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

Lamberti 2015.

Methods An observational prospective study of immediate‐release methylphenidate and cardiovascular effects
Participants Number of participants screened: not stated
Number of participants included: 54
Number of participants followed up: 54
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐5 (subtype: not stated)
Age: mean 12.14 (SD 2.6) years (range 6‐19)
IQ: not stated
Sex: 51 males, 3 females
Methylphenidate‐naïve: 100%
Ethnicity: not stated
Country: Italy
Comorbidity: no cardiovascular, pulmonary, or endocrine disorders
Comedication: not stated
Sociodemographics: not stated
Inclusion criteria
  1. Drug naïve ADHD outpatient

  2. ADHD diagnosis according to DSM‐5 criteria

  3. Attending the Unit of Child Neurology and Psychiatry of the University Polyclinic of Messina between September 2013 and March 2014

  4. New user of immediate‐release methylphenidate

Interventions Methylphenidate: immediate release (IR‐MPH)
Methylphenidate dosage: 10‐60 mg according to the participant's weight
Mean methylphenidate dosage: 18.5 mg/day
Administration schedule: each treatment condition was administered 7 days, 2‐3 times daily, at breakfast (approximately 7:30 am), at lunch (approximately 12:30 pm), and in some cases, early afternoon (approximately 3:30 pm)
Duration of intervention: 4 weeks
Treatment compliance: 100%
Outcomes For each patient, 2 standard 12‐lead ECGs were obtained at a paper speed of 25 mm/second with the same instrument (Cardioline delta 3 plus), on the same day and under similar conditions. The first (predose) ECG examination was performed before the administration of the first daily dose of IR‐MPH; the second (postdose) ECG was executed 2 hours after drug intake, simultaneously with the serum peak of methylphenidate
Non‐serious adverse events
Treatment with immediate‐release methylphenidate was associated with a slight increase of systolic and diastolic BP
Notes Sample calculation: not stated
Ethics approval: the study was approved by the local ethics committee
Funding/vested interests: none
 Key conclusions of the study authors: this study underlines the relative cardiac safety of IR‐MPH in childhood, even if stimulants may exert a cardiovascular effect on BP and HR. However, particular caution should be exercised by physicians in prescribing these drugs to patients with a genetic predisposition to arrhythmias. It might be useful to carry out an ECG examination in all patients starting methylphenidate therapy
Comments from the study authors: the most important limitation of this study includes the lack of a long‐term follow‐up. More studies are needed to confirm the cardiovascular safety during long‐term therapy
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no