Anna Didoni1, Marco Sequi, Pietro Panei, Maurizio Bonati. 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.
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.
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.
Authors: Victoria L Vetter; Josephine Elia; Christopher Erickson; Stuart Berger; Nathan Blum; Karen Uzark; Catherine L Webb Journal: Circulation Date: 2008-04-21 Impact factor: 29.690
Authors: Gregory A Fabiano; William E Pelham; Erika K Coles; Elizabeth M Gnagy; Andrea Chronis-Tuscano; Briannon C O'Connor Journal: Clin Psychol Rev Date: 2008-11-11
Authors: Brooke S G Molina; Stephen P Hinshaw; James M Swanson; L Eugene Arnold; Benedetto Vitiello; Peter S Jensen; Jeffery N Epstein; Betsy Hoza; Lily Hechtman; Howard B Abikoff; Glen R Elliott; Laurence L Greenhill; Jeffrey H Newcorn; Karen C Wells; Timothy Wigal; Robert D Gibbons; Kwan Hur; Patricia R Houck Journal: J Am Acad Child Adolesc Psychiatry Date: 2009-05 Impact factor: 8.829
Authors: J Graham; T Banaschewski; J Buitelaar; D Coghill; M Danckaerts; R W Dittmann; M Döpfner; R Hamilton; C Hollis; M Holtmann; M Hulpke-Wette; M Lecendreux; E Rosenthal; A Rothenberger; P Santosh; J Sergeant; E Simonoff; E Sonuga-Barke; I C K Wong; A Zuddas; H-C Steinhausen; E Taylor Journal: Eur Child Adolesc Psychiatry Date: 2010-11-03 Impact factor: 4.785
Authors: Victoria A Reed; Jan K Buitelaar; Ernie Anand; Kathleen Ann Day; Tamás Treuer; Himanshu P Upadhyaya; David R Coghill; Ludmila A Kryzhanovskaya; Nicola C Savill Journal: CNS Drugs Date: 2016-07 Impact factor: 5.749
Authors: M Pagerols; V Richarte; C Sánchez-Mora; I Garcia-Martínez; M Corrales; M Corominas; B Cormand; M Casas; M Ribasés; J A Ramos-Quiroga Journal: Pharmacogenomics J Date: 2016-01-26 Impact factor: 3.550
Authors: Ole Jakob Storebø; Nadia Pedersen; Erica Ramstad; Maja Lærke Kielsholm; Signe Sofie Nielsen; Helle B Krogh; Carlos R Moreira-Maia; Frederik L Magnusson; Mathilde Holmskov; Trine Gerner; Maria Skoog; Susanne Rosendal; Camilla Groth; Donna Gillies; Kirsten Buch Rasmussen; Dorothy Gauci; Morris Zwi; Richard Kirubakaran; Sasja J Håkonsen; Lise Aagaard; Erik Simonsen; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2018-05-09
Authors: Macey L Murray; Suppachai Insuk; Tobias Banaschewski; Antje C Neubert; Suzanne McCarthy; Jan K Buitelaar; David Coghill; Ralf W Dittmann; Kerstin Konrad; Pietro Panei; Eric Rosenthal; Edmund J Sonuga-Barke; Ian C K Wong Journal: Eur Child Adolesc Psychiatry Date: 2013-03-19 Impact factor: 4.785