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KMID : 1200020190430050582
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Diabetes & Metabolism Journal
2019 Volume.43 No. 5 p.582 ~ p.589
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Comparison of the Efficacy of Rosuvastatin Monotherapy 20 mg with Rosuvastatin 5 mg and Ezetimibe 10 mg Combination Therapy on Lipid Parameters in Patients with Type 2 Diabetes Mellitus
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Hwang You-Cheol
Jun Ji-Eun
Jeong In-Kyung
Ahn Kyu-Jeung
Chung Ho-Yeon
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Abstract
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Background: The apolipoprotein B/A1 (apoB/A1) ratio is a stronger predictor of future cardiovascular disease than is the level of conventional lipids. Statin and ezetimibe combination therapy have shown additional cardioprotective effects over statin monotherapy.
Methods: This was a single-center, randomized, open-label, active-controlled study in Korea. A total of 36 patients with type 2 diabetes mellitus were randomized to either rosuvastatin monotherapy (20 mg/day, n=20) or rosuvastatin/ezetimibe (5 mg/10 mg/day, n=16) combination therapy for 6 weeks.
Results: After the 6-week treatment, low density lipoprotein cholesterol (LDL-C) and apoB reduction were comparable between the two groups (?94.3±15.4 and ?62.0±20.9 mg/dL in the rosuvastatin group, ?89.9±22.7 and ?66.8±21.6 mg/dL in the rosuvastatin/ezetimibe group, P=0.54 and P=0.86, respectively). In addition, change in apoB/A1 ratio (?0.44±0.16 in the rosuvastatin group and ?0.47±0.25 in the rosuvastatin/ezetimibe group, P=0.58) did not differ between the two groups. On the other hand, triglyceride and free fatty acid (FFA) reductions were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group (?10.5 mg/dL [interquartile range (IQR), ?37.5 to 29.5] and 0.0 μEq/L [IQR, ?136.8 to 146.0] in the rosuvastatin group, ?49.5 mg/dL [IQR, ?108.5 to ?27.5] and ?170.5 μEq/L [IQR, ?353.0 to 0.8] in the rosuvastatin/ezetimibe group, P=0.010 and P=0.049, respectively). Both treatments were generally well tolerated, and there were no differences in muscle or liver enzyme elevation.
Conclusion: A 6-week combination therapy of low-dose rosuvastatin and ezetimibe showed LDL-C, apoB, and apoB/A1 ratio reduction comparable to that of high-dose rosuvastatin monotherapy in patients with type 2 diabetes mellitus. Triglyceride and FFA reductions were greater with the combination therapy than with rosuvastatin monotherapy.
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KEYWORD
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Apolipoprotein A-I, Apolipoproteins B, Ezetimibe, Fatty acids, nonesterified, Rosuvastatin calcium, Triglycerides
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