PMC:3933749 / 26795-29682 JSONTXT

{"project":"NEUROSES","denotations":[{"id":"T750","span":{"begin":1419,"end":1424},"obj":"PATO_0000083"},{"id":"T543","span":{"begin":268,"end":273},"obj":"PATO_0001177"},{"id":"T544","span":{"begin":385,"end":400},"obj":"CHEBI_6887"},{"id":"T545","span":{"begin":1119,"end":1134},"obj":"CHEBI_6887"},{"id":"T546","span":{"begin":1229,"end":1244},"obj":"CHEBI_6887"},{"id":"T547","span":{"begin":1305,"end":1320},"obj":"CHEBI_6887"},{"id":"T548","span":{"begin":416,"end":422},"obj":"PATO_0002354"},{"id":"T549","span":{"begin":615,"end":624},"obj":"PATO_0002532"},{"id":"T550","span":{"begin":2033,"end":2042},"obj":"PATO_0001997"},{"id":"T551","span":{"begin":2075,"end":2083},"obj":"PATO_0000442"},{"id":"T552","span":{"begin":2229,"end":2244},"obj":"CHEBI_6887"},{"id":"T553","span":{"begin":2334,"end":2349},"obj":"CHEBI_6887"},{"id":"T554","span":{"begin":2520,"end":2535},"obj":"CHEBI_6887"},{"id":"T555","span":{"begin":2536,"end":2541},"obj":"CHEBI_24433"},{"id":"T556","span":{"begin":2567,"end":2572},"obj":"CHEBI_24433"},{"id":"T557","span":{"begin":2738,"end":2743},"obj":"CHEBI_24433"},{"id":"T558","span":{"begin":2604,"end":2609},"obj":"PATO_0001450"},{"id":"T559","span":{"begin":2669,"end":2680},"obj":"CHEBI_33232"},{"id":"T560","span":{"begin":2847,"end":2854},"obj":"PATO_0002123"}],"text":"Efficacy\nIn 2006, the MTS received an indication for use in pediatric patients with ADHD based on results showing efficacy with 9-h patch wear times in the classroom and community settings (Table 1) [32–36]. Findling et al. [32] conducted a 7-week, randomized, double-blind, placebo-controlled, naturalistic study assessing MTS in 270 pediatric patients with ADHD. Treatment with OROS methylphenidate was used as an active control. The primary efficacy endpoint was the change from baseline ADHD-RS, Version IV (ADHD-RS-IV) total score at study end. The Conners’ Teachers Rating Scale-Revised (CTRS-R) was the main secondary efficacy measure. Parents evaluated their children’s response to treatment using the Conners’ Parents Rating Scale-Revised (CPRS-R). The difference in change from baseline ADHD-RS-IV for MTS versus a placebo patch was statistically significant on the primary analysis (−24.2 with MTS vs. −10.3 with placebo; p \u003c 0.0001). Change from baseline CTRS-R and CPRS-R also showed statistically significant differences between MTS and placebo. The difference in change from baseline ADHD-RS-IV for OROS methylphenidate versus a placebo patch was statistically significant on the primary analysis (−21.6 with OROS methylphenidate vs. −10.3 with placebo; p \u003c 0.0001). All measures with OROS methylphenidate were also statistically significantly better than with placebo treatment [32].\nTable 1 Summary of phase III and IV MTS safety and efficacy trials in children aged 6–12 years ADHD-RS-IV Attention-Deficit Hyperactivity Disorder Rating Scale, Version IV, AE adverse event, BMI body mass index, CPRS-R Conners’ Parents Rating Scale-Revised, CSHQ Children’s Sleep Habits Questionnaire, CTRS-R Conners’ Teachers Rating Scale-Revised, DRS Dermal Response Scale, MPH methylphenidate, MTS methylphenidate transdermal system, NA not applicable, OROS MPH osmotic-release oral system methylphenidate, PBO placebo, PGA Parent Global Assessment scale, TEAE treatment-emergent adverse event\nThe most commonly reported AEs were decreased appetite, nausea, vomiting, and insomnia in all treatment groups, and most AEs were of mild-to-moderate intensity. Percentages of children with any AE were 76 % with MTS, 69 % with OROS methylphenidate, and 56 % with PTS. Discontinuation rates due to AEs were 7, 2, and 1 % in the MTS, OROS methylphenidate, and PTS groups, respectively [32]. The MTS patch was well tolerated, with 7.1 % of patients discontinuing study treatment because of AEs compared with 2.2 % in the OROS methylphenidate group and 1.2 % in the placebo group. Four patients on MTS reported edema, and two patients on MTS discontinued treatment related to application-site reactions. Mild skin irritation occurred in the MTS group in the Findling et al. 2008 study [32], where 77 % of the 98 patients reported no evidence (51.5 %) or minimal evidence (25.5 %) of irritation."}

