Winterstein 2009.
Methods | A 10 year retrospective cohort design evaluating the cardiac safety of methylphenidate and amphetamine salts | |
Participants | Number of participants screened: 2,131,953 Number of participants included: 30,576 Number of participants included in methylphenidate arm: 18,238 Number of participants followed up: 18,238 Number of withdrawals: 0 Diagnosis of ADHD: ICD‐9 (subtype: not stated) Age: mean 8.5‐9.2, range: 3‐20 years old IQ: not stated Sex: 13332 males, 4906 females Methylphenidate‐naïve: 100% Ethnicity: white: 44‐48.2%, African American: 31.6‐34.7%, Hispanic: 14.4‐15.5% Country: USA Comorbidity: circulatory disease (3.5%) Comedication: bronchodilators 15.5‐16.3%, antidepressants 14‐16.4%, antipsychotics 8.2% Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: not stated Methylphenidate dosage: not stated Administration schedule: not stated Duration of intervention: not stated Treatment compliance: not stated |
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Outcomes |
Serious adverse events: Data assembled from the Florida Medicaid fee‐for‐service programme Cardiac event defined as a first emergency department (ED) visit for cardiac disease or symptoms: myocardial infarction, stroke, hypertensive disease (excluding malignant causes), angina, aortic or thoracic aneurysm, arrhythmias, syncope, or tachycardia or palpitation ED visits were chosen as clinical end point because they occur more frequently than hospital admissions or cardiac death and provided the best power to detect even subtle difference between drugs |
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Notes | Sample calculation: no Ethics approval: not stated Funding: funded in part by the Florida Department of Health, Agency for Healthcare Administration Vested interests/authors' affiliations: Dr Gerhard was in part funded by a grant from the Agency for Healthcare Research and Quality Key conclusions of the study authors: exposure to methylphenidate and amphetamines salts showed similar risk for cardiac ED visits Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental information requested through personal email correspondence with the authors in January 2014 with no reply |