Dapoxetine, an effective treatment for the premature ejaculation, but with undesirable effects

June 7, 2012

The latest studies undertaken on the drug dapoxetine demonstrate some unwelcome side effects.

Introduction

Premature ejaculation is one of the most common sexual dysfunctions amongst men; selected test subjects have been used in the collection of serotonin (ISRS) and come to indicate this. The drug Dapoxetine is an ISRS drug with a short to medium lifetime, and has been developed only for use with that in mind.

Objectives

To study the efficiency and resilience of Dapoxetine in treating premature ejaculation.

Study profile

  • Type of study: clinical essay
  • Area of study: treatment
  • Scope of study: communitarian

Methodology

During the study, results were produced from two clinical experiments that utilised the same methodology. The experiments involved 2,614 patients suffering from PE that had previously been in agreement with the principles of DSM-IV. Other patient factors included: 16+ years of age, in a stable relationship and in the two weeks prior to the experiments beginning, having lasted less than two minutes in 75% of any sexual experiences.

Any patients suffering from the following were excluded from the experiment: erectile dysfunction, using any other type of ISRS, antidepressant or other PE drug or psychiatric illness.

Patients who has a female partner who suffered from feminine dysfunction were also excluded.

On a random basis, the patients were given either a placebo drug or a dose of Dapoxetine, which ranged in dosage from 30 to 60mg. The recommendations to all the patients were to engage in around six sexual intercourse experiences per month during the three month study, and to administer the medicine one to three hours before each session. The efficiency of the drugs was analysed on the 4th, 8th and 12th weeks of the study. The main variable appeared to be the duration of ejaculation during intercourse on the 12th week. A second variable was introduced in order to produce a profile of premature ejaculation: a questionnaire that examined the level of significance that PE held for the patient, and what amount of satisfaction they and their partner experienced during intercourse.

Results

Overall, 2,614 patients participated in the study. The average age was 40 years old, the average duration of the problem had been 16 years and, in 65% of the cases, PE was the main concern. There were no major differences amongst the participants of the three groups.

There was a noticeable increase in all groups of being able to last longer during sexual intercourse, however, it was significantly higher in the groups that had been administered the real; Dapoxetine drug; furthermore, the patients that had received a dose of 60mg yielded more successful results than of the ones that had used 30mg. The percentage of patients that were able to last more than three minutes was also more significant in those who received the 60mg dose over the patients who had the placebo drug. The results suggested that differences were noticeable after the first dose and were independent of concerns over PE. The given dosage recommendations suggested that the patient should take the drugs one to three-3 hours before engaging in sexual intercourse. Results showed that it also functioned when taken as early as 30-60 minutes before and that it was still in effect more than four hours after swallowing it. The patient’s amount of control over ejaculation and the satisfaction felt also increased after taking Dapoxetine.

However, secondary side effects that appeared more frequently produced problems such as nausea, diarrhoea, headaches, dizziness, and fainting, with nausea, for example, affecting 20% of the patients that took a 60mg Dapoxetine dose. These side effects in fact caused 5% of the patients to abandon the treatment and tests. A further 3% of Dapoxetine patients suffered some kind of sexual dysfunction, in comparison to 1.5% of patients taking the placebo.

Conclusions

The authors have concluded that Dapoxetine is an efficient and well-tolerated treatment for PE.

Conflicts in interest?

Some of the authors have since received honorary commendations from pharmaceutical laboratories.

Comments

PE is one the most frequent of all sexual dysfunctions in men. However, it is difficult to define individually because there can be no general, universal definition; the primary cause of PE relates to the duration of sexual intercourse (TLEI). Research was undertaken to determine the length of time that men suffering from the condition lasted during intercourse, with the average time lasting around 5.4 minutes and with no clear measure in establishing normality. Furthermore, some 0.5% of men had a duration time of 0.9 minutes and 2.5% lasted 1.3 min. Based on these results, some authors set a milestone marker for the average duration time of sufferers of PE: the minimum time being between one and one and a half minutes. It seems that the severity of the problem is primarily defined by the variety of psychological issues associated with it.

Antidepressants such as Clomipramine or other ISRS drugs are effective in delaying ejaculation in patients with PE, but other research suggests that the time elapsed between administering the medicine and sexual intercourse was too long. This in turned proved to be a handicap, and also provoked the aforementioned side effects that came with the drugs.

The ultimate conclusions that have been drawn from this study are that the ISRS drugs, such as Dapoxetine, are only useful for quick fixes and furthermore have a short lifespan. They have been proved to be useful medicines, but their side effects need to be taken into consideration. Outlining PE has also been tricky to define (TLEI<2min.).

Bibliography

  • Waldinger MD, Zwinderman AH, Schweitzer DH, Olivier B. Relevance of methodological design for the interpretation of efficacy of drug treatment of premature ejaculation: a systematic review and meta-analysis. Int J Impot Res 2004; 16: 369-381.
  • Waldinger MD. Towards evidence-based drug treatment research on premature ejaculation: a critical evaluation of methodology. Int J Impot Res 2003; 15: 309-313.
  • Waldinger MD. Lifelong premature ejaculation: definition, serotonergic neurotransmission and drug treatment. World J Urol 2005; 23: 102-108.

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