Table 4.
Efficacy data (CAARS-INV: SV, CGI-ADHD-S, AAQoL scores) from the short-term and longer-term studies (integrated analyses).
| Parameter | Short-term studies integrated analysis |
Longer-term studies integrated analysis |
||||
|---|---|---|---|---|---|---|
| Placebo | ATX | ATX vs placebo, p-value | Placebo | ATX | ATX vs placebo, p-value | |
| CAARS-Inv: SV total score, n | 863 | 849 | 557 | 663 | ||
| Baseline, mean±SD | 35.2±8.1 | 35.0±8.2 | 35.6±8.2 | 34.8±8.2 | ||
| Endpoint, mean±SD | 26.8±11.2 | 22.6±11.4 | 25.9±11.9 | 21.7±11.6 | ||
| Change to endpoint, mean±SD | −8.4±10.0 | −12.4±10.9 | −9.7±11.8 | −13.2±12.1 | ||
| ATX vs placebo, LS mean (95% CI) | −4.1 (−5.0– −3.2) | <0.001 | −3.9 (−5.2– −2.7) | <0.001 | ||
| CAARS-Inv: SV, inattentive score, n | 863 | 849 | 557 | 665 | ||
| Baseline, mean±SD | 20.4±4.1 | 20.2±4.2 | 20.2±4.1 | 20.0±4.3 | ||
| Endpoint, mean±SD | 15.6±6.3 | 13.3±6.5 | 14.9±6.9 | 12.6±6.7 | ||
| Change to endpoint, mean±SD | −4.7±5.9 | −6.9±6.3 | −5.4±6.9 | −7.5±7.0 | ||
| ATX vs placebo, LS mean (95% CI) | −2.2 (−2.8– −1.7) | <0.001 | −2.2 (−2.9– −1.4) | <0.001 | ||
| CAARS-Inv: SV, hyperactive/ impulsive score, n | 863 | 849 | 557 | 664 | ||
| Baseline, mean±SD | 14.8±5.8 | 14.8±5.8 | 15.4±5.8 | 14.8±5.8 | ||
| Endpoint, mean±SD | 11.2±6.3 | 9.3±6.1 | 11.1±16.2 | 9.1±5.9 | ||
| Change to endpoint, mean±SD | −3.7±5.1 | −5.5±5.5 | −4.3±5.9 | −5.7±6.1 | ||
| ATX vs placebo, LS mean (95% CI) | −1.9 (−2.3– −1.4) | <0.001 | −1.7 (−2.3– −1.1) | <0.001 | ||
| CGI-ADHD-S score, n | 652 | 640 | 611 | 758 | ||
| Baseline, mean±SD | 4.7±0.7 | 4.8±0.7 | 4.6±0.6 | 4.6±0.7 | ||
| Endpoint, mean±SD | 4.1±1.1 | 3.7±1.1 | 3.8±1.1 | 3.5±1.2 | ||
| Change to endpoint, mean±SD | −0.6±1.0 | −1.0±1.2 | −0.8±1.1 | −1.1±1.2 | ||
| ATX vs placebo, LS mean (95% CI) | −0.4 (−0.5– −0.3) | <0.001 | −0.35 (−0.5– −0.2) | <0.001 | ||
| AAQoL total score, n | 561 | 538 | 344 | 440 | ||
| Baseline, mean±SD | 45.1±14.3 | 45.0±14.8 | 47.4±13.1 | 47.2±13.2 | ||
| Endpoint, mean±SD | 54.8±16.4 | 58.7±17.9 | 57.0±17.3 | 60.7±17.2 | ||
| Change to endpoint, mean±SD | 9.7±14.8 | 13.7±16.5 | 9.6±15.8 | 13.5±16.2 | ||
| ATX vs placebo, LS mean (95% CI) | 4.0 (2.2–5.7) | <0.001 | 3.6 (1.5–5.8) | 0.001 | ||
| AAQoL subscore for life productivity measurement, n | 561 | 538 | 342 | 440 | ||
| Baseline, mean±SD | 40.7±19.3 | 40.5±19.2 | 41.4±16.9 | 41.8±16.6 | ||
| Endpoint, mean±SD | 52.4±21.3 | 57.2±22.7 | 53.8±21.0 | 58.9±20.6 | ||
| Change to endpoint, mean±SD | 11.7±19.8 | 16.8±21.7 | 12.4±21.3 | 17.1±20.7 | ||
| ATX vs placebo, LS mean (95% CI) | 4.9 (2.7–7.2) | <0.001 | 4.5 (1.8–7.3) | 0.001 | ||
| AAQoL subscore for psychological health measurement, n | 560 | 539 | 343 | 441 | ||
| Baseline, mean±SD | 46.1±20.1 | 45.8±21.0 | 51.2±19.4 | 49.0±19.8 | ||
| Endpoint, mean±SD | 56.0±21.0 | 59.5±22.6 | 59.3±21.5 | 61.4±21.2 | ||
| Change to endpoint, mean±SD | 9.9±20.5 | 13.6±21.5 | 8.1±19.9 | 12.5±21.0 | ||
| ATX vs placebo, LS mean (95% CI) | 3.7 (1.4–5.9) | 0.001 | 3.1 (0.5–5.7) | 0.021 | ||
| AAQoL subscore for life outlook measurement, n | 558 | 538 | 343 | 440 | ||
| Baseline, mean±SD | 47.0±16.0 | 47.8±16.8 | 49.9±14.0 | 50.7±14.8 | ||
| Endpoint, mean±SD | 53.2±17.8 | 56.4±19.3 | 56.4±17.5 | 60.3±17.6 | ||
| Change to endpoint, mean±SD | 6.2±15.6 | 8.7±18.1 | 6.5±16.0 | 9.7±16.6 | ||
| ATX vs placebo, LS mean (95% CI) | 2.8 (0.9–4.6) | 0.003 | 3.3 (1.1–5.5) | 0.003 | ||
| AAQoL subscore for relationships measurement, n | 561 | 539 | 343 | 440 | ||
| Baseline, mean±SD | 51.1±20.8 | 50.6±20.7 | <0.001 | 52.6±18.8 | 52.4±18.7 | 0.053 |
| Endpoint, mean±SD | 60.8±21.1 | 64.4±21.1 | 62.2±20.3 | 64.7±20.1 | ||
| Change to endpoint, mean±SD | 9.7±20.3 | 13.8±21.1 | 9.5±19.5 | 12.3±19.7 | ||
| ATX vs placebo, LS mean (95% CI) | 3.9 (1.7–6.0) | 2.5 (0.0–5.0) | ||||
AAQoL: Adult ADHD Quality-of-Life; ADHD: attention deficit hyperactivity disorder; ATX: atomoxetine; CAARS-Inv: SV: Conners’ Adult ADHD Rating Scale–Investigator-Rated; CGI-ADHD-S: Clinical Global Impressions of ADHD-Severity; CI: confidence interval (two-sided); LS: least square; n: number of randomized patients with baseline and post-baseline result(s).
Studies LYBY and LYDQ are excluded from CGI-ADHD-S descriptive statistics because they were conducted in comorbid populations. Similarly, Study LYBY did not collect CAARS-Inv: SV data, and Studies LYAA, LYAO and LYBY did not collect AAQoL data, p-values for mean CGI-ADHD-S, CAARS-Inv: SV and AAQoL scores are from the Type III sums of squares analysis of variance (ANOVA) model: change: treatment + study + baseline value; p-values for response rates are from the Cochran Mantel-Haenszel method.