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Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care

Published online by Cambridge University Press:  16 April 2020

Ronette L. Kolotkin ,
Patricia K. Corey-Lisle ,
Ross D. Crosby ,
Hong J. Kan  and
Robert D. McQuade
Ronette L. Kolotkin*
Affiliation:
Department of Community and Family Medicine, Duke University Medical Center, 804 W Trinity Avenue, Durham, NC 27701, USA Obesity and Quality of Life Consulting, 1004 Norwood Avenue, Durham, NC27707, USA
Patricia K. Corey-Lisle
Affiliation:
Bristol–Myers Squibb Co., 5 Research Parkway, Wallingford, CT06492, USA
Ross D. Crosby
Affiliation:
Neuropsychiatric Research Institute, 700 First Avenue South, Fargo, ND58107, USA University of North Dakota School of Medicine and Health Sciences, Fargo, ND58102, USA
Hong J. Kan
Affiliation:
Bristol–Myers Squibb Co., 5 Research Parkway, Wallingford, CT06492, USA
Robert D. McQuade
Affiliation:
Otsuka Pharmaceutical, Princeton, NJ08540, USA
*
*Corresponding author. Obesity and Quality of Life Consulting; 1004 Norwood Avenue, Durham, NC 27707, USA. Tel.: +1 919 493 9995; fax: +1 919 493 9925. E-mail address: rkolotkin@qualityoflifeconsulting.com (R.L. Kolotkin).
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Abstract

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).

Method

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.

Keywords

SchizophreniaObesityQuality of lifeAntipsychotics
Type
Original article
Information
European Psychiatry , Volume 23 , Issue 8 , December 2008 , pp. 561 - 566
Copyright
Copyright © Elsevier Masson SAS 2008

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