Statins in primary biliary cirrhosis: are they safe?
OBJECTIVE
Although cholesterol levels are elevated in patients with primary biliary cirrhosis (PBC), most PBC patients are not at increased risk of dying from atherosclerotic heart disease. There is, however, a subgroup, approximately 10%, who have additional disorders of lipid metabolism. They might benefit from a cholesterol-lowering agent. However, there is concern about using statins in patients with pre-existing liver disease. We therefore reviewed our experience with statins in a large cohort of PBC patients who were seen at Tufts Medical Center during the past decade.


METHODS
From January 1, 1996, until June 30, 2006, 603 patients with PBC were seen by one of us (M.M.K.). Fifty-eight were on statins and five were on ezetimibe. The mean duration of usage was 41 months (range 3-125 months). Alanine aminotransferase (ALT) levels were measured at 3-month intervals.


RESULTS
Statins were well tolerated. No patient complained of muscle pain or weakness. There was no increase in ALT levels. ALT levels were slightly elevated at the time that statins were begun (41.7 +/- 25.1 U/l), and were normal at the last time these patients were seen (39.0 +/- 21.0 U/l) (P <or= 0.303). Serum cholesterol levels decreased by 30%, from 262 +/- 45 mg/dl to 181 +/- 14 mg/dl (P < 0.01). Ezetimibe was also well tolerated.


CONCLUSIONS
Statins are safe in PBC patients who might benefit from their use.
Division of Gastroenterology, Department of Medicine, Tufts Medical Center, Boston, MA 02111, USA.
Murad
M
Abu Rajab
Marshall M
MM
Kaplan
D000368:Aged; D000410:Alanine Transaminase / Q000097:blood* / Q000187:drug effects; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001384:Azetidines / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D000069438:Ezetimibe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000187:drug effects*; D008105:Liver Cirrhosis, Biliary / Q000175:diagnosis / Q000188:drug therapy*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011336:Probability; D012189:Retrospective Studies; D018570:Risk Assessment; D017751:Safety Management; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D001384:Azetidines; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000410:Alanine Transaminase; D000069438:Ezetimibe