SAFETY OF TAMSULOSIN ALONE OR IN COMBINATION WITH 5Α-REDUCTASE INHIBITORS ON LIPID PROFILE, RENAL FUNCTION, AND LIVER PARAMETERS.

Abstract

Background: Tamsulosin and 5α-reductase inhibitors (finasteride and dutasteride) are widely prescribed for benign prostatic hyperplasia (BPH). However, their systemic effects on metabolic, renal, and hepatic functions remain incompletely understood.

Objective: To evaluate the safety profile of tamsulosin monotherapy compared with combination therapies (tamsulosin plus finasteride or dutasteride) on lipid profile, renal function, liver enzymes, and bilirubin levels in men with BPH.

Methods: This cross-sectional study included 102 male participants aged >50 years, divided into five groups: healthy controls (n=26), newly diagnosed treatment-naïve BPH (n=25), BPH receiving tamsulosin monotherapy >3 months (n=26), BPH receiving tamsulosin+finasteride >3 months (n=11), and BPH receiving tamsulosin+dutasteride >3 months (n=14). Serum lipid profile (total cholesterol, triglycerides, HDL-C, LDL-C, VLDL, atherogenic index), renal function (urea, creatinine, eGFR, uACR), liver function (ALT, AST, ALP, GGT, albumin), and bilirubin fractions (total, direct, indirect) were measured using standardized automated methods.

Results: Lipid profile parameters showed no significant differences between treatment groups and controls, with all values remaining within desirable ranges. Renal function tests, including serum urea, creatinine, eGFR, and urinary albumin-to-creatinine ratio, demonstrated no clinically significant alterations across all BPH treatment groups compared to controls. Liver enzymes (ALT, AST, ALP, GGT) and serum albumin levels remained within normal limits across all groups. Total, direct, and indirect bilirubin concentrations showed no significant elevation, indicating preserved hepatic excretory function. Notably, no statistically significant differences were observed between tamsulosin monotherapy and combination therapy groups for any of the measured parameters.

Conclusion: Tamsulosin administered alone or in combination with finasteride or dutasteride for more than three months demonstrated non-significant differences in the measured biochemical parameters among the studied groups represented by no adverse effects on lipid metabolism, renal function, liver enzymes, or bilirubin homeostasis. These findings support the safe use of these therapeutic regimens in elderly BPH patients, including those with underlying metabolic or organ function concerns. Further prospective longitudinal studies with larger sample sizes are warranted to confirm these observations.