Table 3.
Main adverse drug reactions reported in clinical trials
| Short term safety trial 49 (4 weeks) | ||||
|---|---|---|---|---|
| Iloperidone 24 mg/day (n = 295) | Ziprasidone 160 mg/day (n = 149) | Placebo (n = 149) | ||
| EPS (%) | 3 | 9 | 2 | |
| Akathisia (%) | 1 | 7 | 0 | |
| Mean changes from baseline | ||||
| Orthostatic hypotension (%) | 7 | 0 | 2 | |
| QTc prolongation (msec) | 11.4 | 11.3 | 0 | |
| (mean maximum) | 16.2 | 12.3 | −2.4 | |
| Weight gain (kg) | 2.8 | 1.1 | 0.5 | |
| Total cholesterol (mg/dL) | 8.1 | 4.1 | −0.5 | |
| Triglycerides (mg/dL) | 0.8 | 4.6 | 19.5 | |
| Glucose (mg/dL) | 7.9 | 4.7 | 3.2 | |
| Prolactin (ng/mL) | 2.6 | 1.9 | −6.3 | |
|
Short-term safety trials48(6 weeks) | ||||
| Iloperidone 4–24 mg/day (n = 1044) | Haloperidol 15 mg/day (n = 118) | Risperidone 4–8 mg/day (n = 306) | Placebo (n = 440) | |
| EPS (%) | 4–5.4 | 20.3 | 9.5 | 4.8 |
| Akathisia (%) | 1.5–4.8 | 13.6 | 6.9 | 3.6 |
| Mean changes from baseline | ||||
| Orthostatic hypotension (%) | 19.5 | 15.3 | 12.0 | 8.3 |
| QTc prolongation (msec) | 2.9–9.1 | 5.0 | 0.6 | 0 |
| Weight gain (kg) | 1.5–2.1 | −0.1 | 1.5 | −0.3 |
| Total cholesterol (mg/dL) | 0.0 | 0.0 | −3.9 | −7.7 |
| Triglycerides (mg/dL) | −26.5 | 0.0 | −26.5 | −35.4 |
| Glucose (mg/dL) | 7.2–16.2 | 10.8 | 3.6 | −3.6 |
| Prolactin (μg/L) | −38.0/−23.1 | 115.8 | 214.5 | −57.4 |
|
Long-term safety trials50(Data at 6 week) | ||||
| Iloperidone 4–16 mg/day (n = 1231) | Haloperidol 5–20 mg/day (n = 403) | |||
| EPS (%) | 0.6 | 7.7 | ||
| Akathisia (%) | 3.5 | 18.6 | ||
| Mean changes from baseline | ||||
| Orthostatic hypotension (%) | NA | NA | ||
| QTc prolongation (msec) | 3.2 | 4.0 | ||
| Weight gain (kg) | 2.6 | 0.6 | ||
| Total cholesterol (mg/dL) | −0.3 | 7.4 | ||
| Triglycerides (mg/dL) | 0.3 | −0.1 | ||
| Glucose (mg/dL) | 2.7 | −0.4 | ||
| Prolactin (ng/mL) | NA | NA | ||
|
Long-term safety trials50(Data at 52 weeks) | ||||
| Iloperidone 4–16 mg/day (n = 371) | Haloperidol 5–20 mg/day (n = 118) | |||
| EPS (%) | 0.8 | 5.9 | ||
| Akathisia (%) | 3.8 | 14.4 | ||
| Mean changes from baseline | ||||
| Orthostatic hypotension (%) | NA | NA | ||
| QTc prolongation (msec) | 10.3 | 9.4 | ||
| Weight gain (kg) | 3.8 | 2.3 | ||
| Total cholesterol (mg/dL) | 0.9 | 6.9 | ||
| Triglycerides (mg/dL) | 6.8 | 12.1 | ||
| Glucose (mg/dL) | 5.8 | −0.5 | ||
| Prolactin (ng/mL) | NA | NA | ||
Abbreviations: EPS, extrapyramidal symptoms; NA, not available.