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William Montgomery,1 Amir Goren,2 Kristin Kahle-Wrobleski,3 Tomomi Nakamura,4 Kaname Ueda5 1Global Patient Outcomes & Real World Evidence, Eli Lilly Australia, NSW, Australia; 2Real World Evidence, Kantar Health, New York, NY, USA; 3Global Patient Outcomes and Real World Evidence, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA; 4Bio-Medicines, Medical Development Unit, Eli Lilly Japan K.K., Tokyo, Japan; 5Health Outcomes, Health Technology Assessment, & Real World Evidence, Medical Development Unit, Eli Lilly Japan K.K., Kobe, Japan Background: Dementia of Alzheimer’s disease (AD) imposes burdens on patients, caregivers, and society. This cross-sectional study examined caregiver-reported history of disease onset and AD dementia to inform efforts promoting early disease detection and diagnosis.Methods: An online survey collected self-reported cross-sectional data – demographic characteristics, diagnosis, treatment experiences, and other information on disease detection, diagnosis, and treatment – from caregivers of patients with AD dementia. These characteristics were examined as a function of AD dementia severity.Results: Three hundred patients with AD dementia were trichotomized by long-term care insurance levels reported by caregivers: 12.3% (n=37) as low severity, 63.7% (n=191) as medium severity, and 24.0% (n=72) as high severity. The Short-Memory Questionnaire and patient dependency scores both varied significantly across severity groups. AD dementia symptoms were most frequently first detected by a caregiver (58.7%) or the patient’s family (45.7%). However, in 13.7% of cases, symptoms were detected by a health care provider during a routine visit. Memory problems were the most frequent first symptoms (77.3%), followed by repetition (55.7%). Patients (73.7%) were taking symptomatic treatment such as acetylcholinesterase inhibitors or memantine. High-severity patients were older, had been diagnosed with AD dementia for a longer time, had more frequent reports of memory problems as the first symptoms detected, and required more hours of care per day, compared with low-severity patients.Conclusion: Caregivers and families play an integral role in the identification of AD dementia patients, with memory problems being common first symptoms noticed by caregivers that led to a diagnosis of AD dementia. These results provide novel insight into the detection, diagnosis, and treatment of AD dementia in Japan and how these factors differ across the spectrum of disease severity. Keywords: Alzheimer’s disease dementia, Japan, disease history, caregivers, treatment pattern

Hideyuki Imagawa,1 Saurabh P Nagar,2 William Montgomery,3 Tomomi Nakamura,1 Masayo Sato,1 Keith L Davis2 1Medical Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 2RTI Health Solutions, Research Triangle Park, NC, USA; 3Global Patient Outcomes and Real World Evidence, Eli Lilly Australia, NSW, Australia Objective: To describe the characteristics and medication treatment patterns of adult patients with attention-deficit/hyperactivity disorder (ADHD) prescribed atomoxetine in Japan. Materials and methods: A retrospective analysis of insurance claims data was conducted using the Japan Medical Data Center database. Adults (≥18 years) with ADHD who had ≥1 atomoxetine claim from January 1, 2013 to December 31, 2014, and ≥180 to ≤900 days of follow-up were included. First atomoxetine claim defined the index date. Patient characteristics included age, gender, and comorbid conditions. Treatment patterns assessed included rates of atomoxetine discontinuation, switching, persistence, adherence (assessed via the medication possession ratio), and use of concomitant medications. Results: A total of 457 adults met all the inclusion criteria. Mean (SD) age was 32.7 (10.4) years, and 61.0% of patients were male. Nearly 72.0% of the patients had at least one comorbid mental health condition in the baseline period; depression (43.8%) and insomnia (40.7%) were the most common mental health comorbidities. Most common physical comorbidities were chronic obstructive pulmonary disease (14.4%) and diabetes (12.9%). Non-ADHD-specific psychotropics were prescribed to 59.7% of patients during the baseline period and to 65.9% during the follow-up period; 6.6% were prescribed non-ADHD-specific psychotropics concomitantly with atomoxetine. Overall, 40.0% of adults discontinued atomoxetine during the entire follow-up period and 65.9% were persistent with atomoxetine therapy at 3 months post-index date. Mean (SD) atomoxetine medication possession ratio was 0.57 (0.25), and 25.4% switched to an alternative ADHD therapy; methylphenidate (22.4%) and non-ADHD-specific psychotropics (77.6%) were the most common medication alternatives. Nearly 8% augmented atomoxetine with methylphenidates, non-stimulants, or non-ADHD-specific psychotropics. Conclusion: In this observational study, a majority of adults with ADHD treated with atomoxetine were still persistent with therapy at 3 months post-index date, with one quarter switching to alternative ADHD therapy. High proportions of mental health comorbidities, along with high use of non-ADHD-specific psychotropic medications in both the baseline and follow-up periods, were observed among patients with ADHD prescribed atomoxetine. Keywords: ADHD, atomoxetine, treatment patterns, Japan, comorbidity, claims database, adherence, persistence

William Montgomery,1 Kaname Ueda,2 Margaret Jorgensen,3 Shari Stathis,3 Yuanyuan Cheng,3 Tomomi Nakamura2 1Global Patient Outcomes & Real World Evidence, Eli Lilly Australia, Sydney, NSW, Australia; 2Medical Development Unit-Japan, Eli Lilly Japan KK, Kobe, Japan; 3Health Technology Analysts, Lilyfield, NSW, Australia Abstract: The burden of dementia in Japan is large and growing. With the world’s fastest aging population, it is estimated that one in five elderly people will be living with dementia in Japan by 2025. The most common form of dementia is Alzheimer’s disease (AD), accounting for around two-thirds of dementia cases. A systematic review was conducted to examine the epidemiology and associated burden of AD in Japan and to identify how AD is diagnosed and managed in Japan. English and Japanese language databases were searched for articles published between January 2000 and November 2015. Relevant Japanese sources, clinical practice guideline registers, and reference lists were also searched. Systematic reviews and cohort and case–control studies were eligible for inclusion, with a total of 60 studies included. The most recent national survey conducted in six regions of Japan reported the mean prevalence of dementia in people aged ≥65 years to be 15.75% (95% CI: 12.4, 22.2%), which is much higher than the previous estimated rate of 10% in 2010. AD was confirmed as the predominant type of dementia, accounting for 65.8% of all cases. Advancing age and low education were the most consistently reported risk factors for AD dementia. Japanese guidelines for the management of dementia were released in 2010 providing specific guidance for AD about clinical signs, image findings, biochemical markers, and treatment approaches. Pharmacotherapies and non-pharmacotherapies to relieve cognitive symptoms were introduced, as were recommendations to achieve better patient care. No studies reporting treatment patterns were identified. Due to population aging and growing awareness of AD in Japan, health care expenditure and associated burden are expected to soar. This review highlights the importance of early detection, diagnosis, and treatment of AD as strategies to minimize the impact of AD on society in Japan. Keywords: dementia, risk factors, treatment patterns, systematic review

