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QSF may be effective and safe on LPE patients with Gan depression and Shen defificiency syndrome.
New diagnostic criteria for lifelong premature ejaculation (PE) have been proposed by the International Society of Sexual Medicine (ISSM), including an intravaginal ejaculatory latency time (IELT) of less than about 1 minute, lack of control over ejaculation, and PE-related distress or bother.
There are currently no oral or topical agents approved by government regulation agencies for the management of premature ejaculation (PE).
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Premature ejaculation (PE) is a common sexual dysfunction affecting 20% to 30% of men worldwide. Definitions of PE vary, but it is typically characterized by short intravaginal ejaculatory latency time (IELT) with concomitant sexual dissatisfaction and distress. PE may be lifelong or acquired, but its etiology remains unclear. Treatment of PE typically involves pharmacotherapy, particularly when lifelong. Although there are numerous reports on the off-label use of selective serotonin reuptake inhibitors (SSRIs) and other compounds, only 2 treatments have been evaluated in randomized controlled phase 3 clinical trials: PSD502 and dapoxetine (SSRI). Both significantly improved IELT and patient-reported outcome domains of ejaculatory control, sexual satisfaction, and distress as measured by the index of premature ejaculation (IPE), compared with placebo. They constitute the focus of this review. Evidence demonstrated that PSD502, dapoxetine and other SSRIs all significantly improve the symptoms of PE. Systemic use of SSRIs presents risks associated with the known pharmacology of this class. PSD502 allows for topical on-demand treatment applied applied immediately before intercourse, and is not associated with systemic adverse events.
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From MEDLINE (Jan, 1950-Mar, 2008), EMBASE (Jan, 1980-Mar, 2008), The Cochrane Library (Issue 1, 2008) and CNKI (Jan, 1979-Mar, 2008), we retrieved and screened the randomized controlled trials (RCT) and randomized crossover trials (RT) as well as various related data, published and unpublished, on the treatment of PE with SSRIs. The methodological quality of the included trials was evaluated by 2 reviewers. Meta-analyses were conducted with RevMan 5.0 on the homogeneous studies.
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One hundred twenty consecutive potent patients (mean age 40.3 years; range 18-63 years) seeking medical treatment for lifelong PE were enrolled in a prospective phase II study. Moreover, they were assessed regarding detailed medical and sexual history, intravaginal ejaculatory latency time (IELT), International Index of Erectile Function (IIEF), and complete physical examination. The patients received a dapoxetine prescription (30 mg on demand) and unresponded cases received increased dose (60 mg after 3 months). The patients were evaluated at 1, 3, 6, and 12 months, and requested to complete a multiple-choice global assessment questionnaire regarding specific reasons for eventual therapy discontinuation.
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Men with comorbid erectile dysfunction (ED) and premature ejaculation (PE) may be concomitantly prescribed a phosphodiesterase type 5 (PDE5) inhibitor and dapoxetine.
Of the 1,067 subjects randomized, 858 completed the study. Mean Average IELT increased from approximately 1.1 minutes at baseline (across groups) to 2.4, 3.9, and 4.2 minutes with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively, and geometric mean Average IELT increased from approximately 0.9 minutes at baseline (across groups) to 1.8, 2.7, and 3.1 minutes, respectively (fold-increases of 2.0, 2.8, and 3.3, respectively). All PEP measures and the CGI of change were significantly improved with dapoxetine vs. placebo at study endpoint (P < or = 0.005 for all). The most common TEAEs with dapoxetine included nausea, dizziness, somnolence, headache, vomiting, diarrhea, and nasopharyngitis; TEAEs led to discontinuation in 0.3%, 1.7%, and 5.1% of subjects with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively.
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After a 4-week run-in period, 50 patients with lifelong PE entered a 24-week, open-label, prospective study with a 1:1 assignment. Twenty-five patients (group A) received on-demand dapoxetine 30 mg alone, and the remaining 25 patients (group B) combined on-demand dapoxetine 30 mg and SBTx. The CONSORT 2010 statement was adhered to where possible.
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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.
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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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Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT, OSAT, and PEP index score, and similar TEAEs, compared with that of dapoxetine only. Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED.
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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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As opposed to agents that must be taken 4-6 hours prior to coitus and with the methods used here, this group of Dutch men with lifelong PE favor uninterrupted daily drug treatment to delay ejaculation mainly because daily treatment guarantees no interference with the spontaneity of having sex.
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Since the latest meta-analyses using similar criteria (conducted in 2004 and 2005 for selective serotonin reuptake inhibitors [SSRIs] and phosphodiesterase type 5 [PDE-5] inhibitors, respectively), eight studies evaluated SSRIs vs. placebo, one compared SSRIs, two evaluated PDE-5 inhibitors, and one evaluated an SSRI/PDE-5 inhibitor combination. New agents included dapoxetine (five studies) and tramadol (one study). Six studies enrolled men who met an approximation of the ISSM criteria. Although evidence suggests that most SSRIs, tramadol, and dapoxetine increase IELT to varying degrees, few studies included control over ejaculation and PE-related distress or bother as enrollment criteria or used validated patient-reported outcome instruments to evaluate these parameters. Among studies that provided comprehensive adverse event data, safety and tolerability observations in men with PE were generally similar to those observed in other populations; however, with the exception of dapoxetine, known SSRI-class effects (e.g., withdrawal syndrome) were not evaluated in men with PE.
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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.
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The discovery that certain selective serotonin reuptake inhibitors delay ejaculation and the later development and approval of dapoxetine as an on-demand treatment option has led to a dramatic increase in medical interest in premature ejaculation. This paper analyses the diagnostic criteria and the discussion within the medical community about suitable treatments against the backdrop of theories of science, sex and gender. Our conclusion is that the diagnosis itself and the suggested treatments contribute to normative models of sexual conduct and therefore reinforce the norms that cause patients' distress over ejaculating 'too soon'.
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Data were obtained by extensive examination of peer-reviewed published literature.
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Four premature ejaculation (PE) subtypes are distinguished on the basis of the duration of the intravaginal ejaculation latency time (IELT), its course in life, and frequency of complaints. Since the 1930s oral drug treatment and local anesthetics have been used to treat PE. Apart from dapoxetine, all currently available drugs to treat PE (SSRIs, clomipramine, and local anesthetics) are off-label. Not only men with lifelong and acquired PE, but also men with normal IELT values may want to postpone their ejaculation time.
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Dapoxetine on demand can prolong IELT and improve PGI and CCCB, either at the dose of 60 mg or 30 mg, and has an even better efficacy in prolonging IELT and improving PGI at 60 mg.
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Premature ejaculation is a condition for which the cause is not well understood. Several types of treatment with medium to low efficacy are available. More research is necessary to identify the ideal treatment.
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We conducted a 12-wk, open-label, observational study with a 4-wk, postobservational contact. A total of 10,028 patients were enrolled, with 6712 patients (67.6%) treated with dapoxetine 30-60 mg (group A) and 3316 (32.4%) treated with alternative care/nondapoxetine (group B).
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Data from various stages of the clinical development programme were analysed using validated methods for assessing ejaculatory latency. The clinical characteristics were then compared with the pharmacokinetic profile, determined from measured plasma drug concentrations.
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Dapoxetine is a short-acting selective serotonin reuptake inhibitor that was recently approved for the on-demand treatment of premature ejaculation (PE).
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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.