Effect of fixed‐dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS‐ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe)

Abstract

SummaryAimWe aimed to compare the effects of fixed‐dose combinations of ezetimibe plus rosuvastatin to rosuvastatin alone in patients with primary hypercholesterolemia, including a subgroup analysis of patients with diabetes mellitus (DM) or metabolic syndrome (MetS).MethodThis multicenter eight‐week randomized double‐blind phase III study evaluated the safety and efficacy of fixed‐dose combinations of ezetimibe 10 mg plus rosuvastatin, compared with rosuvastatin alone in patients with primary hypercholesterolemia. Four hundred and seven patients with primary hypercholesterolemia who required lipid‐lowering treatment according to the ATP III guideline were randomized to one of the following six treatments for 8 weeks: fixed‐dose combinations with ezetimibe 10 mg daily plus rosuvastatin (5, 10, or 20 mg daily) or rosuvastatin alone (5, 10, or 20 mg daily).ResultsFixed‐dose combination of ezetimibe plus rosuvastatin significantly reduced LDL cholesterol, total cholesterol, and triglyceride levels compared with rosuvastatin alone. Depending on the rosuvastatin dose, these fixed‐dose combinations of ezetimibe plus rosuvastatin provided LDL cholesterol, total cholesterol, and triglyceride reductions of 56%–63%, 37%–43%, and 19%–24%, respectively. Moreover, the effect of combination treatment on cholesterol levels was more pronounced in patients with DM or MetS than in non‐DM or non‐MetS patients, respectively, whereas the effect of rosuvastatin alone did not differ between DM vs non‐DM or MetS vs non‐MetS patients.ConclusionFixed‐dose combinations of ezetimibe and rosuvastatin provided significantly superior efficacy to rosuvastatin alone in lowering LDL cholesterol, total cholesterol, and triglyceride levels. Moreover, the reduction rate was greater in patients with DM or MetS.

A Phase III, Multicenter, Randomized, Double-blind, Active Comparator Clinical Trial to Compare the Efficacy and Safety of Combination Therapy With Ezetimibe and Rosuvastatin Versus Rosuvastatin Monotherapy in Patients With Hypercholesterolemia: I-ROSETTE (Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia) Randomized Controlled Trial

“…Volume 40 Number 2 which was consistent with previous studies. [28][29][30] Another study also found greater LDL-C-lowering efficacy and similar safety profiles of rosuvastatin 5 or 10 mg combined with ezetimibe than those of rosuvastatin 10 or 20 mg monotherapy. 31 In previous research, administration of ezetimibe and rosuvastatin increased the target LDL-C goal from 67% to 96%.…”

Assessment of the Efficacy of Lowering LDL Cholesterol with Rosuvastatin 10 mg in Four Korean Statin Benefit Groups as per ACC/AHA Guidelines (NewStaR4G)

“…However, considering the lower dose of our study protocol, achieving ≥50% reduction in LDL cholesterol in almost half of the study subjects might be considered acceptable. Moreover, it should be considered that increasing the dose of the statin contributes a limited additional reduction rate and may result in a higher rate of side effects [22][23][24].…”

“…A few clinical studies were conducted in Japan, and the reduction rates of LDL cholesterol with rosuvastatin 10 mg were 49.2% [26] and 49.7% [27], which were similar to our study. In Korea, our group recently reported the LDL reduction rate with rosuvastatin 10 mg of 52% [24]. However, the study population of these studies were subjects with familial hypercholesterolemia [26] or hyper LDL cholesterolemia [27], not subjects within the four statin benefit groups as defined by the ACC/AHA guideline.…”

Ezetimibe: Use, costs, and adverse events in Australia

“…The number of prevalent patients on ezetimibe increased over time, and the majority of use was ezetimibe added to a statin. 25,26 There was an increase in the use of ezetimibe and statin fixed combinations without the expected decrease in the concomitant use of individual agents.…”