Purpose: Staphylococcus aureus is a leading cause of bacteremia with a 30-day mortality of 20%. This study evaluated outcomes after implementation of a pharmacist-driven Staphylococcus aureus bacteremia (SAB) initiative in a community hospital. Methods: This retrospective cohort analysis compared patients admitted with SAB between May 2015 and April 2018 (intervention group) to those admitted between May 2012 and April 2015 (historical control group). Pharmacists were notified of and responded to blood cultures positive for Staphylococcus aureus by contacting provider(s) with a bundle of recommendations. Components of the SAB bundle included prompt source control, selection of appropriate intravenous antibiotics, appropriate duration of therapy, repeat blood cultures, echocardiography, and infectious diseases consult. Demographics (age, gender, and race) were collected at baseline. Primary outcome was in-hospital mortality. Compliance with bundle components was also assessed. Results: Eighty-three patients in the control group and 110 patients in the intervention group were included in this study. Demographics were similar at baseline. In-hospital mortality was lower in the intervention group (3.6% vs. 15.7%; p = 0.0033). Bundle compliance was greater in the intervention group (69.1% vs. 39.8%; p < 0.0001). Conclusions: We observed a significant reduction in in-hospital mortality and increased treatment bundle compliance in the intervention cohort with implementation of a pharmacist-driven SAB initiative. Pharmacists’ participation in the care of SAB patients in the form of recommending adherence to treatment bundle components drastically improved clinical outcomes. Widespread adoption and implementation of similar practice models at other institutions may reduce in-hospital mortality for this relatively common and life-threatening infection.

In the early 1990s, oxygenated gasoline was hailed as a partial solution to the nation’s air quality problems. Although the large-scale use of methyl tertiary butyl ether (MTBE) as a gasoline oxygenate successfully improved air quality, it adversely impacted water quality and dramatically exposed leaking underground storage tanks. However, removing MTBE from gasoline could impose significant societal costs—in terms of both gasoline production costs and prices and possible air and water quality impacts. The analysis conducted for this report is based on a comprehensive and internally consistent cost-benefit framework and includes several cost categories largely neglected in prior MTBE analyses, including: (1) the cost to taxpayers of increased ethanol consumption; (2) increases in the cost of oil imports; (3) the effects of changes in gasoline prices on gasoline consumption and thus on automobile emissions; and (4) the potential effect of MTBE substitutes on water quality.

A careful analysis of the costs and benefits of using MTBE as a fuel oxygenate, as compared to use of its most reasonable substitutes, finds that the net private and social costs of MTBE' s alternatives are substantially higher than those of MTBE. The expected costs of future MTBE use have been revised downwards as a result of the state of California's successful program to replace and monitor underground fuel storage tanks, as well as more complete estimates of the incremental clean up costs from MTBE contamination. Moreover, as California has begun to seriously consider the logistics and costs of removing MTBE from gasoline, it has become clear that the cost of MTBE alternatives is higher than previously anticipated. In light of the information that has come to light since California's 1999 decision to phase out MTBE use by 2003, that decision may merit revisiting.

Diego Novick,1 William Montgomery,2 Ellen Vorstenbosch,3 Maria Victoria Moneta,3 Héctor Dueñas,4 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly de Mexico, Mexico City, Mexico Abstract: Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression. Keywords: remission, functional impairment, clinical remission, course of illness, disability, predictors

William Montgomery,1 Masayo Sato,2 Yasuo Nagasaka,2 Jeffrey Vietri3 1Global Patient Outcomes & Real World Evidence, Eli Lilly Australia Pty Ltd., West Ryde, Australia; 2Medical Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 3Kantar Health, Horsham, PA, USA Background: Few data are available that provide estimates of the economic impact of chronic lower back pain (CLBP) in Japan. The current study estimated the patient burden and the direct and indirect medical costs associated with CLBP in Japan using data from a large cross-sectional patient survey. CLBP was hypothesized to be associated with a considerable burden of illness and a large economic impact.Methods: Study participants completed the Japan National Health and Wellness Survey in 2014, which included measures of health-related quality of life (HRQoL), work impairment, impairment to daily activities, and healthcare service use. Data from those reporting CLBP (N=392) were contrasted against those from matched controls without back pain, using age and sex-adjusted models.Results: CLBP patients reported significantly lower HRQoL relative to matched controls. Age- and sex-adjusted models estimated mean annual per patient direct and indirect costs attributable to CLBP to be ¥1,820,297 ($15,239 or €12,551) and ¥1,479,899 ($12,389 or €10,203), respectively, with the majority of direct costs related to hospital expenses (¥1,584,759, which is equivalent to $13,267 and €10,927). In estimating the economic impact of CLBP on society, the CLBP respondents were estimated to include 1,508,524 individuals when extrapolated to the Japanese population (815,461 of them employed). Ultimately, this represented approximately ¥1.2 trillion ($10 billion and €8.3 billion) per year in lost productivity at the time of this study.Conclusion: This study of patients with CLBP in Japan has shown it to be associated with a significant burden on patients and to have a considerable negative impact on the Japanese economy primarily driven by lost productivity. Further research on the effectiveness of interventions to improve the outcomes of those with CLBP is warranted. Keywords: indirect costs, direct costs, work impairment, healthcare resource use, quality of life

