Values, challenges, and responses associated with high-priced potential cures: perspectives of diverse stakeholders in South Korea.

BACKGROUND: The emergence of high-priced potential cures has sparked significant health policy discussions in South Korea, where the healthcare system is funded through a single-payer National Health Insurance model. We conducted focus group interviews (FGIs) and accompanying surveys with diverse stakeholders to comprehensively understand related issues and find better solutions to the challenges brought by these technologies. METHODS: From October to November 2022, 11 FGIs were conducted with stakeholders from various sectors, including government payers, policy and clinical experts, civic and patient organisations, and the pharmaceutical industry, involving a total of 25 participants. These qualitative discussions were supplemented by online surveys to effectively capture and synthesise stakeholder perspectives. RESULTS: Affordability was identified as a critical concern by 84% of stakeholders, followed by clinical uncertainty (76%) and limited value for money (72%). Stakeholders expressed a preference for both financial-based controls and outcome-based pricing strategies to mitigate these challenges. Despite the support for outcome-based refunds, payers raised concerns about the feasibility of instalment payment models, whether linked to outcomes or not, due to the specific challenges of the Korean reimbursement system and the potential risk of 'cumulative liabilities' from ongoing payments for previously administered treatments. In addition, the FGIs highlighted the need for clear budgetary limits for drugs with high uncertainties, with mixed opinions on the creation of special silo funds (64.0% agreement). Less than half (48%) endorsed the use of external reference pricing, currently applied to such essential drugs in South Korea. A significant majority (84%), predominantly non-pharma stakeholders, advocated for addressing cost-effectiveness uncertainty through re-assessment once long-term clinical data become available. CONCLUSIONS: This study uncovers a broad agreement among stakeholders on the need for more effective value assessment methodologies for high-priced potential cures, stressing the importance of more robust and comprehensive re-assessment supported by long-term data collection, rather than primarily relying on external reference pricing. Each type of stakeholders exhibited a cautious approach to their specific uncertainties, suggesting that new funding strategies should accommodate these uncertainties with predefined guidelines and agreements prior to the initiation of managed entry agreements.

Public preferences in healthcare resource allocation: A discrete choice experiment in South Korea.

OBJECTIVES: This study aimed to explore the public view on priority-setting criteria for healthcare resource allocation. Specifically, it investigates how the value of a quality-adjusted life year (QALY) varies depending on patient characteristics. METHODS: A discrete choice experiment was conducted using an online sample of the general South Korean population. Respondents were presented with two competing treatment scenarios. The attributes of the scenarios were age at disease onset, life expectancy without treatment, life-years gain with treatment, health-related quality of life (HRQoL) without treatment, and HRQoL gains with treatment. Two hundred choice sets were generated and randomly allocated into 20 blocks. A conditional logit model was used to estimate the factors affecting the respondents' choices. RESULTS: A total of 3,482 respondents completed the survey. The larger the QALY gain, the more likely it was that the scenario would be chosen but with a diminishing marginal value. Respondents prioritized 40-year-old patients over 5-year-olds and 5-year-olds over 70-year-olds and prioritized baseline HRQoL of 40% and 60% over 20%. Patients at the end of life were not preferred to those with a longer life expectancy. CONCLUSION: Overall, respondents preferred health-maximizing options without explicit consideration for end-of-life patients or those with poor health. In addition, they revealed a kinked preference for patient age, prioritizing middle-aged patients over children and older people.

The impact of the COVID-19 pandemic on life expectancy by the level of area deprivation in South Korea.

Objective: Comparative evidence suggests that the impact of COVID-19 on life expectancy has been relatively milder in South Korea. This study aims to examine whether the pandemic has universal or unequal impacts on life expectancy across 250 districts with varying levels of deprivation. Methods: Using mortality data from 2012 to 2021 obtained from the Microdata Integrated Service of Statistics Korea, we calculated life expectancy at birth and age 65 for both sexes, by deprivation quintiles, before and during the pandemic. We summarized life expectancy gaps using the slope of the inequality index (SII) and further decomposed the gaps by the contribution of age and cause of death using Arriaga's method. Results: Both men and women experienced consistent improvements in life expectancy from 2012 to 2019, but the trend was disrupted during 2020 and 2021, primarily driven by older people. While men in more deprived areas were initially hit harder by the pandemic, the life expectancy gap across deprivation quintiles remained relatively constant and persistent across the study period [SII: -2.48 (CI: -2.70 from -2.27) for 2019 and - 2.84 (CI: -3.06 from -2.63) for 2020]. Middle-aged men from the most deprived areas were the most significant contributors to the life expectancy gap, with liver disease, liver cancer, transport accidents, and intentional injuries being the leading causes, both in the pre and during the pandemic. While these contributors remained largely similar before and during the pandemic, the contribution of transport accidents and liver cancer to the male life expectancy gap slightly decreased during the pandemic, while that of ischemic heart disease and pneumonia slightly increased. A similar increase was also observed for the female life expectancy gap. Conclusion: This study found no clear evidence of an increased life expectancy gap during the pandemic in South Korea, unlike in other countries, although access to emergency healthcare services may have been slightly more disturbed in deprived areas. This achievement can provide lessons for other countries. However, the persistent regional gaps in life expectancy observed over the past decade indicate the need for more targeted public health policies to address this issue.

