Efficacy and Safety of Rosuvastatin and Fenofibric Acid Combination Therapy versus Simvastatin Monotherapy in Patients with Hypercholesterolemia and Hypertriglyceridemia

Abstract

In patients with high LDL-C and TG levels, combination treatment with rosuvastatin/fenofibric acid was well tolerated, and each of the rosuvastatin/fenofibric acid doses produced greater reductions in LDL-C and improvements in other efficacy parameters, compared with simvastatin 40 mg. [Clinical trial is registered at www.clinicaltrials.gov NCT00812955.].

Efficacy and Safety of Rosuvastatin 5 mg in Combination with Fenofibric Acid 135 mg in Patients with Mixed Dyslipidemia – A Phase 3 Study

“…Similarly, studies of atorvastatin or simvastatin in combination with fenofibric acid in patients with mixed dyslipidemia resulted in greater improvements in TG, HDL-C, and LDL-C compared with prespecified monotherapies [9,10]. In addition, fixed-dose combinations of rosuvastatin and fenofibric acid (5/135, 10/135, and 20/135 mg) were found to be more efficacious than simvastatin 40 mg in lowering LDL-C in patients with elevated LDL-C and TG [11]. Lastly, the FIRST Study, an ongoing clinical trial (ClinicalTrials.gov identifier: NCT00616772), is evaluating the effect of oncedaily fenofibric acid or placebo in addition to atorvastatin therapy on carotid intima-media thickness (cIMT) progression in a population of patients with mixed dyslipidemia who have achieved LDL-C goals while receiving atorvastatin.…”

Does Combination Therapy with Statins and Fibrates Prevent Cardiovascular Disease in Diabetic Patients with Atherogenic Mixed Dyslipidemia?

“…The combination treatments produced significantly greater improvements in LDL-C, HDL-C, non-HDL-C, apoB, TG, hsCRP, total cholesterol and apoC-III compared with simvastatin 40 mg/day. Of note, optimal levels for LDL-C (<100 mg/dl, p < 0.001), non-HDL-C (<130 mg/dl, p < 0.001), apoB (<90 mg/dl, p ≤ 0.02), and TG (<150 mg/dl, p < 0.001) were achieved in a significantly higher proportion of patients in each fenofibric acid/rosuvastatin group compared with monotherapy with simvastatin 40 mg/day [177].…”

“…A recent trial randomized patients to receive combination of fenofibric acid 135 mg/day with rosuvastatin 5, 10, or 20 mg/day or to monotherapy with simvastatin 40 mg/day [177]. The combination treatments produced significantly greater improvements in LDL-C, HDL-C, non-HDL-C, apoB, TG, hsCRP, total cholesterol and apoC-III compared with simvastatin 40 mg/day.…”

Opening a New Lipid “Apo-thecary”: Incorporating Apolipoproteins as Potential Risk Factors and Treatment Targets to Reduce Cardiovascular Risk

“…Reductions in Apo B levels from baseline with fibrate monotherapy range from approximately 12% to 18% in different populations. [75][76][77][78][79][80][81][82] However, most trials of fibrates combined with mediumto high-dose statins have failed to show marked additional reductions in Apo B levels compared with statin monotherapy.…”