Diego Novick,1 William Montgomery,2 Tamas Treuer,3 Ai Koyanagi,4 Jaume Aguado,4 Susanne Kraemer,5 Josep Maria Haro4 1Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly and Company, Windlesham, Surrey, UK; 2Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly Australia Pty Ltd, West Ryde, Australia; 3Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly and Company, Budapest, Hungary; 4Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 5Medical Department, Eli Lilly and Company, Bad Homburg, Germany Purpose: Medication nonadherence is common in the treatment of patients with severe mental illness and is a frequent cause of relapse. Different formulations have been developed in an effort to improve medication adherence. The aim of this study was to explore whether there are differential clinical outcomes between two different formulations of olanzapine (orodispersible tablets [ODTs] vs standard oral tablets [SOT]) for the treatment of nonadherent patients with schizophrenia or bipolar disorder.Methods: Data for this analysis were from an observational study conducted in Europe (N=903). Adult schizophrenia and bipolar disorder patients in outpatient settings who initiated or changed to either olanzapine ODT or SOT according to physician decision within the last 45 days were eligible for enrollment. The follow-up period was 1 year. Of the 903 participants, 266 nonadherent patients (Medication Adherence Rating Scale score 0–4 at baseline) were included in the analysis. Clinical outcomes of interest were: 1) hospitalization and 2) relapse identified by the participating psychiatrist or hospitalization. An adjusted logistic regression model was fitted.Results: Patients taking ODT had more severe illness at baseline (P

Diego Novick,1 William Montgomery,2 Tamas Treuer,3 Maria Victoria Moneta,4 Josep Maria Haro4 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Eli Lilly and Company, Neuroscience Research, Budapest, Hungary; 4Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain Abstract: This study explores sex differences in the outcomes of patients with schizophrenia (clinical/functional remission and recovery) across diverse regions of the world (Northern Europe, Southern Europe, Central and Eastern Europe, Latin America, East Asia, and North Africa and the Middle East). Data (n=16,380 for this post hoc analysis) were taken from the World-Schizophrenia Health Outcomes Study. In most regions, females had a later age at first service contact for schizophrenia, a lower level of overall/negative symptom severity, lower rates of alcohol/substance abuse and paid employment, and higher percentages of having a spouse/partner and independent living. Overall, females had slightly higher rates of clinical remission (58.0% vs 51.8%), functional remission (22.8% vs 16.0%), and recovery (16.5% vs 16.0%) at 36 months (P

Yen-Ni Hung,1 Zbigniew Kadziola,2 Alan JM Brnabic,3 Ju-Fen Yeh,4 Jong-Ling Fuh,5,6 Jen-Ping Hwang,7,8 William Montgomery,9 1School of Gerontology Health Management and Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan, Republic of China; 2Real World Analytics, Eli Lilly GmbH, Vienna, Austria; 3Real World Analytics, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 4Department of Medicine, Eli Lilly and Company, Taiwan, Republic of China; 5Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, 6Faculty of Medicine, School of Medicine, National Yang Ming University, 7Department of Psychiatry, Taipei Veterans General Hospital, 8Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan, Republic of China; 9Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia Purpose: The objectives of this study were to estimate the incidence, cumulative incidence, and economic burden of Alzheimer’s disease (AD) in Taiwan, using data from the National Health Insurance Research Database (NHIRD).Materials and methods: This was a retrospective, longitudinal, observational study using data from the Longitudinal Health Insurance Database of the NHIRD. Patients were included in this study if they were 50 years of age or older and their records included a primary or secondary diagnosis of AD. New patients who met inclusion criteria were followed up longitudinally from 2005 to 2010. Costs were calculated for the first year following the diagnosis of AD.Results: Overall, a higher percentage of women than men were diagnosed with AD (54% vs 46%, respectively). The first AD diagnosis occurred most frequently in the age of 75–84 years. The person-year incidence rate increased from 5.63/1,000 persons (95% CI, 5.32–5.94) in 2005 to 8.17/1,000 persons (95% CI, 7.78–8.57) in 2010. The cumulative incidence rate was 33.54/1,000 persons (95% CI, 32.76–34.33) in 2005–2010. The total mean inflated annual costs per patient in new Taiwan dollars (NT$) in the first year of diagnosis ranged from NT$205,413 (2009) to NT$227,110 (2005), with hospitalization representing the largest component.Conclusion: AD represents a substantial burden in Taiwan, and based on the observed increase in incidence rate over time, it is likely that this burden will continue to increase. The findings reported here are consistent with previous research. The NHIRD contains extensive real-world information that can be used to conduct research, allowing us to expand our understanding of the incidence, prevalence, and burden of disease in Taiwan. Keywords: Alzheimer’s disease, incidence, medical costs, resource utilization

William Montgomery,1 Jeffrey Vietri,2 Jing Shi,3 Kei Ogawa,4 Sawako Kariyasu,4 Levent Alev,4 Masaya Nakamura5 1Eli Lilly Australia Pty Ltd., Sydney, NSW, Australia; 2Health Outcomes Practice, Kantar Health, Horsham, PA, 3Health Outcomes Practice, Kantar Health, Princeton, NJ, USA; 4Eli Lilly Japan K.K., Kobe, Japan; 5Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan Objective: The aim of this study was to quantify the impact of pain severity on patient-reported outcomes among individuals diagnosed with chronic low back pain in Japan. Methods: Data were provided by the 2012 Japan National Health and Wellness Survey (N=29,997), a web-based survey of individuals in Japan aged ≥18 years. This analysis included respondents diagnosed with low back pain of ≥3-month duration. Measures included the revised Medical Outcomes Study 36-Item Short-Form Survey Instrument, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Work Productivity and Activity Impairment: General Health questionnaire, and self-reported all-cause health care visits (6 months). Generalized linear models were used to assess the relationship between outcomes and severity of pain in the past week as reported on a numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine), controlling for length of diagnosis, sociodemographics, and general health characteristics. Results: A total of 290 respondents were included in the analysis; mean age was 56 years, 41% were females, and 56% were employed. Pain severity was 3/10 for the first quartile, 5/10 for the median, and 7/10 for the third quartile of this sample. Increasing severity was associated with lower scores for mental and physical component summaries and Short-Form 6D health utility, higher depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores, greater absenteeism and presenteeism, greater activity impairment, and more health care provider visits (all P

