Safety Study of Atomoxetine and Cerebrovascular Outcomes
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
Using a proprietary insurance health claims database, Eli Lilly and Company has contracted
with an external party to conduct a retrospective cohort study of health claims for the time
period from 1 January 2003 through 31 December 2006 (with follow-up of patients through 30
June 2007). This study will evaluate the potential association between atomoxetine and
cerebrovascular events. In this study, the incidence of selected cerebrovascular outcomes as
represented in health claims data among adult patients who initiate therapy with atomoxetine
will be estimated. In particular the study will focus on cerebrovascular accident (CVA) and
transient ischemic attack (TIA) as the outcomes of interest. The incidence for each outcome
among atomoxetine initiators will then be compared to the incidence in a cohort of similar
patients who initiate stimulant treatment and an age and gender-matched general population
cohort. The atomoxetine and stimulant-initiating cohorts will be matched on a broad variety
of variables, including age, gender, diagnoses, medication use, and healthcare utilization
through the use of propensity score matching in order to minimize the influence of
confounding by indication. The analysis will include the cohorts (atomoxetine and stimulant
initiators) from a previous completed study with increased follow-up time (1 January 2003
through 30 June 2007) and accrue new atomoxetine and stimulant ADHD medication initiators
over a 2 year period, so that the study will represent initiators between January 1, 2003 and
December 31, 2006 with follow-up through June 30, 2007.
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
i3 Drug Safety
Treatments:
Atomoxetine Hydrochloride Central Nervous System Stimulants Methylphenidate