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Dapoxetine (Priligy)

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Patient-reported outcomes are clearly improved relative to placebo following dapoxetine therapy, indicating greater control over ejaculation, more satisfaction with intercourse, less ejaculation-related distress, and, importantly, significantly reduced interpersonal difficulty. These data were supported by consistent reports of improvement in Clinical Global Impression of change in PE following treatment with dapoxetine. Further studies are needed to evaluate long-term efficacy and health economics.

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Patient-reported outcomes are clearly improved relative to placebo following dapoxetine therapy, indicating greater control over ejaculation, more satisfaction with intercourse, less ejaculation-related distress, and, importantly, significantly reduced interpersonal difficulty. These data were supported by consistent reports of improvement in Clinical Global Impression of change in PE following treatment with dapoxetine. Further studies are needed to evaluate long-term efficacy and health economics. The unique pharmacology of dapoxetine makes it ideal for on-demand dosing, and the clinical evidence shows dapoxetine to be an efficacious and tolerable treatment for lifelong and acquired PE. Keywords: dapoxetine, intravaginal ejaculatory latency time, patient-reported outcomes, premature ejaculation Dapoxetine (PriligyTM, Johnson and Johnson, Raritan, NJ) is the first and only product licensed for the treatment of premature ejaculation (PE) in men aged 18–64 years.

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At present, dapoxetine is licensed in ten countries, including several countries in Europe, and Mexico, South Korea, and New Zealand.1,2 PE is the most common sexual dysfunction in men, with a global prevalence estimated to be between 20% and 40%.3–5 The uncertainty about prevalence figures is due to the intimate nature of the condition and, until recently, the lack of a universal evidence-based definition. It is probable that many men do not admit to having the condition and do not seek medical advice. PE is characterized by ejaculation prior to, or soon after, vaginal penetration with minimal stimulation, with the male having no control over ejaculation. Definitions have been published by the International Society for Sexual Medicine and in the Diagnostic Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with the key point being the uncontrolled brevity of sexual intercourse.6–8 The negative consequences of PE are significant, cenforce viagra and affect both the male and female partner. As well as obvious sexual dissatisfaction, the condition can cause personal distress, low self-esteem, and interpersonal difficulty.5,9–11 Dapoxetine belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs) which are frequently used to treat depression.

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Prior to the availability of dapoxetine, psychotherapy (eg, cognitive behavior therapy) was widely used to treat PE. More recently, several SSRIs (other than dapoxetine) have been used off-label to treat PE.12,13 These SSRIs were not developed to treat PE,12 in contrast with dapoxetine which was specifically developed for this purpose and has a different pharmacological profile to the other SSRIs,14–17 with properties making it suitable for on-demand dosing.1 The aims of this article are to review the current evidence for use of dapoxetine in the treatment of PE, including the ability of the drug to not only increase time to ejaculation post-penetration, termed intravaginal ejaculatory latency time (IELT), but also to improve patient self-esteem, satisfaction with sexual intercourse, and perceived control over ejaculation. Literature searches were carried out in August 2011 using PubMed ( the Cochrane Database of Systematic Reviews ( NHS Evidence ( and the National Institute for Health and Clinical Excellence (NICE, These databases were searched using the terms “dapoxetine” or “dapoxetine AND premature ejaculation”. Articles involving dapoxetine for the treatment of PE were identified, with priority given to systematic reviews, meta-analyses and integrated analyses, double-blind, randomized, placebo-controlled clinical trials (RCTs), and nonrandomized observational studies. Only articles published in English were selected for inclusion. The unique pharmacology of dapoxetine makes it ideal for on-demand dosing, and the clinical evidence shows dapoxetine to be an efficacious and tolerable treatment for lifelong and acquired PE. Keywords: dapoxetine, intravaginal ejaculatory latency time, patient-reported outcomes, premature ejaculation Dapoxetine (PriligyTM, Johnson and Johnson, Raritan, NJ) is the first and only product licensed for the treatment of premature ejaculation (PE) in men aged 18–64 years. At present, dapoxetine is licensed in ten countries, including several countries in Europe, and Mexico, South Korea, and New Zealand.1,2 PE is the most common sexual dysfunction in men, with a global prevalence estimated to be between 20% and 40%.3–5 The uncertainty about prevalence figures is due to the intimate nature of the condition and, until recently, the lack of a universal evidence-based definition.

