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- Title
Effects of Ezetimibe/Simvastatin 10/20 mg vs. Atorvastatin 20 mg on Apolipoprotein B/Apolipoprotein A1 in Korean Patients with Type 2 Diabetes Mellitus: Results of a Randomized Controlled Trial.
- Authors
Lee, Ju-Hee; Kang, Hyun-Jae; Kim, Hyo-Soo; Sohn, Dae-Won; Oh, Byung-Hee; Park, Young-Bae
- Abstract
Background: Although the efficacy of ezetimibe/simvastatin and atorvastatin on traditional lipid parameters has been studied extensively, the apolipoprotein B/apolipoprotein A1 (ApoB/ApoA1) ratio, which has a better predictive value for cardiovascular events, has not previously been used as a primary endpoint in these two treatment groups. Objective: Our objective was to compare the efficacy and safety of ezetimibe/simvastatin 10/20 mg versus atorvastatin 20 mg once daily in Korean patients with type 2 diabetes mellitus. Study Design: This study was an open-label, randomized, controlled study. Type 2 diabetes patients with high levels of low-density lipoprotein (LDL) cholesterol (>100 mg/dL) were randomized to receive ezetimibe/simvastatin or atorvastatin. Main Outcome Measure: The primary endpoint was the difference in the percent change of ApoB/ApoA1 at 12 weeks, and secondary endpoints were changes in lipid profiles, glycosylated hemoglobin (HbA), homeostatic model assessment (HOMA) index, and C-reactive protein. Results: In total, 132 patients (66 for each group) were enrolled and randomized. After 12 weeks of treatment, the ApoB/ApoA1 ratio was significantly reduced in both groups; however, the difference of changes between the two groups was not statistically significant (ezetimibe/simvastatin −38.6 ± 18.0 % vs. atorvastatin −34.4 ± 15.5 %; p = 0.059). There were no significant differences in changes to total cholesterol, LDL cholesterol, high-density lipoprotein cholesterol, triglycerides, ApoB, and ApoB48 between the two groups. However, the increments of ApoA1 were significantly greater in the ezetimibe/simvastatin group than in the atorvastatin group (2.8 ± 10.0 vs. −1.8 ± 9.8 %; p = 0.002). In the per-protocol analysis, improvement in ApoB/ApoA1 was significantly greater in the ezetimibe/simvastatin group (−42.8 ± 11.8 vs. −36.7 ± 13.2 %; p = 0.019). The changes in HbA, HOMA index, and C-reactive protein were comparable between the two groups. The adverse reaction rate was similar between the two groups (24.2 vs. 34.9 %; p = 0.180). Conclusion: Ezetimibe/simvastatin 10/20 mg is comparable to atorvastatin 20 mg for the management of dyslipidemia, and may have more favorable effects on apolipoprotein profiles than atorvastatin 20 mg in Korean patients with type 2 diabetes mellitus.
- Subjects
SOUTH Korea; EFFECT sizes (Statistics); HYPERLIPIDEMIA; ANTILIPEMIC agents; RESEARCH funding; ACADEMIC medical centers; T-test (Statistics); DATA analysis; DRUG side effects; STATISTICAL sampling; FISHER exact test; RANDOMIZED controlled trials; DESCRIPTIVE statistics; MANN Whitney U Test; CHI-squared test; LDL cholesterol; ATORVASTATIN; TYPE 2 diabetes; APOLIPOPROTEINS; STATISTICS; DATA analysis software; DISEASE complications
- Publication
American Journal of Cardiovascular Drugs, 2013, Vol 13, Issue 5, p343
- ISSN
1175-3277
- Publication type
Article
- DOI
10.1007/s40256-013-0031-6