The present study aimed to investigate prevalence of and reasons for selective serotonin reuptake inhibitor (SSRI) discontinuation, and compare the two most common SSRIs used in premature ejaculation (PE) treatment, in naturalistic settings (that is, outside clinical trials). The sample consisted of 132 Finnish men with a mean age of 42.5 years (s.d.=10.6) who had received medical treatment for lifelong PE. The men were enlisted for the study after identifying individuals from the third author’s (a physician specializing in sexual medicine) patient registry. Participants responded to a secure, online questionnaire. PE treatment-related side effects of, and discontinuation rates for, different SSRIs were retrospectively self-reported. Treatment efficacy and happiness with treatment were retrospectively self-assessed. Discontinuation rates were uniformly high, ranging from 28.8 to 70.6% between different SSRIs. Dapoxetine was associated with the highest dropout rates (70.6%), and paroxetine the lowest, discontinuation rates. Limited efficacy and side effects were the most common reasons for discontinuation. Paroxetine was more effective and better tolerated than dapoxetine. A considerable number of patients chose to spontaneously discontinue treatment, especially so in the case of dapoxetine, corroborating recent studies conducted in naturalistic settings. Further research efforts are necessary to develop new and improve existing PE treatment alternatives.
Premature ejaculation (PE) is regularly cited as the most common sexual complaint in men.1 Numerous different treatment approaches for PE have been proposed over the years, including psychotherapy,2 topical anesthetics (for example, Wyllie and Powell3) and acupuncture,4 often with varying degrees of treatment success. However, drug treatment, particularly with selective serotonin reuptake inhibitor (SSRI)-class drugs, has emerged as the first-choice treatment worldwide, even though SSRIs are typically prescribed off-label in many countries.5 Thus far, only one SSRI compound—dapoxetine—has been granted a marketing permit for PE treatment, and is currently available in several countries in Europe, as well as some countries in Asia, the Asia-Pacific region, and Central and South America.6 Paroxetine has, however, repeatedly been shown to be the most effective SSRI in terms of ejaculation-delaying potency,5, 7 and is commonly prescribed off-label as the preferred treatment alternative also in countries where dapoxetine is available. Other SSRI compounds have also been shown to possess similar ejaculation-delaying properties (for example, sertraline).5
SSRIs are associated with considerable variation in side effect profiles between individuals (for example, Osis and Bishop8), but the causal mechanisms underlying this variation are still largely unknown. Serotonin is involved in a vast number of physiological and psychological functions, regulating not only sexual response, but also mood, and biological functions such as digestion, electrolyte balance, cerebral blood flow and cell differentiation.9 Therefore, drugs that target the serotonergic system can be expected both to be non-specific in nature, as well as to induce non-specific side effects. Dizziness, tiredness and nausea are commonly reported (especially when beginning treatment), as are sexuality-related side effects such as loss of sexual interest, difficulty to achieve orgasm and erectile problems; (see for example, 5, 7, 10). In non-PE settings (that is, when used in treatment of mood disorders), sexual dysfunctions induced by SSRI treatment have been reported with moderate-to-high frequency, with prevalence estimates ranging from 20 to 70% of patients.10 Sexuality-related side effects also tend to be more persistent over the entire course of treatment, in contrast to other side effects such as headache and nausea, which will typically recede in a few weeks after treatment has begun.10 At present, little is known regarding why SSRIs appear to induce relatively strong side effects in some individuals, but not in others. It should be noted, however, that for the time being, SSRIs are generally considered to be well tolerated and safe in the context of PE treatment (see for example, 7, 11, 12, 13).
The aim of the present study was to investigate discontinuation rates and prevalence rates of side effects in a group of Finnish men diagnosed with PE and who had received SSRI treatment for its treatment. On the basis of the previous reports,14, 15 we expected higher dropout rates for dapoxetine than for paroxetine.
Materials and methods
Analyses were based on the responses of 132 men diagnosed with PE (hereafter: ‘PE patients’) (Mage=42.8, s.d.=10.7), who had information available on the instruments used, and who were receiving medical treatment for PE, or had received such treatment at some point but subsequently discontinued treatment. In total, we contacted 419 individuals who had sought treatment for PE at two clinics in Finland. These were identified from the third author’s patient registry. In total, 179 of those we approached responded (four did not wish to participate), and additional four invitation letters were unable to be delivered, suggesting that these individuals had moved or died shortly before the contact attempt, resulting in a final response rate of 43.3%. After excluding participants who had not received PE medication at any stage, the sample consisted of 149 men. In all, 17 of these 149 men had missing values on some questions inquiring about ejaculatory function (12 of whom had missing values on all questions), and were therefore excluded, resulting in the final sample of 132 men.
