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

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.