The aim of this study was to estimate the association between atomoxetine and cerebrovascular accident (CVA) and transient ischemic attack (TIA) in adults.
This cohort study conducted within a health insurance database included 21,606 atomoxetine initiators matched to 21,606 stimulant attention-deficit/hyperactivity disorder (ADHD) medication initiators on the basis of propensity scores and a sample from the source population (N = 42,993). Outcomes were confirmed through a medical record review or a National Death Index search. Poisson regression was used to estimate the rate ratio and 95% confidence interval (CI) of CVA or TIA according to the treatment. Cox regression was used to estimate the hazards ratio (HR) and 95% CI for comparisons across cohorts.
Forty-four CVAs and 21 TIAs occurred during a mean follow-up of 1.5 years. The rate ratio of the current atomoxetine compared with the current stimulant ADHD medication was 1.38 for CVA (95% CI, 0.42-4.54) and 0.31 for TIA (95% CI, 0.04-2.63). Results for atomoxetine compared with the stimulant ADHD medication according to initial cohort assignment were consistent, with no increased risk for CVA or TIA. An increased risk of TIA was observed between initiation of an ADHD medication compared with the general population (HR, 3.44; 95% CI, 1.13-10.60); however, a similar pattern was not observed for CVA (HR, 0.71; 95% CI, 0.34-1.47).
These results do not support an increased risk of CV events with atomoxetine compared with the stimulant ADHD medication. Users of ADHD medications may be at an increased risk of TIA compared with the general population.
From the *i3 Drug Safety, Waltham, MA; and †Eli Lilly and Company, Indianapolis, IN.
Received December 19, 2008; accepted after revision June 5, 2009.
Reprints: Crystal N. Holick, ScD, MPH, HealthCore, Inc, 800 Delaware Ave, 5th Floor, Wilmington, DE 19801-1366 (email: firstname.lastname@example.org).
This research was supported by a contract between i3 Drug Safety, a division of Ingenix Pharmaceutical Services, Inc, and Eli Lilly and Company. The contract granted i3 Drug Safety full control of the study conduct, reporting, and interpretation, as well as the final wording of any resulting manuscript.