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Abstract
This retrospective cohort study examined the risk of selected serious cardiac events
in new users of either astemizole or sedating antihistamines identified from the COMPASS®
Ohio Medicaid population of approximately 1 million active files per year (1986–1992).
(COMPASS is an automated claims database.) There were 15,585 patients in the astemizole
group and 30,105 in the sedating antihistamines group. Reports of ventricular arrhythmia
or sudden death occurring within 30 days of the first antihistamine claim were identified
from Medicaid claims. Medical records were obtained and reviewed by a clinician for
validity of diagnoses. Records for patients without a full 30 days of follow-up were
sought in the National Death Index. Death certificates were obtained for all patients
who died within 30 days of the first antihistamine claim. Of 53 cases identified,
6 were in the astemizole group and 47 in the sedating antihistamines group. The relative
risk for all selected cardiac events among astemizole users compared with sedating
antihistamine users was 0.25 (95% confidence interval: 0.11 to 0.58), and this estimate
did not change substantially when adjusted for age; sex; race; recent history of cardiovascular
disease, arrhythmias, asthma/pulmonary disease, or malignant neoplasms; or concomitant
prescription of other drugs. This study provided no evidence that astemizole users
are at increased risk for cardiac events in the first month of use when compared with
users of sedating antihistamines.
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© 1995 Published by Elsevier Inc.
