Effects of Ezetimibe/Simvastatin 10/20 mg vs. Atorvastatin 20 mg on Apolipoprotein B/Apolipoprotein A1 in Korean Patients with Type 2 Diabetes ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-06-01

AUTHORS

Ju-Hee Lee, Hyun-Jae Kang, Hyo-Soo Kim, Dae-Won Sohn, Byung-Hee Oh, Young-Bae Park

ABSTRACT

BackgroundAlthough 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.ObjectiveOur 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 DesignThis 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 MeasureThe 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 (HbA1c), homeostatic model assessment (HOMA) index, and C-reactive protein.ResultsIn 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 HbA1c, 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).ConclusionEzetimibe/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. More... »

PAGES

343-351

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s40256-013-0031-6

DOI

http://dx.doi.org/10.1007/s40256-013-0031-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1007236759

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23728830


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40 ApoB/ApoA1
41 ApoB/ApoA1 ratio
42 B/Apolipoprotein A1
43 B/apolipoprotein A1 (ApoB/ApoA1) ratio
44 BackgroundAlthough
45 ConclusionEzetimibe/simvastatin 10/20
46 Controlled Trials
47 HOMA index
48 HbA1c
49 Korean patients
50 LDL cholesterol
51 Main Outcome MeasureThe primary endpoint
52 MeasureThe primary endpoint
53 ObjectiveOur objective
54 Outcome MeasureThe primary endpoint
55 ResultsIn total
56 Secondary endpoints
57 adverse reaction rate
58 analysis
59 apoB48
60 apolipoprotein A1
61 apolipoprotein A1 ratio
62 apolipoprotein B/apolipoprotein A1
63 apolipoprotein B/apolipoprotein A1 ratio
64 apolipoprotein profiles
65 assessment index
66 atorvastatin
67 atorvastatin 20
68 atorvastatin group
69 cardiovascular events
70 changes
71 cholesterol
72 designThis study
73 diabetes mellitus
74 difference of changes
75 differences
76 dyslipidemia
77 effect
78 efficacy
79 endpoint
80 events
81 ezetimibe/simvastatin
82 ezetimibe/simvastatin 10/20
83 ezetimibe/simvastatin group
84 favorable effect
85 group
86 hemoglobin
87 high levels
88 high-density lipoprotein cholesterol
89 homeostatic model assessment index
90 improvement
91 increment
92 increments of ApoA1
93 index
94 levels
95 lipid parameters
96 lipid profile
97 lipoprotein cholesterol
98 low-density lipoprotein cholesterol
99 management
100 management of dyslipidemia
101 mellitus
102 model assessment index
103 objective
104 parameters
105 patients
106 percent change
107 predictive value
108 primary endpoint
109 profile
110 protein
111 protocol analysis
112 rate
113 ratio
114 reaction rate
115 reactive protein
116 results
117 safety
118 significant differences
119 simvastatin
120 simvastatin 10/20
121 simvastatin group
122 study
123 total
124 total cholesterol
125 traditional lipid parameters
126 treatment
127 treatment groups
128 trials
129 triglycerides
130 type 2
131 type 2 diabetes mellitus
132 values
133 weeks
134 weeks of treatment
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