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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

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
  1. Between 3‐20 years

  2. ≥ 1 inpatient or outpatient claim for ADHD defined by ICD‐9

  3. Newly started on methylphenidate or amphetamine salts


Exclusion criteria
  1. Eligibility ending

  2. Diagnosis of malignant neoplasm

  3. Turning 21 years

  4. Switching from 1 drug class to the other

  5. Starting to use drugs from both categories concomitantly

  6. When outcome of interest has occurred

Interventions Methylphenidate type: not stated
Methylphenidate dosage: not stated
Administration schedule: not stated
Duration of intervention: not stated
Treatment compliance: not stated
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
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