Data were collected in 2012. Before data collection, we obtained updated postal addresses from the Central Population Registry of Finland for all. Data were collected through a secure online connection following inquiries by postal mail with an invitation to participate in the study. All aspects of the study, including its voluntary nature, were readily explained in the invitation letter. Written informed consent was obtained from all. Participants were instructed to log onto the questionnaire using a personal, randomly generated eight-digit code. If a potential participant had not responded after 2 weeks from the initial contact, a reminder letter was sent. Participants were eligible to participate in a lottery, in which they could win one of three gift vouchers to a national travel agency.
The research plan was approved by the Ethics Committee of the Hospital District of South-West Finland in accordance with the 1964 Declaration of Helsinki.
Both of those who were currently using SSRIs to treat PE, and those who had discontinued SSRI treatment, were asked to indicate what kind of medication they were using (compound and dosage), and for how long (months) they had been using the medication in question.
As we were chiefly interested in side effects and discontinuation of medication in the present study, we enrolled men with clinician-diagnosed PE who were receiving or had previously been receiving pharmacological treatment for PE. For reference, we however decided to measure and report ejaculatory function; for this, we used the Checklist of Early Ejaculation Symptoms (CHEES16), a five-item questionnaire focusing on different aspects of ejaculatory function (ejaculatory latency, frustration relating to early ejaculation symptoms, ejaculatory control, ejaculation with little stimulation, and the extent of how ejaculatory swiftness causes difficulties in the relationship). This questionnaire, a composite measure of parts from three different PE questionnaires, has been shown to have very good reliability and validity, in addition to being adequate with regard to recent changes to PE diagnostic criteria in, for example, the DSM-5.16
The participants had a mean score of 20.39 (s.d.=2.87, min=12, max=25, variable range 5–25) on the CHEES instrument measuring ejaculatory function, in addition to having been diagnosed with lifelong PE by a physician specialized in sexual medicine. A score of >17 on this measure has been shown to be indicative of PE, whereas a score of >21 has been shown to be strongly indicative of PE but with a high false negative rate.16
The prevalence of 19 different side effects was measured on a 5-point Likert scale with the following response options: 1=not at all, 2=to some extent, 3=moderately, 4=much and 5=very much. The side effects inquired about were nausea, dizziness, diarrhea, headache, erectile dysfunction, sleeplessness, vomiting, anxiety, dry mouth, restlessness, nervousness, sweating, sleepiness, tiredness, low sex drive, stomach pain, confusion, weakness and swelling/bloating.
Satisfaction with treatment efficacy and reasons for discontinuation
Satisfaction with treatment efficacy was assessed with a single questionnaire item, ‘How happy have you been with the efficacy of the drug treatment?’ (participants who had discontinued medication were asked the same question in the past tense: ‘How happy were you...?’). Responses were given on a 5-point Likert scale with the response options 1=Very unhappy, 2=Quite unhappy, 3=Neither happy nor unhappy, 4=Quite happy and 5=Happy. Participants who were currently on SSRI medication were instructed to report reasons for possible unhappiness, and participants who had discontinued SSRI medication were instructed to report their reasons for discontinuing treatment, by giving a yes or no answer to one or more of the following statements ‘The medication’s efficacy is/was poor’; ‘The side effects are/were too severe’; ‘The medication is/was too expensive’; ‘Some other reason’. Individuals who indicated that were unhappy with their current treatment, or had discontinued treatment, for ‘some other reason’ were asked to describe the reason(s) in free form.
Statistical analyses and missing values
All statistical analyses were conducted using SPSS 21.0 (IBM, Corp., Armonk, NY, USA). Two individuals had missing values on the items measuring ejaculatory function before taking PE medication, and four individuals on the items measuring ejaculatory function during PE medication. Values were imputed for these individuals using information from other scales measuring ejaculatory function using the expectation maximization procedure in SPSS 21.0.
Medication type, treatment length, discontinuance rates and side effects
Of the participants, 44.7% (n=59) used or had used paroxetine, 38.6% (n=51) used or had used dapoxetine, 12.7% (n=16) some other SSRI (sertraline or escitalopram) and 4.5% (n=6) some other type of drug (for example, tramadol). Given the relatively small group sizes, we decided not to take the strength of medication into account (that is, whether the participant was using 30 or 60 mg tablets of, for example, dapoxetine). Furthermore, as dapoxetine and paroxetine are the most common SSRIs with which PE is treated,5, 7 and because prior research14, 15 gave reason to expect relatively high discontinuation rates for the two drugs, we chose to report results from these analyses separately for these two SSRI groups.
