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A randomized, open-label, parallel, multicenter Phase IV study to compare the efficacy and safety of atorvastatin 10 and 20 mg in high-risk Asian patients with hypercholesterolemia

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Abstract
Background
Although accumulating evidence suggests a more extensive reduction of low-density lipoprotein cholesterol (LDL-C), it is unclear whether a higher statin dose is more effective and costeffective in the Asian population. This study compared the efficacy, safety, and cost-effectiveness of atorvastatin 20 and 10 mg in high-risk Asian patients with hypercholesterolemia.
Methods
A 12-week, open-label, parallel, multicenter, Phase IV randomized controlled trial was conducted at ten hospitals in the Republic of Korea between October 2017 and May 2019. High-risk patients with hypercholesterolemia, defined according to 2015 Korean guidelines for dyslipidemia management, were eligible to participate. We randomly assigned 250 patients at risk of atherosclerotic cardiovascular disease to receive 20 mg (n = 124) or 10 mg (n = 126) of atorvastatin. The primary endpoint was the difference in the mean percentage change in LDL-C levels from baseline after 12 weeks. Cost-effectiveness was measured as an exploratory endpoint.
Results
LDL-C levels were reduced more significantly by atorvastatin 20 mg than by 10 mg after 12 weeks (42.4% vs. 33.5%, p < 0.0001). Significantly more patients achieved target LDL-Clevels (<100 mg/dL for high-risk patients, <70 mg/dL for very high-risk patients) with atorvastatin 20 mg than with 10 mg (40.3% vs. 25.6%, p < 0.05). Apolipoprotein B decreased significantly with atorvastatin 20mg versus 10 mg (?36.2% vs. ?29.9%, p < 0.05). Lipid ratios also showed greater improvement with atorvastatin 20 mg than with 10 mg (total cholesterol/high-density lipoprotein cholesterol ratio, ?33.3% vs. ?29.4%, p < 0.05; apolipoprotein B/apolipoprotein A1 ratio, ?36.7% vs. ?31.4%, p < 0.05). Atorvastatin 20 mg was more costeffective than atorvastatin 10 mg in terms of both the average and incremental cost-effectiveness ratios. Safety and tolerability of atorvastatin 20 mg were comparable to those of atorvastatin 10 mg.
Conclusion
In high-risk Asian patients with hypercholesterolemia, atorvastatin 20 mg was both efficacious in reducing LDL-C and cost-effective compared with atorvastatin 10 mg.
Author(s)
김신재김지박김진원도종형박용현박종성송우혁안성균윤태진조윤형
Issued Date
2021
Type
Article
Keyword
Adverse eventsApolipoproteinsAtorvastatinBlood pressureCardiologyCardiovascular diseaseCardiovascular diseasesCholesterolClinical trialsComparative analysisCost analysisCreatinineData analysisDiabetesDosageDrug dosagesDrug therapyDyslipidemiaEthnicityFDA approvalFenofibrateGraduate schoolsGraduate studiesGuidelinesHealth risksHeart diseasesHemoglobinHospitalsHypercholesterolemiaInternal medicineLabelsLipidsLow density lipoproteinLow density lipoproteinsMedicinePatient safetyPatientsPharmaceutical industryRisk analysisRisk factorsRisk reductionSafetySide effectsStatinsThyroid gland
DOI
10.1371/journal.pone.0245481
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8260
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_plos_journals_2479993832&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,A%20randomized,%20open-label,%20parallel,%20multicenter%20Phase%20IV%20study%20to%20compare%20the%20efficacy%20and%20safety%20of%20atorvastatin%2010%20and%2020%20mg%20in%20high-risk%20Asian%20patients%20with%20hypercholesterolemia&amp;offset=0&amp;pcAvailability=true
Publisher
PLoS One
Location
미국
Language
한국어
ISSN
1932-6203
Citation Volume
16
Citation Number
1
Citation Start Page
e0245481
Citation End Page
0
Appears in Collections:
Medicine > Medicine
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