Systematic Review and Quality Assessment of Health Economic Evaluation Studies (2007-2019) Conducted in South Korea.

BACKGROUND: South Korea formally adopted economic evaluation in December 2006 to aid drug reimbursement decision-making. While this policy change is applied only to pharmaceuticals, it has also sparked interest in economic evaluations for non-pharmaceutical interventions and programmes. OBJECTIVE: This study aimed to provide a snapshot of the current practice for published health economic evaluation studies and critically assess the quality of these studies. METHODS: An electronic search was performed on multiple databases (EMBASE, PubMed, NHS Economic Evaluation Database, Scopus, Korean Medical database, Korean studies Information Service System, and Research Information Sharing Service) to identify health economic evaluation studies published between January 2007 and December 2019. The inclusion criteria were peer-reviewed, original health economic evaluations (cost-utility, cost-effectiveness, cost-minimisation, and cost-benefit analyses) published in English or Korean. Two reviewers selected studies for inclusion and extracted data from the included studies. Key characteristics of these studies were descriptively summarised, and study quality was assessed using the Quality of Health Economic Studies (QHES) instrument on a 100-point scale. RESULTS: A total of 162 studies were included in this review (63 for drugs, 51 for non-pharmaceutical treatments/health technologies, and 48 for health programmes). These numbers confirm a significant increase in the number of publications since the policy introduction. However, the quality of these studies remained relatively low, with a mean QHES score of 57.9 (± 16.0). Study quality also varied substantially, with the QHES scores ranging from 15 to 87. The scores were notably lower in studies with non-pharmaceutical interventions and programmes, cost-effectiveness analyses or cost-benefit analyses, retrospective study-based or simple modelling-based analyses, and those locally published. In addition, a considerable proportion of these studies did not state or specify essential components of economic evaluation, such as perspectives (30.2%), time horizons (29.6%), discount rates (34.6%), and sensitivity analyses (24.7%). While the use of local data either fully or partially was relatively higher for unit costs (94.4%) and resource utilisation (90.1%), it was lower for utility weights (47.1%), treatment effects (63.0%), and baseline risks (70.4%). Transferability or generalisability issues were infrequently discussed when relying on foreign sources. In addition, the included studies were often not well structured, making it difficult to assess their quality. CONCLUSION: These findings suggest that there is still much room for improving the quality of health economic evaluation studies conducted in South Korea. Policymakers should critically evaluate available cost-effectiveness evidence, especially for non-pharmaceutical interventions and programmes, when using it for decision-making in South Korea.

Korean Guidelines for Pharmacoeconomic Evaluations: Updates in the Third Version.

The first version of the pharmacoeconomic (PE) guidelines was published in South Korea in 2006. Despite its first revision in 2011, there were still ambiguities in its interpretation. Moreover, methodologies for estimating effectiveness and costs have also evolved since then. Under these circumstances, the Health Insurance Review and Assessment Service published the third version in January 2021. This article reviews the revision process and major changes made in the new edition of the PE guidelines. The revision was processed through reviews of the previous 50 PE submissions, international guidelines, academic literature, and surveys and advisory meetings to obtain stakeholders' opinions. The analysis perspective has changed from a limited societal perspective to a healthcare system perspective. In addition to the drug with the highest market share, drugs used in clinical trials can be selected as comparators under certain conditions. The discount rate decreased from 5% to 4.5%. Furthermore, the revised guidelines provide more detailed and specific instructions for items including non-inferiority margin, extrapolation, utility elicitation, and uncertainty. Treatment switch and co-dependent technology guidelines are newly included; the budget impact analysis guideline is deleted. Through this revision, transparency and consistency of decision-making is expected to improve.

The Korea-United States Air Quality (KORUS-AQ) field study.

