Dapoxetine Treatment in Patients With Lifelong Premature Ejaculation: The Reasons of a “Waterloo”

Abstract

OBJECTIVETo assess both the acceptance and the discontinuation rates from dapoxetine, the first oral pharmacological agent indicated for the treatment of premature ejaculation (PE). METHODSOne 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. RESULTSTwenty-four of the patients (20%) decided not to start dapoxetine. Fear of using a "drug" was the most frequently reported reason for treatment nonacceptance (50%) and the cost of treatment was the reason for 25% of the patients. Ninety-six patients (80%) started the therapy. Twenty-six percent dropped out after 1 month, 42.7% dropped out after 3 months, 18.7% dropped out at 6 months, 2% dropped out at 12 months, and 10.4% are continuing the therapy after 1 year. The main reasons were effect below expectations 24.4%, costs 22.1%, side effects 19.8%, loss of interest in sex 19.8%, and no efficacy 13.9%. CONCLUSIONTwenty percent of lifelong PE patients seeking medical treatment for early ejaculation freely decided not to start treatment with dapoxetine, and roughly 90% of the patients who started therapy discontinued after 1 year. UROLOGY 82: 620e624, 2013. Ó 2013 Elsevier Inc. P remature ejaculation (PE) is a common sexual dysfunction in men characterized by a short time to, and a lack of control over, ejaculation and is associated with distress for patients and their partners.

On-demand Take of Dapoxetine for the Treatment of Lifelong Premature Ejaculation: Prospective, Randomized, Placebo Controlled Study

“…We didn't see anyone suffer from dry mouth which may be associated with take much water when have drugs. The incidence of adverse events of dapoxetine is relate to the dose,on-demand use of dapoxetine 30mg and 60mg for patients with LPE can be tolerated.Mondaini N et al showed 20% of patients with LPE seek for treatment refused pharmacotherapy by dapoxetine,and nearly 90% of patients started therapy discontinued after 1 year [22].…”

244 Discontinuation of dapoxetine treatment in patients with premature ejaculation: A 2-year prospective observational study

“…3 Dapoxetine is the first oral pharmacologic agent developed to treat PE and is the only SSRI approved for such treatment in more than 60 countries. 4 The introduction of dapoxetine was associated with high expectations, given the optimal efficacy-safety profiles evident in phase 3 trials. 5 However, although several clinical studies have confirmed drug efficacy in increasing the intravaginal ejaculation latency time (IELT) and safety, the rate of discontinuation is as high as when taking off-label SSRIs.…”

“…5 However, although several clinical studies have confirmed drug efficacy in increasing the intravaginal ejaculation latency time (IELT) and safety, the rate of discontinuation is as high as when taking off-label SSRIs. 4,5 The discontinuation rate is high compared with those of PDE5 inhibitors in patients with erectile dysfunction (ED). 4,6 To date, dapoxetine is the only approved medical treatment for PE; no second-line therapy is available in those who do not respond or who refuse to take dapoxetine.…”

“…4,5 The discontinuation rate is high compared with those of PDE5 inhibitors in patients with erectile dysfunction (ED). 4,6 To date, dapoxetine is the only approved medical treatment for PE; no second-line therapy is available in those who do not respond or who refuse to take dapoxetine. Thus, a comprehensive evaluation of factors leading to dropout was needed, especially in a real-practice setting.…”

“…Our finding is similar to those of two studies performed in real-world settings; they were of longer duration than the phase 3 trials. 4,8 Mondaini et al 4 reported that 20% of patients with lifelong PE decided not to start dapoxetine treatment and almost 90% of those who initiated treatment discontinued within 1 year. Jern et al 8 evaluated dapoxetine and paroxetine discontinuation rates, and the prevalence of side effects, in a real-world setting and found that the dapoxetine discontinuation rate was 70.6%.…”