Protective Effect of 5-Alpha Reductase Inhibitors on Atherosclerotic Cardiovascular Disease in Populations With BPH: Evidence From UK Biobank Cohort and Chinese Single Center Database Studies

NCT07196280 | Completed

• 1 other identifier: S2022-700-02
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the impact of 5-alpha reductase inhibitors (5-ARIs) on the incidence of atherosclerotic cardiovascular disease (ASCVD) in patients with benign prostatic hyperplasia (BPH).

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD); Benign Prostatic Hypertrophy (BPH)

Outcome Measures

Primary Outcomes (1)

• Atherosclerotic Cardiovascular Disease

  While both CVD and ASCVD are composite disease categories, CVD encompasses a broader range of cardiovascular and cerebrovascular conditions. To ensure homogeneity in disease classification, we focused on ASCVD, which primarily refers to atherosclerosis-related cardiovascular and cerebrovascular diseases, including ischemic heart disease (IHD) and cerebrovascular disease (CeVD)

  Started taking 5α-reductase inhibitors until December 1, 2022

Interventions

5-Alpha Reductase Inhibitors DRUG

Building on prior studies, drug exposure was defined as receiving 5-ARIs on at least two separate occasions, with an interval of no more than 180 days between prescriptions. Based on exposure status, the cohort was stratified into two groups.

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was derived from the UK Biobank (UKB). Detailed descriptions of the UKB have been published previously.

You may qualify if:

• patients diagnosed with BPH or users of 5-ARIs

You may not qualify if:

• individuals who had cancer prior to the start of follow-up and those with pre-existing ASCVD

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Atherosclerosis; Prostatic Hyperplasia

Interventions

5-alpha Reductase Inhibitors

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 29, 2025
• Study Start: January 1, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share