Table 4.
Responder analyses at end point for prespecified analyses (LOCF, full-analysis set)
| Definition of response | Characteristic | RCT |
RWS |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=111) |
GXR (n=114) |
ATX (n=112) |
GXR (n=503) |
||||||
| Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | ||
| ≥50% reduction from baseline in ADHD-RS-IV total score | Number of participants | 48 | 55 | 45 | 60 | 48 | 58 | 221 | 206 |
| Responders, n (%) | 14 (29.2) | 19 (34.5) | 24 (53.3) | 36 (60.0) | 15 (31.3) | 33 (56.9) | 143 (64.7) | 152 (73.8) | |
| Percent change from placebo (95% CI; P-value) | NA | NA | 24.2 (4.7–43.6; P=0.011) | 25.5 (7.8–43.1; P=0.003) | 2.1 (−16.3 to 20.4; P=0.911) | 22.4 (4.5–40.3; P=0.010) | NA | NA | |
| ≥30% reduction from baseline in ADHD-RS-IV total score | Number of participants | 48 | 55 | 45 | 60 | 48 | 58 | 221 | 206 |
| Responders, n (%) | 24 (50.0) | 32 (58.2) | 35 (77.8) | 50 (83.3) | 28 (58.3) | 45 (77.6) | 180 (81.4) | 181 (87.9) | |
| Percent change from placebo (95% CI; P-value) | NA | NA | 27.8 (9.1–46.4; P=0.008) | 25.2 (9.1–41.2; P<0.001) | 8.3 (−11.5 to 28.2; P=0.511) | 19.4 (2.5–36.3; P=0.008) | NA | NA | |
Notes: P-values based on Cochran–Mantel–Haenszel statistic comparing the treatment groups, including country and age-group, as stratification factors. Not all patients had ADHD-RS-IV total score data available at end point.
Abbreviations: ADHD-RS-IV, Attention-Deficit/Hyperactivity Disorder Rating Scale version IV; ATX, atomoxetine; CI, confidence interval; GXR, guanfacine extended release; LOCF, last observation carried forward; MPH, methylphenidate; NA, not applicable; RCT, randomized controlled trial; RWS, randomized-withdrawal study.