Table 4 Key Efficacy Measures During Long-term Treatment With GXR
Endpoint | Patient populations | Week 0 | Week 50 | Last observation in the treatment period | ||
|---|---|---|---|---|---|---|
Change from week 0 | p-value | Change from week 0 | p-value | |||
ADHD-RS-IVa, mean (95% CI) | ||||||
Total scores | Former placebo patients | 24.76 (22.53, 26.99) | −8.31 (−10.72, −5.89) | <.0001 | −5.94 (−7.53, −4.36) | <.0001 |
Former GXR patients | 22.31 (19.65, 24.97) | −9.11 (−11.19, −7.03) | <.0001 | −7.87 (−9.68, −6.06) | <.0001 | |
New patients | 32.80 (30.93, 34.68) | −19.69 (−23.35, −16.03) | <.0001 | −16.54 (−19.77, −13.31) | <.0001 | |
Inattention score | Former placebo patients | 17.36 (15.97, 18.76) | −5.51 (−7.15, −3.87) | <.0001 | −3.90 (−5.03, −2.76) | <.0001 |
Former GXR patients | 15.37 (13.68, 17.07) | −5.82 (−7.22, −4.42) | <.0001 | −4.87 (−6.04, −3.70) | <.0001 | |
New patients | 21.68 (20.12, 23.24) | −12.10 (−14.70, −9.51) | <.0001 | −10.02 (−12.28, −7.76) | <.0001 | |
Hyperactivity-impulsivity score | Former placebo patients | 7.40 (6.15, 8.65) | −2.80 (−4.00, −1.59) | <.0001 | −2.05 (−2.77, −1.32) | <.0001 |
Former GXR patients | 6.94 (5.55, 8.32) | −3.29 (−4.40, −2.17) | <.0001 | −3.00 (−3.96, −2.04) | <.0001 | |
New patients | 11.12 (9.50, 12.74) | −7.59 (−9.81, −5.36) | <.0001 | −6.51 (−8.25, −4.78) | <.0001 | |
CAARS scores (DSM-IV)a, mean (95% CI) | ||||||
Total ADHD symptoms | Former placebo patients | 25.08 (22.93, 27.23) | −6.27 (−8.65, −3.89) | <.0001 | −4.60 (−6.17, −3.02) | <.0001 |
Former GXR patients | 22.74 (20.07, 25.42) | −8.38 (−10.90, −5.86) | <.0001 | −7.30 (−9.49, −5.10) | <.0001 | |
New patients | 31.32 (28.64, 33.99) | −17.31 (−20.89, −13.73) | <.0001 | −15.08 (−18.49, −11.66) | <.0001 | |
Inattentive symptoms | Former placebo patients | 17.40 (16.14, 18.65) | −3.96 (−5.57, −2.35) | <.0001 | −2.90 (−4.02, −1.79) | <.0001 |
Former GXR patients | 15.55 (13.90, 17.19) | −5.40 (−7.03, −3.77) | <.0001 | −4.51 (−5.89, −3.13) | <.0001 | |
New patients | 20.39 (18.48, 22.30) | −11.00 (−13.54, −8.46) | <.0001 | −9.15 (−11.47, −6.83) | <.0001 | |
Hyperactive-impulsive symptoms | Former placebo patients | 7.68 (6.38, 8.98) | −2.31 (−3.55, −1.06) | .0005 | −1.69 (−2.47, −0.92) | <.0001 |
Former GXR patients | 7.19 (5.79, 8.60) | −2.98 (−4.30, −1.65) | <.0001 | −2.79 (−3.92, −1.66) | <.0001 | |
New patients | 10.93 (9.36, 12.49) | −6.31 (−8.17, −4.45) | <.0001 | −5.93 (−7.56, −4.29) | <.0001 | |
CGI-I response ratesb, % of patients (95% CI) | ||||||
Improvement rate (disease scores 1 or 2) | Former placebo patients | 3.4 (0.7, 9.6)c | 51.0 (36.3, 65.6) | NA | 35.2 (25.3, 46.1) | NA |
Former GXR patients | 4.8 (1.0, 13.5)c | 64.4 (48.8, 78.1) | NA | 53.2 (40.1, 66.0) | NA | |
New patients | 0.0 (0.0, 8.6)c | 79.3 (60.3, 92.0) | NA | 65.9 (49.4, 79.9) | NA | |
PGI-I response ratesb, % of patients (95% CI) | ||||||
Improvement rate (disease scores 1 or 2) | Former placebo patients | 8.0 (3.3, 15.7)c | 28.6 (16.6, 43.3) | NA | 19.3 (11.7, 29.1) | NA |
Former GXR patients | 9.7 (3.6, 19.9)c | 42.2 (27.7, 57.8) | NA | 33.9 (22.3, 47.0) | NA | |
