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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)

Han, KH; Rha, SW; Kang, HJ; Bae, JW; Choi, BJ; Choi, SY; Gwon, HC; Bae, JH; Hong, BK; Choi, DH; Han, KR
Journal of clinical lipidology, 6(4):340-351, 2012
Journal Title
Journal of clinical lipidology
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 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 100 IU/L).

CONCLUSIONS: Conventional doses of pitavastatin and atorvastatin effectively and safely reduce elevated hepatic enzyme concentrations.
MeSH terms
AdultAgedAlanine Transaminase/*bloodCholesterol, LDL/bloodDrug Administration ScheduleFatty Liver/radiographyFemaleHeptanoic Acids/*therapeutic useHumansHydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic useHypercholesterolemia/blood/*drug therapyMaleMiddle AgedPyrroles/*therapeutic useQuinolines/*therapeutic useTriglycerides/blood
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Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
AJOU Authors
최, 병주최, 소연
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