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Fenofibrate plus simvastatin (fixed-dose combination) for the treatment of dyslipidaemia.

Expert opinion on pharmacotherapy (2011-07-09)
Theodosios D Filippatos, Moses S Elisaf
ABSTRACT

Statin use results in a significant reduction of cardiovascular disease (CVD) risk. However, patients still have residual CVD risk, even if they are receiving optimal statin treatment. This review, based on a Pubmed/Scopus search, discusses the available evidence regarding the use of a fixed-dose fenofibrate plus simvastatin combination. This combination is useful for patients with mixed dyslipidaemia because it improves the overall lipoprotein profile. Although in clinical trials the rate of adverse events was not significantly greater than monotherapy, patients who receive combination treatment should be monitored carefully. Furthermore, in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study, this combination did not result in a significant reduction of CVD events compared with simvastatin monotherapy. However, a possible benefit in this trial was observed in the subgroup of patients with high triglyceride and low high-density lipoprotein cholesterol levels. The fixed-dose fenofibrate plus simvastatin combination treatment produces additive results and is safe when patients are properly monitored. Existing evidence appears to support the addition of fenofibrate to simvastatin treatment for the reduction of residual CVD risk in patients with atherogenic dyslipidaemia. However, this combination did not lead to better clinical outcomes in the absence of dyslipidaemia.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Simvastatin, ≥97% (HPLC), solid
Supelco
Simvastatin, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Fenofibrate, ≥99%, powder
Supelco
Fenofibrate, analytical standard
Supelco
Fenofibrate, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Simvastatin, analytical standard
USP
Simvastatin, United States Pharmacopeia (USP) Reference Standard
USP
Fenofibrate, United States Pharmacopeia (USP) Reference Standard
Fenofibrate, European Pharmacopoeia (EP) Reference Standard
Simvastatin, European Pharmacopoeia (EP) Reference Standard