Statin Monotherapy Versus Statin Plus Ezetimibe in Type 2 Diabetes Mellitus: A 12-Week Prospective Cohort Study
Abstract
Objective: This study compared 12-week LDL-C reduction and target attainment with atorvastatin 20 mg alone versus atorvastatin 20 mg plus ezetimibe 10 mg. Methods: This single-centre prospective observational cohort study was conducted at a tertiary care hospital in Rawalpindi, Pakistan, from March to July 2026. Adults aged 30 to 70 years with T2DM and LDL-C ≥70 mg/dL were consecutively enrolled in two routine-care cohorts according to the regimen prescribed by their treating physician. Seventy participants received atorvastatin 20 mg once daily, and 70 received atorvastatin 20 mg plus ezetimibe 10 mg once daily. The primary outcome was the absolute change in LDL-C levels at week 12. An analysis of covariance model was used, with week-12 LDL-C as the dependent variable, treatment group as the fixed factor, and baseline LDL-C as the covariate. Results: All 140 participants completed the follow-up. The mean baseline LDL-C was 125.3 ± 23.1 mg/dL with atorvastatin alone and 127.9 ± 24.8 mg/dL with combination therapy. The mean LDL-C reductions were 35.6 and 54.0 mg/dL, respectively. After adjusting for baseline LDL-C, combination therapy was associated with an additional 18.4 mg/dL reduction (95% CI 12.8 to 24.0; p<0.001). LDL-C < 70 mg/dL was achieved by 26 of 70 participants (37.1%) and 45 of 70 (64.3%) (p=0.001). A reduction of at least 50% occurred in 9 of 70 (12.9%) and 21 of 70 (30.0%) patients (p=0.01). Adverse events were recorded in 10 of 70 (14.3%) and 12 of 70 (17.1%) participants (p=0.64). Conclusion: Atorvastatin 20 mg plus ezetimibe 10 mg was associated with greater 12-week LDL-C reduction and target attainment than atorvastatin 20 mg alone. The observational design, short follow-up, and limited sample size preclude causal inference, safety equivalence assessment, and assessment of cardiovascular benefits. MeSH Keywords: Diabetes Mellitus, Type 2; Dyslipidemias; Hydroxymethylglutaryl-CoA.