Tamás Treuer,1 Luis Méndez,2 William Montgomery,3 Shenghu Wu4 1Neuroscience Research, Eli Lilly and Company, Budapest, Hungary; 2Eli Lilly de Mexico, Mexico City, Mexico; 3Global Patient Outcomes and Real World Evidence, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 4Neuroscience Research, Eli Lilly Asia, Inc, Shanghai, People’s Republic of China Abstract: The purpose of this paper was to systematically review the literature related to research about the factors affecting treatment adherence and discontinuation of atomoxetine in pediatric, adolescent, and adult patients with attention-deficit/hyperactivity disorder (ADHD). Medline was systematically searched using the following prespecified terms: “ADHD”, “Adherence”, “Compliance”, “Discontinuation”, and “Atomoxetine”. We identified 31 articles that met all inclusion and exclusion criteria. The findings from this review indicate that persistence and adherence to atomoxetine treatment were generally high. Factors found to influence adherence and nonadherence to atomoxetine treatment in ADHD in this review include age, sex, the definition of response used, length of treatment, initial dose of treatment, comorbid conditions, and reimbursement. Tolerability was cited as an important reason for treatment discontinuation. More research is needed to understand those factors that can help to identify patients at risk for poor adherence and interventions that could improve treatment adherence early in the stage of this illness to secure a better long-term prognosis. Keywords: atomoxetine, treatment discontinuation, adherence, compliance, ADHD medication, relapse

Diego Novick,1 William Montgomery,2 Jaume Aguado,3 Xiaomei Peng,4 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly and Company, Indianapolis, IN, USA Objective: To investigate the impact of anxiety symptoms on depression outcomes in Asian patients with major depressive disorder (MDD) (n=714). Methods: The 17-item Hamilton Depression Scale (HAMD-17), overall severity, somatic symptoms, and quality of life (QOL) (EuroQOL Questionnaire-5 Dimensions [EQ-5D]) were assessed at baseline and 3 months. Anxiety was measured using items 10 and 11 from the HAMD-17. Linear, tobit, and logistic multiple regression models analyzed the impact of anxiety symptoms on outcomes. Baseline anxiety was related to age and the presence of pain symptoms at baseline. Results: Regression models showed that a higher level of anxiety was associated with a lower frequency of remission and lower QOL at 3 months. Patients with lower baseline anxiety symptoms had higher remission rates (odds ratio for each point of anxiety symptoms, 0.829 [95% confidence interval [CI]: 0.723–0.951]). Patients with higher levels of baseline anxiety had a lower QOL at 3 months (a decrease in EQ-5D tariff score for each point of anxiety symptoms, 0.023 [95% CI: 0.045–0.001]). Conclusion: In conclusion, the presence of anxiety symptoms negatively impacts the outcomes of depression. Keywords: depression, anxiety, Asia, observational, outcomes

Ling Zhang,1–4 Yun Chen,5 Li Yue,5 Qingjing Liu,6 William Montgomery,7 Lihua Zhi,5 Wanqi Wang51Mood Disorders Center, Beijing Anding Hospital, Capital Medical University, 2China Clinical Research Center for Mental Disorders, 3China Center of Depression, Beijing Institute for Brain Disorders, 4Department of Psychiatry, Capital Medical University, Beijing, 5Medical Department, Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, 6Pharmacoeconomics and Outcomes Research, Beijing Brainpower Pharma Consulting Co, Ltd, Beijing, People’s Republic of China; 7Medical Department, Eli Lilly Australia Pty, Ltd, Sydney, NSW, AustraliaObjective: The objective of the study was to investigate medication usage patterns, health care resource utilization, and direct medical costs of patients with major depressive disorder (MDD) in Beijing, People’s Republic of China.Methods: Data were extracted from a random sample of the Beijing Urban Employee Basic Medical Insurance database. Patients aged ≥18 years, with ≥1 primary diagnosis of MDD and 12-month continuous enrollment after their first observed MDD diagnosis between 2012 and 2013 were identified. Those with a diagnosis of schizophrenia, bipolar disorder, or cancer during the analysis period were excluded.Results: In total 8,484 patients, with mean age of 57.2 years, were included and 63% were female. The top three commonly observed comorbidities were hypertension (70.9%), anxiety disorder (68.6%), and coronary heart disease (65.1%). Furthermore, 71.4% of patients were treated with antidepressant medications, including 60.5% of patients treated with selective serotonin reuptake inhibitors, followed by noradrenergic and specific serotonergic antidepressants (9.0%) and serotonin–norepinephrine reuptake inhibitors (8.3%). The proportions of patients who discontinued their initial antidepressant within the first and second months after the index date were 45.4% and 77.0%, respectively. Concomitant medications were prescribed for 76.8% of patients. Only 0.42% of patients experienced ≥1 MDD-related hospitalization(s) during the 1-year follow-up, and the average annual number of hospitalization was 1.2 for those hospitalized. The mean length of stay was 33.4 days per hospitalization. All patients had ≥1 MDD-related outpatient visit(s). The mean annual number of outpatient visits per patient was 3.1. The mean annual direct medical costs per patient with MDD was RMB ¥1,694.1 (48.5% for antidepressant medications), and that for hospitalized patients was RMB ¥21,291.0 (15.0% for antidepressant medications).Conclusion: In Beijing, the majority of patients with MDD were treated in the outpatient setting only and they received antidepressants. Selective serotonin reuptake inhibitors were the most commonly used antidepressants. However, the duration to antidepressant medication was short, and persistence was low. The economic burden of MDD-related hospitalization was considerable.Keywords: depression, People’s Republic of China, antidepressants, health care resource, persistence

