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

Dapoxetin acts by neglecting the effect for the different G protein coupled and ligand gated channels for all

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Dependence	Rare, but psychological reliance possible	Monitor usage, seek help if needed
Withdrawal symptoms	Not well-documented, but consult doctor if discontinuing	Gradual tapering may be advised

5-hydroxytryptamin (5-HT) receptor subtypes, it inhibits the 5-HT transporter

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and activate the 5-HT 2C receptor, an action which

7.5 Alcohol

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Prior authorization

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-Missed Does

Industrial Area, Mahape - 400710 Navi Mumbai. LTD, 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. 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 tadalafil dapoxetine film-coated tablet) in the treatment of patients with PE and concomitant ED. diminishes the operation of 5-HT 1A receptor, thus reattaining equilibrium between the actions of 5-HT 1A and 5-HT

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2C receptors and this leads to increased 5-HT levels

8.2 Lactation

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Sildenafil vs. tadalafil

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Side Effects

Your doctor will adjust the dosage accordingly. The lead time may vary depending on the order volume and destination. You can inquire with their sales team for specific dapoxetine order online delivery timelines. 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. in the synaptic clefts which results in delayed ejaculation [Citation11].

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

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]. 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]. A recent comprehensive novel classification of PE was reported by Raveendran A. 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].

Interactions that increase your risk for side effects

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]. As SSRI, dapoxetine was the first licenced drug with FDA approval used for on-demand management of PE. Nitric oxide (NO) activates guanylate cyclase which increases the intracellular cGMP in the corpus cavernosum causing smooth muscle relaxation.

Sildenafil Citrate + Dapoxetine HCl DC Grade

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%). 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.

Phosphodiesterase 5 inhibitors

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. 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 sildenafil and dapoxetine scores 1, 2, and 3 months after treatment.

Sildenafil and dapoxetine

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). 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 global definition for PE. PDE-5 inhibitors act through increasing nitric oxide which causes relaxation of the smooth muscles of corpus cavernosum and

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

the vas deferens and seminal-vesicles, also they reduce anxiety

• Sildenafil was first approved by the FDA in 1998.
• Dapoxetine was developed specifically for premature ejaculation treatment.
• Both drugs are available in tablet form for oral administration.
• Use of sildenafil may be affected by certain eye conditions.
• Dapoxetine is absorbed quickly and metabolized mainly in the liver.
• Patients should follow the dosage instructions strictly.
• Avoid taking sildenafil with large quantities of grapefruit juice.
• Dapoxetine has been shown to be effective in clinical trials.

from sexual performance which is commonly associated with PE [Citation12].

• Sildenafil helps improve erectile response in men with ED.
• Dapoxetine may enhance control over ejaculation for men with PE.
• Combining sildenafil and dapoxetine can improve sexual satisfaction.
• Use sildenafil with caution in patients with heart conditions.
• Dapoxetine has a short half-life, suitable for on-demand use.
• Patients should avoid high-fat meals immediately before taking sildenafil.
• Dapoxetine should be taken with a full glass of water.
• Both drugs are contraindicated in patients with certain heart problems.