Comparative Efficacy of Two Once Daily Methylphenidate Formulations (Ritalin® LA™ and Concerta®) and Placebo in Children with Attention Deficit Hyperactivity Disorder Across the School Day
Authors: Lopez, Frank1; Silva, Raul2; Pestreich, Linda3; Muniz, Rafael3
Source: Pediatric Drugs, Volume 5, Number 8, 2003 , pp. 545-555(11)
Publisher: Adis International
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Abstract:
Objectives: The primary objective was to compare the differences in clinical efficacy of the starting dose of Ritalin® LA™ (20mg) to the starting dose of Concerta® (18mg), in a laboratory school setting for the duration of an entire school day. Secondary objectives were to compare Ritalin® LA™ 20mg with Concerta® 36mg, and Ritalin® LA™ and both Concerta® doses versus placebo across the school day.Methods: Thirty-six children (29 males, 7 females), aged 6–12 years, with attention deficit hyperactivity disorder, previously stabilized on methylphenidate (MPH), completed this four-way, randomized, single-blind crossover, analog classroom study. Patients were evaluated on day 0 and randomized to receive treatment on days 7, 14, 21, and 28 (Ritalin® LA™ 20mg, Concerta® 18mg, Concerta® 36mg, or placebo).Results: Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale (SKAMP)-attention: The effect of Ritalin® LA™ 20mg across the morning was statistically different from that of Concerta 18mg and 36mg, as demonstrated by the change in the area under the curve (AUC) during the first 4 hours (0–4) from pre-dose. AUC(0–4) for Ritalin®LA™ was −2.48 versus −1.36 for Concerta® 18mg (p = 0.015), and −1.55 for Concerta® 36mg (p = 0.043). AUC(0–8) change from pre-dose for Ritalin® LA™ was −4.48 versus −2.72 for Concerta® 18mg (p = 0.074), and −3.24 for Concerta® 36mg (p = 0.208).SKAMP-deportment: AUC(0–4) for Ritalin® LA™ was −1.67 compared with −0.28 for Concerta® 18mg (p < 0.001), and −0.55 for Concerta® 36mg (p = 0.004). AUC(0–8) change from pre-dose for Ritalin® LA™ was −2.81 compared with −0.82 for Concerta® 18mg (p = 0.018), and −1.34 for Concerta® 36mg (p = 0.078).Combined: Mean AUC(0–4) change from pre-dose for Ritalin® LA™ was −2.05 compared with −0.78 for Concerta® 18mg (p < 0.001), −1.01 for Concerta® 36mg (p = 0.003). The mean AUC(0–8) change from pre-dose for Ritalin® LA™ was −3.58 compared with −1.70 for Concerta® 18mg (p = 0.010), −2.22 for Concerta® 36mg (p = 0.061).Math test-attempted: Mean pre-dose score for Ritalin® LA™ was about 73 compared with 74, 90, and 81 for Concerta® 18mg, 36mg, and placebo, respectively. Mean AUC(0–8) change from pre-dose for Ritalin® LA™ was 202 compared with 115 for Concerta® 18mg (p = 0.135), 137 for Concerta® 36mg (p = 0.265).Math test-correct: Mean pre-dose score for Ritalin® LA™ was 68 compared with 64, 78, and 76 for Concerta® 18mg, 36mg, and placebo, respectively. Mean AUC(0–8) change from pre-dose for Ritalin® LA™ was 183 compared with 100 for Concerta® 18mg (p = 0.144), and 117 for Concerta® 36mg (p = 0.245).Safety: One patient from each treatment group experienced a single mild adverse event that included abdominal pain, nausea, and dyspnea.Conclusion: While both Ritalin® LA™ and Concerta® were shown to be effective, the different release profiles of each formulation can result in distinct differences between the effects on measures of attention and deportment.Keywords: Attention deficit hyperactivity disorder; Children; Methylphenidate
Document Type: Research article
Affiliations: 1: 1 Children's Developmental Center, Maitland, Florida, USA 2: 2 New York University School of Medicine, New York, New York, USA 3: 3 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
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