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Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial.

DC Field Value Language
dc.contributor.authorKim, SH-
dc.contributor.authorSeo, MK-
dc.contributor.authorYoon, MH-
dc.contributor.authorChoi, DH-
dc.contributor.authorHong, TJ-
dc.contributor.authorKim, HS-
dc.date.accessioned2014-05-19T04:12:21Z-
dc.date.available2014-05-19T04:12:21Z-
dc.date.issued2013-
dc.identifier.issn0149-2918-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/9989-
dc.description.abstractBACKGROUND: A manufacturer of atorvastatin is seeking marketing approval in Korea of a generic product for adult patients with primary hypercholesterolemia.



OBJECTIVE: The objective of this study was to compare the efficacy and tolerability of a new generic formulation of atorvastatin (test) with those of an original formulation of atorvastatin (reference) to satisfy regulatory requirements for marketing of the generic product in Korea.



METHODS: Patients enrolled were aged 20 to 79 years with documented primary hypercholesterolemia who did not respond adequately to therapeutic lifestyle changes and with a LDL-C level >100 mg/dL from a high-risk group of coronary artery disease patients. Eligible patients were randomized to receive 1 of the 2 formulations of atorvastatin 20 mg per day for 8 weeks. The primary end point was the percent change in LDL-C level from baseline to week 8. Secondary end points included the percent change in total cholesterol, triglycerides, HDL-C level, apolipoprotein B:apolipoprotein A-I ratio, LDL:HDL ratio, LDL-C particle size, high-sensitivity C-reactive protein from baseline to week 8, and achievement rate of the LDL-C goal.



RESULTS: A total of 298 patients (141 men and 157 women; 149 patients in each group; mean [SD] age, 62.4 [9.2] in the test group vs 60.3 [8.9] years in the reference group) were included. LDL-C levels were significantly decreased from baseline to week 8 in both groups, and there was no significant difference in the percent change in LDL-C level between groups (-44.0% [17.2%] in the test group, -45.4% [16.9%] in the reference group; P = 0.49). The between-group differences in the percent changes in total cholesterol and triglyceride levels were not statistically significant. In addition, there was no significant difference between the 2 groups in percent changes in HDL-C, apolipoprotein B:apolipoprotein A-I ratio, LDL-C:HDL-C ratio, LDL-C particle size, high-sensitivity C-reactive protein, and the achievement rate of the LDL-C goal. Two (1.3%) patients in the reference group (N = 150) experienced treatment-related serious adverse events (AEs): toxic hepatitis and aggravation of chest pain. Common AEs were cough (4.1%), myalgia (2.1%), and indigestion (1.4%) in the test formulation group and cough (5.3%), creatine kinase elevation (2.7%), and edema (0.7%) in the reference formulation group; however, the differences in overall prevalence of AEs between the 2 treatment groups was not significant (P = 0.88).



CONCLUSIONS: There were no significant differences observed in the efficacy and tolerability between the test and reference formulations of atorvastatin in these Korean adult patients with primary hypercholesterolemia.
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dc.language.isoen-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHApolipoprotein A-I/blood-
dc.subject.MESHApolipoproteins B/blood-
dc.subject.MESHAsian Continental Ancestry Group-
dc.subject.MESHBiological Markers/blood-
dc.subject.MESHC-Reactive Protein/metabolism-
dc.subject.MESHChemistry, Pharmaceutical-
dc.subject.MESHCholesterol, HDL/blood-
dc.subject.MESHCholesterol, LDL/blood-
dc.subject.MESHDrugs, Generic/adverse effects/chemistry/*therapeutic use-
dc.subject.MESHFemale-
dc.subject.MESHHeptanoic Acids/adverse effects/chemistry/*therapeutic use-
dc.subject.MESHHumans-
dc.subject.MESHHydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects/chemistry/*therapeutic use-
dc.subject.MESHHypercholesterolemia/blood/diagnosis/*drug therapy/ethnology-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHProspective Studies-
dc.subject.MESHPyrroles/adverse effects/chemistry/*therapeutic use-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHTherapeutic Equivalency-
dc.subject.MESHTime Factors-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHTriglycerides/blood-
dc.subject.MESHYoung Adult-
dc.titleAssessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial.-
dc.typeArticle-
dc.identifier.pmid23274145-
dc.identifier.urlhttp://linkinghub.elsevier.com/retrieve/pii/S0149-2918(12)00657-1-
dc.contributor.affiliatedAuthor윤, 명호-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.clinthera.2012.11.009-
dc.citation.titleClinical therapeutics-
dc.citation.volume35-
dc.citation.number1-
dc.citation.date2013-
dc.citation.startPage77-
dc.citation.endPage86-
dc.identifier.bibliographicCitationClinical therapeutics, 35(1):77-86, 2013-
dc.identifier.eissn1879-114X-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
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