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
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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% |
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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 |
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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 |