Association between PRO 160/120 prescriptions and incidence of benign prostatic hyperplasia complications in Germany: a retrospective cohort study

ABSTRACT

The present study aims to analyze the impact of PRO 160/120 prescriptions on the incidence of urinary incontinence, polyuria (including nocturia), urinary retention, and erectile dysfunction in a real-world setting in Germany and to compare these data with data for the 5-ARIs finasteride and dutasteride, and the α1-adrenoceptor antagonists tamsulosin and tamsulosin/dutasteride fixed-dose combination. This retrospective study was based on the IQVIA Disease Analyzer database and included male patients with an initial prescription of PRO 160/120, finasteride, dutasteride, tamsulosin, or tamsulosin/dutasteride fixed-dose combination between January 2010 and September 2020. Multivariable logistic regression analyses adjusted for age, health insurance, specialty, and relevant co-diagnoses were performed to estimate the association between PRO 160/120 prescriptions and incidence of pre-defined outcomes. A total of 77,923 patients were included in the study, 3,035 of whom received PRO 160/120. PRO 160/120 was significantly associated with reduced incidence of urinary incontinence (OR: 1.48; 95% CI: 1.10–1.98) and urinary retention compared to tamsulosin (OR: 3.39; 95% CI: 1.75–6.57 and tamsulosin/dutasteride (OR: 2.81; 95% CI: 1.35–5.82). Furthermore, PRO 160/120 significantly reduced the incidence of erectile dysfunction compared to dutasteride (OR: 2.79; 95% CI: 1.49–5.25). At the same time, patients receiving PRO 160/120 showed the same incidence of the remaining complications as those taking the reference substances. In conclusion, we observed a significant association between PRO 160/120 prescription and reduced incidence of urinary incontinence and urinary retention compared to tamsulosin and tamsulosin/dutasteride, as well as reduced incidence of erectile dysfunction compared to dutasteride.

KEYWORDS:

• PRO 160/120
• Prostagutt®
• benign prostatic hyperplasia
• urinary incontinence
• erectile dysfunction

Acknowledgments

None stated.

Data availability statement

Derived data supporting the findings of this study are available from the corresponding author on reasonable request.

Declaration of financial/other relationships

SM and MR report receiving consulting fees from Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany. KR and KK are employees of IQVIA, Frankfurt, Germany.

Declaration of funding

This study was funded by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany. The pharmaceutical company was not involved in the study design and analysis but only in the correction of the manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have received an honorarium from PGM for their review work but have no other relevant financial relationships to disclose.