Background: Dyslipidemia management situation in patients with high risk and very high risk has been demonstrated very low, despite the wide use of statins.
Purpose: The aim of this study was to evaluate the efficacy and safety of combination therapy with simvastatin and fenofibrate in patients after coronary artery stenting.
Methods: A total of 153 patients after coronary artery stenting were randomly assigned to receive 10 mg simvastatin (n = 71) and a combination of 10 mg simvastatin plus 200 mg fenofibrate (n = 82) for 1 months. In order to evaluate the clinical effects on lipids-lowering, systemic inflammation response and clinical safety, the follow-up of all patients was carried out at day 10th and 30th after treatment.
Results: Combination treatment was more effective in normalizing lipid profile than monotherapy. The level of low-density lipoprotein cholesterol (LDL-C) in combination group and statins group was 1.89 ± 0.42 and 2.34 ± 0.65 mmol/L at day 10th, 1.55 ± 0.31 and 1.96 ± 0.49 mmol/L at day 30th, respectively. The control rates of LDL-C level in the combination group and the statins group were 76% and 45% at day 30th, respectively. There was no significant improvement on high-density lipoprotein cholesterol (HDL-C) level during follow-up. The triglyceride (TG) levels were significantly reduced in both groups, while no obvious difference was observed between two groups. No significant difference on serum high-sensitivity C-reactive protein (hs-CRP) level between two groups was observed. Moreover, we did not observe any significant correlation between serum lipids levels and serum hs-CRP level during follow-up. The liver dysfunction and muscle related side effects (MRSE), creatine kinase (CK) and myopathy were not observed in both groups.
Conclusion: The results of this study demonstrated that combination therapy with fenofibrate and simvastatin is more effective than monotherapy in patients after coronary artery revasculirisation, and is generally safe and well tolerated.