PMID- 26293742
OWN - NLM
STAT- MEDLINE
DCOM- 20160815
LR  - 20181113
IS  - 1179-1934 (Electronic)
IS  - 1172-7047 (Linking)
VI  - 29
IP  - 10
DP  - 2015
TI  - Safety of Methylphenidate and Atomoxetine in Children with 
      Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National 
      ADHD Registry.
PG  - 865-77
LID - 10.1007/s40263-015-0266-7 [doi]
AB  - OBJECTIVE: The aim of this study was to assess the type and frequency of adverse 
      events (AEs) in children with attention-deficit/hyperactivity disorder (ADHD) 
      treated with methylphenidate or atomoxetine over a 5-year period in a large 
      naturalistic study. METHODS: We draw on data from the Italian ADHD Registry, a 
      national database for postmarketing phase IV pharmacovigilance of ADHD 
      medications across 90 centers. AEs were defined as severe or mild as per the 
      classification of the Italian Medicines Agency. AE frequency in the two treatment 
      groups was compared using incidence rates per 100 person-years (IR100PY) and 
      incidence rate ratios (IRRs). Mantel-Haenszel adjusted IRRs were calculated to 
      control for psychiatric comorbidity. RESULTS: A total of 1350 and 753 
      participants (aged 6-18 years, mean age 10.7 +/- 2.8) were treated with 
      methylphenidate and atomoxetine, respectively, from 2007 to 2012. Ninety 
      participants (7 %) were switched from methylphenidate to atomoxetine, and 138 (18 
      %) from atomoxetine to methylphenidate. Thirty-seven children treated with 
      atomoxetine and 12 with methylphenidate had their medication withdrawn. Overall, 
      645 patients (26.8 %) experienced at least one mild AE (including decreased 
      appetite and irritability, for both drugs) and 95 patients (3.9 %) experienced at 
      least one severe AE (including severe gastrointestinal events). IR100PY were 
      significantly higher in the atomoxetine-treated group compared with the 
      methylphenidate-treated group for a number of mild and severe AEs and for any 
      severe or mild AEs. After controlling for comorbidities, IRR was still 
      significantly higher in the atomoxetine group compared with the methylphenidate 
      group for a number of mild (decreased appetite, weight loss, abdominal pain, 
      dyspepsia, stomach ache, irritability, mood disorder and dizziness) and severe 
      (gastrointestinal, neuropsychiatric, and cardiovascular) AEs. CONCLUSIONS: In 
      this naturalistic study, methylphenidate had a better safety profile than 
      atomoxetine.
FAU - Cortese, Samuele
AU  - Cortese S
AD  - Developmental Brain-Behaviour Laboratory, Department of Psychology, University of 
      Southampton, Highfield Campus, Southampton, UK. samuele.cortese@gmail.com.
AD  - New York University Child Study Center, New York, NY, USA. 
      samuele.cortese@gmail.com.
FAU - Panei, Pietro
AU  - Panei P
AD  - Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore 
      di Sanita, Italian National Institute of Health, Viale Regina Elena, 299, 00161, 
      Rome, Italy. pietro.panei@iss.it.
FAU - Arcieri, Romano
AU  - Arcieri R
AD  - Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore 
      di Sanita, Italian National Institute of Health, Viale Regina Elena, 299, 00161, 
      Rome, Italy.
FAU - Germinario, Elena A P
AU  - Germinario EA
AD  - Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore 
      di Sanita, Italian National Institute of Health, Viale Regina Elena, 299, 00161, 
      Rome, Italy.
FAU - Capuano, Annalisa
AU  - Capuano A
AD  - Department of Experimental Medicine, Regional Center of Pharmacosurveillance and 
      Pharmacoepidemiology, Second University of Naples, Naples, Italy.
FAU - Margari, Lucia
AU  - Margari L
AD  - Child Neuropsychiatry Unit, Department of Neuroscience and Sense Organs, Hospital 
      Polyclinic of Bari, University Aldo Moro, Bari, Italy.
FAU - Chiarotti, Flavia
AU  - Chiarotti F
AD  - Department of Cell Biology and Neurosciences, Istituto Superiore di Sanita, 
      Italian National Institute of Health, Rome, Italy.
FAU - Curatolo, Paolo
AU  - Curatolo P
AD  - Systems Medicine Department, Child Neurology and Psychiatry Unit, Tor Vergata 
      University Hospital of Rome, Rome, Italy.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - New Zealand
TA  - CNS Drugs
JT  - CNS drugs
JID - 9431220
RN  - 0 (Adrenergic Uptake Inhibitors)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Psychotropic Drugs)
RN  - 207ZZ9QZ49 (Methylphenidate)
RN  - 57WVB6I2W0 (Atomoxetine Hydrochloride)
SB  - IM
MH  - Adolescent
MH  - Adrenergic Uptake Inhibitors/adverse effects/therapeutic use
MH  - Atomoxetine Hydrochloride/*adverse effects/therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/diagnosis/*drug 
      therapy/epidemiology
MH  - Central Nervous System Stimulants/adverse effects/therapeutic use
MH  - Child
MH  - Comorbidity
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Italy/epidemiology
MH  - Male
MH  - Methylphenidate/*adverse effects/therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Psychotropic Drugs/*adverse effects/therapeutic use
MH  - Registries
MH  - Severity of Illness Index
EDAT- 2015/08/22 06:00
MHDA- 2016/08/16 06:00
CRDT- 2015/08/22 06:00
PHST- 2015/08/22 06:00 [entrez]
PHST- 2015/08/22 06:00 [pubmed]
PHST- 2016/08/16 06:00 [medline]
AID - 10.1007/s40263-015-0266-7 [pii]
AID - 10.1007/s40263-015-0266-7 [doi]
PST - ppublish
SO  - CNS Drugs. 2015;29(10):865-77. doi: 10.1007/s40263-015-0266-7.