Safety Study of Atomoxetine and Cerebrovascular Outcomes

2014-08-27 03:32:13 | BioPortfolio


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


Cerebrovascular Accident


atomoxetine, Stimulants, No intervention (general population)


For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
United States




Eli Lilly and Company

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:32:13-0400

Clinical Trials [868 Associated Clinical Trials listed on BioPortfolio]

Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident

The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsycholo...

Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)

Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two differ...

An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The...

Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility

Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the utility of s...

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat ADHD) has effects on the body's ability to defend itself against low blood sugar.

PubMed Articles [16759 Associated PubMed Articles listed on BioPortfolio]

Risk of Suicidal Events With Atomoxetine Compared to Stimulant Treatment: A Cohort Study.

Antidepressant effects on increased suicidality in children have raised public concern in recent years. Approved in 2002 for attention-deficit/hyperactivity disorder treatment, the selective noradrena...

Cerebral Microbleeds and Cerebrovascular Reactivity in the General Population: The EDAN Study.

In patients with symptomatic cerebral amyloid angiopathy (CAA), cerebrovascular reactivity to visual stimuli is reduced. Lobar microbleeds are a diagnostic hallmark of CAA, but are also highly prevale...

A study of the effect of visual depth information on upper limb movement by use of measurement of smoothness.

[Purpose] This study verified that the smoothness of reaching movements is able to quantitatively evaluate the effects of two- and three-dimensional images on movement in healthy people. In addition, ...

Stimulants and Pediatric Cardiovascular Risk: A Review.

Concerns about serious cardiovascular (CV) events among stimulant-treated youth have led to clinical and policy debates. Accordingly, several population-based empirical studies have assessed the risk ...

Non-Linear Pharmacokinetics of Atomoxetine in Adult Japanese Patients With ADHD.

The objective was to reveal the relationship between dose and concentration of atomoxetine.

Medical and Biotech [MESH] Definitions

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.

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)

Epidemiologic investigations designed to test a hypothesized cause-effect relation by modifying the supposed causal factor(s) in the study population.

April 25th -26th, 1986 nuclear power accident that occurred at Chernobyl in the former USSR (Ukraine) located 80 miles north of Kiev.

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.

More From BioPortfolio on "Safety Study of Atomoxetine and Cerebrovascular Outcomes"

Quick Search

Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Searches Linking to this Trial