EVALUATION OF ORAL PREGABALIN IN TREATMENT OF PREMATURE EJACULATION

Background: Premature ejaculation (PE) is the most common form of male sexual dysfunction. Treatment modalities include behavioral therapy and medical therapy. No therapy is approved by the FDA for treatment of PE. Pregabalin exerts a negative effect on sexuality by reducing central nervous excitatory transmission via sodium and calcium channel inhibition and potassium (k) channel activation and by unbalancing dopamine serotonine ratio. The aim of this work was to assess the efficacy and safety of oral on demand pregabalin in treatment of premature ejaculation (PE).Methods: This study was conducted on 96 married male patients with primary premature ejaculation (lifelong). All patients were recruited from the andrology outpatient clinic at Al-Azhar University Hospitals (Cairo).The patients were randomly assigned to three groups: Group A: This group included 36 patients. They will receive 150 mg pregabalin 1 – 2 hours prior to sexual intercourse. Group B: This group included 30 patients. They will receive 75 mg pregabalin 1 – 2 hours prior to sexual intercourse. Group C: This group included 30 patients, all of them received identical placebo capsules. All patient will be subjected to the following:Full history: including age, baseline estimated ILET, erectile dysfunction, medical diseases and medications. Local and general physical examination. Couples were encouraged to engage in coitus twice a week and record estimated intravaginal ejaculation latency time (perceived IELT OR PIELT) every time for 2 weeks and report any side effects suspected to be drug related. Results: There was no statistically significant difference between group A, B and C regarding base PIELT. PIELT significantly increased after treatment in group A receiving 150 mg pregabalin. Patients in group B showed mild improvement in their PIELT after receiving 75 mg pregabalin. This improvement was statistically significant. There was no statistically significant difference between Base PIELT and PIELT after treatment among group C patients. There was statistically significant difference between group A and C regarding after treatment PIELT. There was no statistically significant difference between group B and C regarding PIELT after treatment. Comparing post treatment ejaculatory time in different groups, PIELT significantly improved in group A rather than placebo group. This was not present in group B. There was significant improvement in PIELT of group A rather than group B. Conclusion: This is the first report of an oral pregabalin used for the treatment of PE in men. On demand oral pregabalin 150 mg 1 – 2 hours prior to sexual relation, looks to be effective pharmacotherapy of PE. The effect of pregabalin is minimal and may be augmented with higher daily doses. Longer-term safety studies, and those comparing pregabalin with on demand tramadol and dapoxetine are essential to determine the place of pregabalin in the treatment of this distressing condition.