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

Ronette L. Kolotkin, Patricia K. Corey-Lisle, Ross D. Crosby, Hongjun Kan, Robert D. McQuade

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)561-566
Number of pages6
JournalEuropean Psychiatry
Volume23
Issue number8
DOIs
StatePublished - Dec 2008
Externally publishedYes

Fingerprint

Standard of Care
Multicenter Studies
Quality of Life
Weights and Measures
olanzapine
Schizophrenia
Aripiprazole
Risperidone
Self Concept
Antipsychotic Agents
Body Mass Index
Regression Analysis
Clinical Trials
Pharmaceutical Preparations

Keywords

  • Antipsychotics
  • Obesity
  • Quality of life
  • Schizophrenia

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care. / Kolotkin, Ronette L.; Corey-Lisle, Patricia K.; Crosby, Ross D.; Kan, Hongjun; McQuade, Robert D.

In: European Psychiatry, Vol. 23, No. 8, 12.2008, p. 561-566.

Research output: Contribution to journalArticle

Kolotkin, Ronette L. ; Corey-Lisle, Patricia K. ; Crosby, Ross D. ; Kan, Hongjun ; McQuade, Robert D. / Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care. In: European Psychiatry. 2008 ; Vol. 23, No. 8. pp. 561-566.
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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.",
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T1 - Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care

AU - Kolotkin, Ronette L.

AU - Corey-Lisle, Patricia K.

AU - Crosby, Ross D.

AU - Kan, Hongjun

AU - McQuade, Robert D.

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N2 - 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.

AB - 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.

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