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The aim of the study was to determine whether dapoxetine, a short-acting selective serotonin reuptake inhibitor, acts at the spinal or supraspinal level to inhibit the ejaculatory reflex.
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Dapoxetine, a short-acting selective serotonin reuptake inhibitor, is widely prescribed for the treatment of patients with premature ejaculation. The effects of dapoxetine were examined on cloned Kv4.3 channels stably expressed in Chinese hamster ovary cells using the whole-cell patch-clamp technique. Dapoxetine not only reduced the peak amplitude of Kv4.3 currents but also accelerated the decay rate of current inactivation in a concentration-dependent manner. Thus, the concentration-dependent reduction in Kv4.3 was measured from the integral of the current during the depolarizing pulse. Dapoxetine decreased the integral of the Kv4.3 currents over the duration of a depolarizing pulse with an IC(50) of 5.3 μM. Analysis of the time dependence of the block gave estimates of an association rate constant (k(+1)) of 3.9 μM(-1)s(-1) and a dissociation rate constant (k(-1)) of 25.6s(-1). The K(D) (k(-1)/k(+1)) was 6.5 μM, similar to the IC(50) value calculated from the concentration-response curve. The block of Kv4.3 by dapoxetine was highly voltage-dependent at a membrane potential coinciding with the activation of the channels. The additional block by dapoxetine displayed a shallow voltage dependence (δ=0.21) in the full activation voltage range. The steady-state inactivation curves were shifted in the hyperpolarizing direction in the presence of dapoxetine. Dapoxetine also caused a substantial acceleration in closed-state inactivation. Dapoxetine produced a significant use-dependent block, which was accompanied by a delayed recovery from inactivation of Kv4.3 currents. These results indicated that dapoxetine potently blocks Kv4.3 currents by both preferentially binding to the open state of the channels and accelerating the closed-state inactivation. These data could provide insight into the mechanism underlying some of the therapeutic actions of this drug.
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An open-label, three-treatment, six-sequence, three-period crossover study was performed in healthy male subjects. In varying sequences, each subjects received single oral doses of udenafil 200 mg, dapoxetine 60 mg, and both treatments. The periods were separated by a washout period of 7 days. Serial blood samples were collected up to 48 hours after dosing. The plasma concentrations of udenafil and dapoxetine were determined using a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were obtained by non-compartmental analysis. Tolerability was assessed throughout the study.
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Premature ejaculation (PE) is considered to be the most common male sexual dysfunction. The realization that PE may co-exist with ED prompted the use of PDE5-i's alone or in combination with selective serotonin reuptake inhibitors (SSRIs) for treating ejaculatory disorders. Until recently, there was little evidence that PDE5-i's alone may have a role in the treatment of PE in the absence of ED, and current available treatments include only on-demand dapoxetine. However, available data indicate that there is clinical, anatomical, physiological, pharmacological and genetic evidence to explain the efficacy of PDE5-i's. Nine manuscripts that examined the efficacy of PDE5-i's in the treatment of PE, alone or in combination with SSRIs, were retrieved. All studies reported some significant changes in the intravaginal ejaculatory latency time and sexual satisfaction scores, although not all were clinically meaningful. Well-designed multicenter studies are urgently required to further elucidate the efficacy and safety, as well as the mechanisms of action of PDE5-i's in the treatment of PE. The aim of this review is to discuss basic rationale and to show clinical evidence sustaining the possibility to use off-label PDE5-i's to treat PE.
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Contemporary data on the treatment of PE were reviewed and critiqued using the principles of evidence-based medicine.
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The intravaginal ejaculatory latency time (IELT), the premature ejaculation diagnostic tool (PEDT) score, and the treatment-emergent adverse events (TEAEs) were analyzed.
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A sensitive and rapid ultra performance liquid chromatography tandem mass spectroscopy (UPLC-MS/MS) method was developed to determine dapoxetine and its two major metabolites (dapoxetine-N-oxide and desmethyldapoxetine) in human plasma simultaneously. After a simple protein precipitation, the analytes and the combined internal standard (carbamazepine) were separated on an Acquity UPLC BEH C18 column using a mobile phase of acetonitrile and 0.1% formic acid in water with gradient elution. Mass spectrometric analysis was performed using a XEVO TQD triple quadruple mass spectrometer coupled with an electro-spray ionization (ESI) source in the positive ion mode. The MRM transitions are of m/z 306.3→261.2, m/z 322.2→261.2, m/z 292.2→261.2 and m/z 237.1→194.2 for dapoxetine, dapoxetine-N-oxide, desmethyldapoxetine and IS, respectively. The linearity of this method was found to be within the concentration range of 1.0-200ng/mL for dapoxetine; 0.5-100ng/mL for dapoxetine-N-oxide; and 0.1-5.0ng/mL for desmethyldapoxetine in human plasma, respectively. Only 4.0min was needed for an analytical run. Intra-day and inter-day accuracy and precision were within the acceptable limits of ±15% at all of the concentrations. This assay was successfully used to support a clinical pharmacokinetic study following oral administration of dapoxetine tablets in healthy Chinese subjects.
