Cited 62 times in
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 |
---|---|---|
dc.contributor.author | 최동훈 | - |
dc.contributor.author | 홍범기 | - |
dc.date.accessioned | 2014-12-19T17:03:17Z | - |
dc.date.available | 2014-12-19T17:03:17Z | - |
dc.date.issued | 2012 | - |
dc.identifier.issn | 1933-2874 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/90691 | - |
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; ×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. | - |
dc.description.statementOfResponsibility | open | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL LIPIDOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Alanine Transaminase/blood* | - |
dc.subject.MESH | Atorvastatin Calcium | - |
dc.subject.MESH | Cholesterol, LDL/blood | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Fatty Liver/diagnostic imaging | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Heptanoic Acids/therapeutic use* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* | - |
dc.subject.MESH | Hypercholesterolemia/blood | - |
dc.subject.MESH | Hypercholesterolemia/drug therapy* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Pyrroles/therapeutic use* | - |
dc.subject.MESH | Quinolines/therapeutic use* | - |
dc.subject.MESH | Tomography, X-Ray Computed | - |
dc.subject.MESH | Triglycerides/blood | - |
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.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | Ki Hoon Han | - |
dc.contributor.googleauthor | Seung Woon Rha | - |
dc.contributor.googleauthor | Hyun-Jae Kang | - |
dc.contributor.googleauthor | Jang-Whan Bae | - |
dc.contributor.googleauthor | Byoung-Joo Choi | - |
dc.contributor.googleauthor | So-Yeon Choi | - |
dc.contributor.googleauthor | Hyeon-Cheol Gwon | - |
dc.contributor.googleauthor | Jang-Ho Bae Bum-Kee Hong, MDh, Dong-Hoon Choi, MDi, Kyoo-Rok Han, | - |
dc.identifier.doi | 10.1016/j.jacl.2012.01.009 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A04053 | - |
dc.contributor.localId | A04394 | - |
dc.relation.journalcode | J01324 | - |
dc.identifier.pmid | 22836071 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S1933287412000232 | - |
dc.subject.keyword | Alanine transaminase | - |
dc.subject.keyword | Atorvastatin | - |
dc.subject.keyword | Hepatic steatosis | - |
dc.subject.keyword | Hepatotoxicity | - |
dc.subject.keyword | Pitavastatin | - |
dc.contributor.alternativeName | Choi, Dong Hoon | - |
dc.contributor.alternativeName | Hong, Bum Kee | - |
dc.contributor.affiliatedAuthor | Choi, Dong Hoon | - |
dc.contributor.affiliatedAuthor | Hong, Bum Kee | - |
dc.citation.volume | 6 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 340 | - |
dc.citation.endPage | 351 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL LIPIDOLOGY, Vol.6(4) : 340-351, 2012 | - |
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