High-intensity lipid-lowering therapy with rosuvastatin and ezetimibe for uncontrolled dyslipidemia in Indian patients: A real-world study (HILL-INDIA study)

Introduction: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide and dyslipidemia is the major risk factor for CVD. Aim: The aim of the study was to assess the real-world treatment patterns associated with the use of rosuvastatin + ezetimibe combination therapy for lipid management. Methods: This retrospective multicentric, noncomparative, nonrandomized, observational real-world study was conducted at multiple healthcare centers in India. Patients aged ≥18 years (either sex), with uncontrolled dyslipidemia, familial hypercholesteremia, and mixed dyslipidemias, with persistently elevated levels of low-density lipoprotein cholesterol (LDL-C) despite receiving statin therapy were included. Fasting blood LDL-C was monitored in high, very high, and extreme-risk patients. Results: A total of 1465 patients were enrolled with a mean age of 60.87 years and men predominance (67.49%). Median (range) duration of hypercholesteremia of patients was 4.00 (0.40–19.50) years. The majority of patients were on moderate-intensity statin therapy (54.68%), followed by high-intensity statin (27.37%) and low-intensity statin (17.95%). The majority of patients taking moderate-intensity statins (47.38%) had LDL-C levels between 151 and 200 mg/dL, compared to those taking low (36.50%). Combination rosuvastatin + ezetimibe therapy showed a significant reduction in mean LDL-C levels of patients using low, moderate, and high-intensity statins with a mean difference of 100.63 mg/dL, 94.24 mg/dL, and 92.00 mg/dL ( P < 0.001 each) as well as a significant reduction in LDL-C levels, total cholesterol levels, and triglycerides levels ( P < 0.001 each). Conclusion: Rosuvastatin and ezetimibe therapy was an effective and well-tolerated lipid-lowering agent, offering higher efficacy, especially in the reduction of LDL-C levels.