Table 2(b).
Efficacy data from individual longer-term (six-month), placebo-controlled studies: changes by treatment group from baseline.
| Eli Lilly study identifier | LYBV |
LYCU |
LYCW |
|---|---|---|---|
| Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | |
| Number of patients | 109 vs 185 | 216 vs 214 | 234 vs 268 |
| Completion rates (%) | 38.4 vs 48.9 | 37.6 vs 44.6 | 44.4 vs 57.3 |
| CAARS-Inv: SV, mean change from baselinea Total score | −11.5 vs −11.6 (0.412)b | −10.2 vs −13.2 (0.005)c | −8.3 vs −14.3 (<0.001)d |
| Inattention subscore | −6.7 vs −6.9 (0.406) | −5.7 vs −7.4 (0.013) | −4.4 vs −8.1 (<0.001) |
| Hyperactive/impulsive subscore | −4.8 vs −4.7 (0.538) | −4.6 vs −5.8 (0.006) | −3.9 vs −6.2 (<0.001) |
| AAQoL, total score | 11.18 vs 13.90 (0.045) | 8.62 vs 13.14 (0.004) | Scale not used |
| CGI-ADHD-S, mean change from baseline | −0.9 vs −1.0 (0.173) | −0.9 vs −1.2 (0.001) | −0.7 vs −1.2 (<0.001) |
| Response rate (%)e | 33.9 vs 41.1 (0.165) | 29.2 vs 41.6 (0.006) | 24.2 vs 46.6 (<0.001) |
| Mean time to response (days) | Not analyzed | 84 vs 53 (<0.001) | 61 vs 40 (<0.001) |
| Remission rate (CGI-S 1 or 2) | Not analyzed | Not analyzed | 12.1 vs 20.8 (0.011) |
| Mean time to remission (days) | Not analyzed | 142 vs 165 (0.001) | 144 vs 125 (<0.001) |
| Reference | Adler et al., 2008 | Adler et al., 2009b | Young et al., 2011 |
AAQoL: Adult ADHD Quality-of-Life scale; ATX: atomoxetine; CAARS: Connors Adult ADHD Rating Scale; CGI-ADHD-S: Clinical Global Impression of Severity for ADHD.
Mean changes in CAARS-Inv: SV were calculated using the LOCF method.
The primary measure for Study LYBV was Endicott Work Productivity Scale (EWPS), used to evaluate work productivity.
The primary measure for Study LYCU was a repeated measures analysis of the Adult ADHD Investigator Symptom Rating Scale (AISRS), which showed similar results (−11.7 for placebo vs −16.2 for ATX; p=0.001) to the CAARS-Inv: SV.
The primary analysis for Study LYCW was a repeated measures analysis, which showed similar results (−8.7 for placebo vs -16.4 for ATX; p<0.001) to the CAARS-Inv: SV.
Response was defined as a ≥30% CAARS-Inv: SV improvement and CGI-ADHD-S ≤3.