To evaluate efficacy and safety of aripiprazole once-monthly 400mg, an extended release injectable suspension of aripiprazole, in obese (BMI ≥30kg/m2) and non-obese (BMI <30kg/m2) patients with schizophrenia.
Data from a 38-week, double-blind, active-controlled, non-inferiority study (NCT00706654); randomisation (2:2:1) to aripiprazole once-monthly 400mg, oral aripiprazole (10–30mg/day), or aripiprazole once-monthly 50mg assessing the efficacy and safety of aripiprazole once-monthly 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.
A total of 662 patients were randomized to: aripiprazole once-monthly 400mg (n=265); oral aripiprazole (n=266); or aripiprazole once-monthly 50mg (n=131). Of these, the following were obese: aripiprazole once-monthly 400mg: n=95; oral aripiprazole: n=95; aripiprazole once-monthly 50mg: n=43. In the obese patients, the overall relapse rate was significantly (p=0.0012) lower with aripiprazole once-monthly 400mg (7.4%) than with aripiprazole once-monthly 50mg (27.9%). The difference between aripiprazole once-monthly 400mg and ARI (8.4%) was not significantly different. In the non-obese patients, the overall relapse was significantly (p=0.0153) lower with aripiprazole once-monthly 400mg (8.8%) than with aripiprazole once-monthly 50mg (19.3%). The difference between aripiprazole once-monthly 400mg and oral aripiprazole (7.6%) was not significantly different. For patients treated with aripiprazole once-monthly 400mg, the most common treatment emergent adverse events (>10% in any group) were insomnia (obese: 12.6%, non-obese 11.2%), headache (obese: 12.6%, non-obese 8.2%), injection site pain (obese: 11.6%, non-obese 5.3%), akathesia (obese: 10.5%, non-obese 10.6%), upper respiratory tract infection (obese: 10.5%, non-obese <5%). Increased weight was reported as an adverse event in 10.5% of the obese patients and 8.2% in the non-obese patients. In the aripiprazole once-monthly 400mg treated patients, the incidence of shifts from non-obese at baseline to obese during the randomized phase was 7.6% (13/170) and from obese to non-obese was 17.9% (17/95).
The efficacy and tolerability of aripiprazole once-monthly 400mg were similar in both the obese and non-obese subgroups.