EFFECT OF STATINS ALONE VERSUS STATINS COMBINED WITH URSODEOXYCHOLIC ACID ON LIPID PROFILE IN ADULTS WITH DYSLIPIDEMIA: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: The mainstay of treatment for dyslipidaemia, a significant risk factor for cardiovascular disease, is still statins. However, even with the best statin treatment, residual cardiovascular risk still remains. Potential lipid-modulating qualities have been demonstrated by ursodeoxycholic acid (UDCA), which is mostly utilised in hepatobiliary illnesses. The purpose of this research was to examine the safety and efficacy of statin monotherapy and UDCA in improving lipid profiles in persons with dyslipidaemia. Methods: This randomized controlled trial was conducted at Saveetha Medical College and Hospital, including 100 adults aged 30–65 years diagnosed with dyslipidemia. Participants were randomly allocated into two groups: Group A received statins alone (n=50), and Group B received a combination of statins and UDCA (n=50) over a 12-week period. Baseline and post-treatment lipid parameters (LDL-C, HDL-C, TG, and TC), liver enzyme levels (ALT, AST, ALP), and adverse events were monitored and analyzed. Results: Baseline characteristics including age, sex distribution, BMI, and lipid levels were comparable between groups (p > 0.05). After 12 weeks, Group B demonstrated significantly greater reductions in LDL-C (-45.8 vs. -36.3 mg/dL; p < 0.01), TG (-39.4 vs. -28.7 mg/dL; p = 0.02), and TC (-61.6 vs. -47.2 mg/dL; p < 0.01), along with a more pronounced increase in HDL-C (+8.4 vs. +5.1 mg/dL; p < 0.05). Liver function tests remained stable in both groups with no significant differences post-treatment (ALT, AST, ALP; p > 0.05). Adverse events were minimal and comparable between groups, with no cases of hepatotoxicity reported. Conclusion: Without sacrificing hepatic safety, the addition of UDCA to statin treatment resulted in noticeably larger improvements in lipid measures than statin monotherapy. This combo treatment might be a useful supplementary approach to controlling dyslipidaemia and lowering the risk of cardiovascular disease.