The Efficacy and Safety of Dutasteride and Finasteride in Patients With Benign Prostatic Hyperplasia

A Systematic Review and Meta-Analysis

Yao Li; Jie Ma; Xin-Hua Qin; Chuan-Yi Hu


Transl Androl Urol. 2022;11(3):313-324. 

In This Article


BPH is a common disease in men over 50 years old, and its incidence increases with age.[18] The main clinical manifestations of BPH are lower urinary tract symptoms, enlarged PV, decreased peak urine flow, high IPSS score, and increased serum PSA.[19] DHT whose formation is catalyzed by the enzyme 5α-R, plays a vital role in the progression of BPH.[20,21] 5α-R inhibitors can effectively reduce the concentration of DHT in the prostate and promote prostate smooth muscle contraction.[22–24] As 5α-R inhibitors, dutasteride and finasteride are mainly used to improve the symptoms of prostatic hyperplasia. 5α-R is a protease that can convert testosterone to DHT and accelerate the progression of prostate hyperplasia. It has two isoenzymes. Dutasteride is a selective inhibitor of both type I and type II isoenzymes of 5α-R, whereas finasteride selectively inhibits the type II isoform.[25] Although the efficacy of monotherapy has been established clinically,[26,27] the efficacy of the two drugs has not been compared. Therefore, this study systematically examined and compared the efficacy of the two drugs in the treatment of BPH with a meta-analysis.

Eight RCTs involving 2,116 participants were included to compare the efficacy of dutasteride (0.5 mg/day) versus finasteride (5 mg/day) in the treatment of BPH over a period of 6 months. The meta-analysis showed that compared with finasteride, dutasteride could effectively improve Qmax in patients with BPH [MD =0.32; 95% CI: (0.01, 0.63); P=0.04], and the difference was statistically significant. IPSS [MD =0.13; 95% CI: (−0.55, 0.82); P=0.70], PV [MD =−1.25; 95% CI: (−3.30, 0.79); P=0.23), QOL [MD =−0.44; 95% CI: (−0.93, 0.05); P=0.08], serum PSA level [MD =−0.04; 95% CI: (−0.15, 0.07); P=0.5] and the occurrence of ADRs [RR =−0.01; 95% CI: (−0.05, 0.04); P=0.72] showed no significant difference between the two groups. Thus, dutasteride is more effective than finasteride for improving the maximum urine flow rate in patients with BPH. No significant difference was found between dutasteride and finasteride in improving symptoms, PV, reducing PSA level and QOL, or the occurrence of ADRs. Dutasteride is an effective treatment for BPH. Qmax represents the maximum urine flow rate of patients with prostatic hyperplasia, indicating the degree of prostatic hyperplasia, such as BPH.[28,29] Our results showed that dutasteride effectively improved Qmax in patients with BPH compared with finasteride [MD =0.32; 95% CI: (0.01, 0.63); P=0.04]. This suggests that dutasteride may be superior to finasteride in improving Qmax in BPH patients in clinical. BPH is also characterized by increased IPSS, PV, QOL and serum PSA levels. High levels of serum PSA promote the progression of prostatic hyperplasia. Previous results showed that, compared with placebo, both dutasteride and finasteride reduced IPSS and QOL and increased PV and serum PSA levels.[30,31] There was no significant difference in ADRs between the dutasteride and finasteride groups in our analysis. However, it has been reported that long-term treatment with dutasteride leads to erectile dysfunction, decreased testosterone levels, increased glucose and glycosylated hemoglobin, and changes in the blood lipid profile, suggesting metabolic imbalance and decreased gonadal function.[32] Therefore, it is advisable to explain the potential serious side effects of long-term dutasteride therapy to patients prior to initiation of dutasteride therapy.

To a certain degree, there are some limitations and shortcomings in this study. First, there are differences in patient selection and experimental design among studies, resulting in greater heterogeneity in some indicators. Second, the follow-up term of each study was different. Some studies even had no long-term follow-up data. Thus, the long-term efficacy cannot be analyzed. Finally, the articles included were mainly English, which may affect selection bias.

In conclusion, dutasteride is an effective and safe treatment for BPH, with a better effect on improving Qmax than finasteride. Due to the limitations of the methodological quality and sample size of the included studies, this conclusion needs to be verified by stratified RCTs with high volumes and long follow-up times.