The Korea-United States Air Quality (KORUS-AQ) field study was conducted during May-June 2016. The effort was jointly sponsored by the National Institute of Environmental Research of South Korea and the National Aeronautics and Space Administration of the United States. KORUS-AQ offered an unprecedented, multi-perspective view of air quality conditions in South Korea by employing observations from three aircraft, an extensive ground-based network, and three ships along with an array of air quality forecast models. Information gathered during the study is contributing to an improved understanding of the factors controlling air quality in South Korea. The study also provided a valuable test bed for future air quality-observing strategies involving geostationary satellite instruments being launched by both countries to examine air quality throughout the day over Asia and North America. This article presents details on the KORUS-AQ observational assets, study execution, data products, and air quality conditions observed during the study. High-level findings from companion papers in this special issue are also summarized and discussed in relation to the factors controlling fine particle and ozone pollution, current emissions and source apportionment, and expectations for the role of satellite observations in the future. Resulting policy recommendations and advice regarding plans going forward are summarized. These results provide an important update to early feedback previously provided in a Rapid Science Synthesis Report produced for South Korean policy makers in 2017 and form the basis for the Final Science Synthesis Report delivered in 2020.

A Review of Utility Measurement Methods Used in Pharmacoeconomic Submissions to HIRA in South Korea: Methodological Consistency and Areas for Improvement.

Pharmacoeconomic (PE) guidelines, first published in 2006 and later updated in 2011, were developed to guide the preparation and submission of PE data to the Health Insurance Review and Assessment Service (HIRA) for drug reimbursement decision making in South Korea. This study, which was conducted as part of a project for revision of the PE guideline, reviewed utility values used in the PE submissions processed at HIRA during 2014-2018 to identify aspects of the current guidelines that may need to be revisited. A total of 50 PE submissions were processed at HIRA over the 5 years. Of these, 47 submissions that used quality-adjusted life-years as an outcome measure were included in this review. Data were extracted from full copies of the manufacturer's initial submissions and committee documents provided by HIRA. Of the 47 submissions, nearly half (n = 23, 48.9%) used published sources to obtain health state utility values, followed by direct methods using time trade-off (n = 7) or standard gamble (n = 2) and indirect methods with patient-level data using the EQ-5D-3L (n = 4) or the EQ-5D-5L (n = 2). Mapping, using the EQ-5D-3L as a target measure, was also adopted in six submissions, although it was somewhat unfavourably described in the guideline. Notably, 52.2% of the submissions with published sources took utility values from different sources for different health states defined in a single model. In addition, details of utility measurement methods or mapping functions taken from published sources were relatively poorly reported. Moreover, the preferences of the Korean general public, preferred by the guideline, were rarely reflected in the utility values used in submissions relying on published sources (95.7% for foreign values only/mixed) and mapping (66.7%). While most submissions with direct and indirect methods used domestic preference values, the former was occasionally criticised by assessment committees because of health state descriptions. This review highlights a considerable amount of inconsistency in the measurement of utility values used in the PE submissions during 2014-2018, indicating a strong need for methodological standardisation.

Socioeconomic Status and Later-life Mental Health in South Korea.

Objectives: In this study, we examined the potential influence of childhood and adult socioeconomic status (SES) on probable depression, suicide ideation, and self-esteem among men (N = 2938) and women (N = 4319) aged 50 years and older in South Korea. Methods: Our data came from the 2018 Korea Welfare Panel Study. Probable depression was defined as a score ≥16 on the modified Center for Epidemiologic Studies Depression Scale. We assessed suicide ideation with a single item. We assessed self-esteem with the Korean version of the Rosenberg Self-Esteem Scale. Results: The results of multiple regression analyses showed that childhood economic status was rarely associated with mental health. However, current income consistently was associated with all outcomes in both sexes. Unemployment also had important health implications, especially for suicide ideation in men. Notably, the potential influence of income and employment status appeared to outweigh that of education, but not for self-esteem. Conclusions: Childhood economic status, but not adult SES, may have little implication for late-life mental health in present-day South Korea, which has gone through dramatic social and economic changes over the last half century. We discuss the socioeconomic implications of these findings.

Decomposing Income-Related Inequalities in Self-Reported Depression and Self-Rated Health Among Married Immigrants in South Korea.