Diego Novick,1 William Montgomery,2 Josep Maria Haro,3 Maria Victoria Moneta,3 Gang Zhu,4 Li Yue,5 Jihyung Hong,6 Héctor Dueñas,7 Roberto Brugnoli8 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Department of Psychiatry, The First Affiliated Hospital of China Medical University, Shenyang, 5Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People’s Republic of China; 6Department of Healthcare Management, Gachon University, Seongnam, South Korea; 7Eli Lilly de Mexico, Mexico City, Mexico; 8School of Medicine, Sapienza University of Rome, Rome, ItalyPurpose: To assess and compare the levels of functioning in patients with major depressive disorder treated with either duloxetine with a daily dose of ≤60 mg or a selective serotonin reuptake inhibitor (SSRI) as monotherapy for up to 6 months in a naturalistic setting in East Asia. In addition, this study examined the impact of painful physical symptoms (PPS) on the effects of these treatments.Patients and methods: Data for this post hoc analysis were taken from a 6-month prospective observational study involving 1,549 patients with major depressive disorder without sexual dysfunction. The present analysis focused on a subgroup of patients from East Asia (n=587). Functioning was measured using the Sheehan Disability Scale (SDS). Depression severity was assessed using the 16-item Quick Inventory of Depressive Symptomatology-Self Report. PPS were rated using the modified Somatic Symptom Inventory. A mixed model with repeated measures was fitted to compare the levels of functioning between duloxetine-treated (n=227) and SSRI-treated (n=225) patients, adjusting for baseline patient characteristics.Results: The mean SDS total score was similar between the two treatment cohorts (15.46 [standard deviation =6.11] in the duloxetine cohort and 16.36 [standard deviation =6.53] in the SSRI cohort, P=0.077) at baseline. Both descriptive and regression analyses confirmed improvement in functioning in both groups during follow-up, but duloxetine-treated patients achieved better functioning. At 24 weeks, the estimated mean SDS total score was 4.48 (standard error =0.80) in the duloxetine cohort, which was statistically significantly lower (ie, better functioning) than that of 6.76 (standard error =0.77) in the SSRI cohort (P

Jihyung Hong,1 Diego Novick,1 William Montgomery,2 Maria Victoria Moneta,3 Héctor Dueñas,4 Xiaomei Peng,5 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, Sydney, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly de Mexico, Mexico City, Mexico; 5Eli Lilly and Company, Indianapolis, IN, USA Purpose: To assess the levels of quality of life (QoL) in major depressive disorder (MDD) patients treated with either duloxetine or a selective serotonin reuptake inhibitor (SSRI) as monotherapy for up to 6 months in a naturalistic clinical setting mostly in the Middle East, East Asia, and Mexico.Patients and methods: Data for this post hoc analysis were taken from a 6-month prospective observational study involving 1,549 MDD patients without sexual dysfunction. QoL was measured using the EQ-5D instrument. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16), while pain severity was measured using the pain items of the Somatic Symptom Inventory. Regression analyses were performed to compare the levels of QoL between duloxetine-treated (n=556) and SSRI-treated (n=776) patients, adjusting for baseline patient characteristics.Results: These MDD patients, on average, had moderately impaired QoL at baseline, and the level of QoL impairment was similar between the duloxetine and SSRI groups (EQ-5D score of 0.46 [SD =0.32] in the former and 0.47 [SD =0.33] in the latter, P=0.066). Both descriptive and regression analyses confirmed QoL improvements in both groups during follow-up, but duloxetine-treated patients achieved higher QoL. At 24 weeks, the estimated mean EQ-5D score was 0.90 in the duloxetine cohort, which was statistically significantly higher than that of 0.83 in the SSRI cohort (P

Kei Ogawa,1 Shinji Fujikoshi,2 William Montgomery,3 Levent Alev1 1Medical Science, 2Statistical Science, Eli Lilly Japan K.K., Kobe, Japan; 3Global Patient Outcomes and Real World Evidence, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia Objective: We assessed whether quality of life (QoL) improvement in duloxetine-treated patients with diabetic peripheral neuropathic pain (DPNP) correlates with the extent of pain relief.Methods: Pooled data from three multicountry, double-blind, 12-week, placebo-controlled trials of duloxetine-treated (duloxetine 60 mg once daily; total number =335) patients with DPNP were analyzed. Based on improvement in 24-hour average pain scores, patients were stratified into four groups. Improvement in QoL, which was measured as the change from baseline in two patient-reported health outcome measures (Short Form [SF]-36 and five-dimension version of the EuroQol Questionnaire [EQ-5D]), was evaluated and compared among the four groups. Pearson’s correlation coefficient was calculated to assess the correlation between improvement in pain scores and improvement in QoL.Results: The group with more pain improvement generally showed greater mean change from baseline in all of the SF-36 scale scores and on the EQ-5D index. Pearson’s correlation coefficients ranged from 0.114 to 0.401 for the SF-36 scale scores (P

Jing Wu,1 Xiaoning He,1 Li Liu,2 Wenyu Ye,2 William Montgomery,3 Haibo Xue,2 Jeffery S McCombs41School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, People’s Republic of China; 2Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People’s Republic of China; 3Eli Lilly and Company, Sydney, Australia; 4Departments of Clinical Pharmacy and Pharmaceutical Economics and Policy, School of Pharmacy, University of Southern California, Los Angeles, CA, USAObjective: Information concerning the treatment costs of schizophrenia is scarce in People’s Republic of China. The aims of this study were to quantify health care resource utilization and to estimate the direct medical costs for patients with schizophrenia in Tianjin, People’s Republic of China.Methods: Data were obtained from the Tianjin Urban Employee Basic Medical Insurance (UEBMI) database. Adult patients with ≥1 diagnosis of schizophrenia and 12-month continuous enrollment after the first schizophrenia diagnosis between 2008 and 2009 were included. Both schizophrenia-related, psychiatric-related, and all-cause related resource utilization and direct medical costs were estimated.Results: A total of 2,125 patients were included with a mean age of 52.3 years, and 50.7% of the patients were female. The annual mean all-cause costs were $2,863 per patient with psychiatric-related and schizophrenia-related costs accounting for 84.1% and 62.0% respectively. The schizophrenia-related costs for hospitalized patients were eleven times greater than that of patients who were not hospitalized. For schizophrenia-related health services, 60.8% of patients experienced at least one hospitalization with a mean (median) length of stay of 112.1 (71) days and a mean cost of $1,904 per admission; 59.0% of patients experienced at least one outpatient visit with a mean (median) number of visits of 6.2 (4) and a mean cost of $42 per visit during the 12-month follow-up period. Non-medication treatment costs were the most important element (45.7%) of schizophrenia-related costs, followed by laboratory and diagnostic costs (19.9%), medication costs (15.4%), and bed fees (13.3%).Conclusion: The costs related to the treatment of patients with schizophrenia were considerable in Tianjin, People’s Republic of China, driven mainly by schizophrenia-related hospitalizations. Efforts focusing on community-based treatment programs and appropriate choice of drug treatment have the potential to reduce the use of inpatient services and may lead to better clinical and economic outcomes in the management of patients with schizophrenia in People’s Republic of China.Keywords: schizophrenia, health care resource use, direct medical costs, People’s Republic of China