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It is probable that many men do not admit to having the condition and do not seek medical advice.

PE is characterized by ejaculation prior to, or soon after, vaginal penetration with minimal stimulation, with the male having no control over ejaculation.

Definitions have been published by the International Society for Sexual Medicine and in the Diagnostic Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with the key point being the uncontrolled brevity of sexual intercourse.6–8 The negative consequences of PE are significant, cenforce viagra and affect both the male and female partner. As well as obvious sexual dissatisfaction, the condition can cause personal distress, low self-esteem, and interpersonal difficulty.5,9–11 Dapoxetine belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs) which are frequently used to treat depression. Prior to the availability of dapoxetine, psychotherapy (eg, cognitive behavior therapy) was widely used to treat PE. More recently, several SSRIs (other than dapoxetine) have been used off-label to treat PE.12,13 These SSRIs were not developed to treat PE,12 in contrast with dapoxetine which was specifically developed for this purpose and has a different pharmacological profile to the other SSRIs,14–17 with properties making it suitable for on-demand dosing.1 The aims of this article are to review the current evidence for use of dapoxetine in the treatment of PE, including the ability of the drug to not only increase time to ejaculation post-penetration, termed intravaginal ejaculatory latency time (IELT), but also to improve patient self-esteem, satisfaction with sexual intercourse, and perceived control over ejaculation.

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The only randomized, placebo-controlled, double-blind multicenter study evaluating sildenafil showed a 2.6-fold increase in IELT, but this was not statistically significant from placebo.35 However, it did show an improvement in ejaculatory control, confidence, and satisfaction in patient-derived questionnaires. A systematic review of 14 clinical trials assessing the efficacy of phosphodiesterase type 5 inhibitors and on-demand SSRIs concluded that wide ranges of IELT changes were due to inconsistencies in study designs and therefore are difficult to interpret reliably.36 Several years ago, the observation that one of the adverse effects of SSRIs when used to treat depression and other psychological disorders, ie, anorgasmia or delayed ejaculation, suggested SSRIs as a possible pharmacotherapy for PE.8,9 Subsequent research on the central and presynaptic involvement of 5-HT in ejaculation confirmed the mechanism of action of SSRIs in PE and marked a new era in pharmacotherapy for the condition.24 A number of SSRIs are currently used off-label in long-term daily dosing regimens for treatment of PE, including paroxetine, fluoxetine, fluvoxamine, sertraline, and citalopram.

Cite this article

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Literature searches were carried out in August 2011 using PubMed ( the Cochrane Database of Systematic Reviews ( NHS Evidence ( and the National Institute for Health and Clinical Excellence (NICE, These databases were searched using the terms “dapoxetine” or “dapoxetine AND premature ejaculation”. Articles involving dapoxetine for the treatment of PE were identified, with priority given to systematic reviews, meta-analyses and integrated analyses, double-blind, randomized, placebo-controlled clinical trials (RCTs), and nonrandomized observational studies.

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Only articles published in English were selected for inclusion. The references listed in identified articles were used as a further source of relevant studies. PE is highly prevalent and, due to the nature of the disorder, is likely to be under-reported and undertreated.5,18 Reported prevalence has also been variable due to the previous lack of an evidence-based definition. In the past, physicians generally considered PE to have a psychological element, hence the historical use of psychotherapy to treat the condition.

What is Sildenafil 100mg–Dapoxetine 60mg Oral Jelly? Drug Class: PDE5 inhibitor + SSRIActive Ingredients: Sildenafil citrate 100mg, Dapoxetine 60mgMechanism: Enhances penile blood flow and delays ejaculation reflexForm: Oral jelly (5gm sachet)Dosing Frequency: Typically taken before sexual activityRegulatory Status: Prescription-only medicine Uses / Indications

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However, in recent years, the biological component has become more widely understood, and pharmacotherapy is the new focus for the treatment of PE. Two types of PE have been widely 50mg viagra recognized, ie, lifelong (primary) and acquired (secondary) PE. Lifelong PE is present from the first sexual experience onwards, occurs in almost all attempts at intercourse, and is considered to have a neurobiological etiology.