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To compare the safety and efficacy of dapoxetine and acupuncture for the treatment of premature ejaculation (PE) with other treatment methods.
Acute systemic delivery of selective serotonin reuptake inhibitors is capable of modulating the expulsion reflex of ejaculation in anesthetized rats with dapoxetine appearing to be more effective than paroxetine. These findings support the beneficial effect of on-demand administration of dapoxetine for premature ejaculation.
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Erectile dysfunction (ED) is the most frequently treated male sexual dysfunction worldwide. ED is a chronic condition that exerts a negative impact on male self-esteem and nearly all life domains including interpersonal, family, and business relationships.
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In this study, flexible dosing of dapoxetine (30 and 60 mg) appeared effective in the treatment of PE.
Orally disintegrating tablet (ODT) is a user friendly and convenient dosage form. The study aimed to investigate the effect of polymers and wheat starch on the tablet properties of lyophilized ODT, with dapoxetine as model drug. Three polymers (hydroxypropylmethyl cellulose, carbopol 934P and Eudragit(®) EPO) and wheat starch were used as matrix forming materials in preparation of lyophilized ODT. The polymeric dispersion was casted into a mould and kept in a freezer at -20 °C for 4 h before freeze dried for 12 h. It was found that increasing in HPMC and Carbopol 934P concentrations produced tablets with higher hardness and longer disintegration time. In contrast, Eudragit(®) EPO was unable to form tablet with sufficient hardness at various concentrations. Moreover, HPMC seems to have a stronger effect on tablet hardness compared to Carbopol 934P at the same concentration level. ODT of less friable was obtained. Wheat starch acted as binder which strengthen the hardness of ODTs and prolonged the disintegration time. ODT comprising of HPMC and wheat starch at ratio of 2:1 was found to be optimum based upon the tablet properties. The optimum formulation was palatable and 80 % of the drug was released within 30 min in the dissolution study.
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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.
Selective serotonin reuptake inhibitors (SSRIs) may be associated with electrocardiographic effects. The electrocardiographic pharmacodynamics of dapoxetine, a short-acting SSRI being developed for the treatment of premature ejaculation, are compared with those of placebo and moxifloxacin (positive control) in 2 single-center, randomized, crossover studies in healthy men. In study 1, subjects receive 2 doses of dapoxetine 120 mg, given 3 hours apart; a single dose of moxifloxacin 400 mg; and 2 doses of placebo, given 3 hours apart. In study 2, subjects receive single doses of dapoxetine 60 mg, dapoxetine 120 mg, moxifloxacin 400 mg, and placebo. Moxifloxacin significantly increases QT and corrects QT intervals (QTc) compared with placebo in both studies (eg, Bazett-corrected QTc of 11.90 milliseconds [95% confidence interval, 2.68 to 21.11] and 5.06 [95% confidence interval, -2.26 to 12.38]). Dapoxetine 60, 120, and 240 mg do not prolong the QT/QTc interval and have no clinically significant electrocardiographic effects. Dapoxetine and moxifloxacin pharmacokinetics are similar to previous reports. Adverse events are generally mild in severity; nausea is the most common. The results demonstrate that dapoxetine does not have electrocardiographic effects at doses of 60, 120, and 240 mg.
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Several interventions significantly improved IELT. Many interventions also improved sexual satisfaction and other outcomes. However, assessment of longer-term safety and effectiveness is required to evaluate whether or not initial treatment effects are maintained long term, whether or not dose escalation is required, how soon treatment effects end following treatment cessation and whether or not treatments can be stopped and resumed at a later time. In addition, assessment of the AEs associated with long-term treatment and whether or not different doses have differing AE profiles is required.
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The available evidence indicates that dapoxetine would improve the symptoms of premature ejaculation, prolong IELT over 9-24 weeks in men from a wide range of cultural backgrounds, and significantly improve all patients' reported outcomes and the patients' clinical global impressions of premature ejaculation, including more control, greater satisfaction, and less distress.
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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.
To review pharmacologic therapies for treatment of PE.
