Background: Authors evaluating the safety and efficacy of ezetimibe have demonstrated a low occurrence of serious adverse reactions, such as elevations in alanine transaminase (ALT) and/or creatine kinase (CK). This study describes the incidence of ALT and CK elevations among those patients who were prescribed ezetimibe in a large ambulatory care population to further elucidate the safety of ezetimibe in a diverse "real-world" population.
Methods: Adults (≥18 years) with at least one prescription for ezetimibe between January 1, 2002, and December 31, 2007, were eligible. All patients with an ALT greater than 3 times the upper limit of normal (3X ULN) and/or CK greater than 3X ULN any time after the first sold date of ezetimibe were identified. Medical records were reviewed by the use of predetermined assessment criteria to further classify patients and determine whether the elevation was possibly related, related, or not related to ezetimibe treatment.
Results: There were 4958 patients with a prescription for ezetimibe within the study period. Of these patients, 4332 (87%) had either an ALT or CK drawn. There were 82 patients identified with ALT greater than 3X ULN (n = 44) or with a CK greater than 3X ULN (n = 38). Of 82 patients, 17 (21%) were deemed possibly related to ezetimibe, of which only 5 (0.1%) had no other reasons noted for the elevation. In all cases the ezetimibe was prescribed in combination with a statin.
Conclusions: The incidence of ALT or CK elevations greater than 3X ULN in a large diverse population of patients was rare and similar to placebo rates in other published trials.
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