APPENDICES. A systematic review and economic model of the ...

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Appendix 12
Core symptoms Educational performance Quality of life Adverse events
306 participants were included in analyses of safety
Any adverse event: occurrence
Total: n = 126 (41.2%)
OROS: 42.3%
IR-MPH: 46.2%
Placebo: 34.7%
Not reported Mean CGI (investigator rated)
Mean (SD), OROS MPH/IR-
MPH/placebo
End of study (n = 263): 4.24*
(1.34)/4.19* (1.45)/2.48 (1.67)
Overall treatment effect: F(2,260) =
39.35, *p < 0.001 compared with
placebo
Withdrawals:
OROS: n = 1, depression
IR-MPH: n = 1, emotional lability
Placebo: n = 1, tics
CGI: % much or very much
improved at end of study (n = 192)
OROS MPH: 46.7%; IR-MPH:
47.2%; placebo: 16.7%
Headache: occurrence
OROS: 14.4%
IR-MPH: 5.8%
Placebo: 10.2%
Abdominal pain: occurrence
OROS: 6.7%
IR: 5.8%
Placebo: 1.0%
Global Efficacy (parent) end of study:
mean (SD) (n = 247)
OROS: 1.47 (1.07); significantly
different from placebo (p < 0.05)
IR-MPH: 1.28 (0.93); significantly
different from placebo (p < 0.05)
Placebo: 0.61 (0.93)
Overall treatment effect: F(2,244) =
16.71 (p < 0.001)
IOWA-C mean scores:
Inattention/overactivity (teacher rated)
Mean (SD), OROS MPH/IR-MPH/placebo
Baseline (n = 276): 9.74 (4.1)/9.94 (3.7)/10.28 (3.8)
Week 1 (n = 238): 5.58* (3.64)/5.70* (3.84)/9.87
(4.09)
*p < 0.05 compared with placebo; no significant
differences between OROS and IR-MPH
(p = 0.838)
End of study (n = 271): 5.98* (3.91)/6.35*
(4.31)/9.77 (4.02)
*p < 0.05 compared with placebo; no significant
differences between OROS and IR-MPH
(p = 0.539)
Overall treatment effect (week 1): F(2,235) =
30.59, p < 0.001
Overall treatment effect (end of study): F(2,258) =
21.95, p < 0.001
Sleep:
At baseline, most were assessed as having good or
excellent sleep: 70.5, 72.8 and 76.6% in OROS, IR and
placebo groups. On days 14 and 28, >65% continued
to have good or excellent sleep quality. There appeared
to be no significant differences between groups
Appetite:
At day 14, 22.5, 18.8 and 12.0% in the OROS, IR-MPH
and placebo groups, respectively had eaten less than
usual in the preceding 2 weeks. There were significant
differences between the active and placebo arms
(p < 0.001). Percentages were similar on day 28
Global Efficacy (teacher) end of
study: mean (SD) (n = 233)
OROS: 1.42 (0.97); significantly
different from placebo (p < 0.05)
IR-MPH: 1.43 (1.01); significantly
different from placebo (p < 0.05)
Placebo: 0.62 (0.81)
Overall treatment effect: F(2,230) =
17.64, p < 0.001
Global efficacy (teacher): % rated
good or excellent
OROS: 42.9%
IR: 46.9%
Placebo: 17.7%
IOWA-C mean scores:
Inattention/overactivity (parent rated)
Mean (SD), OROS MPH/IR-MPH/placebo
Baseline (n = 281): 11.08* (2.6)/9.90 (3.2)/10.44
(3.0)
*p < 0.01 compared with IR-MPH
Week 1 (n = 243): 5.38* (3.38)/5.44* (3.22)/9.48
(3.78)
*p < 0.05 compared with placebo
End of study (n = 265): 6.29* (3.54)/6.17* (3.19)/
10.11 (3.92)
*p < 0.05 compared with placebo
Overall treatment effect (week 1): F(2,240) =
36.49, p < 0.001
Overall treatment effect (end of study): F(2,262) =
34.22, p < 0.001
Tics:
New onset or clinically significant increase
IR-MPH: n = 1
Placebo: n = 4
SNAP-IV Inattention (teacher rated)
Mean (SD), OROS MPH/IR-MPH/placebo
Baseline (n = 274): 2.03 (0.7)/2.06 (0.6)/2.04 (0.7)
End of study (n = 236): 1.34* (0.84)/1.26*
(0.79)/1.97 (0.79)
continued