A review on the rationale and clinical use of concomitant rosuvastatin and fenofibrate/fenofibric acid therapy

Abstract

Mixed dyslipidemia, characterized by a lipid triad of elevated triglycerides (TG), elevated low-density lipoprotein-cholesterol (LDL-C) and reduced high-density lipoprotein-cholesterol (HDL-C), is a common and frequently difficult to manage condition. The use of combination medications is often needed to effectively treat the lipid triad. The co-administration of statins and fibrates may provide the desired endpoints but safety issues such as toxicity to the muscles, liver and kidneys are a concern. Given the potency of rosuvastatin to lower LDL-C and fenofibrate’s effectiveness in lowering TG, the use of this specific combination may be desirable in treating mixed dyslipidemia. Pharmacokinetic studies revealed no significant interactions with the concomitant use of rosuvastatin and fenofibrate or its active metabolite fenofibric acid. Clinical studies evaluating the efficacy and safety of this combination therapy demonstrate significant reductions in TG and LDL-C levels, and elevations in HDL-C. Safety data from clinical trials reveal no major adverse reactions. However, case reports of adverse events have been published and monitoring for potential adverse reactions of the individual agents is advised. Overall, current data suggest the combination of rosuvastatin and fenofibrate or fenofibric acid is a safe combination to utilize when managing difficult to treat mixed dyslipidemia patients.

Rosuvastatin plus fenofibrate in diabetic dyslipidemia: a hospital record based study

“…It is quite common that atherosclerosis and blood vessel disease may develop even before diabetes is diagnosed. 11,12 The treatment of Rosuvastatin and Fenofibrates has altered the Serum Total Cholesterol, LDL, and TGL and subsequent gradual increase in HDL (Table 9). Lowering LDL has become a primary goal in cardiovascular prevention and commonly estimated from quantitative measurements of total and HDL-cholesterol and plasma triglycerides (TG) using the empirical relationship of Friedewald et al And also, LDL has been associated with the development of plaque deposits on artery walls, which narrow the passage and restrict blood flow.…”

Antidepressant‐like effects of fenofibrate in mice via the hippocampal brain‐derived neurotrophic factor signalling pathway

“…Thus, fenofibrate may have more pharmacological effects involving BDNF. In addition, pharmacokinetic studies have revealed that fenofibrate is rapidly metabolized to fenofibric acid in vivo, which is responsible for the majority of its clinical effects (Strain et al, 2010). Fenofibric acid can also activate the PPAR-α.…”

Rosuvastatin: A Review of the Pharmacology and Clinical Effectiveness in Cardiovascular Disease

“…Further clinical trials are required to establish the benefits in clinical outcomes of combination of rosuvastatin with fenofibrate. The use of rosuvastatin 40 mg with fenofibric acid or fenofibrate has not been evaluated and should therefore not be prescribed routinely 88. Several studies have shown the efficacy and safety of rosuvastatin in combination with ezetimibe, bile acid sequestrants and fish oils 89,90.…”

“…The use of rosuvastatin 40 mg with fenofibric acid or fenofibrate has not been evaluated and should therefore not be prescribed routinely. 88 Several studies have shown the efficacy and safety of rosuvastatin in combination with ezetimibe, bile acid sequestrants and fish oils. 89 , 90 Some small trials and angiographic studies have demonstrated some benefit from combination therapy though this has not been corroborated by randomised clinical trial data.…”