Table 6.
Incidence and Management of Akathisia (Pooled Schizophrenia Safety Population)
| Incidence of Akathisia TEAEs | Placebo N=683 | Cariprazine 1.5–6 mg N=2048 |
|---|---|---|
| Patients with akathisia, n (%) | 23 (3.4) | 299 (14.6) |
| Akathisia events, na | 23 | 334 |
| Mild, n (%) | 14 (60.8) | 180 (53.9) |
| Moderate, n (%) | 8 (34.8) | 145 (43.5) |
| Severe, n (%) | 1 (4.4) | 9 (2.6) |
| Akathisia Treated with Anti-EPS Medication | ||
| Akathisia events treated with anti-EPS medication, n (%) | 12 (52.1) | 188 (56.3) |
| Median time of anti-EPS medication administration, days, n | 7 | 18 |
| Median time to resolution of akathisia with anti-EPS medication, days, n | 16 | 17 |
| Unresolved events after anti-EPS treatment, n (%) | 7 (58.3) | 28 (14.9) |
| Akathisia Treated With Study Drug Down-Titration | ||
| Akathisia events resulting in study drug down-titration, n (%)b | – | 61 (18.3) |
| Median time to resolution of akathisia in patients with study drug down-titration, days, n | – | 15 |
| Unresolved events in patients with study drug down-titration, n (%) | – | 4 (6.6) |
| Discontinuation | ||
| Akathisia events resulting in discontinuation, n (%) | 1/23 (4.4) | 21/334 (6.3) |
Notes: aA patient might have experienced more than one akathisia event; events were counted separately if there were 3 or more days between them; bDepending on the timing of the event, down-titration may not have been allowed in the fixed-dose studies.
Abbreviations: EPS, extrapyramidal symptoms; TEAEs, treatment-emergent adverse events.