Meta-Analysis of Efficacy and Safety of Tadalafil Plus Tamsulosin Compared with Tadalafil Alone in Treating Men with Benign Prostatic Hyperplasia and Erectile Dysfunction

Zhou, Zhongbao; Xiang, Zheng; Wu, Jitao; Gao, Zhenli; Xu, Zhunan; Cui, Yuanshan

doi:10.1177/1557988319882597

Cited by 11 publications

(18 citation statements)

References 28 publications

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“…Moreover, significantly higher incidences of pain were found in the combination group, relative to the tamsulosin group. However, the severity was mild or moderate and did not significantly affect the number of discontinuations due to AEs or pain, which was contrary to results from previous studies (Zhou et al, 2019). However, the included studies did not elaborate how the side effects arising from treatment were handled, which may lead to emotional fluctuation in patients during medication that could affect the final outcome.…”

Section: Discussionmentioning

confidence: 59%

“…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 a combination therapy ( Zhou et al, 2019 ). Furthermore, several discrepancies are evident regarding the number of randomized controlled trials (RCTs) included as well as analysis of outcome indicators.…”

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confidence: 99%

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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

Sun

Yao

et al. 2020

Am J Mens Health

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We report safety and efficacy of a 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 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 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.

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Section: Discussionmentioning

confidence: 59%

mentioning

confidence: 99%

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

Sun

Yao

et al. 2020

Am J Mens Health

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“…Despite the limitations of this study, the authors confirmed that, compared with tadalafil alone, combination therapy was associated with a significant improvement of total IPSS, QoL, and Qmax, with a more remarkable improvement of voiding IPSS. However, a higher rate of TEAEs and a higher discontinuation rate were recorded for combination therapy [ 36 ].…”

Section: Resultsmentioning

confidence: 99%

Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED

et al. 2020

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Purpose of Review Aim of our systematic review is to evaluate and summarize the efficacy and safety of tadalafil alone or in combination with tamsulosin for the management of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). Recent Findings Daily tadalafil, in particular 5 mg, according to retrieved studies, appears to be both safe and effective in treating LUTS/BPH and ED, compared with placebo or tamsulosin. The combination of daily tadalafil 5 mg and tamsulosin 0.4 mg allows a better improvement of LUTS compared with both the monotherapies, even if with an increased, but acceptable and tolerated, adverse events rate. After discontinuation of tamsulosin or tadalafil in patients previously treated with their combination, the improvement of LUTS retains significance compared with baseline. Summary Tadalafil 5 mg should be considered a primary treatment option for patients with LUTS/BPH and ED. Evidence highlight an excellent tolerability, safety, and effectiveness profile, both alone or in combination with tamsulosin 0.4 mg. A better efficacy on LUTS relief has been observed for combination therapy, preserving also sexual function. The further switch to monotherapy allows to preserve LUTS relief, but tadalafil only is able to retain ED improvement. Our results support the evidence for a more and more tailored and modular LUTS treatment.

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“…Recent meta-analyses comparing the effect of tamsulosin as a monotherapy and a cotherapy with tadalafil in improving LUTS/BPH, have concluded that cotherapy might be more suitable for patients than monotherapy ( 12 , 13 ). However, analyses of tadalafil 5 mg monotherapy administered once daily for the treatment of LUTS/BPH are rare.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of 12-week Monotherapy With Once Daily 5 mg Tadalafil for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: Evidence-based Analysis

et al. 2021

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Background: Tadalafil has been approved for the treatment of benign prostatic hyperplasia (BPH) for nearly 10 years. However, there are insufficient evidence-based studies of the efficacy and safety of tadalafil in treating lower urinary tract symptoms of BPH (LUTS/BPH).Objective: To evaluate the therapeutic effect and clinical safety of tadalafil monotherapy (5 mg once daily for 12 weeks) for LUTS/BPH.Methods: A total of 13 studies (15 randomized clinical trials [RCTs]) were extracted from the following databases: PubMed, Cochrane Central Register of Controlled Trials, Embase, and Web of Science for the period up to July 2021. The quality of the included RCTs was evaluated independently by two authors, who, respectively, extracted data according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses principles. Conflicts were settled by a discussion with two-third of senior authors. All data analyses were conducted by the Review Manager, version 5.4.Results: Regarding efficacy, 12-week trials indicated that 5 mg once daily tadalafil showed a significantly lower and, consequently, better total International Prostate Symptom Score (IPSS) than the placebo did (mean difference [MD]: −1.97, 95% CI: −2.24 to −1.70; P < 0.00001). In addition, significant differences were found between the tadalafil regimen and the placebo in the IPSS voiding subscore (MD: −1.30, 95% CI: −1.48 to −1.11; P < 0.00001), the IPSS storage subscore (MD: −0.70, 95% CI: −0.82 to −0.58; P < 0.00001), the IPSS quality of life (MD: −0.29, 95% CI: −0.35 to −0.22; P < 0.00001), and BPH impact index (MD: −0.58, 95% CI: −0.76 to −0.40; P < 0.00001). The safety analysis did not show a significant difference in serious adverse events between the two groups (risk ratio: 1.27, 95% CI: 0.80–2.01; P = 0.31), although the adverse events occurred at a higher incidence in the tadalafil group than in the placebo.Conclusions: This study demonstrates that once daily 5 mg tadalafil is a potentially effective and safe treatment choice with excellent tolerability for patients with LUTS/BPH.Systematic Review Registration: Identifier (CRD42021228840).

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Meta-Analysis of Efficacy and Safety of Tadalafil Plus Tamsulosin Compared with Tadalafil Alone in Treating Men with Benign Prostatic Hyperplasia and Erectile Dysfunction

Cited by 11 publications

References 28 publications

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

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

Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED

Efficacy and Safety of 12-week Monotherapy With Once Daily 5 mg Tadalafil for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: Evidence-based Analysis

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