Diabetes Metab J.  2019 Oct;43(5):582-589. 10.4093/dmj.2018.0124.

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

Affiliations
  • 1Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea. khmcilyong@khnmc.or.kr

Abstract

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.

Keyword

Apolipoprotein A-I; Apolipoproteins B; Ezetimibe; Fatty acids, nonesterified; Rosuvastatin calcium; Triglycerides

MeSH Terms

Apolipoprotein A-I
Apolipoproteins
Apolipoproteins B
Cardiovascular Diseases
Cholesterol, LDL
Diabetes Mellitus, Type 2*
Ezetimibe*
Fatty Acids, Nonesterified
Hand
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Korea
Liver
Rosuvastatin Calcium*
Triglycerides
Apolipoprotein A-I
Apolipoproteins
Apolipoproteins B
Cholesterol, LDL
Ezetimibe
Fatty Acids, Nonesterified
Rosuvastatin Calcium
Triglycerides
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