Combination of Sertraline and Sildenafil versus Sertraline Monotherapy in the Treatment of Acquired Premature Ejaculation without Concomitant Diseases

Abstract

Objective: To determine the efficacy and safety of sertraline monotherapy and combination therapy with sertraline and sildenafil in the treatment of APE without concomitant diseases. Methods:The study was conducted in 120 outpatients diagnosed with APE but without concomitant diseases. These patients were randomly divided into two groups: group A was treated with 50 mg sertraline daily; group B was treated with 50 mg sertraline daily and 50 mg sildenafil as needed. Assessment of the efficacy and safety of the two therapies was performed after 4 and 8 weeks. Patient or partner reports of Intravaginal Ejaculatory Latency Time (IELT), Premature Ejaculation Profile (PEP), Clinical Global Impression of Change (CGIC), and Treatment-Emergent Adverse Events (TEAEs) were assessed in this study. All the assessments were compared in the two groups after the treatment period. The efficacy was assessed by IELT, PEP and CGIC. On the other hand, safety was assessed by TEAEs.Results: 112 participants completed the study voluntarily. The two groups were similar regarding demographics. At the end of study period, both groups had significant improvements in IELT and PEP measures compared with pretreatment (P<0.001). Compared with group A, group B had significantly greater values of IELT (7.20 ± 2.93 vs. 5.04 ± 2.79), PEP measures, and CGIC (subjects reporting at least 'better': 58.2% vs. 35.8%) (P<0.05 for all). Adverse effects including headache, flushing, etc. were found in both groups, and the total incidence was higher in group B than group A (31.7% vs. 23.3%, respectively), but the difference was not significant. All the adverse effects were mild and tolerated. Conclusion:Both sertraline monotherapy and combination therapy with sildenafil and sertraline were efficacious and safe in the treatment of APE without concomitant diseases. The combination therapy had a higher efficacy than sertraline monotherapy without more adverse effects.

Phosphodiesterase Type 5 Inhibitors for Premature Ejaculation: A Systematic Review and Meta-analysis

“…Four RCTs were described as single-blind or open-label and were considered at high risk of performance bias. [14–17] One RCT was considered at high risk of selective reporting as although IELT and secondary outcomes were assessed, IELT outcomes were not reported and secondary outcomes minimally reported (no data)[14]. One RCT was considered to be at overall high risk of bias as group allocation sequence was according to patients’ presentation at clinic[17].…”

“…[14–17] One RCT was considered at high risk of selective reporting as although IELT and secondary outcomes were assessed, IELT outcomes were not reported and secondary outcomes minimally reported (no data)[14]. One RCT was considered to be at overall high risk of bias as group allocation sequence was according to patients’ presentation at clinic[17]. One RCT was considered to be at overall high risk of bias as numbers withdrawing at six months were imbalanced, with >30% in one group and no indication whether these participants were included in the analysis or otherwise[16].…”

“…One RCT recruited men with both lifelong and acquired PE[19] and one RCT recruited only me with acquired PE. [17] The remaining RCTs recruited samples comprising men with lifelong PE. Where reported, men with erectile dysfunction (ED) were excluded.…”

Current and Emerging Treatments for Premature Ejaculation

“…The high level of correlation between improved erectile function with sildenafil and reduced severity of PE reported by Li et al [92] and the superior IELT fold increase observed with vardenafil compared with sertraline reported by Sommer et al indicate that PDE5i-related reduced PE severity is due to improved erectile function [77]. The IELT fold increase observed by Sommer et al with on-demand sertraline (4.4) is less than those reported in reviewed studies on men with normal erectile function (mean 5.57, range 3.0-8.5) [71,72,75,93], suggesting that men with PE and comorbid ED are less responsive to on-demand SSRIs and are best managed with a PDE5i alone or in combination with an SSRI.…”

“…This may be compounded by the presence of high levels of performance anxiety related to their ED, which serves to only worsen their prematurity. There is evidence to suggest that PDE5is alone or in combination with an SSRI may have a role in the management of A-PE in men with comorbid ED [71,72,75,77,[92][93][94][95][96].…”