title: Statins are not a risk factor for liver damage associated with intravenous glucocorticoid pulse therapy for Graves' orbitopathy.
abstract: OBJECTIVE
  Acute liver damage (ALD) is associated with high-dose intravenous (iv) glucocorticoid (GC) (ivGC) pulse therapy in ~1 % of patients for Graves' orbitopathy (GO). It has been proposed that statins may increase the risk of ALD. Here we investigated the frequency of ALD according to the assumption of statins in a large retrospective cohort study.
  
  
  METHODS
  We studied 1076 consecutive patients with GO given ivGC. ALD was defined as an increase in alanine aminotransferase ≥300 U/l.
  
  
  RESULTS
  At the time of ivGC, 62 patients were taking statins and 1014 were not. The frequency of ALD has been reported to be 1.2 cases/100,000 statins users and 1300/100,000 in GO patients given ivGC. Thus, the expected frequency of ALD in patients given both statins and ivGC is 1560/100,000. Transferring these data to our series, one would have expected at least 0.96 cases of ALD (~one case), in the 62 patients given both ivGC and statins. However, no cases of ALD were observed in patients given statins, and the previously reported 14 cases of ALD in this series were seen in patients who were not taking statins.
  
  
  CONCLUSIONS
  The lack of observation of cases of ALD in patients given ivGC and statins is quite reassuring. Although caution should be applied to any patient candidate to ivGC treatment and this should be particularly accurate in patients given statins, our findings somehow justify the use of ivGC in patients under statins, although further studies in larger cohorts are needed to confirm our conclusions.
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Sabini
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Sisti
authors.affiliation: Hepatology Unit, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Coco
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Leo
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Ionni
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Menconi
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: M A
authors.initials: MA
authors.lastname: Profilo
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Mazzi
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Rocchi
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Latrofa
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Vitti
authors.affiliation: Hepatology Unit, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Brunetto
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Marcocci
authors.affiliation: Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy. michele.marino@med.unipi.it.
authors.forename: M
authors.initials: M
authors.lastname: Marinò
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000032:analysis; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D049970:Graves Ophthalmopathy / Q000188:drug therapy*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008107:Liver Diseases / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D055815:Young Adult
chemical_list: D015415:Biomarkers; D005938:Glucocorticoids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: Glucocorticoid; Graves’ ophthalmopathy; Hepatitis; Statins