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May 16, 2026International Urology and Nephrology0 citationsOpen Access

Association of phosphodiesterase type 5 inhibitor use with cardiovascular and renal outcomes in male kidney transplant recipients with benign prostatic hyperplasia or erectile dysfunction

JHJan Yuan-Sheng Hsu JLJian‐Ri Li CCChuan-Shu Chen

Key Points

This study aims to evaluate the associations of PDE5 inhibitor use with cardiovascular and renal outcomes in male kidney transplant recipients with benign prostatic hyperplasia or erectile dysfunction.
Retrospective cohort study using TriNetX Global Collaborative Network data (January 2015–December 2023).
Male kidney transplant recipients ≥ 40 years with erectile dysfunction or benign prostatic hyperplasia were examined with propensity-matched controls.
Primary outcomes analyzed included all-cause mortality and major adverse cardiovascular events using Cox regression and Kaplan-Meier methods.
PDE5 inhibitor exposure was inversely associated with all-cause mortality (HR 0.574–0.697).
MACE excluding death showed inverse associations in the erectile dysfunction cohort for tadalafil (HR 0.527, all doses HR 0.620).
Two secondary outcomes, MACE excluding death and AMI in the erectile dysfunction tadalafil cohort, were significant after correction (q = 0.023, q = 0.041).

Abstract

Phosphodiesterase type 5 (PDE5) inhibitors are commonly prescribed for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) in kidney transplant recipients (KTRs), but their cardiovascular and renal associations in this population remain unexamined. This study evaluated these associations in male KTRs with ED or BPH. This retrospective cohort study used TriNetX Global Collaborative Network data (January 2015–December 2023). Male KTRs ≥ 40 years with ED or BPH were identified using a unified diagnosis index date in both arms, with PDE5 inhibitor exposure bounded to days 0–365. Three drug strata (tadalafil 5 mg daily, tadalafil, sildenafil) were propensity-matched 1:1 against controls on thirty covariates. Balance was assessed by standardized mean differences. Primary outcomes (all-cause mortality, MACE excluding death, MAKE excluding death) were analyzed by Cox regression and Kaplan–Meier methods. Secondary outcomes comprised individual components (AMI, stroke, and dialysis initiation). All-cause mortality was inversely associated with PDE5 inhibitor exposure across all six strata (HR 0.574–0.697). MACE excluding death was inversely associated in the ED cohort for tadalafil 5 mg daily (HR 0.527) and tadalafil all doses (HR 0.620), but not sildenafil; no composite associations reached significance in the BPH cohort. Two secondary outcomes survived Benjamini–Hochberg correction: MACE excluding death and AMI in the ED tadalafil all-doses stratum (q = 0.023 and q = 0.041). Negative control outcomes near unity supported propensity score balance. PDE5 inhibitor exposure was associated with lower all-cause mortality in male KTRs with ED or BPH. Composite cardiovascular and renal associations were stratum-dependent. These findings are hypothesis-generating and require prospective evaluation.

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