Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care.
BACKGROUND
This is a secondary analysis of clinical trial data collected in 12 European countries. We examined changes in weight and weight-related quality of life among community patients with schizophrenia treated with aripiprazole (ARI) versus standard of care (SOC), consisting of other marketed atypical antipsychotics (olanzapine, quetiapine, and risperidone).


METHODS
Five-hundred and fifty-five patients whose clinical symptoms were not optimally controlled and/or experienced tolerability problems with current medication were randomized to ARI (10-30 mg/day) or SOC. Weight and weight-related quality of life (using the IWQOL-Lite) were assessed at baseline, and weeks 8, 18 and 26. Random regression analysis across all time points using all available data was used to compare groups on changes in weight and IWQOL-Lite. Meaningful change from baseline was also assessed.


RESULTS
Participants were 59.7% male, with a mean age of 38.5 years (SD 10.9) and mean baseline body mass index of 27.2 (SD 5.1). ARI participants lost an average of 1.7% of baseline weight in comparison to a gain of 2.1% by SOC participants (p<0.0001) at 26 weeks. ARI participants experienced significantly greater increases in physical function, self-esteem, sexual life, and IWQOL-Lite total score. At 26 weeks, 20.7% of ARI participants experienced meaningful improvements in IWQOL-Lite score, versus 13.5% of SOC participants. A clinically meaningful change in weight was also associated with a meaningful change in quality of life (p<0.001). A potential limitation of this study was its funding by a pharmaceutical company.


CONCLUSIONS
Compared to standard of care, patients with schizophrenia treated with aripiprazole experienced decreased weight and improved weight-related quality of life over 26 weeks. These changes were both statistically and clinically significant.
Kolotkin
Ronette L
RL
Department of Community and Family Medicine, Duke University Medical Center, 804 W Trinity Avenue, Durham, NC 27701, USA. rkolotkin@qualityoflifeconsulting.com
Corey-Lisle
Patricia K
PK
Crosby
Ross D
RD
Kan
Hong J
HJ
McQuade
Robert D
RD
D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000068180:Aripiprazole; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D003987:Dibenzothiazepines / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000139:chemically induced / Q000523:psychology; D000077152:Olanzapine; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use; D011788:Quality of Life / Q000523:psychology*; D000069348:Quetiapine Fumarate; D015363:Quinolones / Q000009:adverse effects* / Q000627:therapeutic use; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D012649:Self Concept; D012917:Social Adjustment
D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D010879:Piperazines; D015363:Quinolones; D001569:Benzodiazepines; D000069348:Quetiapine Fumarate; D000068180:Aripiprazole; D018967:Risperidone; D000077152:Olanzapine