Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-12-01T09:06:30.697Z Has data issue: false hasContentIssue false
  • English
  • Français

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: [email protected] (R.L. Kolotkin).
Get access

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Allison, D.Mackell, J.McDonnell, D.The impact of weight gain on quality of life among persons with schizophrenia Psychiatr Serv. 2003; 54 4565–567CrossRefGoogle ScholarPubMed
American Diabetes Association, Consensus development conference on antipsychotic drugs and obesity and diabetes Diabetes Care. 2004; 27 2596–601Google Scholar
Angermeyer, M.Matschinger, .Neuroleptics and quality of life. A patient survey Psychiatr Prax. 2000; 27 264–68Google ScholarPubMed
Brixner, D.Said, .Corey-Lisle, P.Tuomari, A.L'Italien, G.Stockdale, .et al.Naturalistic impact of second-generation antipsychotics on weight gain Ann Pharmacother. 2006; 40 4626–632CrossRefGoogle ScholarPubMed
Catapano, .Castle, .Obesity in schizophrenia: what can be done about it? Australas Psychiatry. 2004; 12 123–25CrossRefGoogle Scholar
Crosby, R.Kolotkin, R.Williams, G.An integrated method to determine meaningful changes in health-related quality of life J Clin Epidemiol. 2004; 57 111153–1160CrossRefGoogle ScholarPubMed
Dubisar, B.Stoner, S.Reynolds, .Khan, .Ramlatchman, .Adverse effects of atypical antipsychotic agents and their effects on quality of life Pharmacotherapy. 2004; 24 7843–847CrossRefGoogle ScholarPubMed
Engel, S.Crosby, R.Kolotkin, R.Hartley, G.Williams, G.Wonderlich, S.et al.The impact of weight loss and regain on obesity-specific quality of life: mirror image or differential effect Obes Res. 11 2003 1207–1213CrossRefGoogle ScholarPubMed
Fakhoury, W.Wright, .Wallace, .Prevalence and extent of distress of adverse effects of antipsychotics among callers to a United Kingdom National Mental Health Helpline Int Clin Psychopharmacol. 2001; 16 3153–162CrossRefGoogle ScholarPubMed
FDA, Guidance for the clinical evaluation of weight-control drugs http://wwwfdagov/cder/guidance/obesitypdf 1996Google Scholar
Gadbury, G.Coffey, C.Allison, D.Modern statistical methods for handling missing repeated measurements in obesity trial data: beyond LOCF Obes Rev. 2003; 4 3175–184CrossRefGoogle ScholarPubMed
Gentile, .Long-term treatment with atypical antipsychotics and the risk of weight gain: a literature analysis Drug Saf. 2006; 29 4303–319CrossRefGoogle ScholarPubMed
Homel, .Casey, .Allison, D.Changes in body mass index for individuals with and without schizophrenia, 1987–1996 Schizophr Res. 2002; 55 3277–284CrossRefGoogle ScholarPubMed
Jia, .Lubetkin, E.The impact of obesity on health-related quality-of-life in the general adult US population J Public Health (Oxf). 2005; 27 2156–164CrossRefGoogle ScholarPubMed
Kerwin, .Millet, .Herman, .Banki, C.Lublin, .Pans, .et al.A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients Schizophrenia Trial of Aripiprazole (STAR) study Eur Psychiatry. 2007 Oct; 22 7433–443 [Epub 2007 Jun 7]CrossRefGoogle ScholarPubMed
Kolotkin, R.Crosby, R.Psychometric evaluation of the Impact Of Weight On Quality Of Life-Lite Questionnaire (IWQOL-Lite) in a community sample Qual Life Res. 2002; 11 2157–171CrossRefGoogle Scholar
Kolotkin, .Crosby, .Corey-Lisle, .Li, .Swanson, .Performance of a weight-related measure of quality of life in a psychiatric sample Qual Life Res. 2006; 15 4587–596CrossRefGoogle Scholar
Kolotkin, R.Crosby, R.Kosloski, K.Williams, G.Development of a brief measure to assess quality of life in obesity Obes Res. 9 2001 102–111CrossRefGoogle ScholarPubMed
Kolotkin, R.Crosby, R.Williams, G.Hartley, G.Nicol, .The relationship between health-related quality of life and weight loss Obes Res. 9 2001 564–571CrossRefGoogle ScholarPubMed
Kolotkin, R.Meter, .Williams, G.Quality of life and obesity Obes Rev. 2 2001 219–229CrossRefGoogle ScholarPubMed
Lieberman, J.Comparative effectiveness of antipsychotic drugs: a commentary on Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia study (CUtLASS 1) and Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Arch Gen Psychiatry. 2006; 63 101069–1072 10.1001/archpsyc.63.10.1069CrossRefGoogle Scholar
McQuade, R.Stock, .Marcus, .Jody, .Gharbia, N.Vanveggel, .et al.A comparison of weight change during treatment with olanzapine or aripiprazole: results from a randomized, double-blind study J Clin Psychiatry. 65 Suppl 18 2004 47–56Google ScholarPubMed
Muller, D.Muglia, .Fortune, .Kennedy, J.Pharmacogenetics of antipsychotic-induced weight gain Pharmacol Res. 2004; 49 4309–329CrossRefGoogle ScholarPubMed
Nasrallah, .A review of the effect of atypical antipsychotics on weight Psychoneuroendocrinology. 28 Suppl 1 2003 83–96CrossRefGoogle ScholarPubMed
Sach, T.Barton, G.Doherty, .Muir, K.Jenkinson, .Avery, A.The relationship between body mass index and health-related quality of life: comparing the EQ-5D, EuroQol VAS and SF-6D Int J Obes (Lond). 31 2007 189–196CrossRefGoogle ScholarPubMed
Schwartz, T.Nihalani, .Jindal, .Virk, .Jones, .Psychiatric medication-induced obesity: a review Obes Rev. 2004; 5 2115–121CrossRefGoogle ScholarPubMed
Strassnig, .Brar, J.Ganguli, .Body mass index and quality of life in community-dwelling patients with schizophrenia Schizophr Res. 62 1–2 2003 73–76CrossRefGoogle ScholarPubMed
Susce, M.Villanueva, .Diaz, F.de Leon, .Obesity and associated complications in patients with severe mental illnesses: a cross-sectional survey J Clin Psychiatry. 2005; 66 2167–173CrossRefGoogle ScholarPubMed
Tardieu, .Micallef, .Gentile, .Blin, .Weight gain profiles of new anti-psychotics: public health consequences Obes Rev. 2003; 4 3129–138CrossRefGoogle ScholarPubMed
Toalson, .Ahmed, .Hardy, .Kabinoff, .The metabolic syndrome in patients with severe mental illnesses Prim Care Companion J Clin Psychiatry. 2004; 6 4152–158CrossRefGoogle ScholarPubMed
Uzun, .Kozumplik, .Mimica, .Folnegovic-Smalc, .Aripiprazole: an overview of a novel antipsychotic Psychiatr Danub. 17 1-2 2005 67–75Google ScholarPubMed
Virk, .Schwartz, T.Jindal, .Nihalani, .Jones, .Psychiatric medication induced obesity: an aetiologic review Obes Rev. 2004; 5 3167–170CrossRefGoogle Scholar
Weiden, P.Mackell, J.McDonnell, D.Obesity as a risk factor for antipsychotic noncompliance Schizophr Res. 2004; 66 151–57CrossRefGoogle ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.