Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy |
| |
| Institution: | 1. Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea;2. Gachon Cardiovascular Research Institute, Incheon, Republic of Korea;3. Cardiovascular Medicine, Hokko Memorial Clinic, Sapporo, Japan;4. Radiology, Gachon University Gil Medical Center, Incheon, Republic of Korea;5. Department of Statistics, University of Seoul, Seoul, Republic of Korea;6. Geriatric Department, Nagoya University, Nagoya, Japan;1. Louisville Metabolic and Atherosclerosis Research Center, Inc., Louisville, KY, USA;2. Excel Medical Clinical Trials, Inc., Boca Raton, FL, USA;3. Utah Lipid Center, Salt Lake City, UT, USA;4. Brigham and Women''s Hospital, Boston, MA, USA;5. Esperion Therapeutics, Inc., Ann Arbor, MI, USA;6. Baylor College of Medicine, Houston, TX, USA;1. Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts;2. Department of Interventional Cardiology, Tokyo Medical & Dental University, Tokyo, Japan;3. Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts;4. Department of Cardiovascular Medicine, Nara Medical University, Nara, Japan;5. Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan;6. Division of Cardiology, Kyung Hee University Hospital, Seoul, Republic of Korea;1. Department of Medical Sciences, University of Torino and Division of Cardiology Azienda Ospedaliera Universitaria Città della Salute di Torino, Turin, Italy;2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC;3. Division of Cardiology, University of Perugia School of Medicine, Perugia, Italy;4. Department of Molecular Medicine, University of Pavia and Cardiac Intensive Care Unit and Laboratories for Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;5. Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada;6. Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK |
| |
| Abstract: | PurposeThe goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy.MethodsThis study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups.FindingsReductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non–HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074).ImplicationsEzetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606. |
| |
| Keywords: | Combination therapy Ezetimibe Hypercholesterolemia Rosuvastatin |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
