PMID- 23274145
OWN - NLM
STAT- MEDLINE
DCOM- 20130702
LR  - 20221207
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 35
IP  - 1
DP  - 2013 Jan
TI  - Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in 
      Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, 
      randomized trial.
PG  - 77-86
LID - S0149-2918(12)00657-1 [pii]
LID - 10.1016/j.clinthera.2012.11.009 [doi]
AB  - BACKGROUND: 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.
CI  - Copyright (c) 2013 Elsevier HS Journals, Inc. All rights reserved.
FAU - Kim, Sang-Hyun
AU  - Kim SH
AD  - Division of Cardiology, Department of Internal Medicine, Seoul National 
      University College of Medicine, Seoul, Republic of Korea.
FAU - Seo, Myung-Ki
AU  - Seo MK
FAU - Yoon, Myeong-Ho
AU  - Yoon MH
FAU - Choi, Dong-Hoon
AU  - Choi DH
FAU - Hong, Taek-Jong
AU  - Hong TJ
FAU - Kim, Hyo-Soo
AU  - Kim HS
LA  - eng
SI  - ClinicalTrials.gov/NCT01285544
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121228
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (APOA1 protein, human)
RN  - 0 (Apolipoprotein A-I)
RN  - 0 (Apolipoproteins B)
RN  - 0 (Biomarkers)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Drugs, Generic)
RN  - 0 (Heptanoic Acids)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Pyrroles)
RN  - 0 (Triglycerides)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - A0JWA85V8F (Atorvastatin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Apolipoprotein A-I/blood
MH  - Apolipoproteins B/blood
MH  - Asian People
MH  - Atorvastatin
MH  - Biomarkers/blood
MH  - C-Reactive Protein/metabolism
MH  - Chemistry, Pharmaceutical
MH  - Cholesterol, HDL/blood
MH  - Cholesterol, LDL/blood
MH  - Drugs, Generic/adverse effects/chemistry/*therapeutic use
MH  - Female
MH  - Heptanoic Acids/adverse effects/chemistry/*therapeutic use
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse 
      effects/chemistry/*therapeutic use
MH  - Hypercholesterolemia/blood/diagnosis/*drug therapy/ethnology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrroles/adverse effects/chemistry/*therapeutic use
MH  - Republic of Korea
MH  - Therapeutic Equivalency
MH  - Time Factors
MH  - Treatment Outcome
MH  - Triglycerides/blood
MH  - Young Adult
EDAT- 2013/01/01 06:00
MHDA- 2013/07/03 06:00
CRDT- 2013/01/01 06:00
PHST- 2012/11/27 00:00 [accepted]
PHST- 2013/01/01 06:00 [entrez]
PHST- 2013/01/01 06:00 [pubmed]
PHST- 2013/07/03 06:00 [medline]
AID - S0149-2918(12)00657-1 [pii]
AID - 10.1016/j.clinthera.2012.11.009 [doi]
PST - ppublish
SO  - Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 
      Dec 28.