Table 2.
Treatment And Outcome Characteristics of 29 Children and Adolescents Treated with Ziprasidone
| Treatment Characteristic | Total (n=29) | Normal QTc Duration and QT Dispersion (n=22) | Abnormal* QTc Duration or QT Dispersion (n=7) | P-Value |
|---|---|---|---|---|
| Ziprasidone Treatment | ||||
| Duration of Ziprasidone Treatment (days ± SD) | 99.3 ± 108.7 | 96.1 ± 97.8 | 109.4 ± 146.7 | 0.78 |
| Highest Daily Dose of Ziprasidone at Time of EKG (mg ± SD) | 89.0 ± 52.3 | 98.2 ± 49.7 | 60.0 ± 52.9 | 0.093 |
| Mean Ziprasidone Serum level (microg/L ± SD)a | 108.8 ± 75.3 | 109.3 ± 66.2 | 107.5 ± 104.6 | 0.96 |
| Comedications At Longest QTc (No. and %) | ||||
| Total number of comedications (±SD) | 1.48 ± 0.85 | 1.45 ± 0.86 | 1.57 ± 1.13 | 0.77 |
| Patients on > 2 Psychotropic Medications (N, %) | 12 (41.4) | 7 (31.8) | 5 (71.4) | 0.06 |
| Mood stabilizers | 12 (41.4) | 8 (36.4) | 4 (57.4) | 0.09 |
| Antidepressants | 5 (17.2) | 5 (20.0) | 0 (0.0) | 0.16 |
| Anxiolytics/Hypnotics | 4 (13.8) | 4 (16.0) | 0 (0.0) | 0.22 |
| Psychostimulants | 4 (13.8) | 3 (13.6) | 1 (14.3) | 0.19 |
| Anticholinergics | 2 (6.9) | 2 (9.1) | 0 (0.0) | 0.40 |
| Other psychotropics b | 4 (13.8) | 3 (13.6) | 1 (14.3) | 0.97 |
| Longest QTc | ||||
| Duration of Treatment at Longest QTc (days ± SD) | 47.6 ± 46.0 | 48.2 ± 48.9 | 45.7 ± 33.2 | 0.90 |
| Daily Ziprasidone dose at Longest QTc (mg ± SD) | 71.3 ± 48.2 | 76.5 ± 47.0 | 54.3 ± 52.6 | 0.29 |
| Ziprasidone Serum Level at Longest QTc (microg/L ± SD)c | 70.1 ± 51.4 | 67.1 ± 36.1 | 78.6 ± 96.5 | 0.70 |
| Longest QTc Dispersion | ||||
| Duration of Treatment at Longest QTc Dispersion (days ± SD) | 60.4 ± 73.2 | 63.6 ± 81.4 | 51.4 ± 37.1 | 0.69 |
| Daily Ziprasidone dose at Longest QTc Dispersion (level ± SD) | 77.4 ± 49.7 | 84.4 ± 49.7 | 57.5 ± 49.5 | 0.20 |
| Ziprasidone Serum Level at Longest QTc Dispersion (level ± SD)d | 66.1 ± 68.2 | 61.7 ± 41.8 | 82.3 ± 101.3 | 0.55 |
*
QTc was considered prolonged if greater than 450 msec or 60 msec longer than at baseline (9). QTc dispersion was considered abnormal if greater than 100 msec (13)
a
Based on 19 patients with information normal QTc: n=14, abnormal QTc: n=5.
b
Other psychotropic medications: alpha-2 agonists, beta blockers, antihistamines
c
Based on 19 patients with information normal QTc: n=15, abnormal QTc: n=5
d
Based on 19 patients with information normal QTc: n=17, abnormal QTc: n=2