Jeffrey Vietri,1 Tempei Otsubo,2 William Montgomery,3 Toshinaga Tsuji,4 Eiji Harada5 1Health Outcomes Practice, Kantar Health, Milan, Italy; 2Tokyo Shinjuku Medical Center, Tokyo, Japan; 3Eli Lilly Australia Pty Ltd., West Ryde, Australia; 4Medical Affairs, Shionogi & Co., Ltd., Osaka, Japan; 5Eli Lilly Japan KK, Kobe, Japan Background: Depression is often associated with painful physical symptoms. Previous research has seldom assessed the relationship between the severity of physical symptoms and the severity of mental and emotional symptoms of depression or other health outcomes, and no such studies have been conducted previously among individuals with depression in Japan. The aim of this study was to assess the relationship between the severity of physical pain and depression and other outcomes among individuals in Japan diagnosed with depression.Methods: Data for individuals aged 18 and older in Japan who reported being diagnosed with depression and also reported physical pain were obtained from the Japan National Health and Wellness Survey. These respondents were characterized on sociodemographics and health characteristics, and the relationship between ratings of severity on pain in the last week and health outcomes were assessed using bivariate correlations and generalized linear models. Measures included the Patient Health Questionnaire for depression severity, Medical Outcomes Study 12-Item Short Form Survey Instrument for health-related quality of life, the Work Productivity and Activity Impairment for work and activity impairment, and 6-month report of health care use.Results: More severe physical pain in the past week was correlated with more severe depression, worse health-related quality of life, lower health utility, greater impairment at work, and more health care provider visits. These relationships remained significant after incorporating sociodemographics and health characteristics in the statistical models.Conclusion: Individuals whose depression is accompanied by more severe physical pain have a higher burden of illness than those whose depression includes less severe pain, suggesting that even partially ameliorating painful physical symptoms may significantly benefit patients with depression. Clinicians should take the presence and severity of physical pain into account and consider treating both the physical and emotional symptoms of these patients. Keywords: painful physical symptoms, quality of life, work impairment, health care use

Diego Novick,1 William Montgomery,2 Victoria Moneta,3 Xiaomei Peng,4 Roberto Brugnoli,5 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, Australia; 3Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly and Company, Indianapolis, IN, USA; 5Department of Neuroscience, School of Medicine, Sapienza University of Rome, Rome, Italy Purpose: To describe pharmacological treatment patterns in Asian patients with major depressive disorder (MDD), including duration of treatment, reasons for medication discontinuation, rate of medication nonadherence, factors associated with medication nonadherence, and impact of medication nonadherence on depression outcomes.Patients and methods: Data were from a prospective, observational 3-month study of East Asian MDD inpatients from 40 sites in six East Asian countries who initiated antidepressant treatment at baseline (n=569). Assessments included the Clinical Global Impression-Severity scale (CGI-S), 17-item Hamilton Depression Rating Scale (HAMD-17), painful physical symptoms, response and remission, employment status, quality of life (QoL) (EuroQOL Questionnaire-5 Dimensions [EQ-5D]) and health state using the visual analog scale, adherence by clinician opinion, and patient self-report. Cox proportional hazards modeling, Kaplan–Meier survival analysis, and regression modeling were employed.Results: Median time to discontinuation for any reason was 70 days (95% confidence interval: 47; 95). Reasons for discontinuation were inadequate response in 64.1%, nonadherence in 6.2%, and adverse events in 4.1%; 25.6% who discontinued experienced an adequate response to treatment. In those patients who had an adequate response, age and country were significantly associated with time to medication discontinuation. Patient-reported nonadherence was 57.5% and clinician-reported nonadherence was 14.6% (62/426). At 3 months, nonadherent patients had significantly higher disease severity (CGI-S, P=0.0001; HAMD-17, P

Diego Novick,1 Jihyung Hong,1 William Montgomery,2 Héctor Dueñas,3 Magdy Gado,4 Josep Maria Haro5 1Eli Lilly and Company, Windlesham, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, Australia; 3Eli Lilly de Mexico, Mexico City, Mexico; 4Eli Lilly and Company, Riyadh, Saudi Arabia; 5Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain Background: This study examined potential predictors of remission among patients treated for major depressive disorder (MDD) in a naturalistic clinical setting, mostly in the Middle East, East Asia, and Mexico. Methods: Data for this post hoc analysis were taken from a 6-month prospective, noninterventional, observational study that involved 1,549 MDD patients without sexual dysfunction at baseline in 12 countries worldwide. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Depression-related pain was measured using the pain-related items of the Somatic Symptom Inventory. Remission was defined as a QIDS-SR16 score ≤5. Generalized estimating equation regression models were used to examine baseline factors associated with remission during follow-up. Results: Being from East Asia (odds ratio [OR] 0.48 versus Mexico; P

