Cardiovascular safety of ADHD medications: rationale for and design of an investigator-initiated observational study

Pharmacoepidemiology and Drug Safety
Sean HennessyBrian L Strom

Abstract

To describe the design and rationale of an investigator-initiated observational study to examine the cardiovascular safety of the following commonly-used medications to treat attention deficit hyperactivity disorder (ADHD): amphetamines, methylphenidate, and atomoxetine. We are conducting an observational cohort study using data from five large Medicaid programs and the HealthCore Integrated Research Database (HIRD(SM)), which is derived from administrative data from commercial health plans. Our primary outcomes of interest are (1) sudden death/ventricular arrhythmia, (2) stroke, (3) myocardial infarction, and (4) stroke or myocardial infarction as a composite outcome. These claims diagnoses have been previously validated in adults, and the positive predictive value in children will be examined as part of this study. Secondary outcomes are (1) all-cause death, (2) non-suicide death, and (3) non-accident death. All design decisions have been made to minimize bias toward the null. Based on our pilot data, we expect to have at least 90% power to detect a minimum detectable hazard ratio (HR) of 3.0 in children and adolescents who initiate an ADHD medication for each outcome of interest (except for MI, for which the expected minimum...Continue Reading

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Citations

May 4, 2011·European Journal of Clinical Pharmacology·Anna DidoniUNKNOWN Lombardy ADHD Registry Group
Feb 20, 2013·Irish Journal of Medical Science·M Stuhec, V Svab
May 18, 2011·Pediatrics·Hedi SchellemanSean Hennessy
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Jul 6, 2012·Pharmacoepidemiology and Drug Safety·Vincent Lo ReBrian L Strom
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Aug 15, 2018·Pharmacoepidemiology and Drug Safety·Sigal KaplanJudith K Jones
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