Drug combination choices of 5α-reductase inhibitors and α-blockers in patients with benign prostatic hyperplasia: a study based on the FAERS database.

BACKGROUND

In clinical practice, 5α-reductase inhibitors (5ARIs) and α-blockers (ABs) are commonly prescribed for benign prostatic hyperplasia (BPH). However, evidence supporting rational selection of combination therapy remains limited. The FDA Adverse Event Reporting System (FAERS) database is a valuable resource for investigating the safety profile and concomitant use patterns of these medications.

METHODS

This study analyzed adverse events (AEs) from 2004Q1 to 2024Q4 in BPH patients receiving combination therapy with 5ARIs and ABs. Drug-drug interactions (DDIs) were evaluated using five established algorithms, and disproportionality analysis was performed to identify targeted AEs associated with these medication classes.

RESULTS

Disproportionality analysis revealed that 5ARIs were predominantly linked to sexual dysfunction, whereas ABs were primarily associated with renal impairment. Additionally, certain drugs showed strong associations with physical discomfort, neurological symptoms, hypotension, and shock-related events. DDI analysis indicated that co-administration of 5ARIs and ABs may exacerbate both renal impairment and sexual dysfunction. Notably, the combination of tamsulosin and dutasteride significantly prolonged the time to resistance to dutasteride in BPH patients. These findings are consistent with prior clinical studies and align well with existing clinical and epidemiological evidence.

CONCLUSION

The results provide meaningful insights into optimizing drug selection in BPH treatment. We recommend close monitoring of relevant safety parameters when implementing combination therapies.