Men who take dapoxetine (DPX) for premature ejaculation appear to have low rates of treatment emergent adverse events (TEAEs), according to new research published in The Journal of Sexual Medicine.
TEAEs are side effects that occur after the start of treatment.
Dapoxetine, a selective serotonin reuptake inhibitor (SSRI), has been approved in over 60 countries for treatment of premature ejaculation. Unlike other SSRIs, the drug is known to work quickly and can be used on an on-demand basis, which might reduce rates of adverse events compared to other SSRIs.
While dapoxetine is believed to have a good safety profile, more research on TEAEs was needed.
To that end, a team of researchers from Italy investigated further.
As part of a larger project called the PAUSE study, the research specifically examined “adverse events of special interest,” which include effects on mood, neurocognitive function, the cardiovascular system, the urogenital system and sexual function, accidental injury, and abnormal bleeding.
The study involved 7,545 men from seven European countries. All of the men had premature ejaculation, and their mean age was 40.5 years.
Over twelve weeks, 6128 patients took at least one dose of dapoxetine (30-60 mg). The remaining 1,417 patients took an alternative oral treatment (AOT), such as other SSRIs and phosphodiesterase type 5 inhibitors, which are often prescribed for erectile dysfunction.
Almost 11% of the men taking dapoxetine discontinued its use. For the AOT group, the discontinuation rate was almost 7%. Overall, however, 1% of the men who dropped out did so because of TEAEs.
Patients in the AOT group had a higher rate of TEAEs of special interest, particularly in the neurocognitive-related, mood-related, and urogenital/sexual function categories. Incidence rates of cardiovascular TEAEs were higher in the dapoxetine group (1.6%) than in the AOT group (1.3%).
The authors noted that men taking dapoxetine had “high treatment adherence.”
“Data from this large, observational, multinational post-marketing study have demonstrated that DPX has an overall favorable safety profile, with significantly fewer [adverse events] related to mood, neurocognition, urogenital/sexual dysfunction, when compared to AOT” they added.
Resources
The Journal of Sexual Medicine
Verze, Paolo, MD, PhD, et al.
“Comparison of Treatment of Emergent Adverse Events in Men With Premature Ejaculation Treated With Dapoxetine and Alternate Oral Treatments: Results From a Large Multinational Observational Trial”
(Full-text. February 2016)
http://www.jsm.jsexmed.org/article/S1743-6095(15)00052-1/fulltext