Table 2.
Summary of efficacy outcomes for lisdexamfetamine dimesylate and osmotic-release oral system methylphenidate in children and adolescents with attention-deficit hyperactivity disorder (full analysis set)
| LDX minus placebo | OROS-MPH minus placebo | LDX minus OROS-MPH | |
|---|---|---|---|
| ADHD-RS-IV a | |||
| Difference in LS mean change in ADHD-RS-IV total score from baseline to endpoint | −18.6 | −13.0 | −5.6 |
| 95 % CI | −21.5 to −15.7 | −15.9 to −10.2 | −8.4 to −2.7 |
| p value | <0.001 | <0.001 | <0.001 |
| Effect size | 1.80 | 1.26 | 0.54 |
| CGI-I | |||
| Difference in percentage of patients ‘improved’ at endpoint (%)b | 63.6 | 46.2 | 17.4 |
| 95 % CI | 53.0–74.1 | 34.6–57.7 | 5.0–29.8 |
| p value | <0.001 | <0.001 | <0.05 |
| NNT | 2 | 3 | 6 |
| Responders (≥30 % reduction from baseline in ADHD-RS-IV total score and CGI-I of 1 or 2) | |||
| Difference in percentage of responders at endpoint (%) | 63.5 | 45.2 | 18.3 |
| 95 % CI | 53.0–74.1 | 33.9–56.5 | 5.4–31.3 |
| p value | <0.001 | <0.001 | <0.05 |
| NNT | 2 | 3 | 6 |
| Responders (ADHD-RS-IV total score ≤ mean for age) c | |||
| Difference in percentage of responders at endpoint (%) | 50.6 | 36.5 | 14.0 |
| 95 % CI | 39.0–62.1 | 24.8–48.3 | 0.6–27.4 |
| p value | <0.001 | <0.001 | 0.050 |
| NNT | 2 | 3 | 8 |
p values are based on the difference between active drug and placebo (predefined comparison) and the difference between LDX and OROS-MPH (post hoc comparison). Data are provided for the full analysis set: LDX (n = 104); placebo (n = 106); OROS-MPH (n = 107). All percentages are based on the number of patients with data at that visit in each treatment group. Endpoint was the last on-treatment, post-baseline visit with a non-missing assessment
aA decrease from baseline in the ADHD-RS-IV total score indicates an improvement in ADHD symptoms
bImprovement was defined as a CGI-I score of 1 (very much improved) or 2 (much improved)
cResponder analysis based on normative data
ADHD attention-deficit hyperactivity disorder; ADHD-RS-IV ADHD Rating Scale IV, CGI-I Clinical Global Impressions-Improvement, CI confidence interval, LDX lisdexamfetamine dimesylate, LS least squares, NNT number needed to treat, OROS-MPH osmotic-release oral system methylphenidate