Effect of Rosuvastatin on Oxidative Stress in Patients with Type 2 Diabetes Mellitus: A Prospective Interventional Study

Abstract

Introduction: Diabetes Mellitus (DM) is an established risk factor for Cardiovascular Disease (CVD). Oxidative Stress (OS) and inflammation are linked to CVD in Type 2 Diabetes Mellitus (T2DM). Rosuvastatin is a statin of choice in patients at high cardiovascular risk due to its pharmacokinetic efficacy as well as patient safety. There is limited data on the effect of rosuvastatin on OS among Indian subjects with T2DM. Aim: To assess the effect of rosuvastatin 20 mg for 12 weeks on oxidant and antioxidant status in patients with T2DM. Materials and Methods: This prospective interventional study was conducted in the Department of Biochemistry at Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India, from March 2018 to February 2019. A total of 24 patients diagnosed with T2DM were included in the study and were administered rosuvastatin tablets (20 mg/day) orally for a period of 12 weeks. The oxidant markers {Malondialdehyde (MDA) and Protein Carbonyl Content (PCC)} and antioxidant markers {Ferric Reducing Ability of Plasma (FRAP) and protein thiols} were analysed spectrophotometrically using standard methods. Paired samples t-test/Wilcoxon’s signed-rank test was used as appropriate for the comparison of markers at baseline and after 12 weeks of rosuvastatin intervention. The association between markers studied was assessed using linear regression with the Generalised Estimating Equations (GEE). Results: The mean age of the study subjects was 48.04±7.96 years. There were 17 male patients (70.8%). Rosuvastatin 20 mg/day showed a lipid-lowering effect {Total Cholesterol (TC), Triglyceride (TG), Low-density lipoprotein cholesterol (LDL-C)}, an increase in the antioxidant and anti-atherogenic Hi-density lipoprotein cholesterol (HDL-C). It also showed a beneficial effect on OS markers as evidenced by a significant decrease in oxidant markers MDA (-9.06%), PCC (-21.2%) (p<0.05) and an increase in antioxidant markers FRAP (+9.08%) and protein thiols (+11.8%) (p<0.05) 12 weeks after treatment in patients with T2DM. A change in LDL-C was positively associated with a change in MDA and PCC in patients with diabetes postintervention (p<0.001). Conclusion: The findings of the present study suggest that rosuvastatin 20 mg for 12 weeks produces a beneficial effect on CV risk in patients with T2DM. The decrease in OS and the LDL-C levels can thus decrease the formation of oxidised LDL, which initiates the atherosclerotic process.