Relative association of treatment-emergent adverse events with quality of life of patients with schizophrenia: post hoc analysis from a 3-year observational study Cecilia Adrianze ´n 1 * , Cesar Arango-Da ´vila 2 , Danilo Martı ´nez Araujo 3 , Ignacio Ruı ´z 4 , Richard J. Walton 5 , Martin Dossenbach 6 and Jamie Karagianis 7,8 1 Eli Lilly Peru ´, Lima, Peru ´ 2 Valle del Lili Foundation, Research Group of Neurosciences, Psychiatry and Mental Health, Libre University, Cali, Colombia 3 Women’s Hospitalization Ward, Department of Psychiatry and Clinical Psychology, Military Hospital ‘‘Dr Carlos Arvelo’’, Caracas, DC, Venezuela 4 Eli Lilly de Me ´xico, S.A. de C.V. Barranca del Muerto 329-1, Me ´xico City, DF, Me ´xico 5 Intercontinental Information Sciences, Eli Lilly Australia Pty Limited, Macquarie Park, NSW, Australia 6 Eli Lilly and Company, GmbH, Vienna, Austria 7 Eli Lilly and Company, Toronto, Canada 8 Memorial University of Newfoundland, St. John’s, Canada Objective To explore the relative association of adverse events with health-related quality of life (HRQL) in patients (N ¼ 16 091) with schizophrenia, treated with antipsychotic medication. Methods In this post hoc analysis of data from two 3-year observational studies, a mixed effects model with repeated measures was used to evaluate the association between HRQL (EuroQoL visual analogue scale (EQ-VAS)) and pre-specified covariates including: severity of illness, extrapyramidal symptoms, tardive dyskinesia, sexual dysfunction, and clinically significant weight gain (> 7% increase from baseline after  3 months of treatment). Results Mean EQ-VAS increased from 47.8  21.7 at baseline to 72.4  18.4 after 36 months. The rank order of the negative association of adverse events with HRQL was: sexual dysfunction (effect estimate 4.04; 95% CI 4.30 to 3.79), extrapyramidal symptoms (effect estimate 2.09; 95% CI 2.43 to 1.75), and tardive dyskinesia (effect estimate 0.89; 95% CI 1.46 to 0.32). Conclusions Differences were observed in the direction and magnitude of the association between each adverse event and HRQL. Recognition of the relative association of adverse events with HRQL may contribute to improved adherence of patients with schizophrenia to antipsychotic therapy. Copyright # 2010 John Wiley & Sons, Ltd. key words — adverse events; antipsychotic agents; observational; quality of life; schizophrenia INTRODUCTION Quality of life is defined by the World Health Organization as an ‘‘individual’s perceptions of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns’’ (The WHOQOL Group, 1995). Health-related Quality of Life (HRQL) is generally considered a multi-dimen- sional, patient-reported outcome, including assess- ments of physical, emotional, social, and occupational functioning (Bobes et al., 2005). Quality of life is an important outcome associated with the long-term success of treatment of patients with schizophrenia (Awad et al., 1995; Hofer et al., 2004; Tandon et al., 2006). Several HRQL assessment tools have been validated for use in patients with schizophrenia. Generic scales such as the World Health Organization Quality of Life Assessment (WHOQOL), the 36-Item Short form Health Survey (SF-36) and the EuroQoL Questionnaire-5 dimensions (EQ-5D), can be used to assess HRQL in patients and in the general population. Specific tools, such as the Self-report Quality of Life Measure for People with Schizophrenia (SQLS), are typically used to assess patients with severe mental illness or when disease-specific HRQL information is required. Both types of HRQL assessments have human psychopharmacology Hum. Psychopharmacol Clin Exp 2010; 25: 439–447. Published online in Wiley Online Library (wileyonlinelibrary.com).DOI: 10.1002/hup.1143 * Correspondence to: C. Adrianze ´n, Eli Lilly Peru ´, Las Begonias 441, Piso 11, San Isidro, Lima, Peru ´. E-mail: cadrianzen@lilly.com Copyright # 2010 John Wiley & Sons, Ltd. Received 26 January 2010 Accepted 13 July 2010