The mean time on medication was 13.3 months (s.d.=13.73). Overall, 53.0% (n=70) of the participants were currently on medication whereas 47.0% (n=62) had discontinued their medication. Discontinuing the medication was not related to the age of the participants (P =0.256). Figure 1 shows the discontinuance rates as a function of time on medication.
The decisions to discontinue were mostly taken relatively soon after onset of medication. In fact, nobody discontinued the medication after 30 months’ usage. The discontinuation rate was 70.6% for dapoxetine, 28.8% for paroxetine and 50.0% for other SSRIs. These differences were significant (χ2=19.13, P<0.001). Pairwise comparisons showed that the effect was due to a higher discontinuation rate among dapoxetine vs paroxetine users (P<0.001), whereas neither dapoxetine (P=0.130) nor paroxetine (P=0.111) users differed from the other SSRI group (note that only 17 individuals had used some other SSRI than dapoxetine or paroxetine).
Not surprisingly, those who had discontinued treatment were less satisfied (M=2.84, s.d.=1.23; scale 1=very dissatisfied, 5=very satisfied) with the efficacy of the medication compared with those who continued it (M=3.93, s.d.=1.03, t=5.55, P<0.001). However, it should be noted that on average, even participants who had discontinued their medication were not exceptionally unhappy with the medication’s efficacy (3 on the scale indicates being ‘neither happy nor unhappy’). Instead, prevalence of side effects showed a clearer difference between patients who continued and discontinued treatment in terms of reasons for dissatisfaction with treatment. Among those who persisted with treatment, 2.9% expressed concerns regarding too many side effects, compared with 37.1% of those who had discontinued treatment (χ2=25.11, P<0.001). Poor treatment efficacy was, however, the second most prevalent reason for discontinuation (continued 15.7%; discontinued 35.5%, χ2=6.85, P=0.009), followed by the medication being too expensive, although in this latter case, the difference between those who had continued and discontinued medication did not reach statistical significance (continued 4.3%; discontinued 12.9%, χ2=4.36, P=0.074). It is also noteworthy that a relatively large proportion of those currently receiving SSRI treatment (14.1%) were unhappy or very unhappy with the efficacy of the treatment.
Next, we looked in more detail the prevalence of side effects in the two groups. We included only participants on (any) SSRI medication in these analyses. Table 1 shows both the occurrence of side effects and how strong they were. The most prevalent side effects were nausea and dizziness, which were reported to some degree by more than a third of the participants. Some participants reported that the side effects of nausea, tiredness and diarrhea were very strong for them. There were some differences in side effects between those who had continued and those who had discontinued the medication. Nausea, anxiety, stomach pain, dizziness and vomiting were all more prevalent among those who had discontinued their medication, suggesting that these side effects were a stronger influence than other side effects on the decision to discontinue the medication. Low libido and erectile dysfunction were more prevalent among those who continued their medication. Length of time on medication was not related to the likelihood of the participants reporting the different side effects.
We then looked at whether the side effects differed between those using/having used paroxetine and those using/having used dapoxetine. For most side effects, there were no significant differences between dapoxetine and paroxetine users. Most significant differences between the two SSRI compounds were observed so that dapoxetine was associated with increased side effect prevalence. These were nausea (paroxetine 25.0%; dapoxetine 58.8%, χ2=13.53, P<0.001), headache (paroxetine 15.6%; dapoxetine 35.3%, χ2=5.96, P=0.015), vomiting (paroxetine 0%; dapoxetine 7.8%, χ2=5.20, P=0.023), dry mouth (paroxetine 23.4%; dapoxetine 45.1%, χ2=6.02, P=0.014), diarrhea (paroxetine 15.6%; dapoxetine 31.4%, χ2=4.02, P=0.045) and feeling weak or unsteady (paroxetine 3.1%; dapoxetine 31.4%, χ2=17.15, P<0.001). Paroxetine reported a slightly higher frequency of side effects compared with dapoxetine only in the case of erectile dysfunction, although this difference did not quite achieve statistical significance (paroxetine 23.4%; dapoxetine 9.8%, χ2=3.67, P=0.055).