Health inequalities among immigrant minorities have been under-researched in South Korea. This study, therefore, measured the extent of income-related inequalities in self-reported depression and self-rated health (SRH) among married immigrants in South Korea and decomposed them into sociodemographic determinants using data from the 2015 National Survey of Multicultural Families (n = 15,231). The mean age of this sample was 37.8 years (SD = 10.8) and the mean duration of residence was 10.1 years (SD = 7.4). Eighty-five percent were female, and of these, 86.5% were from low/middle-income countries. Of these married immigrants, 34.6% reported experiences of depressive symptoms in the past year, and 9.5% reported their current health to be poor or very poor (weighted). The results also indicated substantial pro-rich health inequalities with the Erreygers concentration index of -0.1298 for self-reported depression and that of -0.1231 for poor SRH. Socioeconomic positions, reflected in income, subjective social status, and employment status, alongside satisfaction with a spouse, appeared to have much greater contributions to the overall inequality than demographics and type of migration. These findings suggest that social welfare policies and programmes can play important roles in reducing health inequalities that are 'avoidable and unnecessary' among married immigrants in South Korea.

Effects of Ethnic Identity on the Relationship Between Mental Health and Perceived Discrimination Among Ethnic Return Migrants: The Case of Korean Chinese Return-Migrated to South Korea.

This study examined the relationship among mental health, perceived discrimination and ethnic identity among Korean Chinese (Joseonjok) who have return-migrated to South Korea. A survey was conducted with 399 Joseonjok adults (≥ 19 years) residing in the capital city Seoul or nearby. Depression was measured using the (self-report) Center for Epidemiologic Studies Depression Scale-Korean (CES-D-K) version (n = 292, mean age = 42.6, female = 56.5%). Perceived discrimination and ethnic identity were assessed with single-item questions. The mean CES-D-K total score was 9.3 (SD = 8.4) and 20.6% had clinical depression (cut-off score: 16). Perceived discrimination was positively associated with CES-D-K scores (regression coefficient = 2.09, p = 0.04). This association was stronger in those identifying themselves more strongly as 'Korean' than 'Chinese'. Discrimination by 'co-ethnic hosts' can have a greater impact on mental health among those ethnic return migrants with a stronger ethnic identity. More efforts are needed to help them better integrate into South Korean society.

The areas of life dissatisfaction and their relationships to depression at different life stages: findings from a nationally representative survey.

This study examined the areas of life dissatisfaction and their relationships to depression at different life stages in men and women, independently of socio-demographic characteristics in South Korea. Data were taken from the 2016 Korea Welfare Panel Study. Depression was assessed using the 11-items of the Center for Epidemiologic Studies Depression Scale (CES-D) and probable depression was defined as the CES-D-11 score of ≥9. Level of satisfaction was measured in seven different life domains (health, family income, residential environment, family relationship, occupation, social relationship and leisure activities) using a 5-point Likert scale. Dissatisfaction was defined as 'very dissatisfied' and 'dissatisfied'. Respondents were grouped into: young (19-39 years; n = 2,713), middle-aged (40-64; n = 4,864) and older adults (65+; n = 4,669). The mean age of the participants was 56.0 years (SD = 18.6) and 57.1% were female (unweighted). The mean CES-D-11 score was 3.5 (SD = 4.8) and 13.7% (n = 1,675) had probable depression (unweighted). The percentage of domain-specific dissatisfaction was highest in family income (28.7%), followed by health (15.9%), leisure activities (14.9%), occupation (11.6%), residential environment (10.2%), social relationship (3.5%) and family relationship (3.0%) (weighted). These percentages were similar across all age groups, except for health and family income in both sexes. In addition, the association between domain-specific dissatisfaction and probable depression was generally stronger in women than in men across all age groups. Logistic regression results (weighted) showed that dissatisfaction with health and leisure activities were consistently associated with probable depression across almost all age groups in both sexes. In addition, family relationship appeared more important in older women, whereas social relationship appeared more important in older men. Meanwhile, dissatisfaction with family income and occupation did not appear to consistently predict depression above and beyond objective indicators, except for older women. Taken together, these findings would help develop sex- and age-specific policies to tackle depression in South Korea.

Relative importance of the EQ-5D five dimensions among patients with chronic diseases in South Korea - a comparison with the general population preference weights.

