PRN Paroxetine for Premature Ejaculation
Abstract & Commentary
Synopsis: This study found that patients who are unwilling to use SSRIs on a daily basis for premature ejaculation, either due to cost or the desire to minimize side effects, may benefit from using paroxetine on an as-needed basis.
Source: McMahon CG, Touma K. Treatment of premature ejaculation with paroxetine hydrochloride as needed: 2 single-blind placebo controlled crossover studies. J Urol 1999; 161:1826-1830.
The current article reports data from two separate trials evaluating the efficacy of paroxetine hydrochloride (Paxil) given PRN for the treatment of premature ejaculation. Both trials were of single-blind, placebo-controlled, crossover design conducted in patients with premature ejaculation. In the second trial, the paroxetine-treated subjects received scheduled daily doses of the drug before changing to using paroxetine as needed before sexual intercourse.
The first study (n = 26) consisted of men (mean age, 39.5 years) who were randomized to receive paroxetine 20 mg or placebo, as needed, 3-4 hours before planned intercourse. The second study involved 42 men (mean age, 40.5 years) who were randomized to receive 10 mg of paroxetine or placebo, initially as daily treatment. In both studies, treatment was continued for four weeks followed by a three-week washout period and subsequent crossover to the other treatment arm. During both trials, subjects were given a diary to record sexual activity information such as frequency of coitus, quality of erection and orgasm, and ejaculatory latency time (measured with a stopwatch). In addition, patients were asked not to use condoms or topical penile anesthetic creams or sprays.
In the first study, there was no appreciable benefit noticed during the placebo phase, while ejaculatory latency times were significantly prolonged from a mean baseline of 0.3 minutes to a mean of approximately 3.5 minutes during active paroxetine treatment. Similar results were seen in the second study, where ejaculatory latency times were significantly prolonged from a mean baseline of 0.5 minutes to a mean of approximately 5 minutes in the active arms. The greater magnitude of response in the second study was hypothesized to be the result of the initial two-week daily administration of paroxetine. In both studies, the mean frequency of coitus increased in all active arm treatment periods, suggesting an improvement in sexual stimulation and satisfaction.
Paroxetine treatment was well tolerated overall, resulting in side effects in 17% of regularly scheduled paroxetine-treated subjects compared to 5% of placebo-treated subjects. No side effects were reported during the paroxetine as needed treatment arms, suggesting that regularly scheduled doses results in an increased likelihood of side effects (anorexia, anejaculation, gastrointestinal upset, and reduced libido) in addition to a greater magnitude of response. Erectile dysfunction was not reported in paroxetine-treated subjects; however, two placebo-treated subjects did experience this effect.
Comment by Michael F. Barber, PharmD
The results of the current studies are important for two reasons. First, while there have been reports of successful treatment of premature ejaculation with serotonergic antidepressants such as SSRIs and clomipramine, this is the first published report of the effectiveness of paroxetine used as needed before sexual intercourse. Patients who are unwilling to use SSRIs on a daily basis for premature ejaculation, either due to cost or the desire to minimize side effects, may benefit from using paroxetine on an as-needed basis. This is strikingly in contrast to the use of SSRIs for the treatment of depressive and anxiety disorders, in which regular daily dosing is necessary to attain and sustain the therapeutic effect of these agents. Second, this report underscores the magnitude of the class-wide effect of SSRIs in terms of their propensity to cause delayed ejaculation. This is easily the most common sexual side effect of SSRIs and should be discussed with patients who are initiated on such agents in order to facilitate patient adherence.
The current study supports the use of paroxetine for use in patients with premature ejaculation who do not wish to receive regularly scheduled daily doses. However, a theoretical problem that could arise during such a regimen are withdrawal symptoms in patients who are having intercourse on a daily basis and then stop using paroxetine for some period of time afterward. This could be prevented by discussing a tapering period with patients in whom paroxetine has been used daily for periods of time longer than a week, or by using SSRIs with a longer half-life.
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