Safety considerations with fenofibrate/simvastatin combination

被引：20

作者：

Filippatos, Theodosios D. ^{[1
]}

Elisaf, Moses S. ^{[2
]}

机构：

[1] Univ Ioannina, Sch Med, Dept Internal Med, GR-45110 Ioannina, Greece

[2] Univ Ioannina, Sch Med, Dept Internal Med, Med, GR-45110 Ioannina, Greece

来源：

EXPERT OPINION ON DRUG SAFETY | 2015年 / 14卷 / 09期

关键词：

adverse effects; cardiovascular disease; drug interactions; fenofibrate; mixed dyslipidemia; pharmacokinetics; safety; simvastatin; tolerability; RANDOMIZED CONTROLLED-TRIAL; TYPE-2; DIABETES-MELLITUS; HMG-COA REDUCTASE; SIMVASTATIN ACID CONCENTRATIONS; CONTROL-CARDIOVASCULAR-RISK; TERM FENOFIBRATE THERAPY; CORONARY-HEART-DISEASE; LIPID-LOWERING DRUGS; FATTY LIVER-DISEASE; METABOLIC SYNDROME;

D O I：

10.1517/14740338.2015.1056778

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Introduction: Fenofibrate/simvastatin combination is useful for patients with mixed dyslipidemia. Aim of this review is to critically present the safety aspects of the fenofibrate/simvastatin combination. Areas covered: Current evidence regarding the adverse effects of fenofibrate/simvastatin combination is critically presented based on the results of large randomized controlled trials and other relevant studies. Additionally, clinical pharmacology, drug interactions and the effects of fenofibrate and simvastatin on metabolic variables and cardiovascular risk are briefly described. Expert opinion: Large randomized clinical trials show that the combined administration of fenofibrate with simvastatin is not associated with significantly increased incidence of serious adverse events compared with simvastatin monotherapy. The incidence of rhabdomyolysis is slightly increased with fibrate/statin combination compared with monotherapy but the actual risk is very low. Although fenofibrate increases creatinine and homocysteine serum levels, the incidence of diabetic nephropathy and thrombotic events was not significantly increased with fenofibrate/simvastatin combination compared with simvastatin monotherapy in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. Furthermore, a decrease in albuminuria was observed with fenofibrate in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and ACCORD Lipid trials. Overall, the combined administration of fenofibrate with simvastatin appears to be safe, unless clinicians give fenofibrate/sirnvastatin combination to patients with predisposing risk factors for the occurrence of adverse events.

引用

页码：1481 / 1493

页数：13

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