New patients | 9.8 (2.7, 23.1)c | 37.9 (20.7, 57.5) | NA | 31.7 (18.1, 48.1) | NA | |
Patients not ill or borderline mentally illb, % of patients (95% CI) | ||||||
CGI-S scores 1 or 2 | Former placebo patients | 0.0 (0.0, 4.1) | 14.3 (5.9, 27.2) | NA | 8.0 (3.3, 15.7) | NA |
Former GXR patients | 0.0 (0.0, 5.8) | 26.7 (14.6, 41.9) | NA | 22.6 (12.9, 35.0) | NA | |
New patients | 0.0 (0.0, 8.6) | 20.7 (8.0, 39.7) | NA | 17.1 (7.2, 32.1) | NA | |
AAQoLa, mean (95% CI) | ||||||
Total score | Former placebo patients | 46.43 (43.21, 49.64) | 4.13 (0.50, 7.75) | .0266 | 2.81 (0.31, 5.30) | .0282 |
Former GXR patients | 54.27 (49.78, 58.77) | 4.29 (0.35, 8.23) | .0334 | 4.04 (0.88, 7.20) | .0131 | |
New patients | 43.28 (38.38, 48.17) | 12.75 (6.68, 18.81) | .0002 | 9.22 (4.11, 14.34) | .0008 | |
Life productivity | Former placebo patients | 48.04 (43.75, 52.33) | 2.64 (−3.32, 8.61) | .3775 | 2.89 (−0.94, 6.72) | .1377 |
Former GXR patients | 57.88 (52.69, 63.08) | 8.74 (4.69, 12.79) | <.0001 | 8.08 (4.76, 11.41) | <.0001 | |
New patients | 44.29 (37.72, 50.86) | 17.08 (9.11, 25.06) | .0001 | 14.38 (7.75, 21.00) | <.0001 | |
Psychological health | Former placebo patients | 47.02 (42.20, 51.83) | 5.27 (0.57, 9.97) | .0286 | 2.60 (−1.14, 6.34) | .1710 |
Former GXR patients | 54.91 (48.88, 60.93) | 2.78 (−2.69, 8.25) | .3117 | 1.57 (−2.82, 5.96) | .4771 | |
New patients | 43.39 (36.92, 49.86) | 11.35 (4.29, 18.41) | .0027 | 5.62 (−0.57, 11.82) | .0739 | |
Life outlook | Former placebo patients | 41.93 (38.20, 45.66) | 2.59 (−1.97, 7.15) | .2597 | 1.37 (−1.76, 4.51) | .3868 |
Former GXR patients | 46.10 (41.64, 50.56) | −1.90 (−6.44, 2.63) | .4016 | −0.35 (−4.08, 3.37) | .8510 | |
New patients | 40.17 (35.10, 45.24) | 8.23 (1.25, 15.21) | .0225 | 6.06 (0.71, 11.41) | .0275 | |
Relationships | Former placebo patients | 48.47 (44.01, 52.92) | 8.16 (2.70, 13.63) | .0042 | 4.88 (1.15, 8.61) | .0109 |
Former GXR patients | 57.02 (50.97, 63.06) | 5.00 (−1.10, 11.10) | .1058 | 4.26 (−0.82, 9.34) | .0984 | |
New patients | 45.24 (38.72, 51.77) | 11.21 (3.26, 19.16) | .0074 | 6.63 (−0.12, 13.37) | .0542 | |
BRIEF-A T-scorea, mean (95% CI) | ||||||
Inhibit | Former placebo patients | 57.24 (54.81, 59.66) | −3.69 (−6.39, −0.99) | .0084 | −2.39 (−4.15, −0.63) | .0084 |
Former GXR patients | 51.68 (49.20, 54.16) | −1.84 (−4.04, 0.35) | .0977 | −2.66 (−4.65, −0.66) | .0098 | |
New patients | 59.68 (56.49, 62.87) | −8.07 (−11.76, −4.38) | .0001 | −8.25 (−11.28, −5.22) | <.0001 | |
Shift | Former placebo patients | 69.55 (66.83, 72.27) | −5.84 (−9.00, −2.68) | .0005 | −3.29 (−5.51, −1.08) | .0040 |
Former GXR patients | 62.73 (59.04, 66.41) | −4.60 (−8.30, −0.90) | .0159 | −3.70 (−6.57, −0.84) | .0121 | |
New patients | 70.07 (66.33, 73.81) | −8.86 (−11.81, −5.91) | <.0001 | −8.63 (−11.18, −6.07) | <.0001 | |
Emotional control | Former placebo patients | 57.80 (55.51, 60.08) | −4.39 (−7.55, −1.23) | .0075 | −3.26 (−5.34, −1.18) | .0025 |
Former GXR patients | 53.32 (50.75, 55.89) | −2.22 (−4.97, 0.53) | .1104 | −1.52 (−3.72, 0.67) | .1703 | |
New patients | 59.98 (56.74, 63.22) | −5.41 (−7.60, −3.23) | <.0001 | −4.53 (−6.68, −2.37) | .0001 | |
