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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.

Introduced non-native mammals can have negative impactsonnative biota and it is important that their ecologies are quantified so that potential impacts can be understood. Red-necked wallabies (Notamacropus rufogriseus (Desmarest, 1817)) became established on the Isle of Man (IOM), an island with UNESCO Biosphere status, following their escape from zoological collections in the mid-1900s. We estimated wallaby circadial activity and population densities using camera trap surveys and random encounter models. Their range in the IOM was derived from public sightings sourced via social media. Wallaby diet and niche breadth were quantified via microscopic examination of faecal material and compared with those of the European hare (Lepus europaeus Pallas, 1778). The mean ([+ or -]SE) population density was 26.4 [+ or -] 6.9 wallabies/[km.sup.2], the mean ([+ or -]SE) population size was 1742 [+ or -] 455 individuals, and the species' range was 282 [km.sup.2], comprising 49% of the island. Wallaby diets were dominated by grasses, sedges, and rushes; niche breadth of wallabies and hares (0.55 and 0.59, respectively) and overlap (0.60) suggest some potential for interspecific competition and (or) synergistic impacts on rare or vulnerable plant species. The IOM wallaby population is understudied and additional research is required to further describe population parameters, potential impacts on species of conservation interest, and direct and indirect economic costs and benefits. Key words: non-native species, population density, diet, activity, macropod, red-necked wallaby, Notamacropus rufogriseus, European hare, Lepus europaeus. Les mammiferes non indigenes introduits peuvent avoir des effets negatifs sur le biote indigene, et il est important de quantifier leur ecologie afin de comprendre ces impacts potentiels. Des wallabys a cou rouge (Notamacropus rufogriseus (Desmarest, 1817)) se sont etablis dans l'ile de Man (IOM), une reserve de biosphere de l'UNESCO, apres s'etre echappes de collections zoologiques au milieu du 20e siecle. Nous avons estime l'activite circadienne et les densites de population des wallabys en utilisant des releves au piege photographique et des modeles de rencontres aleatoires. Leur aire de repartition dans l'IOM a ete etablie a la lumiere de signalements du public obtenus de medias sociaux. Le regime alimentaire et l'etendue de la niche des wallabys ont ete quantifies par l'examen microscopique de matieres fecales et compares a ceux du lievre d'Europe (Lepus europaeus Pallas, 1778). La densite de population moyenne ([+ or -]ET) etait de 26,4 [+ or -] 6,9 wallabys/[km.sup.2], la taille de population moyenne ([+ or -]ET) etait de 1742 [+ or -] 455 individus et l'aire de repartition de l'espece occupait 282 [km.sup.2], soit 49 % de l'ile. Les regimes alimentaires des wallabys etaient domines par des graminees, des carex et des joncs; les etendues de niche des wallabys et des lievres (0,55 et 0,59, respectivement) et leur chevauchement (0,60) indiquent qu'il pourrait y avoir un potentiel de concurrence interspecifique et d'impacts synergiques sur des especes de plantes rares ou vulnerables. La population de wallabys de l'IOM est sous-etudiee, et d'autres travaux sont necessaires pour en decrire plus en detail les parametres demographiques, les impacts potentiels sur les especes d'interet pour la conservation et les couts et avantages economiques directs et indirects. [Traduit par la Redaction] Mots-cles: espece non indigene, densite de population, regime alimentaire, activite, macropode, wallaby a cou rouge, Notamacropus rufogriseus, lievre d'Europe, Lepus europaeus., Introduction Introduced non-native species can have significant negative effects on naive native biota (Parker et al. 1999; Sakai et al. 2001; Rejmanek et al. 2002). Biological invasions (i.e., the incursion [...]

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