| Cardiovascular safety of ADHD medications: rationale for and design of an investigator-initiated observational study. | |
| | |
MedLine Citation:
|
PMID: 20623519 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
PURPOSE: 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. METHODS: 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 detectable HR is 7.9). The expected minimum detectable HR is 1.7 for each outcome for adult incident ADHD medication users. RESULTS: Forthcoming. CONCLUSIONS: Potential limitations to this study include a low expected event rate in children and adolescents, potentially incomplete ascertainment of outcomes, and potential confounding by unmeasured variables. Nevertheless, this study will provide important information about the cardiovascular safety of ADHD medications. |
| | |
Authors:
|
Sean Hennessy; Hedi Schelleman; Gregory W Daniel; Warren B Bilker; Stephen E Kimmel; James Guevara; Mark J Cziraky; Brian L Strom |
Related Documents
:
|
9265919 - Switching antipsychotic medications. 7428279 - Urine concentration of 3-ethyl-5-hydroxy-4,5-dimethyl-delta 3-pyrrolin-2-one ('mauve fa... 20382439 - The discrepancy in attention deficit hyperactivity disorder (adhd) medications diffusio... 18830439 - Once-daily treatment of adhd with guanfacine: patient implications. 11411819 - Priapism associated with conventional and atypical antipsychotic medications: a review. 10830149 - Nefazodone and the treatment of nonparaphilic compulsive sexual behavior: a retrospecti... 10786479 - Percutaneous transluminal myocardial revascularization. a new treatment for angina. 18066419 - Development of hospital data warehouse for cost analysis of dpc based on medical costs. 22196099 - Decompressive craniectomy in a neurologically devastated pregnant woman to maintain fet... |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Pharmacoepidemiology and drug safety Volume: 19 ISSN: 1099-1557 ISO Abbreviation: Pharmacoepidemiol Drug Saf Publication Date: 2010 Sep |
Date Detail:
|
Created Date: 2010-09-02 Completed Date: 2010-12-13 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9208369 Medline TA: Pharmacoepidemiol Drug Saf Country: England |
Other Details:
|
Languages: eng Pagination: 934-41 Citation Subset: IM |
Copyright Information:
|
(c) 2010 John Wiley & Sons, Ltd. |
Affiliation:
|
Center for Clinical Epidemiology and Biostatistics, and Department of Biostatistics & Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. hennessy@upenn.edu |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adolescent Adrenergic Uptake Inhibitors / adverse effects*, therapeutic use Amphetamines / adverse effects, therapeutic use Attention Deficit Disorder with Hyperactivity / drug therapy Cardiovascular Diseases / chemically induced*, epidemiology, physiopathology Central Nervous System Stimulants / adverse effects*, therapeutic use Child Cohort Studies Databases, Factual Humans Methylphenidate / adverse effects, therapeutic use Myocardial Infarction / chemically induced, epidemiology Propylamines / adverse effects, therapeutic use Research Design United States / epidemiology |
| Chemical | |
Reg. No./Substance:
|
0/Adrenergic Uptake Inhibitors; 0/Amphetamines; 0/Central Nervous System Stimulants; 0/Propylamines; 113-45-1/Methylphenidate; 83015-26-3/atomoxetine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Magnetic Membrane Gating: Single-Pore Membranes Gated by Microelectromagnetic Traps (Adv. Mater. 25/...
Next Document: Nanoparticle Arrays: Selective Assembly of Sub-Micrometer Polymer Particles (Adv. Mater. 25/2010).