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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)

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dc.contributor.authorHan, KH-
dc.contributor.authorRha, SW-
dc.contributor.authorKang, HJ-
dc.contributor.authorBae, JW-
dc.contributor.authorChoi, BJ-
dc.contributor.authorChoi, SY-
dc.contributor.authorGwon, HC-
dc.contributor.authorBae, JH-
dc.contributor.authorHong, BK-
dc.contributor.authorChoi, DH-
dc.contributor.authorHan, KR-
dc.date.accessioned2013-04-22T22:28:17Z-
dc.date.available2013-04-22T22:28:17Z-
dc.date.issued2012-
dc.identifier.issn1933-2874-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/7806-
dc.description.abstractBACKGROUND: 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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dc.language.isoen-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAlanine Transaminase-
dc.subject.MESHCholesterol, LDL-
dc.subject.MESHDrug Administration Schedule-
dc.subject.MESHFatty Liver-
dc.subject.MESHFemale-
dc.subject.MESHHeptanoic Acids-
dc.subject.MESHHumans-
dc.subject.MESHHydroxymethylglutaryl-CoA Reductase Inhibitors-
dc.subject.MESHHypercholesterolemia-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPyrroles-
dc.subject.MESHQuinolines-
dc.subject.MESHTriglycerides-
dc.titleEvaluation 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.typeArticle-
dc.identifier.pmid22836071-
dc.identifier.urlhttp://linkinghub.elsevier.com/retrieve/pii/S1933-2874(12)00023-2-
dc.contributor.affiliatedAuthor최, 병주-
dc.contributor.affiliatedAuthor최, 소연-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.jacl.2012.01.009-
dc.citation.titleJournal of clinical lipidology-
dc.citation.volume6-
dc.citation.number4-
dc.citation.date2012-
dc.citation.startPage340-
dc.citation.endPage351-
dc.identifier.bibliographicCitationJournal of clinical lipidology, 6(4). : 340-351, 2012-
dc.relation.journalidJ019332874-
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Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
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