According to a study published in the Diabetes & Metabolism Journal, 6 weeks of daily combination therapy low-dose rosuvastatin/ezetimibe showed reduction in low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apoB) and apolipoprotein B/A1 (apoB/A1) ratio comparable to that of high-dose rosuvastatin monotherapy in patients with type 2 diabetes mellitus (T2DM). Triglyceride and FFA reductions were greater with the combination therapy than with rosuvastatin monotherapy.
Researchers evaluated 36 patients with type 2 diabetes mellitus who were randomly assigned to receive either rosuvastatin monotherapy (20 mg/day; n=20) or rosuvastatin/ezetimibe combination therapy (5 mg/10 mg/day; n=16) for 6 weeks. They assessed the change in apoB/A1 ratio and lipid parameters from baseline to the end of the 6-week treatment.
After 6 weeks of treatment, LDL-C levels significantly decreased in both groups (rosuvastatin group, –94.3±15.4 mg/dL and rosuvastatin/ezetimibe group, 89.9±22.7 mg/dL) with no significant difference between the 2 groups (P=.54). Changes in apoB and apoB/A1 ratio did not differ in both the rosuvastatin and rosuvastatin/ezetimibe groups (–62.0±20.9 mg/dL and –0.44 [–0.56 to –0.34], respectively, and –66.8±21.6 mg/dL and –0.38 [–0.54 to –0.32], respectively) (P=.86 and P=.58, respectively). Reductions in triglycerides and free fatty acids were greater in the rosuvastatin/ezetimibe group (–49.5 mg/dL [interquartile range (IQR), –108.5 to –27.5] and –170.5 μEq/L [IQR, –353.0 to 0.8], respectively) vs the rosuvastatin group (–10.5 mg/dL [IQR, –37.5 to 29.5] and 0.0 μEq/L [IQR, –136.8 to 146.0, respectively] (P=.1 and P=.5, respectively). Both treatments were generally well tolerated and no significant liver or muscle enzyme elevations were noted.
Authors concluded, “Further studies are warranted to determine whether the low-intensity statin with ezetimibe combination therapy provides additional cardiovascular benefits over high-intensity statin monotherapy; hence, a cardiovascular outcome study is needed to confirm the clinical significance of our findings.”