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MEDLINE and the proceedings of major international and regional scientific meetings during the period 1994-2010 were searched for publications or abstracts using the word dapoxetine in the title, abstract or keywords. This search was then manually cross-referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase 1, 2 and 3 efficacy and safety studies and drug-interaction studies.
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Dapoxetine, as the first drug developed for PE, is an effective and safe treatment for PE and represents a major advance in sexual medicine.
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In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor, dapoxetine provided meaningful treatment benefit and was generally well tolerated.
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The study included 64 patients who reported premature ejaculation who were unhappy with the treatment with 'on demand' dapoxetine 30 mg, either due to its adverse effects or because of its overall inefficacy. They were divided into two groups of 33 and 31 respectively by simple randomization, with Group A treated with 'on demand' silodosin 4 mg three hours prior to intercourse, whereas Group B was treated with placebo. Pre- and post-treatment intravaginal ejaculatory latency time (IELT), premature ejaculation profile (PEP) and clinical global impression of change (CGIC) for premature ejaculation were evaluated.
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Dapoxetine hydrochloride is a potent inhibitor of serotonin reuptake transporters. Dapoxetine is suited for 'on-demand' treatment of PE because of its rapid absorption and short initial half-life.
The aim of this study was to review evidence supporting the efficacy and safety of oral agents for the treatment of PE in the context of the new ISSM criteria.
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The analyses support the validity of the CGIC measure in men with PE. The CGIC can provide clinicians in practice with a valid and brief outcome assessment of their patient's condition.
Of 495 subjects randomized, 429 completed the study. Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point (5.2 vs. 3.4 minutes) and weeks 4, 8, and 12 (P ≤ 0.002 for all). Men who described their PE at least "better" using the CGIC were significantly greater with dapoxetine vs. placebo at end point (56.5% vs. 35.4%) and weeks 4, 8, and 12 (P ≤ 0.001 for all). Significantly better outcomes were also reported with dapoxetine vs. placebo on PEP measures. Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135). TEAEs led to discontinuation in 1.6% of subjects in both groups. Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea (9.2%), headache (4.4%), diarrhea (3.6%), dizziness (2.4%), and dizziness postural (2.4%).
We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094.
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Pudendal motoneuron reflex discharges elicited by bilateral electrical stimulation of the dorsal nerves of the penis were used as an experimental model of the expulsion reflex of ejaculation to investigate the effect of acute intravenous delivery of dapoxetine, a short acting selective serotonin reuptake inhibitor, in anesthetized rats. Dapoxetine was compared with paroxetine, the selective serotonin reuptake inhibitor of reference.
Premature ejaculation (PE), the most common male sexual dysfunction, impacts the quality of life of not only the affected male but also his partner. Despite its prevalence, there are currently no United States Food and Drug Administration-approved therapies for PE. In 2004, the American Urological Association published treatment guidelines for PE that recommended the serotonergic antidepressants paroxetine, sertraline, clomipramine and fluoxetine, as well as topical lidocaine-prilocaine cream. None of these treatments were developed for PE, and all have limitations associated with their use. Therapies in development may have advantages over the currently available treatments. These include PSD-502, a metered-dose aerosol of lidocaine and prilocaine used as an on-demand local treatment, and dapoxetine, an on-demand short-acting selective serotonin reuptake inhibitor. Together with a recent, evidence-based definition of PE, these novel therapies should improve sexual function and quality of life in men suffering from PE.
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On-demand oral medication of dapoxetine is effective and well-tolerated for the treatment of premature ejaculation.
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To present integrated efficacy and safety data from phase 3 trials of dapoxetine.
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Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on demand (prn) in men with PE and ED who were being treated with PDE5 inhibitors.
Currently used treatment options for PE.
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Conventional theories and therapies for premature ejaculation (PE) are based on assumptions not always supported by evidence. This review of the current literature on the physiology of the ejaculatory control, pathogenesis of PE, and available therapies shows that PE is still far from being fully understood. However, several interesting hypotheses have been formulated, and solid, evidence-based clinical data are currently available for dapoxetine, the unique, first-line, officially approved pharmacotherapy for PE. Further growth in the field of PE will occur only when we shift from opinion-based classifications, definitions, and hypotheses to robust, noncontroversial data grounded on evidence.
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The most common adverse events with dapoxetine are nausea, dizziness, somnolence, headache, diarrhoea and insomnia. Usually they do not lead to drug discontinuation.
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The pudendal motoneuron reflex discharges (PMRDs) model was used as an experimental paradigm of the ejaculatory expulsion reflex in anaesthetised male rats. A spinal site of action was evaluated by testing the effect of intrathecal delivery of dapoxetine on PMRDs elicited by electric stimulation of the dorsal nerves of the penis (DNP). A supraspinal site of action was evaluated by testing the effect of intravenous administration of dapoxetine on DNP-induced PMRDs in rats with chemical bilateral lesion of the lateral paragigantocellular nucleus (LPGi).
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The incidence rate of predefined TEAEs of special interest (mood and related, neurocognitive related, cardiovascular, urogenital and sexual function, accidental injury, and abnormal bleeding) in the DPX and the AOT groups, and the rate of AEs leading to study discontinuation.
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Thermogravimetric analysis, derivative thermogravimetry, differential thermal analysis and differential scanning calorimetry were used to determine the thermal behavior and purity of the drugs under investigation. Thermodynamic parameters such as activation energy, enthalpy, entropy and Gibbs free energy were calculated.
