EPA-0809 - Aripiprazole once-monthly for the treatment of schizophrenia in obese and non-obese patients; a post-hoc analysis

Abstract

To evaluate efficacy and safety of aripiprazole once-monthly 400mg (AOM-400mg), an extended release injectable suspension of aripiprazole, in obese (BMI =30kg/m 2 ) and non-obese (BMI <30kg/m 2 ) patients with schizophrenia. Data from a 38-week, double-blind, active-controlled, non-inferiority study (NCT00706654); randomisation (2:2:1) to AOM-400mg, oral aripiprazole (10-30mg/day) (ARI), or aripiprazole once-monthly 50mg (AOM-50mg) assessing the efficacy and safety of AOM in patients requiring chronic antipsychotic treatment were used for this post-hoc analysis. We report the overall relapse rates in the 38-week randomized phase. Comparisons of overall relapse rates were analyzed using the Chi-squared test. 662 patients were randomized to: AOM-400mg (n=265); ARI (n=266); or AOM-50mg (n=131). Of these, the following were obese: AOM- 400mg: n=95; ARI: n=95; AOM-50mg: n=43. In the obese patients, the overall relapse rate was significantly (p=0.0012) lower with AOM-400mg (7.4%) than with AOM-50mg (27.9%). The difference between AOM-400mg and ARI (8.4%) was not significantly different. In the non-obese patients, the overall relapse was significantly (p=0.0153) lower with AOM-400mg (8.8%) than with AOM-50mg (19.3%). The difference between AOM-400mg and ARI (7.6%) was not significantly different. For patients treated with AOM-400mg, the most common TEAEs (>10% in any group) are presented in Table 1. Table 1 . TEAE: AOM-400mg Obese Non-obese Insomnia 12.6% 11.2% Headache 12.6% 8.2% Injection site pain 11.6% 5.3% Akathesia 10.5% 10.6% Upper respiriatory tract infection 10.5% <5% Weight increase 10.5% 8.2% Weight decrease 6.3% 11.8% The efficacy and tolerability of aripiprazole once-monthly 400mg were similar in both the obese and non-obese subgroups. Supported by Otsuka Pharmaceutical Development & Commercialization, Inc. , and H. Lundbeck A/S