madman
Super Moderator
Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED
A. Sebastianelli & P. Spatafora & S. Morselli & L. Vignozzi & S. Serni & K. T. McVary & S. Kaplan & S. Gravas & C. Chapple & Mauro Gacci
Abstract
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 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 for the preservation of 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.
Introduction
The strong correlation between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has now emerged from several preclinical and clinical trials [1]. LUTS due to benign prostatic hyperplasia (BPH) has been recognized as an independent risk factor for ED, thus contributing to the worsening of quality of life (QoL) in the male population [1]. Moreover, medical treatments for LUTS/BPH are able to significantly impact sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED has been widely reported in patients treated with alpha-blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH [2, 3].
Phosphodiesterase type 5 inhibitors (PDE5is) represent the gold standard for the treatment of ED. Moreover, PDE5is proved to be effective also for the treatment of LUTS in several preclinical and clinical trials, since they were found to be able to increase oxygenation and blood supply, reduce intraprostatic inflammation, and reduce the smooth muscle tone of the lower urinary tract [4–7]. Indeed, PDE5 was demonstrated to be highly expressed not only in penile corpora cavernosa but also in the male bladder, urethra, and prostate [8–10]. Noteworthy, tadalafil 5 mg once daily has been approved and more and more prescribed in the last years as a valuable treatment option for patients complaining LUTS with or without comorbid ED [2, 4–7]. The efficacy of PDE5is on LUTS relief has been evaluated also in combination with ABs. Currently, the only AB approved by the Food and Drug administration for combination treatment with tadalafil is tamsulosin, since a favorable additive effect compared with monotherapy has been proven both on sexual function (increase of International Index of Erectile Function (IIEF) score) and LUTS due to BPH (improvement of International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax)) [11].
Tamsulosin is one of the most prescribed α1-blockers as first-line therapy for LUTS associated with a benign prostatic enlargement (BPE) or obstruction (BPO) and one of the leading comparators in clinical trials. Therefore, the opportunity to treat both ED and LUTS by using tadalafil alone or in combination with tamsulosin may allow new and more and more tailored therapeutic strategies. However, the balance between efficacy and tolerability represents the crucial point for the treatment of LUTS due to BPH and ED [12].
Conclusions
In conclusion, daily tadalafil, in particular at a dosage of 5 mg, is effective for the treatments of LUTS/BPH and ED. All the available evidence shows that the occurrence of TEAEs is low and most of the patients are “satisfied” by this treatment. Combination therapy of tadalafil 5 mg and tamsulosin 0.4 mg allows a further improvement of urinary symptoms and ED, against a higher rate of TAEs. Discontinuation of tamsulosin or tadalafil, after combination therapy, seems to allow preservation of the results obtained for LUTS relief. However, tadalafil only is able to retain ED improvement.
A. Sebastianelli & P. Spatafora & S. Morselli & L. Vignozzi & S. Serni & K. T. McVary & S. Kaplan & S. Gravas & C. Chapple & Mauro Gacci
Abstract
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 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 for the preservation of 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.
Introduction
The strong correlation between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has now emerged from several preclinical and clinical trials [1]. LUTS due to benign prostatic hyperplasia (BPH) has been recognized as an independent risk factor for ED, thus contributing to the worsening of quality of life (QoL) in the male population [1]. Moreover, medical treatments for LUTS/BPH are able to significantly impact sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED has been widely reported in patients treated with alpha-blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH [2, 3].
Phosphodiesterase type 5 inhibitors (PDE5is) represent the gold standard for the treatment of ED. Moreover, PDE5is proved to be effective also for the treatment of LUTS in several preclinical and clinical trials, since they were found to be able to increase oxygenation and blood supply, reduce intraprostatic inflammation, and reduce the smooth muscle tone of the lower urinary tract [4–7]. Indeed, PDE5 was demonstrated to be highly expressed not only in penile corpora cavernosa but also in the male bladder, urethra, and prostate [8–10]. Noteworthy, tadalafil 5 mg once daily has been approved and more and more prescribed in the last years as a valuable treatment option for patients complaining LUTS with or without comorbid ED [2, 4–7]. The efficacy of PDE5is on LUTS relief has been evaluated also in combination with ABs. Currently, the only AB approved by the Food and Drug administration for combination treatment with tadalafil is tamsulosin, since a favorable additive effect compared with monotherapy has been proven both on sexual function (increase of International Index of Erectile Function (IIEF) score) and LUTS due to BPH (improvement of International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax)) [11].
Tamsulosin is one of the most prescribed α1-blockers as first-line therapy for LUTS associated with a benign prostatic enlargement (BPE) or obstruction (BPO) and one of the leading comparators in clinical trials. Therefore, the opportunity to treat both ED and LUTS by using tadalafil alone or in combination with tamsulosin may allow new and more and more tailored therapeutic strategies. However, the balance between efficacy and tolerability represents the crucial point for the treatment of LUTS due to BPH and ED [12].
Conclusions
In conclusion, daily tadalafil, in particular at a dosage of 5 mg, is effective for the treatments of LUTS/BPH and ED. All the available evidence shows that the occurrence of TEAEs is low and most of the patients are “satisfied” by this treatment. Combination therapy of tadalafil 5 mg and tamsulosin 0.4 mg allows a further improvement of urinary symptoms and ED, against a higher rate of TAEs. Discontinuation of tamsulosin or tadalafil, after combination therapy, seems to allow preservation of the results obtained for LUTS relief. However, tadalafil only is able to retain ED improvement.
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