William Montgomery,1 Zbigniew Kadziola,2 Wenye Ye,3 Hai Bo Xue,4 Li Liu,4 Tamás Treuer5 1Global Patient Outcomes and Real World Evidence, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 2Real World Analytics Capabilities, Eli Lilly GmbH, Vienna, Austria; 3Real World Analytics, Eli Lilly and Company, Indianapolis, IN, USA; 4Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People’s Republic of China; 5Neuroscience Research, Eli Lilly and Company, Budapest, HungaryPurpose: The aim of this study was to investigate the correlation between changes in symptoms and changes in self-reported quality of life among Chinese patients with schizophrenia who were switched from a typical antipsychotic to olanzapine during usual outpatient care. Patients and methods: This post hoc analysis was conducted using data from the Chinese subgroup (n=475) of a multicountry, 12-month, prospective, noninterventional, observational study. The primary publication previously reported the efficacy, safety, and quality of life among patients who switched from a typical antipsychotic to olanzapine. Patients with schizophrenia were included if their symptoms were inadequately controlled with a typical antipsychotic and they were switched to olanzapine. Symptom severity was measured using the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity scale (CGI-S). Health-Related Quality of Life (HRQOL) was assessed using the World Health Organization Quality of Life–Abbreviated (WHOQOL-BREF). Paired t-tests were performed to assess changes from baseline to endpoint. Pearson’s correlation coefficients (r) were used to assess the correlations between change in symptoms (BPRS and CGI-S scores) and change in HRQOL (WHOQOL-BREF scores). Results: Symptoms and HRQOL both improved significantly over the 12 months of treatment (P

Yuanlin Song,1,* Yicheng Yang,2,* Wendong Chen,3,4 Wei Liu,2 Kai Wang,2 Xuehai Li,5 Ke Wang,2 Manny Papadimitropoulos,3,6 William Montgomery7 1Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, 2Lilly Suzhou Pharmaceutical Co, Ltd, Shanghai Branch, Shanghai, People's Republic of China; 3Division of Social and Administrative Pharmacy, Leslie Dan Faculty of Pharmacy, University of Toronto, 4Normin Health, Toronto, ON, Canada; 5VitalStrategic Research Institute, Shanghai, People's Republic of China; 6Global Health Outcomes Research, Eli Lilly, Indianapolis, IN, USA; 7Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia *These authors contributed equally to this work Aims: To evaluate clinical outcomes and allocation of hospital costs associated with empirical use of vancomycin or linezolid for hospital-acquired pneumonia (HAP) in the People's Republic of China. Methods: Hospital episodes including HAP treated by vancomycin or linezolid between 2008 and 2012 in a Chinese tertiary care hospital were retrospectively identified from hospital administrative databases. Propensity score methods created best-matched pairs for the antibiotics. The matched pairs were used for adjusted comparisons on clinical response and allocation of hospital costs. Multiple regression analyses adjusting residual imbalance after matching were performed to confirm adjusted comparisons. Results: Sixty matched pairs were created. Adjusted comparisons between vancomycin and linezolid showed similar clinical response rates (clinical cure: 30.0% versus 31.7%, respectively; P=0.847; treatment failure: 55.0% versus 45.0%, respectively; P=0.289) but a significantly lower in-hospital mortality rate for vancomycin (3.3% versus 18.3%, respectively; P=0.013). After further adjusting for the imbalanced variables between matched treatment groups, the risks of treatment failure associated with the two antibiotics were comparable (odds ratio: 1.139; P=0.308) and there was a nonsignificant trend of lower risk of in-hospital mortality associated with vancomycin (odds ratio: 0.186; P=0.055). The total hospital costs associated with vancomycin had a nonsignificant trend of being lower, likely because of its significantly lower acquisition costs (median: RMB 2,880 versus RMB 8,194; P

William Montgomery,1 Tamas Treuer,2 Wenyu Ye,3 Hai Bo Xue,4 Sheng Hu Wu,4 Li Liu,4 Zbigniew Kadziola,5 Michael D Stensland,6 Haya Ascher-Svanum7 1Global Health Outcomes Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 2Neuroscience Research, Eli Lilly and Company, Budapest, Hungary; 3Global Statistical Sciences, Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People's Republic of China; 4Medical Department, Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People's Republic of China; 5Global Statistical Sciences, Eli Lilly GmbH, Vienna, Republic of Austria; 6Agile Outcomes Research, Inc., Rochester, MN, USA; 7Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA Objectives: This study examined whether participation in a weight control program (WCP) by patients with schizophrenia treated with olanzapine was also associated with improvements in clinical and functional outcomes. Methods: A post-hoc analysis was conducted using data from the Chinese subgroup (n=330) of a multi-country, 6-month, prospective, observational study of outpatients with schizophrenia who initiated or switched to oral olanzapine. At study entry and monthly visits, participants were assessed with the Clinical Global Impression of Severity, and measures of patient insight, social activities, and work impairment. The primary comparison was between the 153 patients who participated in a WCP at study entry (n=93) or during the study (n=60) and the 177 patients who did not participate in a weight control program (non-WCP). Mixed Models for Repeated Measures with baseline covariates were used to compare outcomes over time. Kaplan–Meier survival analysis was used to assess time to response. Results: Participants had a mean age of 29.0 years and 29.3 years, and 51.0% and 57.6% were female for WCP and non-WCP groups, respectively. Average initiated daily dose for olanzapine was 9.5±5.4 mg. WCP participants gained less weight than non-participants (3.9 kg vs 4.9 kg, P=0.03) and showed statistically significant better clinical and functional outcomes: greater improvement in illness severity (–2.8 vs –2.1, P

