Liver function testing in patients on HMG-CoA reductase inhibitors
Meyers Primary Care Institute
Aged; Drug Labeling; Drug-Induced Liver Injury; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Liver Function Tests; Male; Middle Aged; Retrospective Studies; United States; United States Food and Drug Administration
Health Services Research | Primary Care
PURPOSE: The Food and Drug Administration currently requires the labeling of HMG-CoA reductase inhibitors to recommend liver function tests (LFTs) before the start of therapy and at various intervals during therapy, depending on the specific agent. We sought to determine the frequency and patterns of LFT screening in patients receiving HMG-CoA reductase inhibitors.
METHODS: A retrospective study was conducted at a staff-model health maintenance organization among 4178 new users of HMG-CoA reductase inhibitors during the period 1 January 1991 through 31 December 1996. The number and proportions of HMG-CoA reductase inhibitor therapy courses with baseline LFTs (within 180 days prior to dispensing), follow-up LFTs and LFT abnormalities were calculated.
RESULTS: For the initial HMG-CoA reductase inhibitor dispensed, 1947 patients (47%) had at least one screening LFT at baseline and 3063 (73%) had at least one follow-up LFT. Twenty-seven (0.9%) patients with at least one follow-up LFT performed had a level greater than 3 times the upper limit of normal. In a random sample of 100 discontinued patients, none discontinued due to elevated LFTs or liver disease.
CONCLUSIONS: A large proportion of patients dispensed HMG-CoA reductase inhibitors in this managed care setting did not have baseline and follow-up LFTs performed. Modest LFT abnormalities were common among users of HMG-CoA reductase inhibitors; however, in this population, serious abnormalities were rare.
DOI of Published Version
Pharmacoepidemiol Drug Saf. 2003 Jun;12(4):307-13. Link to article on publisher's site
Pharmacoepidemiology and drug safety
Andrade, Susan E.; Donahue, James G.; Chan, K. Arnold; Watson, Douglas J.; and Platt, Richard, "Liver function testing in patients on HMG-CoA reductase inhibitors" (2003). Meyers Primary Care Institute Publications and Presentations. 311.