notes
United States	Prescription-only	Regulated by FDA	Cannot buy without prescription
European Union	Prescription required	EMA oversight	Varies by country
India	Available OTC or prescription	Controlled sales in some states	Lower cost, variable quality
Australia	Prescription-only	TGA regulation	Strict prescription policies

Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) define PE as a persistent or recurrent ejaculation that occurs within approximately 1 minute after vaginal penetration and before the individual wishes it. The problem must present for at least 6 months and present on almost all (approximately 75–100%) or on all occasions of sexual attempts with clinically significant distress and cannot be explained by a nonsexual mental disorder or as a result of severe relationship distress and is not attributable to the effects of a substance/medication or other medical condition [Citation3,Citation4].

7.1 Nitrates

ED is commonly reported among patients with PE.Although recent guidelines recommend to treat ED first in men with both PE and ED, this recommendation is not based on evidence and there is limited data about the efficacy and safety of dapoxetin / sildenafil combination therapy for these patients. The aim of this study is to evaluate the clinical efficacy and safety of the dapoxetine / sildenafil combination (Dapoxil 30/50 mg film-coated tablet) in the treatment of patients with PE and concomitant ED. In a single-center, single-arm, open-label clinical study, 74 patients with lifelong / acquired PE and ED were included between October 2016 to September 2017.Patients received on demand dapoxetine / sildenafil (30/50 mg film-coated tablets) 1-3 hours before sexual intercourse for 4 weeks (2 days a week and no more than once a day). All patients were instructed to record their intravaginal ejaculatory latency time (IELT). They were also instructed to complete Premature Ejaculation Diagnostic The study was completed with 53 patients (71.62%).

Interactions that increase your risk for side effects

Mean age of the patients was 45.32±10.05. Before the treatment, geometric mean IELT of the patients was 22.72±15.16 seconds, mean PEDT score was 16.85±2.42, mean PEP score was 3.36±1.12and IIEF-EF score was 13.17±3.33. At the end of the 4-week treatment period, statistically significant improvements were observed in the mean IELTs, PEP and IIEF-EF scores compared to the patients' pre-treatment values (69.47±103.34;p<0.001, 9.92±2.36;p<0.001, The dapoxetine/ sildenafil combination therapy significantly improves the IELT values and patient reported outcome measures of PE patients who also suffer from ED. Although several side effects were reported, these were mild and reversible. To compare the efficacy of tadalafil alone, dapoxetine alone, and tadalafil with dapoxetine as a combination therapy for the treatment of premature ejaculation. A recent comprehensive novel classification of PE was reported by Raveendran A.

• Sildenafil is not recommended for use by women.
• Dapoxetine is approved specifically for men with PE.
• Both drugs help improve sexual confidence and performance.
• Proper hydration can help mitigate side effects.
• Patients with retinal disorders should consult a healthcare professional.
• Use of these medications does not protect against sexually transmitted infections.
• Combining medications without medical guidance can be dangerous.
• Inform your doctor if you experience any adverse reactions.

In this classification, the grading of the severity of reduction of IELT was reported as mild or grade 1 (IELT of 2 to 3 minutes), moderate or grade 2 (IELT of 1 to less than 2 minutes), severe or grade 3 (IELT less than 1 minute), and extreme or grade 4 (ejaculation occurring prior to vaginal penetration) [Citation5].

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

Premature ejaculation is a frequent male sexual dysfunction, although the real incidence is unclear, 24% to 30% of males may be affected [Citation6,Citation7]. Several drugs as tricyclic antidepressants (e.g. clomipramine) and tramadol could be used for treatment of PE. Selective serotonin-reuptake-inhibitors (SSRIs), like escitalopram, fluoxetine, serteralin, paroxetine and dapoxetine are the most common medications used for management of PE [Citation8–10].

Medical uses

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CAS registry number (Chemical Abstracts Service)

T. C. Industrial Area, Mahape - 400710 Navi Mumbai. LTD, dapoxetine 60mg tablet price Flat 55, Cosgrove House, Hatton Road, Wembley, HA0 1RQ 058 The Efficacy and Safety of Dapoxetine / Sildenafil Combination Therapy in the Treatment of Men with Premature Ejaculation and Erectile Dysfunction – DAP-SPEED Study - ScienceDirect Please enable JavaScript to use all the features on this page. 058 The Efficacy and Safety of Dapoxetine / Sildenafil Combination Therapy in the Treatment of Men with Premature Ejaculation and Erectile Dysfunction – DAP-SPEED Study Author links open overlay panelM.Tuken1, M.G.Culha2, E.C.Serefoglu3 Premature ejaculation (PE) and erectile dysfunction (ED) are the most prevalent sexual disorders in men. As SSRI, dapoxetine was the first licenced drug with FDA approval used for on-demand management of PE.

• Sildenafil's effects last approximately 4-6 hours.
• Dapoxetine's onset is rapid, within 1-3 hours of intake.
• Side effects of sildenafil may include nasal congestion and visual changes.
• Dapoxetine may cause dry mouth and sweating as side effects.
• Combining these drugs might increase the risk of side effects.
• Usage should be based on a healthcare provider’s assessment.
• Patients with kidney or liver issues need dosage adjustments.
• Proper storage of medications is essential to maintain efficacy.

Dapoxetin acts by neglecting the effect for the different G protein coupled and ligand gated channels for all 5-hydroxytryptamin (5-HT) receptor subtypes, it inhibits the 5-HT transporter and activate the 5-HT 2C receptor, an action which diminishes the operation of 5-HT 1A receptor, thus reattaining equilibrium between the actions of 5-HT 1A and 5-HT 2C receptors and this leads to increased 5-HT levels in the synaptic clefts which results in delayed ejaculation [Citation11].

Publication types

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Mechanism of action

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