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 BV
- Keywords
- Alanine transaminase; Atorvastatin; Hepatic steatosis; Hepatotoxicity; Pitavastatin
- Citation
- Journal of Clinical Lipidology, v.6, no.4, pp 340 - 351
- Pages
- 12
- Indexed
- SCIE
SCOPUS
- Journal Title
- Journal of Clinical Lipidology
- Volume
- 6
- Number
- 4
- Start Page
- 340
- End Page
- 351
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/11879
- DOI
- 10.1016/j.jacl.2012.01.009
- ISSN
- 1933-2874
1876-4789
- 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; ×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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