Clinical trials with SSRIs, in general, frequently report markedly better treatment efficacy figures, lower dropout rates, and lower frequencies and reduced severity of side effects compared with ‘real world’ clinical estimations in naturalistic settings.8 Similarly, in the context of PE treatment, discontinuation rates have typically been low to moderate in later phases of clinical trials. For example, a recent, large-scale phase III trial with dapoxetine had discontinuation rates of about 5% or less,13 although in another similar trial, only 53% of the participants completed the entire study.10 Relatively few studies outside the clinical trial setting have been conducted with the specific aim to assess discontinuation rates in PE treatment with SSRI-class drugs, but such studies typically suggest that discontinuation rates are, in fact, high in naturalistic settings. For example, a recent study by Mondaini et al.14 showed that almost 90% of patients prescribed dapoxetine chose to discontinue treatment within 12 months (most dropping out within 3 months), citing adverse events and poor treatment efficacy as the primary reasons for discontinuation. In a study with a shorter follow-up span (6 months), Salonia et al.15 reported a dropout rate of about 31% in a study involving paroxetine. In the latter study, poor efficacy was the most cited (75%) reason for dropping out, followed by temporary loss of interest in sex (15%) due to relationship issues and side effects (10%).
In the present study, discontinuation rates were high among patients who had been prescribed SSRIs for PE treatment (47%), with dapoxetine users (70.6%) significantly more likely to discontinue medication than paroxetine (28.8%) users. Discontinuation rates in the present study largely corroborated previous reports from PE treatment studies in naturalistic settings (that is, 30% for paroxetine in Salonia et al.15 and 90% for dapoxetine in Mondaini et al.14). Salonia et al.15 noted that a substantial part of their patients refused to begin SSRI treatment in the first place, citing reluctance to take ‘antidepressants’ as the primary reason (effectively bringing the total non-compliance rate, that is, those who refused to begin paroxetine treatment and those who discontinued it within 3 months combined, up to 51%). It is possible that cultural factors pertaining to stigmatization of using antidepressant medication (both Mondaini et al. and Salonia et al. data were collected in Italy) could cause variation in dropout rates between studies conducted in different countries. In other contexts, such as treatment of mood disorders, relatively high but quite variable discontinuation rates for SSRIs have been reported in naturalistic settings, ranging from around 20%17 up to figures as high as 75%.18, 19
Dapoxetine is generally reported to be effective, well tolerated and safe (for example, McMahon20). However, the results of the present study, taken together with those reported by Mondaini et al.,14 suggest that dapoxetine could, in fact, be more unsuitable than other SSRIs in PE treatment. Although both the present study and that of Mondaini et al.14 were conducted on relatively small samples compared with most later-phase clinical trials (for example, Pryor et al.21), the discontinuation rates the two aforementioned studies reported from naturalistic settings must be considered remarkable. It is intriguing to speculate why such high rates of non-preference have not been discovered in the extensive clinical trials that have been conducted. Mondaini et al.14 suggested that large dropouts from SSRI treatment of PE are, at least in part, due to scepticism toward off-label prescriptions (that is, patients are more reluctant to take a drug that was not designed specifically to treat their particular problem), however this cannot be true for dapoxetine, which enjoys a marketing permit in Finland since 2009. However it is possible that patient-perceived social stigma associated with taking drugs of a class best known for treatment of psychiatric problems accounts for some dropout percentage. Another potential reason is that industry-funded research could generate results that overestimate the positive aspects of a drug, a finding that has been established in the literature (for a systematic review, see for example, Lexchin et al.22). Concerns have also previously been raised in the literature that dapoxetine may have been presented more favourably than off-label SSRIs in research papers.23 However, further studies in larger samples are required to draw definite conclusions regarding preference for dapoxetine in naturalistic settings.
The number of individuals who had used some other SSRI drug than paroxetine or dapoxetine was small in the present study, and therefore no comparisons involving other SSRIs than the aforementioned could be made. However, results from comparisons of different SSRIs in other contexts than PE have revealed that there appears to be differences between different SSRIs in terms of tolerability, suggesting higher discontinuation rates for paroxetine in comparison with, for example, sertraline and citalopram.18 This suggests that paroxetine—the most potent SSRI24—could still be more likely than other SSRIs to cause disabilitating side effects in PE treatment. Dapoxetine cannot be included in any similar comparison, as there are no reports, to our knowledge, for its use in any other context than PE treatment.
