Benzodiazepine use during cariprazine treatment in acute schizophrenia

Abstract

Introduction: Although antipsychotics are first‐line treatments for schizophrenia, benzodiazepines (BZDs) are often used as concomitant medications in acutely exacerbated patients due to their anxiolytic and sedative effects. Cariprazine (CAR), a D3‐preferring dopamine D2/D3 partial agonist antipsychotic, has been examined in many clinical studies for the treatment of acute schizophrenia, with and without benzodiazepines. Objectives: To delineate the effects of benzodiazepine‐use during cariprazine treatment in acute schizophrenia. Methods: Pooled data of cariprazine‐treated (1.5‐6mg/day) and placebo‐treated patients from four short‐term, randomised, doubleblind trials (NCT00404573, NCT01104766, NCT01104779, NCT00694707) were analysed. Baseline characteristics (age, duration of illness) and efficacy outcome parameters (Total and Hostility Factor Score of the Positive and Negative Syndrome Scale [PANSS]) were compared in patients receiving benzodiazepines (for more ≥3 consecutive days) and not receiving benzodiazepines (<3 consecutive days). Results:Altogether, 36.7% and 40.7% of the CAR‐treated and PBOtreated patients required BZDs. BZD‐taking was associated with a higher age in both the CAR‐treated (p=0.0002) and PBO‐treated (p<0.0001) patients, and with longer illness‐duration in both treatment groups (p<0.0001). PANSS Total Score at baseline was similar for BZD users and non‐users (CAR: LS Mean=96.36 and 96.27; PBO: LS Mean=95.55 and 96.66). Change from baseline in the PANSS Total Score was greater for patients who did not use BZD vs those who did (CAR: LS Mean= ‐23.8 vs LS Mean 17.2, p<0.0001; PBO: LS Mean= ‐14.0 vs LS Mean 12.9, p=0.5776). Conclusions: These findings may suggest that requiring benzodiazepines is a potential indicator of longer illness duration and poorer response in acute schizophrenia.