Effects of once-daily osmotic-release methylphenidate on blood pressure and heart rate in children with attention-deficit/hyperactivity disorder: results from a one-year follow-up study.
OBJECTIVE
Studies of vital signs in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) receiving stimulants indicate a variable effect on blood pressure (BP) and heart rate (HR). We evaluated the longer-term effects on vital signs of once-daily osmotic-release methylphenidate (MPH, Concerta) in children with ADHD.


METHODS
As part of a 1-year open-extension trial, we studied children with ADHD (aged 6-13 years; baseline assessment, n = 432) who were entered into an open-label study of osmotic-release MPH (18-54 mg) for up to 1 year. Subjects' BP and HR were recorded at monthly visits and, when applicable, analyses were by last observation carried forward.


RESULTS
Compared to off-drug baseline, osmotic-release MPH was associated with minor clinical, although statistically significant, changes in systolic and diastolic blood pressure (DBP) (3.3 and 1.5 mm Hg, Ps < 0.001) and HR (3.9 bpm, P < 0.0001) at 12-month end point. There was no clear dose-response relationship. There was no tolerance to the pressor effects of osmotic-release MPH over the 1-year period. There was an inverse relationship between baseline vital signs and positive change in vital signs at end point.


CONCLUSIONS
Over a 12-month period, osmotic-release MPH produced minor clinical, although statistically significant, changes in BP and HR in children with ADHD.
Wilens
Timothy E
TE
Clinical Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. wilens@helix.mgh.harvard.edu
Biederman
Joseph
J
Lerner
Marc
M
D000284:Administration, Oral; D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects* / Q000502:physiology; D002648:Child; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006339:Heart Rate / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D008774:Methylphenidate / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D013997:Time Factors
D003692:Delayed-Action Preparations; D008774:Methylphenidate