Most individuals who decided to discontinue medication did so relatively shortly after beginning treatment. In addition, side effects were common although generally mild, and patients who discontinued treatment experienced nausea, anxiety, stomach pain, confusion and vomiting with significantly elevated frequency compared with patients who did not discontinue medication. Interestingly, decreased sexual desire and erectile problems were significantly more common among individuals who continued SSRI medication, possibly suggesting that these problems are associated with long-term, continuous use (this finding was not explained by age effects). Dapoxetine users were more likely than paroxetine users to report nausea, headache, vomiting, dry mouth and weakness (possibly explaining the markedly higher discontinuation rate), whereas paroxetine users were more likely to report erectile dysfunction.
The present study had a relatively low response rate, although it is fully comparable to other sexuality-related survey studies (for example, Bailey et al.25). We also used retrospective recollection to gather data regarding side effects during treatment for those who had discontinued. As such, our data may be vulnerable to recollection bias. While individual reports of adverse events and their intensity may, perhaps, be especially vulnerable to recall bias, the prevalence patterns of side effects were similar between the present study and a large-scale summary of dapoxetine trials involving 1162 men from 22 countries10 (for example, so that nausea, dizziness and headache were among the top-five most commonly reported in both studies). In terms of the key study question, we consider it highly unlikely that recall bias would explain the reported discontinuation rates.
Another possible source of bias in the present study is selection bias. We had no raw data from clinical drug trials to our disposal when conducting the present study and as such, no statistical comparisons could be made to estimate possible confounding effects of selection. However, in terms of age, our study sample was very similar to a relatively recent summary of phase III dapoxetine trials,10 in which the mean age of participants varied from 39.6 to 40.5 years (42.5 years in the present study). Standard deviations for age were also similar (s.d.=9.53–9.98 in Buvat et al.10 and s.d.=10.6 in the present study). As shown in Table 2, ejaculatory function as measured by the Premature Ejaculation Profile26 was relatively similar between the present study and that of Buvat et al.10 as well, although the participants in the present study presented with more pronounced PE symptoms. The patients in the present study did, however, report more frequent side effects compared with Buvat et al.’s study.10 For example, 30.6% of those on a 60-mg dose of dapoxetine reported nausea in the drug trial, this figure was almost twice as high in the present study (58.2%). Similarly, 13.6% reported experiencing headaches in the dapoxetine trial (on the 60-mg dose), whereas the corresponding figure in the present study was 34.5%.
While it is likely that there are de facto differences between drug trial populations and a study population collected in naturalistic settings (for example, stringent exclusion criteria are typically imposed on drug trial populations, but patients presenting with PE will usually not be refused treatment if they present with comorbidities; drug trials typically present data only from patients who complete all parts of the study and may therefore overestimate drug tolerance rates). Therefore, data from naturalistic setting studies are important to consider regardless of similarity with drug trial cohorts, because they are likely a more accurate reflection of the actual clientele of patients that are encountered by clinicians in their day-to-day practice.
Furthermore, we were not able to compare the individuals who decided to participate in the present study with the individuals who did not participate, and as such, our study may be vulnerable to response bias. This is because our ethical research permit did not allow for involving any subject without informed consent. However, our results regarding discontinuation rates were very similar to previous studies conducted in naturalistic settings both for dapoxetine14 and for paroxetine,15 and the reasons for drug discontinuation were also similar between the present study and the two aforementioned, suggesting that our study population was representative.
In conclusion, while SSRI-class drugs certainly have ejaculation-delaying potency, they appear to be unsuitable for a relatively high number of patients judging from discontinuation rates, especially so in the case of dapoxetine. According to the literature, discontinuation rates and prevalence of side effects are consistently higher than reported in most clinical trials. Physicians treating PE pharmacologically are advised to keep up-to-date with the current psychopharmacological literature to stay on track regarding the latest reports of SSRI effects and side effects.
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This research was funded by Grant No. 138291, a personal post-doctoral research grant awarded to the first author, from the Academy of Finland. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
During the past 3 years, the third author (Dr Piha) has received financial compensation from Eli Lilly (lecturer, conducting scientific studies), Janssen-Cilag (conducting scientific studies), PharmaNord (lecturer, consultant) and MEDA (lecturer, consultant). None of the aforementioned have had any role in the present study, including data collection, preparation or analysis.
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Jern, P., Johansson, A., Piha, J. et al. Antidepressant treatment of premature ejaculation: discontinuation rates and prevalence of side effects for dapoxetine and paroxetine in a naturalistic setting. Int J Impot Res 27, 75–80 (2015). https://doi.org/10.1038/ijir.2014.37
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