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One-year prospective follow-up of pharmacological treatment in children with attention-deficit/hyperactivity disorder

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Objectives

To delineate the safety and tolerability profile of methylphenidate and atomoxetine in children and adolescents with attention deficit hyperactivity disorder (ADHD) monitored for more than 1 year.

Design

A cohort study analyzing data from the national ADHD register on patients from the Lombardy Region treated with MPH or atomoxetine.

Participants

A total of 229 children (median age 11 years, range 6–17), enrolled in 15 regional centers between June 2007 and May 2010.

Results

The prevalence rate of pharmacological treatment for ADHD was 0.23%, whereas the estimated ADHD prevalence in the population was 0.95%. In total, 73.8% of patients had been treated with atomoxetine (10–90 mg daily) or MPH (10–75 mg daily); 22% of patients also received an additional psychotropic drug. Of the treated children, 26.9% discontinued the drug prior to 1 year of treatment, mostly because of adverse effects (28.6%). No new or unexpected adverse events (rate 39.2%) were encountered. Decreased appetite, headache, and unstable mood were the leading events. The most severe events occurred in two boys: one experienced absence seizures for the first time with MPH, the other experienced hallucinations with atomoxetine. Therapy was discontinued in ten male patients (7.7%) because of adverse events. All patients with adverse effects recovered well.

Conclusions

A very low rate of ADHD prevalence was estimated in Italian children compared to that reported in other countries. Although the medications for ADHD are generally well tolerated, with only mild or minor adverse effects in most cases, their rational use can only be guaranteed by disseminating and monitoring evidence-based practices and by monitoring the safety and efficacy of treatments in both the short and long terms with appropriate tools and approaches.

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Lombardy ADHD Registry Group

Stefano Conte, Marco Pezzani: Bergamo; Silvana Bertella, Massimo Molteni, Daniela Simone: Bosisio Parini, LC; Francesco Rinaldi: Breno, BS; Paola Effedri, Elena Filippini, Alessandra Tiberti: Brescia; Nadia Fteita, Maria Terragni: Como; Daniele Arisi: Cremona; Giuseppe A. Chiarenza, Grazia Lo Torto, Luciano Montaldi: Garbagnate, MI; Ottaviano Martinelli, Roberta Pazienza, Davide Villani: Lecco; Ernesta Ricotta: Legnano, MI; Rosacarla Quartieri, Paola Morosini: Lodi; Federica Aggio, Claudio Bissoli, Maurizio Bonati, Emilio Brunati, Maria Antonella Costantino, Anna Didoni, Emiddio Fornaro, Carlo Lenti, Gabriella Mauri, Paola Olgiati, Alberto Ottolini, Monica Saccani, Vera Valenti: Milan; Umberto Balottin, Giorgio Rossi: Pavia; Corrado Meraviglia, Maria Grazia Palmieri: Sondrio; Paolo Piccinelli, Cristiano Termine: Varese.

Contributors

MB and PP participated in designing of the national ADHD registry and in its set-up and running. AD and MS participated in data collection and analysis of patients from the Lombardy Region. MB verified the collection of data, their analysis and interpretation and wrote the report. All authors participated in editing the report and have seen and approved the final version.

Funding

The study has been funded in part by the Italian Medicines Regulatory Agency, AIFA (Study FARM5AJL82)

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Authors and Affiliations

  1. Department of Public Health and of the Laboratory for Mother and Child Health, “Mario Negri” Pharmacological Research Institute, Via Giuseppe La Masa 19, 20156, Milan, Italy

    Anna Didoni, Marco Sequi & Maurizio Bonati

  2. Italian National Institute of Health, Drug Research and Evaluation Unit, Rome, Italy

    Pietro Panei

Authors
  1. Anna Didoni
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  2. Marco Sequi
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  3. Pietro Panei
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  4. Maurizio Bonati
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Consortia

on behalf of the “Lombardy ADHD Registry Group”

Corresponding author

Correspondence to Maurizio Bonati.

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Didoni, A., Sequi, M., Panei, P. et al. One-year prospective follow-up of pharmacological treatment in children with attention-deficit/hyperactivity disorder. Eur J Clin Pharmacol 67, 1061–1067 (2011). https://doi.org/10.1007/s00228-011-1050-3

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  • DOI: https://doi.org/10.1007/s00228-011-1050-3

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