Table 7.
BMI-z Score Change from Baseline (A) and Categoric Weight Change from Baseline (B)
|
A. BMI-z score change from baseline | ||||
|---|---|---|---|---|
| |
RCT |
OLE |
|
|
| Baseline | Ziprasidone | Placebo | Ziprasidone | |
| n | 193 | 90 | 221 | |
| n (%) | n (%) | n (%) | ||
| < −2 | 0 | 0 | 0 | |
| ≥−2 to<−1.5 | 8 (4.2) | 5 (5.6) | 12 (5.4) | |
| ≥−1.5 to<−1 | 23 (11.9) | 7 (7.8) | 21 (9.5) | |
| ≥−1 to<−0.5 | 21 (10.9) | 7 (7.8) | 26 (11.8) | |
| ≥−0.5 to<0 | 24 (12.4) | 14 (15.6) | 28 (12.7) | |
| ≥0 to<0.5 | 34 (17.6) | 14 (15.6) | 33 (14.9) | |
| ≥0.5 to<1.0 | 30 (15.5) | 11 (12.2) | 34 (15.4) | |
| ≥1.0 to<1.5 | 24 (12.4) | 19 (21.1) | 35 (15.8) | |
| ≥1.5 to<2.0 | 20 (10.4) | 8 (8.9) | 23 (10.4) | |
| ≥2 to<2.5 | 7 (3.6) | 5 (5.6) | 9 (4.1) | |
| ≥2.5 to<3 | 2 (1.0) | 0 | 0 | |
| ≥3 | 0 | 0 | 0 | |
| Week 6 or week 26/early termination change from baseline | ||||
| n | 134 | 52 | 221 | |
| n (%) | n (%) | n (%) | ||
| < −2 | 0 | 0 | 0 | |
| ≥−2 to<−1.5 | 0 | 0 | 1 (0.5) | |
| ≥−1.5 to<−1 | 0 | 0 | 6 (3.0) | |
| ≥−1 to<−0.5 | 6 (4.5) | 1 (1.9) | 10 (4.9) | |
| ≥−0.5 to<0 | 83 (61.9) | 29 (55.8) | 105 (51.7) | |
| ≥ 0 to<0.5 | 42 (31.3) | 22 (42.3) | 69 (34.0) | |
| ≥ 0.5 to<1.0 | 3 (2.2) | 0 | 6 (3.0) | |
| ≥ 1.0 to<1.5 | 0 | 0 | 3 (1.5) | |
| ≥ 1.5 to<2.0 | 0 | 0 | 3 (1.5) | |
| ≥ 2 to<2.5 | 0 | 0 | 0 | |
| ≥2.5 to<3 | 0 | 0 | 0 | |
| ≥3 | 0 | 0 | 0 | |
| B. Weight categories at baseline and shift from baselinea | ||||
| n | 193 | 90 | 221 | |
| Baseline underweight, n(%) | 1 (0.5) | 1 (1.1) | 1 (0.5) | |
| Baseline normal weight, n(%) | 140 (72.5) | 58 (64.4) | 155 (70.1) | |
| Baseline overweight, n(%) | 31 (16.1) | 22 (24.4) | 45 (20.4) | |
| Baseline Obese, n(%) | 21 (10.9) | 9 (10.0) | 20 (9.1) | |
|
RCT: Shift from baseline to week 6/ET | ||||
|---|---|---|---|---|
| Ziprasidone | Underweight | Normal weight | Overweight | Obese |
| Baseline underweight | 1 | 0 | 0 | 0 |
| Baseline normal weight | 1 | 130 | 1 | 0 |
| Baseline overweight | 0 | 4 | 22 | 2 |
| Baseline obese | 0 | 0 | 1 | 17 |
|
RCT: Shift from baseline to week 6/ET | ||||
|---|---|---|---|---|
| Placebo | Underweight | Normal weight | Overweight | Obese |
| Baseline underweight | 0 | 1 | 0 | 0 |
| Baseline normal weight | 0 | 54 | 1 | 0 |
| Baseline overweight | 0 | 4 | 18 | 0 |
| Baseline obese | 0 | 0 | 0 | 9 |
|
OLE: shift from baseline to week 26/ET | ||||
|---|---|---|---|---|
| Ziprasidone | Underweight | Normal weight | Overweight | Obese |
| Baseline underweight | 1 | 0 | 0 | 0 |
| Baseline normal weight | 1 | 136 | 6 | 0 |
| Baseline overweight | 0 | 5 | 31 | 5 |
| Baseline obese | 0 | 0 | 5 | 13 |
a
Based on Centers for Disease Control and Prevention (CDC) growth charts:
BMI percentile<5th was defined as underweight; BMI percentile ≥5th and<85th was defined as normal weight; BMI percentile ≥85th and <95th was defined as overweight; and BMI percentile ≥95th was defined as obese.
BMI, body mass index; ET, end of treatment; OLE, open-label extension; RCT, randomized controlled trial.