Self-monitor | Former placebo patients | 61.81 (58.70, 64.91) | −6.39 (−8.98, −3.79) | <.0001 | −4.48 (−6.45, −2.52) | <.0001 |
Former GXR patients | 56.06 (52.73, 59.40) | −4.93 (-8.10, -1.76) | .0031 | −4.23 (−6.87, −1.58) | .0022 | |
New patients | 61.24 (56.70, 65.79) | −7.86 (−11.77, −3.96) | .0003 | −6.23 (−10.05, −2.40) | .0021 | |
Behavioral regulation index | Former placebo patients | 63.09 (60.46, 65.73) | −6.02 (−9.06, −2.98) | .0002 | −4.06 (−6.05, −2.07) | .0001 |
Former GXR patients | 56.39 (53.43, 59.35) | −3.71 (−6.52, −0.90) | .0109 | −3.26 (−5.52, −1.01) | .0053 | |
New patients | 64.73 (61.24, 68.23) | −8.72 (−11.53, −5.92) | <.0001 | −7.98 (−10.72, −5.23) | <.0001 | |
Initiate | Former placebo patients | 68.51 (65.65, 71.38) | −5.49 (−8.51, −2.46) | .0006 | −3.87 (−5.94, −1.80) | .0004 |
Former GXR patients | 59.71 (56.58, 62.84) | −3.31 (−6.64, 0.02) | .0514 | −2.03 (−4.87, 0.80) | .1563 | |
New patients | 69.10 (64.97, 73.22) | −10.38 (−13.98, −6.78) | <.0001 | −8.95 (−12.11, −5.79) | <.0001 | |
Working memory | Former placebo patients | 73.91 (71.07, 76.75) | −4.80 (−8.45, −1.15) | .0111 | −3.31 (−5.68, −0.93) | .0069 |
Former GXR patients | 66.18 (62.57, 69.78) | −4.78 (−8.24, −1.32) | .0079 | −3.92 (−6.70, −1.13) | .0066 | |
New patients | 74.10 (70.29, 77.91) | −10.93 (−14.98, −6.88) | <.0001 | −10.15 (−13.73, −6.57) | <.0001 | |
Plan/organize | Former placebo patients | 70.51 (67.74, 73.28) | −3.86 (−6.94, −0.78) | .0152 | −2.32 (−4.37, −0.27) | .0270 |
Former GXR patients | 63.02 (59.52, 66.51) | −3.69 (−7.09, −0.29) | .0340 | −3.00 (−5.90, −0.10) | .0426 | |
New patients | 70.51 (66.57, 74.45) | −8.90 (−12.63, −5.16) | <.0001 | −8.75 (−11.90, −5.60) | <.0001 | |
Task monitor | Former placebo patients | 72.63 (69.56, 75.69) | −6.76 (−9.95, −3.56) | <.0001 | −4.07 (−6.35, −1.79) | .0006 |
Former GXR patients | 63.85 (60.22, 67.49) | −7.02 (−11.06, −2.99) | .0011 | −4.89 (−8.34, −1.43) | .0063 | |
New patients | 70.71 (66.07, 75.34) | −8.93 (−13.17, −4.70) | .0002 | −8.35 (−12.12, −4.58) | <.0001 | |
Organization of materials | Former placebo patients | 65.97 (63.95, 67.98) | −5.00 (−7.82, −2.18) | .0008 | −3.24 (−5.21, −1.26) | .0016 |
Former GXR patients | 58.61 (55.77, 61.45) | −3.31 (−5.55, −1.08) | .0046 | −2.87 (−4.62, −1.11) | .0018 | |
New patients | 65.73 (62.43, 69.03) | −8.41 (−11.90, −4.93) | <.0001 | −7.88 (−11.03, −4.72) | <.0001 | |
Metacognition index | Former placebo patients | 73.36 (70.51, 76.21) | −5.80 (−9.04, −2.55) | .0008 | −3.75 (−5.86, −1.65) | .0007 |
Former GXR patients | 64.16 (60.65, 67.68) | −5.02 (−8.21, −1.83) | .0028 | −3.82 (−6.44, −1.20) | .0050 | |
New patients | 73.24 (69.29, 77.20) | −11.14 (−14.95, −7.33) | <.0001 | −10.35 (−13.69, −7.01) | <.0001 | |
GEC index | Former placebo patients | 70.52 (67.76, 73.29) | −6.41 (−9.59, −3.22) | .0002 | −4.22 (−6.30, −2.15) | .0001 |
Former GXR patients | 61.73 (58.32, 65.13) | −4.84 (−7.96, −1.73) | .0031 | −3.90 (−6.45, −1.36) | .0032 | |
New patients | 71.10 (67.26, 74.93) | −10.86 (−14.29, −7.43) | <0001 | −10.05 (−13.21, −6.89) | <.0001 | |