scholarly journals Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature

2020 ◽  
Vol 91 (4) ◽  
pp. 205-210
Author(s):  
Gian Maria Busetto ◽  
Francesco Del Giudice ◽  
Daniele D'Agostino ◽  
Daniele Romagnoli ◽  
Andrea Minervini ◽  
...  

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated. Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH. Materials and methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs). Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients. Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.

2018 ◽  
Vol 16 (2) ◽  
pp. 35-39
Author(s):  
Md Saifuddin Ahmed Siddique ◽  
Sharmin Nahar Bashar ◽  
Farid Uddin Ahmed

Background: Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) are common in elder men and a number of drugs alone or in combination are clinically used for this disorder. To assess the efficacy and safety of combined Alfuzosin plus Finasteride, in patients with LUTS due to BHP.Methods: In this hospital-based, Quasi-experimental study (One-Group Pre test-Post test Design) without Control Groups, 30 consecutive patients were selected as per set criteria for medical management of BPH with combination of 10mg Alfuzosin and 5mg Finasteride, for 12-months, in the outpatient Department of Urology, in Chittagong Medical College Hospital. The primary efficacy criteria were improvement in symptoms (International Prostate Symptom Score (IPSS) peak urinary flow rate and reduction of prostate volume from baseline.Results: Combination therapy with Alfuzosin plus Finasteride was effective in improving the symptoms and peak urinary flow rate from the first follow-up visit (Day 90) in comparison to baseline score. The mean change in the IPSS from baseline at endpoint was 10±1.87 (p=0.001). The percentage increase in the peak urinary flow rate was 4.8 mL/s, compared with 11.0±1.82 mL/s at baseline (p=0.001). The patients’ quality of life also significantly improved. The percentage decrease in prostate volume at end point was 15.13±11.3 cc (p=0.001). Overall, this combination therapy was well tolerated. The incidence of orthostatic hypotension as determined by systematic blood pressure measurements was only 3(10%). No clinically relevant ejaculation disorders were observed.Conclusion: Alfuzosin plus Finasteride provides effective relief from the symptoms of benign prostatic hyperplasia by reducing the size of the prostate. It is well tolerated from a cardiovascular viewpoint and is not associated with abnormal ejaculation.Chatt Maa Shi Hosp Med Coll J; Vol.16 (2); July 2017; Page 35-39


2012 ◽  
Vol 40 (3) ◽  
pp. 899-908 ◽  
Author(s):  
K-J Joo ◽  
W-S Sung ◽  
S-H Park ◽  
W-J Yang ◽  
T-H Kim

OBJECTIVE: This study compared α-blocker monotherapy with combination therapy involving an α-blocker and a 5-α reductase inhibitor for benign prostatic hyperplasia (BPH), according to baseline prostate volume. METHODS: Korean men diagnosed with BPH were randomized to 12 months' treatment with 0.2 mg tamsulosin or 0.2 mg tamsulosin plus 0.5 mg dutasteride. Prostate specific antigen (PSA), prostate volume, transition zone volume (TZV), International Prostate Symptom Score (IPSS), maximal urinary flow rate ( Qmax), postvoid residual urine volume and sexual function were assessed at baseline and after 12 months' treatment. Variables were analysed based on baseline prostate volumes of ≤ 35 ml or > 35 ml. RESULTS: In total, 216 men with BPH were included. Combination therapy resulted in significant improvements in prostate volume, TZV, PSA, IPSS and Qmax, which were most pronounced in men with a prostate volume > 35 ml. CONCLUSIONS: Tamsulosin monotherapy was sufficient treatment for BPH in Korean men with a prostate volume ≤ 35 ml. Combination tamsulosin and dutasteride therapy provided greater benefits than tamsulosin monotherapy in men with BPH whose prostate volume was > 35 ml.


The Prostate ◽  
1998 ◽  
Vol 34 (2) ◽  
pp. 121-128 ◽  
Author(s):  
Alessandro Sciarra ◽  
Giuseppe D'Eramo ◽  
Paolo Casale ◽  
Andrea Loreto ◽  
Maurizio Buscarini ◽  
...  

2019 ◽  
Vol 13 (4) ◽  
pp. 155798831987038 ◽  
Author(s):  
Bing-Hui Li ◽  
Tong Deng ◽  
Qiao Huang ◽  
Hao Zi ◽  
Hong Weng ◽  
...  

The objective of this study was to evaluate association between body mass index (BMI) and prostate volume (PV), international prostate symptom scores (IPSS), maximum urinary flow rate ( Qmax), and post-void residual (PVR) of Chinese benign prostatic hyperplasia (BPH) patients. All newly diagnosed BPH patients between September 2016 and August 2018 were selected and 788 patients were included. According to BMI, the patients were categorized into four groups, while according to PV, IPSS, Qmax, and PVR, they were categorized into two groups based on clinical significant cutoffs. Univariable and multivariable logistic regressions and a restricted cubic spline (RCS) were applied to explore the relationship of BMI with categorical PV, IPSS, Qmax, and PVR. Compared with normal BMI, obesity presented significant association with increased risk of larger PV (>80 ml) in both unadjusted and adjusted models (unadjusted odds ratio [OR] = 1.772, 95% CI [1.201, 2.614], p = .004; adjusted OR = 1.912, 95% CI [1.212, 3.017], p = .005); however, underweight or overweight did not present a significant connection with such risk. No significant effect was identified for BMI on IPSS, Qmax, or PVR in either unadjusted or adjusted model. Nonlinear test including BMI using RCS and adjusting for confounders showed no significance ( p > .05); however, a significant linear relationship was ascertained between BMI and the risk of larger PV ( p < .001). In conclusion, there was a significant linear association between BMI and the risk of larger PV in BPH patients. Hence, this suggests urologists should consider both BMI and PV when providing surgical treatment for BPH patients.


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