Safety Study of Atomoxetine and Cerebrovascular Outcomes
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.
Study Design
Observational Model: Cohort, Time Perspective: Retrospective
Conditions
Cerebrovascular Accident
Intervention
atomoxetine, Stimulants, No intervention (general population)
Location
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Indianapolis
Indiana
United States
Status
Completed
Source
Eli Lilly and Company
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00634439
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Population Surveillance
Ongoing scrutiny of a population (general population, study population, target population, etc.), generally using methods distinguished by their practicability, uniformity, and frequently their rapidity, rather than by complete accuracy.
Maximum Allowable Concentration
The maximum exposure to a biologically active physical or chemical agent that is allowed during an 8-hour period (a workday) in a population of workers, or during a 24-hour period in the general population, which does not appear to cause appreciable harm, whether immediate or delayed for any period, in the target population. (From Lewis Dictionary of Toxicology, 1st ed)
Intervention Studies
Epidemiologic investigations designed to test a hypothesized cause-effect relation by modifying the supposed causal factor(s) in the study population.
Chernobyl Nuclear Accident
April 25th -26th, 1986 nuclear power accident that occurred at Chernobyl in the former USSR (Ukraine) located 80 miles north of Kiev.
Succinimides
A subclass of IMIDES with the general structure of pyrrolidinedione. They are prepared by the distillation of ammonium succinate. They are sweet-tasting compounds that are used as chemical intermediates and plant growth stimulants.
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