Rapid (premature) ejaculation (RE) is defined as persistent or recurrent ejaculation with minimal sexual stimulation before, upon, or shortly after penetration and before it is wished by the man or his partner. RE is the most frequently encountered sexual complaint of men and couples. Estimates suggest that as many as one third of all sexually active men suffer from RE. RE has been treated with various modalities. These include behavioral therapy, topical applications, oral pharmacotherapy and intracavernosal vasoactive drug injection. The success rates of these modalities are variable, however, to date an approved treatment does not exist. In this article, we review the evidence surrounding the pharmacological management of RE. The search included (i) a MEDLINE search from 1980 through August 2005 limited to English-language medical literature; (ii) relevant abstracts from 2003, 2004, and 2005; and (iii) a pipeline search for therapeutics in development. The review does not include behavioral therapy. The distinct feature of this review is that the level of evidence supporting each treatment will be discussed in details. Results showed that there is consistent evidence which supports the daily use of paroxetine, clomipramine, sertraline and fluoxetine for the treatment of RE. There is no strong evidence suggesting the use of these previous drugs on an as-needed basis. There is strong evidence to suggest the use of dapoxetine on an as-needed in RE. Available evidence indicates that topical anesthetic agents such as prilocaine-lidocaine and SS-cream appears to be effective in treatment of RE. There is no strong evidence to suggest that PDEI5 could prolong IELT in RE when used on-demand. In conclusion, based on literature data, although some drugs may be effective in treatment of RE, more extended multi-center prospective double-blind, placebo-controlled stopwatch studies on the benefits of SSRIs, SNRIs and PDEI5 in RE are required.
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There were no differences between the groups in terms of age, body mass index, baseline IELT and PEDT scores (p > 0.05). After 4 weeks, IELT was significantly longer compared to baseline values in all groups (p < 0.001 for all comparisons). Comparisons between the groups showed that changes in IELT and PEDT observed after 4 weeks with dapoxetine 60 mg was significantly higher than those achieved in all other groups (p < 0.001 for all comparisons), changes observed with dapoxetine 30 mg was significantly higher than those achieved with acupuncture and sham acupuncture groups (p < 0.001 for both comparisons) and changes observed with acupuncture was significantly higher than those observed with sham acupuncture (p < 0.001).
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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.
Using the Medline, 48 articles published from January 1st, 1996 to August 1st, 2006 concerning the use of SSRIs and their possible mechanisms in alleviating PE were found and reviewed.
Objective To evaluate the effect of interventions for premature ejaculation (PE) in the management of patients with chronic prostatitis and secondary premature ejaculation. Methods Totally 90 patients diagnosed as chronic prostatitis with PE were randomly divided into control group (n=45) and interventional group (n=45). Control group received a conventional therapy consisted of oral administration of antibiotics,α-receptor blocker,and proprietary Chinese medicine for clearing away heat and promoting diuresis. Interventional group received a conventional therapy combined with treatment for ameliorating the PE symptom (oral dapoxetine on-demand and ejaculation control exercise).National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI),Chinese Index of Sexual Function for Premature Ejaculation (CIPE)-5 questionnaires,intravaginal ejaculatory latency time,and the number of coituses per week were applied for evaluating the treatment outcomes. Results Follow-up was accomplished in 35 and 38 patients in the control and interventional group.The CIPE-5 score,intravaginal ejaculatory latency time,and the number of coituses per week were significantly improved in both two groups but more significantly in interventional group (all P<0.05). The NIH-CPSI pain,urination,and quality of life subscores and total score were improved significantly in both two groups after treatment,but the NIH-CPSI pain and quality of life subscores had been improved more significantly in the interventional group (all P<0.05). The variation of NIH-CPSI was negatively correlated with that of CIPE-5 in both two groups (r=-0.362,P=0.016;r=-0.330,P=0.021). Conclusions For CP with secondary PE patients,the interventions for PE can not only improve the quality of sexual life but also help improve the NIH-CPSI pain and quality of life subscores. PE should be routinely screened and treated during the management of CP.p.
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The study was a prospective, 12-week, open-label study to evaluate the efficacy and safety of flexible-dose dapoxetine in men with PE diagnosed by a Premature Ejaculation Diagnostic Tool score of at least 11, a self-estimated intravaginal ejaculation latency time (IELT) no longer than 2 minutes, and an International Index of Erectile Function erectile function domain score of at least 21.
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The present study showed that dapoxetine inhibits ejaculatory expulsion reflex by acting at a supraspinal level with LPGi as a necessary brain structure for this effect.
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Premature ejaculation (PE) is the most common form of male sexual dysfunction, with an estimated worldwide prevalence of 20–30%.1 Although PE is not life threatening, it has significant impact on quality of life. The fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)defines PE as “persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it” that “causes marked distress or interpersonal difficulty” and “is not due exclusively to the direct effects of a substance.”2 The International Society for Sexual Medicine, which recently modified the definition to include the threshold ejaculatory latency time, defines PEas “male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within 1 min of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences such as distress, bother, frustration, and/or the avoidance of sexual intimacy.”3 The lack of ejaculatory control is consistent among all clinical definitions of PE and is a highly sensitive predictor of the condition.