Multicentric study,to assess efficacy and security of controlled release OROS methylphenidate in children with attention deficit hyperactivity disorders.

Juan Carlos Reséndiz-Aparicio; Eduardo Barragán-Pérez; Abraham Dayán-Nahman; Hugo Ceja-Moreno; Matilde Ruiz-García; Saúl Garza-Morales; Mario Cáceres-Vargas; Carmen Lara-Muñoz; Esteban Rodríguez-Rodríguez; Leticia Munive-Báez; Ana Teresa Díaz-Calvo; Rosa Elena Ulloa

2005, Number 3

Bol Med Hosp Infant Mex 2005; 62 (3)

Multicentric study,to assess efficacy and security of controlled release OROS methylphenidate in children with attention deficit hyperactivity disorders.

Reséndiz-Aparicio JC, Barragán-Pérez E, Dayán-Nahman A, Ceja-Moreno H, Ruiz-García M, Garza-Morales S, Cáceres-Vargas M, Lara-Muñoz C, Rodríguez-Rodríguez E, Munive-Báez L, Díaz-Calvo AT, Ulloa RE

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ABSTRACT

Introduction. Objective: to assess the efficacy of controlled release OROS MPH (Concerta®) in children with attention deficit/hyperactivity disorder (ADHD) previously treated with immediate release methylphenidate (MPH IR).
Material and methods. Children with ADHD,all subtypes, ages 6 to 12 years, with good response to MPH, were switched from IR MPH to OROS MPH once a day (qd in the morning) at 18 to 54 mg/day in a 1 year follow-up trial. The primary end-points for analysis were the last available patient visit using last observation carried forward. The scales used were CGI, Yale’s for tics, somatometry, appetite and sleep evaluation from parents, and adverse events record.
Results. We included 97 patients, 26 drop-outs [4 (4%) for treatment failure and 2 (2%) hyporexia and cramps]. Of the 71 patients, 64 (90%) male and 7 (10%) female, mean age 9 ± 2 years, initial mean weigth33.8 ± 9.7 kg and final 34.7 ± 9.9 kg (normal growth). Children with OROS MPH showed significantly greater reductions in core ADHD symptoms. On the basis of mean teacher and parents Iowa Conners and Peers interactions ratings were a significant improvement (P =0.001,Student t). CGI ratings were improve-ment as well. The most common adverse events were headache (7%) and hyporexia (6%) mild and transient.
Conclusion. For the treatment of core ADHD symptoms, OROS MPH dosed qd were well tolerated andefficacy treatment and there were no negative impact on sleep and appetite.

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