madman
Super Moderator
Efficacy and Safety of Combination Comprising Tamsulosin and PDE5-Is, Relative to Monotherapies, in Treating Lower Urinary Tract Symptoms and Erectile Dysfunction Associated With Benign Prostatic Hyperplasia: A Meta-Analysis
Abstract
We report the safety and efficacy of combination therapy, comprising tamsulosin and phosphodiesterase type 5 inhibitors (PDE5-Is), relative to monotherapy, to ascertain its potential in treating lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) secondary to benign prostatic hyperplasia (BPH) after 3 months’ treatment. We screened MEDLINE, EMBASE, and the Cochrane Controlled Trials Register databases, for randomized controlled trials, and obtained eight articles comprising 1144 participants. Results showed that the combination group had superior outcomes with regard to International Prostate Symptom Score (IPSS) and Qmax, compared to the other two groups. The combination group also had superior efficacy with regard to the International Index of Erectile Function (IIEF) than the tamsulosin group, but not over the PDE5-Is group. Further, the combination group showed better efficacy in IPSS voiding and quality of life (QoL) compared to the PDE5-Is group. An analysis of safety outcomes revealed extremely high adverse events (AEs) and pain in the combination group. However, therapy discontinuation due to pain and AEs did not increase with the increase in AEs. Overall, our findings indicate that a combination of tamsulosin and PDE5-Is is superior to individual tamsulosin and PDE5-Is monotherapy, with regard to improving LUTS and ED secondary to BPH.
Benign prostatic hyperplasia (BPH), distinguished by hyperplasia of smooth muscles and epithelial cells in the transitional part of the prostate is one of the most popular geriatric diseases, whose incidence rises with age (Laumann et al., 2007; Olesovsky & Kapoor, 2016; Zhang & Park, 2015). Generally, BPH clinically manifests as lower urinary tract symptoms (LUTS), mainly nocturia, urine flow interruption, and susceptibility to acute urinary retention (AUR), among others. In addition, the disease is also associated with erectile dysfunction (ED) and ejaculatory dysfunction (Anderson et al., 2001; Rosen, 2006; Vallancien et al., 2003). Previous studies have reported a strong correlation between severe LUTS and ED (El-Sakka, 2006). Based on this, we will focus on ED-related clinical therapies during LUTS treatment. Alpha-1 adrenoceptor antagonists (represented by tamsulosin) represent the first-line drug used for managing BPH-related LUTS, with its role in the management of ED also being explored (Hofner et al., 1999). Previous research has applied phosphodiesterase type 5 inhibitors (PDE5-Is; represented by tadalafil, sildenafil, vardenafil), for ED management, and reported their efficacy in relieving BPH-related LUTS (Andersson et al., 2011; Chapple et al., 2015). A combination of tamsulosin and PDE5-Is has also been tested, owing to their complementary action during the treatment of LUTS and ED. This therapy has gained considerable attention.
To date, three meta-analyses have demonstrated the efficacy of tamsulosin or PDE5-Is alone in alleviating LUTS and ED (Laydner et al., 2011; Liu et al., 2011; Zhang et al., 2019). However, only one has described the efficacy of combination therapy (Zhou et al., 2019). Furthermore, several discrepancies are evident regarding the number of randomized controlled trials (RCTs) included as well as the analysis of outcome indicators. One of the reasons may be a language barrier, since restrictions on the English language may hamper adequate interpretation of results. Therefore, we sought to comprehensively evaluate the efficacy and safety of a combined therapy comprising tamsulosin and PDE5-Is, relative to respective monotherapies, for treatment of BPH-related LUTS and ED after 3 months of treatment using a meta-analysis.
Conclusion
The combination therapy exhibited superior efficacy in treating BPH-related LUTS and ED, compared to tamsulosin and PDE5-Is monotherapies. Although the combination therapy generated a higher incidence of AEs than monotherapies, the effects were not severe and could be well tolerated.
Abstract
We report the safety and efficacy of combination therapy, comprising tamsulosin and phosphodiesterase type 5 inhibitors (PDE5-Is), relative to monotherapy, to ascertain its potential in treating lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) secondary to benign prostatic hyperplasia (BPH) after 3 months’ treatment. We screened MEDLINE, EMBASE, and the Cochrane Controlled Trials Register databases, for randomized controlled trials, and obtained eight articles comprising 1144 participants. Results showed that the combination group had superior outcomes with regard to International Prostate Symptom Score (IPSS) and Qmax, compared to the other two groups. The combination group also had superior efficacy with regard to the International Index of Erectile Function (IIEF) than the tamsulosin group, but not over the PDE5-Is group. Further, the combination group showed better efficacy in IPSS voiding and quality of life (QoL) compared to the PDE5-Is group. An analysis of safety outcomes revealed extremely high adverse events (AEs) and pain in the combination group. However, therapy discontinuation due to pain and AEs did not increase with the increase in AEs. Overall, our findings indicate that a combination of tamsulosin and PDE5-Is is superior to individual tamsulosin and PDE5-Is monotherapy, with regard to improving LUTS and ED secondary to BPH.
Benign prostatic hyperplasia (BPH), distinguished by hyperplasia of smooth muscles and epithelial cells in the transitional part of the prostate is one of the most popular geriatric diseases, whose incidence rises with age (Laumann et al., 2007; Olesovsky & Kapoor, 2016; Zhang & Park, 2015). Generally, BPH clinically manifests as lower urinary tract symptoms (LUTS), mainly nocturia, urine flow interruption, and susceptibility to acute urinary retention (AUR), among others. In addition, the disease is also associated with erectile dysfunction (ED) and ejaculatory dysfunction (Anderson et al., 2001; Rosen, 2006; Vallancien et al., 2003). Previous studies have reported a strong correlation between severe LUTS and ED (El-Sakka, 2006). Based on this, we will focus on ED-related clinical therapies during LUTS treatment. Alpha-1 adrenoceptor antagonists (represented by tamsulosin) represent the first-line drug used for managing BPH-related LUTS, with its role in the management of ED also being explored (Hofner et al., 1999). Previous research has applied phosphodiesterase type 5 inhibitors (PDE5-Is; represented by tadalafil, sildenafil, vardenafil), for ED management, and reported their efficacy in relieving BPH-related LUTS (Andersson et al., 2011; Chapple et al., 2015). A combination of tamsulosin and PDE5-Is has also been tested, owing to their complementary action during the treatment of LUTS and ED. This therapy has gained considerable attention.
To date, three meta-analyses have demonstrated the efficacy of tamsulosin or PDE5-Is alone in alleviating LUTS and ED (Laydner et al., 2011; Liu et al., 2011; Zhang et al., 2019). However, only one has described the efficacy of combination therapy (Zhou et al., 2019). Furthermore, several discrepancies are evident regarding the number of randomized controlled trials (RCTs) included as well as the analysis of outcome indicators. One of the reasons may be a language barrier, since restrictions on the English language may hamper adequate interpretation of results. Therefore, we sought to comprehensively evaluate the efficacy and safety of a combined therapy comprising tamsulosin and PDE5-Is, relative to respective monotherapies, for treatment of BPH-related LUTS and ED after 3 months of treatment using a meta-analysis.
Conclusion
The combination therapy exhibited superior efficacy in treating BPH-related LUTS and ED, compared to tamsulosin and PDE5-Is monotherapies. Although the combination therapy generated a higher incidence of AEs than monotherapies, the effects were not severe and could be well tolerated.
