The Efficacy and Safety of Moderate-Intensity Rosuvastatin with Ezetimibe versus High-Intensity Rosuvastatin in High Atherosclerotic Cardiovascular Disease Risk Patients with Type 2 Diabetes Mellitus: A Randomized, Multicenter, Open, Parallel, Phase 4 Study.

Autor: Moon JS; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea., Park IR; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea., Kim SS; Department of Internal Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea., Kim HS; Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea., Kim NH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul., Kim SG; Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul., Ko SH; Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea., Lee JH; Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea., Lee I; Department of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea., Lee BK; Clinical Operation Team, Yuhan Corporation, Seoul, Korea., Won KC; Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Jazyk: angličtina
Zdroj: Diabetes & metabolism journal [Diabetes Metab J] 2023 Nov; Vol. 47 (6), pp. 818-825. Date of Electronic Publication: 2023 Nov 24.
DOI: 10.4093/dmj.2023.0171
Abstrakt: Backgruound: To investigate the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe combination compared to highintensity rosuvastatin in high atherosclerotic cardiovascular disease (ASCVD) risk patients with type 2 diabetes mellitus (T2DM).
Methods: This study was a randomized, multicenter, open, parallel phase 4 study, and enrolled T2DM subjects with an estimated 10-year ASCVD risk ≥7.5%. The primary endpoint was the low-density lipoprotein cholesterol (LDL-C) change rate after 24-week rosuvastatin 10 mg/ezetimibe 10 mg treatment was non-inferior to that of rosuvastatin 20 mg. The achievement proportion of 10-year ASCVD risk <7.5% or comprehensive lipid target (LDL-C <70 mg/dL, non-high-density lipoprotein cholesterol <100 mg/dL, and apolipoprotein B <80 mg/dL) without discontinuation, and several metabolic parameters were explored as secondary endpoints.
Results: A hundred and six participants were assigned to each group. Both groups showed significant reduction in % change of LDL-C from baseline at week 24 (-63.90±6.89 vs. -55.44±6.85, combination vs. monotherapy, p=0.0378; respectively), but the combination treatment was superior to high-intensity monotherapy in LDL-C change (%) from baseline (least square [LS] mean difference, -8.47; 95% confidence interval, -16.44 to -0.49; p=0.0378). The combination treatment showed a higher proportion of achieved comprehensive lipid targets rather than monotherapy (85.36% vs. 62.22% in monotherapy, p=0.015). The ezetimibe combination significantly improved homeostasis model assessment of β-cell function even without A1c changes (LS mean difference, 17.13; p=0.0185).
Conclusion: In high ASCVD risk patients with T2DM, the combination of moderate-intensity rosuvastatin and ezetimibe was not only non-inferior but also superior to improving dyslipidemia with additional benefits compared to high-intensity rosuvastatin monotherapy.
Databáze: MEDLINE
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