Cardiovascular effects of longer-term, high-dose OROS methylphenidate in adolescents with attention deficit hyperactivity disorder

J Pediatr. 2009 Jul;155(1):84-9, 89.e1. doi: 10.1016/j.jpeds.2009.02.008. Epub 2009 Apr 25.

Abstract

Objective: To examine the effects of high doses of extended-release methylphenidate (OROS MPH) on cardiovascular variables in adolescents with attention deficit hyperactivity disorder (ADHD).

Study design: ECG indices plus systolic blood pressure (SBP), diastolic BP (DBP) and heart rate (HR) were assessed during an open-label study of OROS MPH in 114 adolescents with ADHD (doses up to 1.5 mg/kg/d). Cardiovascular parameters were assessed at 6 weeks and 6 months.

Results: Small but statistically significant changes in DBP and HR were observed at 6 weeks, without further increases up to 6 months' follow-up. A small but statistically significant increase in SBP was observed over time. Twenty-nine percent of patients had isolated elevations in BP readings prior to study entry, and 14% had >3 consecutive visits at which elevated BP were observed during OROS MPH treatment. No clinically significant changes in ECG parameters were observed. No serious cardiovascular adverse events occurred.

Conclusions: Treatment with relatively high doses of OROS MPH was associated with small but statistically significant mean increases in BP and HR, primarily during the first 6 weeks of treatment, without clinically meaningful changes in ECG. These observations are consistent with previous reports using lower doses.

Trial registration: ClinicalTrials.gov NCT00181714.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Blood Pressure / drug effects*
  • Central Nervous System Stimulants / administration & dosage
  • Central Nervous System Stimulants / adverse effects*
  • Child
  • Delayed-Action Preparations
  • Diastole / drug effects
  • Dose-Response Relationship, Drug
  • Electrocardiography
  • Female
  • Follow-Up Studies
  • Heart Rate / drug effects*
  • Humans
  • Male
  • Methylphenidate / administration & dosage
  • Methylphenidate / adverse effects*
  • Prospective Studies
  • Systole / drug effects

Substances

  • Central Nervous System Stimulants
  • Delayed-Action Preparations
  • Methylphenidate

Associated data

  • ClinicalTrials.gov/NCT00181714