Comparison of Finasteride and Dutasteride on Risk of Prostate Cancer in Patients with Benign Prostatic Hyperplasia: A Pooled Analysis of 15 Real-world Databases

Dae Yul Yang; Won-Woo Seo; Rae Woong Park; Sang Youl Rhee; Jae Myung Cha; Yoon Soo Hah; Chang Won Jeong; Kyung-Jin Kim; Hyeon-Jong Yang; Do Kyung Kim; Ji Yong Ha

doi:10.5534/wjmh.230327

Comparison of Finasteride and Dutasteride on Risk of Prostate Cancer in Patients with Benign Prostatic Hyperplasia: A Pooled Analysis of 15 Real-world Databases

World J Mens Health. 2024 May 20. doi: 10.5534/wjmh.230327. Online ahead of print.

Authors

Dae Yul Yang¹, Won-Woo Seo², Rae Woong Park³, Sang Youl Rhee^{4

5}, Jae Myung Cha⁶, Yoon Soo Hah⁷, Chang Won Jeong⁸, Kyung-Jin Kim⁹, Hyeon-Jong Yang¹⁰, Do Kyung Kim¹¹, Ji Yong Ha¹²

Affiliations

¹ Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
² Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea. wonwooda@gmail.com.
³ Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea.
⁴ Department of Endocrinology and Metabolism, Kyung Hee University College of Medicine, Seoul, Korea.
⁵ Center for Digital Health, Kyung Hee University, Seoul, Korea.
⁶ Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Korea.
⁷ Department of Urology, Daegu Catholic University School of Medicine, Daegu, Korea.
⁸ Central Research Center of Biomedical Research Institute, Wonkwang University Hospital, Iksan, Korea.
⁹ Department of Internal Medicine, Ewha Womans University Medical Center, Ewha Womans University School of Medicine, Seoul, Korea.
¹⁰ Department of Pediatrics, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
¹¹ Department of Urology, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
¹² Department of Urology, Keimyung University Dongsan Hospital, Daegu, Korea.

PMID: 38772542
DOI: 10.5534/wjmh.230327

Abstract

Purpose: Finasteride and dutasteride are used to treat benign prostatic hyperplasia (BPH) and reduce the risk of developing prostate cancer. Finasteride blocks only the type 2 form of 5-alpha-reductase, whereas dutasteride blocks both type 1 and 2 forms of the enzyme. Previous studies suggest the possibility that dutasteride may be superior to finasteride in preventing prostate cancer. We directly compared the effects of finasteride and dutasteride on the risk of prostate cancer in patients with BPH using a pooled analysis of 15 real-world databases.

Materials and methods: We conducted a multicenter, cohort study of new-users of finasteride and dutasteride. We include patients who were prescribed 5 mg finasteride or dutasteride for the first time to treat BPH and had at least 180 days of prescription. We excluded patients with a history of prostate cancer or a prostate-specific antigen level ≥ 4 ng/mL before the study drug prescription. Cox regression analysis was performed to examine the hazard ratio (HR) for prostate cancer after propensity score (PS) matching.

Results: A total of 8,284 patients of new-users of finasteride and 8,670 patients of new-users of dutasteride were included across the 15 databases. In the overall population, compared to dutasteride, finasteride was associated with a lower risk of prostate cancer in both on-treatment and intent-to-treat time-at-risk periods. After 1:1 PS matching, 4,897 patients using finasteride and 4,897 patients using dutasteride were enrolled in the present study. No significant differences were observed for risk of prostate cancer between finasteride and dutasteride both on-treatment (HR=0.66, 95% confidence interval [CI]: 0.44-1.00; p=0.051) and intent-to-treat time-at-risk periods (HR=0.87, 95% CI: 0.67-1.14; p=0.310).

Conclusions: Using real-world databases, the present study demonstrated that dutasteride was not associated with a lower risk of prostate cancer than finasteride in patients with BPH.

Keywords: Dutasteride; Finasteride; Prostatic hyperplasia; Prostatic neoplasms.