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Dapoxetine is a short-acting selective serotonin reuptake inhibitor developed for the on-demand treatment of premature ejaculation and is approved in some European Union countries, as well as Mexico and Korea, for this indication. The pharmacokinetics of dapoxetine 30 mg and 60 mg in healthy Chinese (single dose), Japanese, and Caucasian men (single and multiple dose) were assessed in 2 studies. In the 3 ethnic groups, dapoxetine was rapidly absorbed following oral administration, with peak plasma concentrations evident approximately 1 hour after dosing, independent of dose, dosing frequency (single or multiple dosing), or ethnicity. Dapoxetine was eliminated in a biphasic manner with an apparent mean terminal half-life of 14 to 17 hours. There was a dose-proportional increase in dapoxetine maximum plasma concentration (C(max)) and area under concentration-time curves (AUCs). The single-dose pharmacokinetic parameters of dapoxetine metabolites were also similar for the 3 ethnic groups, as were the pharmacokinetics of dapoxetine and its metabolites following single and multiple dosing in Caucasian and Japanese men. Dapoxetine was well tolerated by all 3 ethnic groups.
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In the present study, the inhibitory effects of hesperetin (HSP) on human cardiac Kv1.5 channels expressed in HEK 293 cells and the ultra-rapid delayed rectifier K(+) current (Ikur) in human atrial myocytes were examined by using the whole-cell configuration of the patch-clamp techniques. We found that hesperetin rapidly and reversibly suppressed human Kv1.5 current in a concentration dependent manner with a half-maximal inhibition (IC50) of 23.15 μΜ with a Hill coefficient of 0.89. The current was maximally diminished about 71.36% at a concentration of 300μM hesperetin. Hesperetin significantly positive shifted the steady-state activation curve of Kv1.5, while negative shifted the steady-state inactivation curve. Hesperetin also accelerated the inactivation and markedly slowed the recovery from the inactivation of Kv1.5 currents. Block of Kv1.5 currents by hesperetin was in a frequency dependent manner. However, inclusion of 30μM hesperetin in pipette solution produced no effect on Kv1.5 channel current, while the current were remarkable and reversibly inhibited by extracellular application of 30μM hesperetin. We also found that hesperetin potently and reversibly inhibited the ultra-repaid delayed K(+) current (Ikur) in human atrial myocytes, which is in consistent with the effects of hesperetin on Kv1.5 currents in HEK 293 cells. In conclusion, hesperetin is a potent inhibitor of Ikur (which is encoded by Kv1.5), with blockade probably due to blocking of both open state and inactivated state channels from outside of the cell.
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Premature ejaculation (PE) is the most common sexual problem affecting men. It can affect men at all ages and has a serious impact on the quality of life for men and their partners. Currently there are no pharmaceutical agents approved for use in the UK, and so all drugs used for this condition are off label. Behavioral therapy has been used to treat PE, but the results are not durable once therapy has been concluded. Several topical therapies have been used including severance-secret (SS) cream, lignocaine spray, lidocaine-prilocaine cream and lidocaine-prilocaine spray (TEMPE). There has been recent interest in the selective serotonin reuptake inhibitors (SSRIs) for the treatment of PE, due to the fact that one of their common side effects is delayed ejaculation. Currently used SSRIs have several non-sexual side effects and long half lives, therefore there has been interest in developing a short acting, efficacious SSRI that can be used on-demand for PE. Dapoxetine has been recently evaluated for the treatment of PE by several groups, and results so far appear promising.
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Pubmed search for efficacy, mode of action and side effects for each molecule. Additional data were searched from the French regulatory agencies web sites (HAS and ANSM).
To study how men with lifelong PE feel about the use of serotonergic antidepressants, and which option they would prefer for themselves: either a daily drug, a drug to be used on demand, or a topical anesthetic cream to be applied on demand.
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The guideline of the International Society for Sexual Medicine for the treatment of PE has provided evidence-based recommendations for the pharmacotherapy of lifelong and acquired PE. Selective serotonin reuptake inhibitors (SSRIs) delay ejaculation by interfering with the serotonin (5-HT) neurotransmission system in the central nervous system. Attention is given not only to the well-known but also to the recently published, very rare side effects of SSRIs.
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This randomized, double-blind, parallel-group, placebo-controlled, phase 3 trial, conducted in 22 countries, enrolled men (N=1162) > or = 18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE for > or = 6 mo, with an intravaginal ejaculatory latency time (IELT) < or = 2 min in > or = 75% of intercourse episodes at baseline.
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The safety analysis was performed on 6128 patients treated with DPX and 1417 with AOT. The incidence of TEAEs of special interest in each AE category was greater for patients treated with AOT than with DPX. The higher differences were observed in the neurocognitive-related category (DPX 1.9% vs. AOT 4.7%; P < .001), in the mood and related category (DPX 0.4% vs. AOT 1.1%; P < .001), and in the urogenital system/sexual function (DPX 0.4% vs. AOT 0.8%; P = .04). Cardiovascular TEAEs were the only AEs numerically greater in the DPX group (1.3 vs. 1.6%, P = .34). The overall discontinuation rate was 10.9% in the DPX group and 6.9% in the AOT group).
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The Manichean diagnosis, psychogenic or organic, is the first and most frequent diagnostic scope managing sexual disorders. The aim of this Controversy is to discuss if this philosophy is still useful both in the conceptual and clinical perspective.