Clinical trial NCT00634439: Safety Study of Atomoxetine and Cerebrovascular Outcomes
Official title: Atomoxetine and Cerebrovascular Outcomes in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Transient Ischemic Attack
ADHD
Keywords: cerebrovascular accident
stroke
transient ischemic attack
TIA
CVA
attention deficit hyperactivity disorder
ADHD
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: i3 Drug Safety
First posted: 2008-03-13
Enrollment: 72000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The source population is derived from the proprietary Ingenix RDM, with a cross-sectional population of approximately 12 million current health plan members across the US at the beginning of 2007 who have both medical and prescription benefit coverage.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* patients 18 years or older
* received dispensing of one of the study medications during the time period of the study (January 1, 2003 - December 31, 2006)
* 6 months of continuous enrollment prior to first dispensing

Exclusion Criteria:

* presence of pre-existing arrhythmia and heart failure during the baseline period

Primary outcomes:
measure: Cerebrovascular Accident (CVA)
timeFrame: January 2003 - June 2007
measure: Transient Ischemic Attack (TIA)
timeFrame: January 2003 - June 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM- 5PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: