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PEDIATRICS Vol. 114 No. 2 August 2004, pp. 514

Italian Attention-Deficit/Hyperactivity Disorder Registry

Pietro Panei, MD
Romano Arcieri, MD
Stefano Vella, MD
Italian National Institute of Health
Drug Research and Evaluation
00161 Rome, Italy

Maurizio Bonati, MD
Mario Negri Institute for Drug Research
20157 Milan, Italy

Nello Martini, ChD
Italian Drug Agency
00100 Rome, Italy

Alessandro Zuddas, MD
Child Neuroscience Department
University of Cagliari
09124 Cagliari, Italy

To the Editor.—

A recent study by the MTA Cooperative Group1 showed that a management based on drug medication or combined therapy (medication and behavioral modification) are superior to behavior modification alone in the treatment of attention-deficit/hyperactivity disorder (ADHD). The benefit of treatments was evaluated at 14 and 24 months. The results of this study are different from the results of the Canadian meta-analysis2 that showed unclear efficacy after 4 weeks of short-acting methylphenidate treatment in individuals ≤18 years old. The trials included in the Canadian meta-analysis are smaller than the MTA study, and the meta-analysis was also focused on a safety profile of the pharmacological treatment, with loss of appetite and growth retardation most often reported with parents and teachers reporting that serious episodes of decreased appetite were significantly more common when children were on methylphenidate rather than placebo.3 Methylphenidate-related adverse events were dose-dependent and, generally, diminished over time. The risk/benefit profile is directly related to the severity of ADHD. In addition, long-term follow-up data are not available.

Because of these reasons, the Italian Drug Committee in the last year approved the use of this drug under controlled prescription based on ADHD diagnosis and staging performed at reference centers.

All Italian children with ADHD will be included in a registry coordinated by the Italian National Institute of Health and the Italian Drug Agency for an observational period of 24 months. The registry also will directly involve family pediatricians, schools, and parents’ associations. The Italian population of 5- to 12-year-olds is ~4 500 000. The expected prevalence of ADHD ranges from 60 000 (1%) to 180 000 (4%) children. Children with ADHD may receive 1 of 3 treatments (methylphenidate, behavioral, or methylphenidate and behavioral combined), but all children will be followed prospectively. The scheduled length of follow-up is 24 months, with interim evaluation of safety of treatment every 6 months. The primary objectives of our study are the standardization of ADHD management and assessment of long-term safety of methylphenidate. Despite being observational and nonrandomized, we also hope to gather important information regarding efficacy of the treatments, the main outcomes being improvements in the hyperactivity index, social skills, and school-performance gain.

REFERENCES

  1. MTA Cooperative Group. National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: 24-month outcomes of treatment strategies for attention-deficit/hyperactivity disorder. Pediatrics.2004; 113 :754 –761[Abstract/Free Full Text]
  2. Schachter HM, Pham B, King J, Langford S, Moher D. How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis. CMAJ.2001; 165 :1475 –1488[Abstract/Free Full Text]
  3. MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry.1999; 56 :1073 –1086[Abstract/Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics




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