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Table 2 Clinical studies assessing the efficacy of MPH-MR 30:70

From: Clinical use of a modified release methylphenidate in the treatment of childhood attention deficit hyperactivity disorder

Parameter Information
Study Greenhill et al., 2002 [33]
Type Community setting. Multicentre, placebo-controlled, USA.
Population characteristics 6-16 years old, mild ADHD
Interventions Placebo (163), MPH-MR 30:70 (158)
Dose and duration 20-60 mg/day, titrated to optimum efficacy (3 weeks)
Outcome measures Teacher and Parent Conners' Global Index, CGI-S, CGI-I
Conclusions Equasym XL administered once daily in the morning was well tolerated and significantly more effective than placebo in controlling ADHD symptoms throughout the school day. Symptom control was achieved in the morning and afternoon.
Study Findling et al., 2006 [19]
Type Community setting. Non-inferiority, Australia, Canada and USA.
Population characteristics 6-12 years old, ADHD
Interventions Placebo, Ritalin (IR), MPH-MR 30:70
Dose and duration According to prestudy MPH regimen. Equasym XL, 20-60 mg/day; Ritalin, 10-30 mg twice daily (3 weeks).
Outcome measures Teacher's and parent's IOWA Conners' Rating Scale
Conclusions Equasym XL once daily was statistically non-inferior to Ritalin twice daily in the treatment of school-age children with methylphenidate-responsive ADHD. Both Equasym XL and Ritalin were superior to placebo in controlling ADHD symptoms, and were well tolerated.
Study Swanson et al., 2004 [23]
Type Laboratory-classroom setting. Double-blind, three-way, crossover study, USA.
Population characteristics 6-12 years old, confirmed ADHD
Interventions MPH-MR 30:70, Concerta XL
Dose and duration Assigned to low (20 or 18 mg/day), medium (40 or 36 mg/day) or high (60 or 54 mg/day) dose according to prestudy MPH dose. Crossover design, so all patients received both active agents and placebo for 7 days each throughout a 3-week period.
Outcome measures SKAMP Rating Scale, PERMP
Conclusions There were statistically significant differences between the efficacy of Equasym XL and Concerta in children with ADHD in the laboratory school setting. As predicted by the PK/PD model, clinical superiority at any time point was achieved by the formulation with the highest expected plasma methylphenidate concentration.
  1. ADHD = attention deficit hyperactivity disorder; CGI-I = Clinical Global Impression-Improvement; CGI-S = Clinical Global Impression-Severity; IOWA = inattention/overactivity with aggression; IR = immediate release; PERMP = Permanent Product Measure of Performance; SKAMP = Swanson, Kotkin, Agler, M-Flynn and Pelham.