Jihyung Hong,1 Diego Novick,1 Tamás Treuer,2 William Montgomery,3 Virginia S Haynes,4 Shenghu Wu,5 Josep Maria Haro61Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly and Company, Neuroscience Research, Budapest, Hungary; 3Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 4Eli Lilly and Company, Indianapolis, IN, US; 5Eli Lilly China, Shanghai, People's Republic of China; 6Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, SpainPurpose: To assess baseline predictors and consequences of medication non-adherence in the treatment of pediatric patients with attention-deficit/hyperactivity disorder (ADHD) from Central Europe and East Asia.Patients and methods: Data for this post-hoc analysis were taken from a 1-year prospective, observational study that included a total of 1,068 newly-diagnosed pediatric patients with ADHD symptoms from Central Europe and East Asia. Medication adherence during the week prior to each visit was assessed by treating physicians using a 5-point Likert scale, and then dichotomized into either adherent or non-adherent. Clinical severity was measured by the Clinical Global Impressions-ADHD-Severity (CGI-ADHD) scale and the Child Symptom Inventory-4 (CSI-4) Checklist. Health-Related Quality of Life (HRQoL) was measured using the Child Health and Illness Profile-Child Edition (CHIP-CE). Regression analyses were used to assess baseline predictors of overall adherence during follow-up, and the impact of time-varying adherence on subsequent outcomes: response (defined as a decrease of at least 1 point in CGI), changes in CGI-ADHD, CSI-4, and the five dimensions of CHIP-CE.Results: Of the 860 patients analyzed, 64.5% (71.6% in Central Europe and 55.5% in East Asia) were rated as adherent and 35.5% as non-adherent during follow-up. Being from East Asia was found to be a strong predictor of non-adherence. In East Asia, a family history of ADHD and parental emotional distress were associated with non-adherence, while having no other children living at home was associated with non-adherence in Central Europe as well as in the overall sample. Non-adherence was associated with poorer response and less improvement on CGI-ADHD and CSI-4, but not on CHIP-CE.Conclusion: Non-adherence to medication is common in the treatment of ADHD, particularly in East Asia. Non-adherence was associated with poorer response and less improvement in clinical severity. A limitation of this study is that medication adherence was assessed by the treating clinician using a single item question.Keywords: ADHD, non-adherence, response, effectiveness, Asia, Central Europe

William Montgomery,1 Li Liu,2 Michael D Stensland,5 Hai Bo Xue,2 Tamas Treuer,4 Haya Ascher-Svanum31Eli Lilly and Company, Sydney, NSW, Australia; 2Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People's Republic of China; 3Eli Lilly and Company, Global Health Outcomes, Indianapolis, IN, USA; 4Eli Lilly and Company, Budapest, Hungary; 5Agile Outcomes Research, Inc, Rochester, MN, USABackground: This article describes the personal, societal, and economic burden attributable to schizophrenia in the People's Republic of China and highlights the potential for effective outpatient treatment to reduce this burden given recent changes in the Chinese health care system. The importance of effective antipsychotic therapy in reducing the burden of schizophrenia is also examined.Methods: Published research on the burden, disability, management, and economic costs of schizophrenia in the People's Republic of China was examined in the context of the larger body of global research. Research written in English or Chinese and published before June 2012 was identified using PubMed, CNKI, and Wanfang Med database searches. The contribution of effective antipsychotic therapy in reducing the risk for relapse and hospitalization and improving patients' functioning is described.Results: Schizophrenia imposes a substantial burden on Chinese society, with indirect costs accounting for the majority of the total cost. Functional impairment is high, leading to lost wages and work impairment. In the People's Republic of China, schizophrenia is the most common diagnosis among hospitalized psychiatric patients. Ongoing changes in the Chinese health care system may reduce some barriers to effective relapse prevention in schizophrenia and potentially reduce hospitalizations. The use of antipsychotics for acute episodes and maintenance treatment has been shown to decrease symptom severity and reduce the risk for relapse and hospitalization. However, discontinuing antipsychotic medication appears common and is a strong predictor of relapse. Cost-effectiveness research in the People's Republic of China is needed to examine the potential gains from improved outpatient antipsychotic treatment.Conclusion: Schizophrenia is a very costly mental illness in terms of personal, economic, and societal burden, both in the People's Republic of China and globally. When treated effectively, patients tend to persist longer with antipsychotic treatment, have fewer costly relapses, and have improved functioning. Further research examining the long-term effects of reducing barriers to effective treatments on the societal burden of schizophrenia in the People's Republic of China is needed.Keywords: People's Republic of China, schizophrenia, relapse, review, health care costs, antipsychotic agents

Diego Novick,1 William Montgomery,2 Zbigniew Kadziola,3 Victoria Moneta,4 Xiaomei Peng,5 Roberto Brugnoli,6 Josep Maria Haro41Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Eli Lilly Austria GmbH, Vienna, Austria; 4Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 5Eli Lilly and Company, Indianapolis, IN, USA; 6Università di Roma, “Sapienza,” Rome, ItalyBackground: Patients with major depressive disorder (MDD) may suffer from concomitant pain symptoms. The aim of this study is to determine whether the presence of painful physical symptoms (PPS) influences quality of life when taking into account baseline depression severity.Methods: Patients with a new or first episode of MDD (n = 909) were enrolled in a 3-month prospective observational study in East Asia. The Hamilton Depression Rating Scale, Clinical Global Impression-Severity score, Somatic Symptom Inventory, and EuroQoL questionnaire-5 Dimensions (EQ-5D) and EQ-Visual Analogue Scale (EQ-VAS) were assessed at baseline and 3 months’ follow-up. The presence of PPS was defined as a mean score of ≥2 on the Somatic Symptom Inventory pain-related items. Regression analyses determined predictors of quality of life at 3 months, adjusting for age, sex, depressive symptoms, overall severity, and quality of life at baseline.Results: PPS were present (PPS+) at baseline in 52% of patients. During the 3-month follow-up, EQ-VAS scores improved from 47.7 (standard deviation [SD] 20.6) to 72.5 (SD 20.4), and EQ-5D improved from 0.48 (SD 0.34) to 0.80 (SD 0.26). At 3 months, mean EQ-VAS was 66.4 (SD 21.2) for baseline PPS+ patients versus 78.5 (SD 17.6) for baseline PPS- patients, and mean EQ-5D was 0.71 (SD 0.29) versus 0.89 (SD 0.18). PPS+ at baseline was a significant predictor of quality of life at 3 months after adjusting for sociodemographic and baseline clinical variables.Conclusion: The presence of painful physical symptoms is associated with less improvement in quality of life in patients receiving treatment for major depression, even when adjusting for depression severity.Keywords: pain, depression, quality of life, treatment, Asia, course