Efficacy and safety of fenofibrate combined with simvastatin in treatment of patients with type 2 diabetes and dyslipidemia

Ma Jia; Tang Jinyan; Liu Wen; Lu Yuan; Kong Ran; Lu Peipei; Zhou Changsheng

doi:10.3969/j.issn.1672-8157.2025.05.017

Abstract：Objective To explore the efficacy and safety of fenofibrate combined with simvastatin in the treatment of type 2 diabetes(T2DM)patients with dyslipidemia.Methods A total of 100 patients with T2DM and dyslipidemia admitted to The People's Hospital of Rugao from January 2022 to January 2024 were included in this study.According to the random allocation using envelope method,the patients were divided into the simvastatin group(n=50,metformin(0.5 g/time,twice a day)+simvastatin(10 mg/time,once a day),continuous administration for 3 months)and the combined fenofibrate group(n=50,fenofibrate(0.1 g/time,once a day),continuous ad-ministration for 3 months based on the regimen in the simvastatin group).The clinical efficacy,blood glucose changes(fasting plasma glucose(FPG),2 h postprandial blood glucose(2 h PG),glycosylated hemoglobin(HbA1c)),blood lipids indicators(triglyceride(TG),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),apolipoprotein B(ApoB)),body mass(body fat percentage(BF%),body mass index),endothelial function indicators(nitric oxide(NO),endothelin-1(ET-1))and adverse drug reactions were compared between the two groups.Results The clinical efficacy in the combined fenofi-brate group was significantly higher than that in the simvastatin group(χ2=4.000,P=0.046).After treatment,the levels of FPG,2 h PG and HbA1c in both groups were significantly decreased,and they were significantly lower in the combined group than in the control group(t=3.093,2.204,2.825,P=0.003,0.030,0.006).The levels of TG,TC,LDL-C and ApoB in both groups after treatment were sig-nificantly reduced while the HDL-C level was significantly enhanced,and the levels of TG,TC,LDL-C and ApoB were significantly lower(t=2.580,4.060,5.112 5.369,P=0.011,<0.001,<0.001,<0.001),while the HDL-C level was significantly higher in the combined fenofibrate group than in the simvastatin group(t=4.849,P<0.001).The blood lipid compliance rate of the combined fenofibrate group was significantly higher than that of the simvastatin group(χ2=4.332,P=0.037).The BF%and BMI were significantly decreased in both groups,and these indicators in the combined fenofibrate group were significantly lower than those in the simvastatin group(t=5.323,6.539,both P<0.001).The level of NO in both groups was significantly increased,while that of ET-1 was significantly decreased.The level of NO in the combined fenofibrate group was significantly higher than that in the simvastatin group(t=4.976,P<0.001),while that of ET-1 was significantly lower(t=4.688,P<0.001).There was no statistical significance in the incidence of adverse reactions between the combined fenofibrate group(8.00%)and the simvastatin group(4.00%)(χ2=0.709,P=0.400).Conclusion Fenofibrate combined with simvastatin can effectively treat T2DM patients with dyslipidemia since it can control blood glucose and blood lipids,reduce body mass and improve vascular endothelial indicators.Meanwhile,it is safe and effective.