PE Treatment - Dapoxetine

[ Treatment ]


Dapoxetine is a new compound which has been the subject of much investigation because of the promise that it holds for the drug treatment of PE. In one study by Pryor and Althhof, over 2600 men with PE underwent a 12 week treatment period, during which their IELT (intra vaginal ejaculatory latency time) was measured by using a stop watch -- being held by the sexual partner! You may think that this investigation methodology leaves a considerable amount be desired, nonetheless since all men were using the same method it is indicative of the success or failure of the treatment.

After a two-week baseline period, men were divided into groups with either placebo or Dapoxetine prescribed in 30 or 60 mg doses on an "as needed" basis for three months. The investigators questioned the men about the feelings they had of control over ejaculation and the level of satisfaction they experienced with sexual intercourse.

There was a significant difference between the treatment groups, in that the IELT improved from 0.9 to 1.75 minutes in the placebo group, 0.92 to 2.78 minutes in the 30 mg Dapoxetine group, and 0.91 to 3.32 minutes in the 60 mg Dapoxetine group.

Men receiving both 30 and 60 mg Dapoxetine were significantly better in increasing IELT after the first dose. Unfortunately, side-effects included nausea (almost 10% of men taking the 30 mg dose, and 20% of the men taking the 60 mg dose), headaches, diarrhea and dizziness. It seems unlikely that the medication is going to be licensed for use in this context in the near future in the USA.

As I have said many times, the only evidence that is worth anything for the effectiveness of premature ejaculation treatment is evidence-based medical studies. Indeed, where you are using a drug such as Dapoxetine, it's absolutely essential to conduct these studies. We also know that premature ejaculation is a major issue among men it's certainly the most common male sexual dysfunction, although there is considerable disagreement about how prevalent it may be stop nonetheless, for the majority of men who have it, premature ejaculation causes emotional distress and a reduced quality of sexual pleasure. It can also adversely impact on a man's relationship with his partner, because women frequently experience feelings of anger or inadequacy, sometimes coming to the conclusion that their partner does not love them, particularly if he cannot be bothered to gain some degree of control over his ejaculation.

Historically, premature ejaculation has been treated with some kind of talking therapy, either cognitive therapy, behavioral therapy, or by some kind of premature ejaculation exercise, together with sensate focus, the squeeze technique and the stop start technique. You can imagine therefore, what a revelation it was when the observation was made that SSRI antidepressants selective serotonin reuptake inhibitors usually used to treat depression another psychological disorders, had an impact on ejaculation time. Early work on compounds such as Prozac demonstrated the inadequacy of these compounds for either on demand or routine administration as a method of controlling ejaculatory latency. Johnson & Johnson set to work with the vigor, and developed a compound known as Dapoxetine, marketed as Priligy in Europe, specifically for the treatment of premature ejaculation. The question is, does it work? Does it actually provide enough benefit to justify prescribing it for sexual dysfunction?

McCarty and Dinsmore, of the Royal Victoria Hospital, Belfast, conducted an evidence-based review of the effectiveness of Dapoxetine in the treatment of premature ejaculation. To sum up their results: they concluded there was "substantial" evidence that administration of Dapoxetine in either 30 mg or 60 mg dosage, taken on demand, significantly improved intravaginal ejaculatory latency time. The greater control over ejaculation which men reported when taking this drug apparently produces more satisfaction with sex, no doubt greater self-esteem, and significantly less interpersonal conflict. They concluded by observing that the pharmacology of Dapoxetine is such that it is an ideal "on demand" drug for this sexual dysfunction. Let's look at the data.

First of all, let's look at the summary of the pharmacology of Dapoxetine, as reported from this meta-analysis of published studies in this area. Dapoxetine is claimed to be rapidly absorbed after oral administration, the peak levels of the compound in the bloodstream being reached one hour after administration, with a short initial half life of 1.4 hours. Its terminal half life is just under 19 hours, and it doesn't appear to accumulate in the body. So, yes, on the face of it, this looks like a reasonable compound for men who want to extend intravaginal ejaculatory latency time (IELT) during sexual intercourse. IELT is actually the only reasonable measure of improvement in ejaculatory latency, consisting as it does of the time between information and ejaculation.

By looking at studies which recruited men with premature ejaculation, as defined by an IELT of less than or equal to 2 minutes in at least three quarters of their sexual attractions with their partners, it was found that the mean IELT significantly increased in all men after treatment with either 30 mg 60 mg doses of Dapoxetine. And indeed, when you say that 30 mg of Dapoxetine can increase the time for which man can make love before he ejaculates by three times, it certainly does look very impressive. The point is, however, that you have to remember that we're talking about an increase from roughly about 1 minute of lovemaking prior to ejaculation to around 3 minutes of lovemaking. Therefore, in absolute terms, even though this seems to be a dramatic improvement, the absolute time for which a man can make love when he's on these fairly "heavy duty" medications is still not actually very impressive.

In many studies, it's commonplace to actually use a questionnaire to give a qualitative assessment of how men with rapid ejaculation actually perceive their sexual performance. One of the most common tools used for this is the premature ejaculation profile, a validated tool designed to investigate various characteristics of PE and work out how effective the treatment has been. There are several items on which men give a score to themselves on a five-point scale for example, perceived control over ejaculation, personal distress related to early ejaculation, relationship difficulties, and satisfaction with sex. The administration of Dapoxetine produced self-reported improvements in control over ejaculation for example the number of men who reported that they had "good" control over their ejaculation after 12 weeks of taking Dapoxetine increased from 0.6% to 26.2% if this study.

Now, you may call me cynical but I don't think this is actually too impressive. I acknowledge that for those men and their partners who are experiencing very troublesome early ejaculation, these may seem to be massive improvements, but compared to, let's say, just for example, the staying power needed to enable the woman to reach orgasm through vaginal penetration and thrusting, they're not that impressive. Nonetheless, even the partners of the men in these investigations reported that they were significantly more satisfied with sexual intercourse after the Dapoxetine treatment had been administered to their male partners. There is a direct correlation between perceived control over ejaculation and satisfaction with intercourse hardly surprising, it has to be said, but nonetheless significant.

Clearly women, who appreciate feeling the intimate connection of lovemaking, will also appreciate any increase in the duration of sex, and regard it as a significant improvement in the quality of intercourse. And indeed, with long-term, on demand, use of Dapoxetine, at the higher dose of 60 mg, more than 80% of men reported that they were at least "fairly" satisfied with sexual intercourse after nine months. Needless to say, there are similar findings related to personal distress and interpersonal difficulty. But for me, the point is not so much whether or not Dapoxetine actually improves sex it clearly does to some degree. For me, the question is more about the consequences or side effects of taking SSRIs for a sexual dysfunction, and the limited improvements that are achieved, at least in comparison to the potential inherent in human sexual expression.

To conclude, as the authors of this study do, that oral Dapoxetine is "indicated for the treatment of men aged 18 to 64 years with premature ejaculation" seems a little premature (pun not intended). Furthermore, Dapoxetine is contraindicated in anybody who has liver problems, and among those who are taking what turns out to be a fairly significant list of other medications. Leaving all of that aside, it's worth pointing out that while Dapoxetine appeared to bring about a threefold increase in IELT, a simple placebo resulted in a twofold increase, which undermines the superficially impressive benefits of taking this drug.

Side effects of Dapoxetine include nausea and dizziness, and occasionally adverse cardiovascular events.