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Effects of Fixed-Dose Combination of Low-Intensity Rosuvastatin and Ezetimibe Versus Moderate-Intensity Rosuvastatin Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia: A Randomized, Double-Blind, Multicenter, Phase III Study

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Abstract
urpose: We investigated whether the combination therapy of low-intensity rosuvastatin and ezetimibe is an useful alternative to moderate-intensity rosuvastatin monotherapy in patients requiring cholesterol-lowering therapy.

Methods: This was a multicenter randomized, double-blind study to investigate the safety and efficacy of a fixed-dose combination of rosuvastatin 2.5 mg and ezetimibe 10 mg (R2.5+E10) compared to those of ezetimibe 10 mg monotherapy (E10), rosuvastatin 2.5 mg (R2.5), and rosuvastatin 5 mg monotherapy (R5) in patients with hypercholesterolemia. A total of 348 patients at 15 centers in Korea were screened, and 279 patients were randomized to different groups in the study. Clinical and laboratory examinations were performed at baseline and 4 and 8 weeks after intervention. The primary endpoint was the percentage change of low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up.

Findings: Baseline characteristics were similar among the four groups. There were significant changes in lipid profiles at the 8-week follow-up. A greater decrease in the LDL cholesterol levels (primary endpoint) were found in the R2.5+E10 group (-45.7±18.6%) than in the E10 group (-16.7±14.7%, p<0.0001), R2.5 group (-32.6±15.1%, p<0.0001), and R5 group (-38.9±13.9%, p=0.0003). Similar outcomes were observed regarding the decrease in total cholesterol, non-high-density lipoprotein (HDL) cholesterol, and apolipoprotein B protein. In addition, changes in the triglyceride and HDL levels in the R2.5+E10 group were significantly different compared with those in the E10 group; however, the changes were similar to those in the other treatment groups. In patients with low and moderate risk, all patients achieved the target LDL cholesterol levels in the R2.5+E10 group (100%) compared to 13.0% in the E10 group, 47.6% in the R2.5 group, and 65.2% in the R5 group. Adverse effects were rare and similar in the four groups.

Implications: Fixed-dose combination of low-intensity rosuvastatin and ezetimibe was more effective in lowering LDL cholesterol and achieving LDL cholesterol goals than moderate-intensity rosuvastatin monotherapy. These findings suggest that the combination therapy of low-intensity rosuvastatin and ezetimibe is an useful alternative to moderate-intensity rosuvastatin monotherapy for cholesterol management, particularly in patients with low and moderate risk. ClinicalTrials.gov identifier: NCT04652349.
Author(s)
강태수김무현김병진김봉식김석연김원김정선신한준안영근이무용이승아이철환조진만채인호홍순준홍택종
Issued Date
2021
Type
Article
Keyword
Care and treatmentDosage and administrationDrug therapyCombinationezetimibeHypercholesterolemiaL이-ㅊRosubastatinrosubastatin calcium
DOI
10.1016/j.clinthera.2021.07.016
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8274
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2564487374&amp;context=PC&amp;vid=ULSAN&amp;lang=ko_KR&amp;search_scope=default_scope&amp;adaptor=primo_central_multiple_fe&amp;tab=default_tab&amp;query=any,contains,Effects%20of%20Fixed-Dose%20Combination%20of%20Low-Intensity%20Rosuvastatin%20and%20Ezetimibe%20Versus%20Moderate-Intensity%20Rosuvastatin%20Monotherapy%20on%20Lipid%20Profiles%20in%20Patients%20With%20Hypercholesterolemia:%20A%20Randomized,%20Double-Blind,%20Multicenter,%20Phase%20III%20Study&amp;offset=0&amp;pcAvailability=true
Publisher
CLINICAL THERAPEUTICS
Location
미국
Language
한국어
ISSN
0149-2918
Citation Volume
149
Citation Number
21
Citation Start Page
261
Citation End Page
267
Appears in Collections:
Medicine > Medicine
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