Clinical efficacy of ezetimibe add-on to atorvastatin on lipid profile in post-PCI patients: evidence from a south indian population

Cardiovascular diseases often cause severe ischemic block or narrowing of coronary arteries, obstructing blood flow to the myocardium. Percutaneous coronary intervention (PCI) is a nonsurgical, invasive procedure for treating these conditions. Statins are the standard secondary preventive measure due to their pleiotropic effects. Research on therapeutic efficacy of the Atorvastatin–ezetimibe combination in improving the quality of life of post-PCI patients, using short-term biochemical and exploratory HRQoL evidence in an underrepresented South Indian cohort, is limited. Only few studies have simultaneously evaluated lipid and inflammatory responses to ezetimibe add-on therapy in a South Indian post-PCI cohort. This study aimed to compare the effectiveness of ezetimibe when it is added to atorvastatin in patients with a history of PCI. Among 80 randomized patients, 72 patients’ data were available for the final analysis. Atorvastatin monotherapy (Group A) was compared with the atorvastatin–ezetimibe group (Group B). The primary endpoint, absolute reduction in LDL-C from baseline to 12 weeks, was significantly greater in Group B than in Group A (70.3 ± 2.8 (B) vs. 84.6 ± 3.1(A) mg/dL at 12th week; between-group difference 14.3 mg/dL [95% CI: −16.5, − 12.1]; Cohen’s d = 0.65; p = 0.009). Secondary endpoints: HDL-C increased significantly more in Group B (44.2 ± 2.3 vs. 37.5 ± 1.9 mg/dL; difference 6.7 mg/dL [95% CI: 5.72–7.68]; Cohen’s d = 3.18; p = 0.004); triglycerides were lower in Group B (85.6 ± 3.7 vs. 101.4 ± 5.0 mg/dL; difference 15.8 mg/dL [95% CI: 13.78–17.82]; Cohen’s d = 3.59; p = 0.003). The exploratory endpoints, CRP was markedly reduced in Group B at 12 weeks (8 ± 1.9 vs. 18 ± 1.9 mg/L; difference 10.0 mg/L [95% CI: −12.8, − 7.2]; Cohen’s d = 0.68; p < 0.0001). Exploratory HRQoL assessments (SF-36) favored Group B in four of eight domains after Bonferroni correction. No serious drug-related adverse events were recorded; Analyses were performed using the intention-to-treat (ITT) approach with LOCF imputation and a pre-specified per-protocol (PP) sensitivity analysis. Compared with atorvastatin alone, ezetimibe, when used as an add-on therapy to atorvastatin improved the lipid profile and CRP levels. This combination therapy was associated with improved quality of life, and long-term trials are needed to confirm these findings and assess the impact on clinical events. Clinical Trials RegistryIndia (CTRI), CTRI/2026/08/115,114, registered on 5 August 2026. Retrospectively registered.