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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).

 Ki Hoon Han  ;  Seung Woon Rha  ;  Hyun-Jae Kang  ;  Jang-Whan Bae  ;  Byoung-Joo Choi  ;  So-Yeon Choi  ;  Hyeon-Cheol Gwon  ;  Jang-Ho Bae Bum-Kee Hong, MDh, Dong-Hoon Choi, MDi, Kyoo-Rok Han, 
 JOURNAL OF CLINICAL LIPIDOLOGY, Vol.6(4) : 340-351, 2012 
Journal Title
Issue Date
Adult ; Aged ; Alanine Transaminase/blood* ; Atorvastatin Calcium ; Cholesterol, LDL/blood ; Drug Administration Schedule ; Fatty Liver/diagnostic imaging ; Female ; Heptanoic Acids/therapeutic use* ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* ; Hypercholesterolemia/blood ; Hypercholesterolemia/drug therapy* ; Male ; Middle Aged ; Pyrroles/therapeutic use* ; Quinolines/therapeutic use* ; Tomography, X-Ray Computed ; Triglycerides/blood
Alanine transaminase ; Atorvastatin ; Hepatic steatosis ; Hepatotoxicity ; Pitavastatin
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; ×1.25≥ and ≤×2.5 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× 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 statins 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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
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