Abstract
Objective: The purpose of this study was to assess the cardiovascular effects of drugs used for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents treated in community care centers in Italy. Methods: This study was an open, prospective, observational study of youth with ADHD treated with atomoxetine (ATX) and methylphenidate (MPH). Measurements of blood pressure and heart rate, and electrocardiogram (ECG) assessment were performed at baseline and at regular intervals up to 24 months. Results: By June 2010, 1758 youth were enrolled in the Italian ADHD National Registry. Statistically significant increases were observed in cardiovascular measures: in the MPH group after 6 months in heart rate (+2.01, p=0.01); in the ATX group after 6 months in diastolic pressure (+1.60, p=0.01) and in heart rate (+2.93, p=0.001), and after 12 months in heart rate (+3.26, p=0.003). Compared with the baseline, 59 patients had an alteration of ECG during the follow-up period. Although at 12 months, the probability of detecting an abnormal ECG was higher in the MPH group than in the ATX group, only 2 out of 30 cases at 6 months with altered ECG were considered to have experienced serious adverse events. One case was treated with ATX and one with MPH, and arrhythmia was the detected abnormality. Conclusions: Treatment with MPH and ATX in youth appears to have a small but significant impact on the cardiovascular system. The long-term impact of these medications is unknown. Several clinically meaningless ECG alterations were observed mostly in MPH-treated youth. We therefore suggest evaluating cardiovascular risks at baseline.
| Original language | English |
|---|---|
| Pages (from-to) | 423-431 |
| Number of pages | 9 |
| Journal | Journal of Child and Adolescent Psychopharmacology |
| Volume | 22 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Dec 1 2012 |
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ASJC Scopus subject areas
- Pharmacology (medical)
- Pediatrics, Perinatology, and Child Health
- Psychiatry and Mental health
Cite this
Cardiovascular measures in children and adolescents with attention-deficit/hyperactivity disorder who are new users of methylphenidate and atomoxetine. / Arcieri, Romano; Germinario, Elena A P; Bonati, Maurizio; Masi, Gabriele; Zuddas, Alessandro; Vella, Stefano; Chiarotti, Flavia; Panei, Pietro.
In: Journal of Child and Adolescent Psychopharmacology, Vol. 22, No. 6, 01.12.2012, p. 423-431.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Cardiovascular measures in children and adolescents with attention-deficit/hyperactivity disorder who are new users of methylphenidate and atomoxetine
AU - Arcieri, Romano
AU - Germinario, Elena A P
AU - Bonati, Maurizio
AU - Masi, Gabriele
AU - Zuddas, Alessandro
AU - Vella, Stefano
AU - Chiarotti, Flavia
AU - Panei, Pietro
PY - 2012/12/1
Y1 - 2012/12/1
N2 - Objective: The purpose of this study was to assess the cardiovascular effects of drugs used for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents treated in community care centers in Italy. Methods: This study was an open, prospective, observational study of youth with ADHD treated with atomoxetine (ATX) and methylphenidate (MPH). Measurements of blood pressure and heart rate, and electrocardiogram (ECG) assessment were performed at baseline and at regular intervals up to 24 months. Results: By June 2010, 1758 youth were enrolled in the Italian ADHD National Registry. Statistically significant increases were observed in cardiovascular measures: in the MPH group after 6 months in heart rate (+2.01, p=0.01); in the ATX group after 6 months in diastolic pressure (+1.60, p=0.01) and in heart rate (+2.93, p=0.001), and after 12 months in heart rate (+3.26, p=0.003). Compared with the baseline, 59 patients had an alteration of ECG during the follow-up period. Although at 12 months, the probability of detecting an abnormal ECG was higher in the MPH group than in the ATX group, only 2 out of 30 cases at 6 months with altered ECG were considered to have experienced serious adverse events. One case was treated with ATX and one with MPH, and arrhythmia was the detected abnormality. Conclusions: Treatment with MPH and ATX in youth appears to have a small but significant impact on the cardiovascular system. The long-term impact of these medications is unknown. Several clinically meaningless ECG alterations were observed mostly in MPH-treated youth. We therefore suggest evaluating cardiovascular risks at baseline.
AB - Objective: The purpose of this study was to assess the cardiovascular effects of drugs used for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents treated in community care centers in Italy. Methods: This study was an open, prospective, observational study of youth with ADHD treated with atomoxetine (ATX) and methylphenidate (MPH). Measurements of blood pressure and heart rate, and electrocardiogram (ECG) assessment were performed at baseline and at regular intervals up to 24 months. Results: By June 2010, 1758 youth were enrolled in the Italian ADHD National Registry. Statistically significant increases were observed in cardiovascular measures: in the MPH group after 6 months in heart rate (+2.01, p=0.01); in the ATX group after 6 months in diastolic pressure (+1.60, p=0.01) and in heart rate (+2.93, p=0.001), and after 12 months in heart rate (+3.26, p=0.003). Compared with the baseline, 59 patients had an alteration of ECG during the follow-up period. Although at 12 months, the probability of detecting an abnormal ECG was higher in the MPH group than in the ATX group, only 2 out of 30 cases at 6 months with altered ECG were considered to have experienced serious adverse events. One case was treated with ATX and one with MPH, and arrhythmia was the detected abnormality. Conclusions: Treatment with MPH and ATX in youth appears to have a small but significant impact on the cardiovascular system. The long-term impact of these medications is unknown. Several clinically meaningless ECG alterations were observed mostly in MPH-treated youth. We therefore suggest evaluating cardiovascular risks at baseline.
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UR - http://www.scopus.com/inward/citedby.url?scp=84871226888&partnerID=8YFLogxK
U2 - 10.1089/cap.2012.0014
DO - 10.1089/cap.2012.0014
M3 - Article
C2 - 23362511
AN - SCOPUS:84871226888
VL - 22
SP - 423
EP - 431
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
SN - 1044-5463
IS - 6
ER -