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)
DC Field | Value | Language |
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dc.contributor.author | Han, Ki Hoon | - |
dc.contributor.author | Rha, Seung Woon | - |
dc.contributor.author | Kang, Hyun-Jae | - |
dc.contributor.author | Bae, Jang-Whan | - |
dc.contributor.author | Choi, Byoung-Joo | - |
dc.contributor.author | Choi, So-Yeon | - |
dc.contributor.author | Gwon, Hyeon-Cheol | - |
dc.contributor.author | Bae, Jang-Ho | - |
dc.contributor.author | Hong, Bum-Kee | - |
dc.contributor.author | Choi, Dong-Hoon | - |
dc.contributor.author | Han, Kyoo-Rok | - |
dc.date.accessioned | 2021-09-06T17:03:35Z | - |
dc.date.available | 2021-09-06T17:03:35Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2012-08 | - |
dc.identifier.issn | 1933-2874 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/107767 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.subject | FATTY LIVER-DISEASE | - |
dc.subject | NONALCOHOLIC STEATOHEPATITIS | - |
dc.subject | STEATOSIS | - |
dc.subject | STATINS | - |
dc.subject | DONORS | - |
dc.subject | CT | - |
dc.title | 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) | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Rha, Seung Woon | - |
dc.identifier.doi | 10.1016/j.jacl.2012.01.009 | - |
dc.identifier.scopusid | 2-s2.0-84864196086 | - |
dc.identifier.wosid | 000307144000008 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL LIPIDOLOGY, v.6, no.4, pp.340 - 351 | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL LIPIDOLOGY | - |
dc.citation.title | JOURNAL OF CLINICAL LIPIDOLOGY | - |
dc.citation.volume | 6 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 340 | - |
dc.citation.endPage | 351 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | FATTY LIVER-DISEASE | - |
dc.subject.keywordPlus | NONALCOHOLIC STEATOHEPATITIS | - |
dc.subject.keywordPlus | STEATOSIS | - |
dc.subject.keywordPlus | STATINS | - |
dc.subject.keywordPlus | DONORS | - |
dc.subject.keywordPlus | CT | - |
dc.subject.keywordAuthor | Alanine transaminase | - |
dc.subject.keywordAuthor | Atorvastatin | - |
dc.subject.keywordAuthor | Hepatic steatosis | - |
dc.subject.keywordAuthor | Hepatotoxicity | - |
dc.subject.keywordAuthor | Pitavastatin | - |
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