Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) Study: a post-hoc analysis.

Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) Study: a post-hoc analysis.

MedLine Citation:	PMID: 21109302 Owner: NLM Status: MEDLINE
Abstract/OtherAbstract:	BACKGROUND: Long-term statin treatment reduces the frequency of cardiovascular events, but safety and efficacy in patients with abnormal liver tests is unclear. We assessed whether statin therapy is safe and effective for these patients through post-hoc analysis of the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) study population. METHODS: GREACE was a prospective, intention-to-treat study that randomly assigned by a computer-generated randomisation list 1600 patients with coronary heart disease (aged <75 years, with serum concentrations of LDL cholesterol >2·6 mmol/L and triglycerides <4·5 mmol/L) at the Hippokration University Hospital, Thessaloniki, Greece to receive statin or usual care, which could include statins. The primary outcome of our post-hoc analysis was risk reduction for first recurrent cardiovascular event in patients treated with a statin who had moderately abnormal liver tests (defined as serum alanine aminotransferase or aspartate aminotransferase concentrations of less than three times the upper limit of normal) compared with patients with abnormal liver tests who did not receive a statin. This risk reduction was compared with that for patients treated (or not) with statin and normal liver tests. FINDINGS: Of 437 patients with moderately abnormal liver tests at baseline, which were possibly associated with non-alcoholic fatty liver disease, 227 who were treated with a statin (mainly atorvastatin 24 mg per day) had substantial improvement in liver tests (p<0·0001) whereas 210 not treated with a statin had further increases of liver enzyme concentrations. Cardiovascular events occurred in 22 (10%) of 227 patients with abnormal liver tests who received statin (3·2 events per 100 patient-years) and 63 (30%) of 210 patients with abnormal liver tests who did not receive statin (10·0 events per 100 patient-years; 68% relative risk reduction, p<0·0001). This cardiovascular disease benefit was greater (p=0·0074) than it was in patients with normal liver tests (90 [14%] events in 653 patients receiving a statin [4·6 per 100 patient-years] vs 117 [23%] in 510 patients not receiving a statin [7·6 per 100 patient-years]; 39% relative risk reduction, p<0·0001). Seven (<1%) of 880 participants who received a statin discontinued statin treatment because of liver-related adverse effects (transaminase concentrations more than three-times the upper limit of normal). INTERPRETATION: Statin treatment is safe and can improve liver tests and reduce cardiovascular morbidity in patients with mild-to-moderately abnormal liver tests that are potentially attributable to non-alcoholic fatty liver disease. FUNDING: None.

Authors:	Vasilios G Athyros; Konstantinos Tziomalos; Thomas D Gossios; Theodora Griva; Panagiotis Anagnostis; Konstantinos Kargiotis; Efstathios D Pagourelias; Eleni Theocharidou; Asterios Karagiannis; Dimitri P Mikhailidis;
Publication Detail:	Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-11-23
Journal Detail:	Title: Lancet Volume: 376 ISSN: 1474-547X ISO Abbreviation: Lancet Publication Date: 2010 Dec
Date Detail:	Created Date: 2010-12-06 Completed Date: 2010-12-16 Revised Date: 2011-10-17
Medline Journal Info:	Nlm Unique ID: 2985213R Medline TA: Lancet Country: England
Other Details:	Languages: eng Pagination: 1916-22 Citation Subset: AIM; IM
Copyright Information:	Copyright © 2010 Elsevier Ltd. All rights reserved.
Affiliation:	Second Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.
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MeSH Terms
Descriptor/Qualifier:	Aged Cardiovascular Diseases / drug therapy* Coronary Disease / complications, drug therapy Fatty Liver / blood, complications, drug therapy Female Greece Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use* Liver Function Tests Male Middle Aged Prospective Studies Recurrence Risk Reduction Behavior Time Factors Treatment Outcome
Chemical
Reg. No./Substance:	0/Hydroxymethylglutaryl-CoA Reductase Inhibitors
Investigator
Investigator/Affiliation:	G Baharoudis / ; S Basdekas / ; V Bouloukos / ; E Christaki / ; S Dimopoulou / ; E Hartamba / ; A Kakafika / ; M Kapousouzi / ; H Koumaras / ; E Mitsiou / ; A Papageorgiou / ; A Pehlivanidis / ; D Petridis / ; Z Sekeri / ; A Skaperdas / ; A Symeonidis /
Comments/Corrections
Comment In:	J Fam Pract. 2011 Sep;60(9):536-8 [PMID: 21901179 ] Lancet. 2010 Dec 4;376(9756):1882-3 [PMID: 21109303 ] Nat Rev Cardiol. 2011 Feb;8(2):65 [PMID: 21348145 ] Lancet. 2011 Mar 26;377(9771):1075; author reply 1075-6 [PMID: 21440805 ]

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