Evaluation of short-term safety and efficacy of HMG-CoA reductase inhibitors in hypercholesterolemic patients with elevated serum alanine transaminase concentrations: PITCH study (PITavastatin versus atorvastatin to evaluate the effect on patients with hypercholesterolemia and mild to moderate hepatic damage)
- Authors
- Han, Ki Hoon; Rha, Seung Woon; Kang, Hyun-Jae; Bae, Jang-Whan; Choi, Byoung-Joo; Choi, So-Yeon; Gwon, Hyeon-Cheol; Bae, Jang-Ho; Hong, Bum-Kee; Choi, Dong-Hoon; Han, Kyoo-Rok
- Issue Date
- Aug-2012
- Publisher
- ELSEVIER SCIENCE INC
- Keywords
- Alanine transaminase; Atorvastatin; Hepatic steatosis; Hepatotoxicity; Pitavastatin
- Citation
- JOURNAL OF CLINICAL LIPIDOLOGY, v.6, no.4, pp.340 - 351
- Indexed
- SCIE
SCOPUS
- Journal Title
- JOURNAL OF CLINICAL LIPIDOLOGY
- Volume
- 6
- Number
- 4
- Start Page
- 340
- End Page
- 351
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/107767
- DOI
- 10.1016/j.jacl.2012.01.009
- ISSN
- 1933-2874
- Abstract
- BACKGROUND: We evaluated the safety and efficacy of the 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitors atorvastatin and pitavastatin in patients with mild-to-moderate increased levels of hepatic enzymes. METHODS AND RESULTS: In this 12-week, prospective, randomized, open-label, active drug-controlled, and dose-titration study, 189 subjects with elevated low-density lipoprotein cholesterol (>= 3.36 mmol/L) and alanine transaminase (ALT; X 1.25 >= and <= X2.5 ULN; 50-100 IU/L) concentrations, but nonalcoholic and serologically negative for viral hepatitis markers at screening, were randomized to 12 weeks of treatment with pitavastatin 2-4 mg/day (PITA, n = 97) or atorvastatin 10-20 mg/day (ATOR, n = 92). Pitavastatin and atorvastatin equally reduced low-density lipoprotein cholesterol concentrations (-34.6 +/- 16.0% and -38.1 +/- 16.2%, respectively, P < .0001 each by analysis of variance). Seven (n = 4 PITA, n = 3 ATOR) and 10 (n = 5 PITA, n = 5 ATOR) patients experienced episodes of ALT >100 IU/L at weeks 4 and 12, respectively, with one patient in each group excluded because of severe ALT elevation >3 X ULN (>120 IU/L) at week 4. The 135 patients with persistently increased ALT concentrations at screening and randomization showed significant reductions in ALT after 12 weeks of treatment with PITA (n = 68, -8.4%) or ATOR (n = 67, -8.9%; P < .05. analysis of variance). Serial nonenhanced computed tomography in 38 subjects (n = 18 PITA, n = 20 ATOR) showed that both stains reduced the severity of hepatic steatosis, especially in subjects with clear hepatic steatosis at baseline (n = 9 PITA, n = 10 ATOR). Statin treatment of another 38 subjects with spontaneous normalization of ALT at randomization had little effect on ALT levels but did not induce severe ALT elevation (>100 IU/L). CONCLUSIONS: Conventional doses of pitavastatin and atorvastatin effectively and safely reduce elevated hepatic enzyme concentrations. (C) 2012 National Lipid Association. All rights reserved.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - Graduate School > Department of Biomedical Sciences > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.