{"project":"2_test","denotations":[{"id":"24532028-18312050-22892266","span":{"begin":200,"end":202},"obj":"18312050"},{"id":"24532028-19808143-22892266","span":{"begin":200,"end":202},"obj":"19808143"},{"id":"24532028-18400982-22892266","span":{"begin":200,"end":202},"obj":"18400982"},{"id":"24532028-17712237-22892266","span":{"begin":200,"end":202},"obj":"17712237"},{"id":"24532028-18312050-22892267","span":{"begin":225,"end":227},"obj":"18312050"},{"id":"24532028-18312050-22892268","span":{"begin":1395,"end":1397},"obj":"18312050"},{"id":"24532028-18312050-22892273","span":{"begin":2381,"end":2383},"obj":"18312050"},{"id":"24532028-18312050-22892274","span":{"begin":2779,"end":2781},"obj":"18312050"}],"text":"Efficacy\nIn 2006, the MTS received an indication for use in pediatric patients with ADHD based on results showing efficacy with 9-h patch wear times in the classroom and community settings (Table 1) [32–36]. Findling et al. [32] conducted a 7-week, randomized, double-blind, placebo-controlled, naturalistic study assessing MTS in 270 pediatric patients with ADHD. Treatment with OROS methylphenidate was used as an active control. The primary efficacy endpoint was the change from baseline ADHD-RS, Version IV (ADHD-RS-IV) total score at study end. The Conners’ Teachers Rating Scale-Revised (CTRS-R) was the main secondary efficacy measure. Parents evaluated their children’s response to treatment using the Conners’ Parents Rating Scale-Revised (CPRS-R). The difference in change from baseline ADHD-RS-IV for MTS versus a placebo patch was statistically significant on the primary analysis (−24.2 with MTS vs. −10.3 with placebo; p \u003c 0.0001). Change from baseline CTRS-R and CPRS-R also showed statistically significant differences between MTS and placebo. The difference in change from baseline ADHD-RS-IV for OROS methylphenidate versus a placebo patch was statistically significant on the primary analysis (−21.6 with OROS methylphenidate vs. −10.3 with placebo; p \u003c 0.0001). All measures with OROS methylphenidate were also statistically significantly better than with placebo treatment [32].\nTable 1 Summary of phase III and IV MTS safety and efficacy trials in children aged 6–12 years ADHD-RS-IV Attention-Deficit Hyperactivity Disorder Rating Scale, Version IV, AE adverse event, BMI body mass index, CPRS-R Conners’ Parents Rating Scale-Revised, CSHQ Children’s Sleep Habits Questionnaire, CTRS-R Conners’ Teachers Rating Scale-Revised, DRS Dermal Response Scale, MPH methylphenidate, MTS methylphenidate transdermal system, NA not applicable, OROS MPH osmotic-release oral system methylphenidate, PBO placebo, PGA Parent Global Assessment scale, TEAE treatment-emergent adverse event\nThe most commonly reported AEs were decreased appetite, nausea, vomiting, and insomnia in all treatment groups, and most AEs were of mild-to-moderate intensity. Percentages of children with any AE were 76 % with MTS, 69 % with OROS methylphenidate, and 56 % with PTS. Discontinuation rates due to AEs were 7, 2, and 1 % in the MTS, OROS methylphenidate, and PTS groups, respectively [32]. The MTS patch was well tolerated, with 7.1 % of patients discontinuing study treatment because of AEs compared with 2.2 % in the OROS methylphenidate group and 1.2 % in the placebo group. Four patients on MTS reported edema, and two patients on MTS discontinued treatment related to application-site reactions. Mild skin irritation occurred in the MTS group in the Findling et al. 2008 study [32], where 77 % of the 98 patients reported no evidence (51.5 %) or minimal evidence (25.5 %) of irritation."}