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Safety Study of Atomoxetine and Cerebrovascular Outcomes

This study has been completed.
i3 Drug Safety
Information provided by:
Eli Lilly and Company Identifier:
First received: March 4, 2008
Last updated: September 14, 2009
Last verified: September 2009
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.

Condition Intervention
Cerebrovascular Accident
Transient Ischemic Attack
Drug: atomoxetine
Drug: Stimulants
Other: No intervention (general population)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Atomoxetine and Cerebrovascular Outcomes in Adults

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Cerebrovascular Accident (CVA) [ Time Frame: January 2003 - June 2007 ]
  • Transient Ischemic Attack (TIA) [ Time Frame: January 2003 - June 2007 ]

Estimated Enrollment: 72000
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients 18 years or older who received a first dispensing of atomoxetine during the time period of the study (January 1, 2003 through December 31, 2006) and had at least 6 months of continuous enrollment prior to first dispensing are included in the study cohort. Patients are excluded for presence of pre-existing arrhythmia and heart failure during the baseline period. The study entry date for this cohort is the date of first atomoxetine dispensing.
Drug: atomoxetine
Other Names:
  • LY139603
  • Strattera
All patients 18 years or older who received a first dispensing of a stimulant medication (methylphenidate or mixed salts of amphetamine) during the time period of the study with no dispensing of the same drug in the prior 6 months and had at least 6 months of continuous enrollment prior to the first dispensing are identified. Patients are excluded for presence of pre-existing arrhythmia and heart failure during the baseline period. Patients who are matched to atomoxetine initiators using this propensity score method are retained and followed as one comparator cohort. The study entry date is the date of the first dispensing of a comparator ADHD medication.
Drug: Stimulants
Methylphenidate, amphetamines (including Adderall and mixed salts)
Patients with at least 6 months of continuous enrollment in the database, and without a history of arrhythmia or heart failure during the baseline period are sampled and frequency matched on age and gender to the atomoxetine cohort in a 2:1 ratio. Study entry dates are assigned so as to be similar to the distribution of study entry dates in the atomoxetine cohort. Patients identified and matched as initiators of atomoxetine or stimulant ADHD medications are not eligible for inclusion in this cohort
Other: No intervention (general population)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00634439

United States, Indiana
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
Indianapolis, Indiana, United States
Sponsors and Collaborators
Eli Lilly and Company
i3 Drug Safety
Study Director: Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM- 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00634439     History of Changes
Other Study ID Numbers: 12414
Study First Received: March 4, 2008
Last Updated: September 14, 2009

Keywords provided by Eli Lilly and Company:
cerebrovascular accident
transient ischemic attack
attention deficit hyperactivity disorder

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Dopamine Agents processed this record on May 25, 2017