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The references listed in identified articles were used as a further source of relevant studies. PE is highly prevalent and, due to the nature of the disorder, is likely to be under-reported and undertreated.5,18 Reported prevalence has also been variable due to the previous lack of an evidence-based definition. In the past, physicians generally considered PE to have a psychological element, hence the historical use of psychotherapy to treat the condition. However, in recent years, the biological component has become more widely understood, and pharmacotherapy is the new focus for the treatment of PE. Two types of PE have been widely 50mg viagra recognized, ie, lifelong (primary) and acquired (secondary) PE.

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Lifelong PE is present from the first sexual experience onwards, occurs in almost all attempts at intercourse, and is considered to have a neurobiological etiology. Secondary PE occurs later in life after a period of perceived normal ejaculatory control, and may have a psychological and neurobiological etiology. This type of PE may be triggered by stress or linked to adverse events associated with medications.19,20 Waldinger et al suggested that, in addition to these well known types of PE, there are two other subtypes, ie, natural variable PE and premature-like ejaculatory dysfunction.21 Natural variable PE refers to those men reporting occasional early ejaculation in the course of normal events, whilst with the latter, men experience or complain of PE while having normal or prolonged IELT.22,23 Despite the above classifications, features common to all PE are an inability to control ejaculation, ejaculation prior to/soon after vaginal penetration, embarrassment, low self-esteem, personal distress, and often interpersonal difficulty and relationship problems as a result of the lack of sexual satisfaction for both the man and his partner.6,7 The first evidence-based definition of lifelong PE has recently been published by the International Society for Sexual Medicine, and includes the criterion of “ejaculation which always or nearly always occurs prior to or within about 1 minute of vaginal penetration”, ie, an IELT of 1 minute or less. Other specified criteria are “… 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”.8 Prior to this, researchers recruiting patients for clinical studies of PE tended to use the definition given in the DSM-IV-TR, which is similar to that of the International Society for Sexual Medicine, but does not specify an IELT threshold.6 The etiology of PE is multifactorial, and associations with psychological, environmental, endocrine, and neurobiological factors have been made. Control of ejaculation is under neuronal control from the supraspinal level and involves various neurotransmitters, the most widely studied of which is serotonin (5-hydroxytryptamine, 5-HT).

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The role of 5-HT in the pathophysiology of PE is complex, with at least three receptor subtypes (5-HT1a, 5-HT1b, 5-HT2c) being known to play a role.24 Recently, there has been interest in investigating a potential genetic basis for PE.25 It is postulated that a polymorphism of the serotonin transporter gene (5-HTT) may be associated with the response to treatment with SSRIs.26 Due to a perceived psychosomatic aspect of PE, psychotherapy, such as sex therapy or cognitive therapy, has been widely used historically to treat PE.12 The aim of such treatment is to encourage self-confidence and improve communication and intimacy between PE patients and their partners, in the hope of improving performance and reducing the anxiety associated with intercourse. Behavioral methods are also used to reduce the urgency to ejaculate, including squeezing the glans of the penis or intermittent penetration, although the latter may actually lead to prolonged sexual frustration rather than greater penetrative time.27 Despite some reported short-term efficacy, there is little evidence of any long-term benefit associated with these treatment methods.1,9,28,29 The use of topical anesthetic creams was first described by Schapiro in 1943, the rationale being that reduced penile sensitivity would result in prolongation of sexual intercourse without adversely affecting the sensation of ejaculation.30,31 Prilocaine/lidocaine cream (EMLA®) has commonly been used off-license in the first-line management of PE. A novel metered-dose aerosol spray of lidocaine/prilocaine (TEMPE®) was found to increase IELT significantly compared with placebo (up to an eight-fold increase in one study) but is awaiting licensing.30,32–34 On face value, these topical treatments may appear ideal for on-demand use in PE, but they have several disadvantages, including genital numbness for both the patient and partner, reduced ability to maintain an erection, and messy application.12 As a 25 mg viagra result, these topical therapies have never achieved widespread acceptability. The phosphodiesterase type 5 inhibitors, which are licensed for the treatment of erectile dysfunction, have been evaluated for use in PE. Despite their success in treating erectile dysfunction, there are limited data to support their use in PE alone. Secondary PE occurs later in life after a period of perceived normal ejaculatory control, and may have a psychological and neurobiological etiology. This type of PE may be triggered by stress or linked to adverse events associated with medications.19,20 Waldinger et al suggested that, in addition to these well known types of PE, there are two other subtypes, ie, natural variable PE and premature-like ejaculatory dysfunction.21 Natural variable PE refers to those men reporting occasional early ejaculation in the course of normal events, whilst with the latter, men experience or complain of PE while having normal or prolonged IELT.22,23 Despite the above classifications, features common to all PE are an inability to control ejaculation, ejaculation prior to/soon after vaginal penetration, embarrassment, low self-esteem, personal distress, and often interpersonal difficulty and relationship problems as a result of the lack of sexual satisfaction for both the man and his partner.6,7 The first evidence-based definition of lifelong PE has recently been published by the International Society for Sexual Medicine, and includes the criterion of “ejaculation which always or nearly always occurs prior to or within about 1 minute of vaginal penetration”, ie, an IELT of 1 minute or less.

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Other specified criteria are “… 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”.8 Prior to this, researchers recruiting patients for clinical studies of PE tended to use the definition given in the DSM-IV-TR, which is similar to that of the International Society for Sexual Medicine, but does not specify an IELT threshold.6 The etiology of PE is multifactorial, and associations with psychological, environmental, endocrine, and neurobiological factors have been made.

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Sudden blood pressure drop Rare Risk for hypertensive patients Severe

Control of ejaculation is under neuronal control from the supraspinal level and involves various neurotransmitters, the most widely studied of which is serotonin (5-hydroxytryptamine, 5-HT).

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The role of 5-HT in the pathophysiology of PE is complex, with at least three receptor subtypes (5-HT1a, 5-HT1b, 5-HT2c) being known to play a role.24 Recently, there has been interest in investigating a potential genetic basis for PE.25 It is postulated that a polymorphism of the serotonin transporter gene (5-HTT) may be associated with the response to treatment with SSRIs.26 Due to a perceived psychosomatic aspect of PE, psychotherapy, such as sex therapy or cognitive therapy, has been widely used historically to treat PE.12 The aim of such treatment is to encourage self-confidence and improve communication and intimacy between PE patients and their partners, in the hope of improving performance and reducing the anxiety associated with intercourse. Behavioral methods are also used to reduce the urgency to ejaculate, including squeezing the glans of the penis or intermittent penetration, although the latter may actually lead to prolonged sexual frustration rather than greater penetrative time.27 Despite some reported short-term efficacy, there is little evidence of any long-term benefit associated with these treatment methods.1,9,28,29 The use of topical anesthetic creams was first described by Schapiro in 1943, the rationale being that reduced penile sensitivity would result in prolongation of sexual intercourse without adversely affecting the sensation of ejaculation.30,31 Prilocaine/lidocaine cream (EMLA®) has commonly been used off-license in the first-line management of PE. A novel metered-dose aerosol spray of lidocaine/prilocaine (TEMPE®) was found to increase IELT significantly compared with placebo (up to an eight-fold increase in one study) but is awaiting licensing.30,32–34 On face value, these topical treatments may appear ideal for on-demand use in PE, but they have several disadvantages, including genital numbness for both the patient and partner, reduced ability to maintain an erection, and messy application.12 As a 25 mg viagra result, these topical therapies have never achieved widespread acceptability. The phosphodiesterase type 5 inhibitors, which are licensed for the treatment of erectile dysfunction, have been evaluated for use in PE.

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Despite their success in treating erectile dysfunction, there are limited data to support their use in PE alone.

The only randomized, placebo-controlled, double-blind multicenter study evaluating sildenafil showed a 2.6-fold increase in IELT, but this was not statistically significant from placebo.35 However, it did show an improvement in ejaculatory control, confidence, and satisfaction in patient-derived questionnaires. A systematic review of 14 clinical trials assessing the efficacy of phosphodiesterase type 5 inhibitors and on-demand SSRIs concluded that wide ranges of IELT changes were due to inconsistencies in study designs and therefore are difficult to interpret reliably.36 Several years ago, the observation that one of the adverse effects of SSRIs when used to treat depression and other psychological disorders, ie, anorgasmia or delayed ejaculation, suggested SSRIs as a possible pharmacotherapy for PE.8,9 Subsequent research on the central and presynaptic involvement of 5-HT in ejaculation confirmed the mechanism of action of SSRIs in PE and marked a new era in pharmacotherapy for the condition.24 A number of SSRIs are currently used off-label in long-term daily dosing regimens for treatment of PE, including paroxetine, fluoxetine, fluvoxamine, sertraline, and citalopram.

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