Table 2(a).
Efficacy data from individual short-term (10–16 weeks), placebo-controlled studies: changes by treatment group from baseline.
| Eli Lilly study identifier | LYAA |
LYAO |
LYEE |
LYBY |
LYDQ |
LYDZ |
|---|---|---|---|---|---|---|
| Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | Placebo vs ATX (p-value) | |
| Number of patients | 134 vs 133 | 124 vs 124 | 195 vs 191 | 75 vs 72 | 158 vs 171 | 198 vs 192 |
| Completion rates (%) | 72.3 vs 77.0 | 63.6 vs 70.1 | 80.5 vs 87.2 | 44.4 vs 64.0 | 56.7 vs 62.8 | 52.5 vs 57.8 |
| CAARS-Inv: SV, mean change from baselinea Total score | −6.0 vs −9.5 (0.006) | −6.7 vs −10.5 (0.002) | −8.8 vs −14.3 (<0.001) | Scale not usedb | −5.6 vs −8.7 (<0.001) | −7.2 vs −10.7 (<0.001) |
| Inattention subscore | −3.1 vs −5.0 (0.010) | −3.5 vs −5.8 (0.001) | −5.1 vs −8.2 (<0.001) | −3.6 vs −4.8 (0.001) | −4.3 vs −5.7 (<0.001) | |
| Hyperactive/ impulsive subscore | −2.9 vs −4.5 (0.017) | −3.2 vs −4.7 (0.012) | −3.7 vs −6.1 (<0.001) | −2.0 vs −3.9 (<0.001) | −2.9 vs −5.0 (<0.001) | |
| AAQoL, total score | Scale not used | Scale not used | 8.2 vs 12.8 (<0.001) | Scale not usedb | 11.1 vs 14.9 (0.030) | 11.0 vs 15.8 (0.005) |
| CGI-ADHD-S or CGI-Overall-S, mean change from baselinec | −0.4 vs −0.8 (0.011) | −0.5 vs −0.9 (0.002) | −0.8 vs −1.3 (<0.001) | −0.7 vs −1.0 (0.048) | −0.6 vs −0.8 (0.022) | −0.7 vs −1.1 (<0.001) |
| Response rate (%)d | 20.9 vs 27.8 (0.188) | 22.0 vs 29.8 (0.103) | 23.6 vs 34.8 (<0.001) | Not analyzed | Not analyzed | 22.1 vs 34.4 (0.002) |
| Reference | Marchant et al., 2011 | Marchant et al., 2011 | Goto et al., 2013 | Wilens et al., 2011 | Adler et al., 2009a | Durell et al., 2013 |
AAQoL: Adult ADHD Quality-of-Life scale; ADHD: attention deficit hyperactivity disorder; ATX: atomoxetine; CAARS-Inv: SV: Connors’ Adult ADHD Rating Scale, Investigator Rated; CGI-ADHD-S: Clinical Global Impression of Severity for ADHD; CGI-Overall-S: Clinical Global Impressions Overall-Severity.
Mean changes in CAARS-Inv: SV were calculated using the last observation carried forward (LOCF) method.
Study LYBY used the Adult ADHD Investigator Symptom Rating Scale (AISRS) instead of CAARS. With AISRS, total scores (placebo vs ATX) were −8.3 vs −13.6 (p=0.007), inattention scores were −4.4 vs −7.2 (p=0.013) and hyperactivity/impulsive scores were −3.9 vs −6.5 (p=0.009).
The CGI Overall-S scale was administered in Studies LYBY and LYDQ. CGI Overall evaluated the severity of both ADHD and a secondary condition.
Response in Studies LYAA, LYAO, LYEE, and LYDZ was defined as a decrease of ≥30% (from baseline through final observation point) in CAARS-Inv: SV total ADHD symptom score and a CGI-ADHD-S ≤3 at endpoint.