BACKGROUND: Who should provide the values of health states in economic evaluations of health technologies has long been the subject of debate. This study examined and compared the relative importance of the EQ-5D five dimensions, using both patient-reported values and general population tariffs, among patients with chronic diseases in South Korea and also assessed the pattern of the discrepancy between patient and general population values by type of chronic diseases. METHODS: Data were taken from the 2013 Korea Health Panel survey. This analysis focused on adult patients with chronic diseases (n = 3216). Patient-reported EQ-5D profiles and visual analogue scale (VAS) values were used to assess the relative importance of the EQ-5D five dimensions among these patients, using a linear regression model. The relative importance of the EQ-5D dimensions was then compared to the EQ-5D tariffs elicited from the general population. The relative magnitude of the discrepancies between patient and general population values was also assessed by type of chronic diseases. RESULTS: Anxiety/depression and pain/discomfort appeared to have the largest impact on the self-rated patient VAS, which fairly contrasted with the general population model. In addition, a further regression analysis showed that the discrepancy between patient and general population values varied with the type of chronic diseases. The greatest discrepancy between the two was found in patients with diseases of the blood and blood-forming organs, neoplasms and diseases of the digestive system. CONCLUSIONS: These analyses revealed differences in the relative weights attached to the EQ-5D dimensions between patient groups and the general population, particularly in those 'non-tangible' dimensions. These differences consequently led to greater discrepancies between patient and general population values in certain patient groups, which can have significant implications for resource allocation decisions in South Korea.

Subjective Social Status and Unhealthy Behaviors among South Korean Adults.

Objective This study was an exploration of the associations between socioeconomic status (SES), particularly subjective social status (SSS), and unhealthy behaviors among South Korean adults. Methods Data were taken from the 2013 Korea Health Panel survey data. SSS was measured using the MacArthur scale. Overweight/obesity was defined as body mass index of ≥25. Other behaviors were assessed using closed questions. Sex-stratified logistic regression analyses were conducted with 10,482 respondents (N = 6875 for nonadherence), including SSS, conventional socioeconomic measures and demographics. Results A pattern of SSS gradients in unhealthy behaviors, except for medication nonadherence, were observed among women, but they were statistically significant only for current smoking and physical inactivity. Such patterns were rarely observed among men, except for current smoking. Education-related inequalities also were found in overweight/obesity and current smoking for both sexes, but with an inverse gradient in overweight/obesity for men. An independent role of income was limited only to physical inactivity among women. Conclusion These findings highlight stronger socioeconomic gradients in unhealthy behaviors for women than for men in South Korea. SSS, together with education, may have greater implications than income in understanding unhealthy behaviors. A multifaceted approach is needed to understand the relationships more fully.

Functional Impairment and Painful Physical Symptoms in Patients with Major Depressive Disorder Treated with Antidepressants: Real-World Evidence from the Middle East.

BACKGROUND: The Global Burden of Disease 2010 study reported the relative size of major depressive disorder (MDD) burden to be greater in the Middle East and North Africa than anywhere else. However, little research has been carried out to examine the comparative effectiveness of antidepressants in this region. OBJECTIVE: To assess and compare functioning levels in Middle Eastern patients with MDD treated with either duloxetine or a selective serotonin reuptake inhibitor (SSRI), and to examine the impacts of depression-related pain on functioning by the type of treatment. METHOD: This post-hoc analysis, which focused on Middle Eastern patients, used data from a 6-month prospective observational study that included 1,549 MDD patients without sexual dysfunction. Levels of functional impairment and depression-related pain were assessed using the Sheehan Disability Scale (SDS) and the modified Somatic Symptom Inventory, respectively. A mixed model with repeated measures (MMRM) was employed. RESULTS: The mean age of the patients was 37.3 (SD=8.4) years, and 34.6% were female. Patient functioning was, on average, moderately impaired at baseline, but improved substantially during follow-up in both the duloxetine (n=152) and the SSRI (n=123) cohorts. The MMRM results showed a lower level of functional impairment at 24 weeks in the duloxetine cohort than in the SSRI cohort (p<0.001). Pain severity at baseline was positively associated with functional impairment during follow-up only in the SSRI cohort (p=0.003). CONCLUSION: Duloxetine-treated MDD patients achieved better functioning than SSRI-treated patients. This treatment difference was partly driven by depression-related pain.

The economic burden of advanced gastric cancer in Taiwan.

BACKGROUND: Gastric cancer is one of the leading causes of cancer-related deaths in both sexes worldwide, especially in Eastern Asia. This study aimed to estimate the economic burden of advanced gastric cancer (AGC) in Taiwan. METHODS: The costs of AGC in 2013 were estimated using resource use data from a chart review study (n = 122 with AGC) and national statistics. Annual per-patient costs, where patients' follow-up periods were adjusted for, were estimated with 82 patients who had complete resource use data. The costs were composed of direct medical costs, direct non-medical costs (healthcare travel and caregiver costs), morbidity costs, and mortality costs. Relevant unit costs were retrieved mainly from literature and national statistics, and applied to the resource use data. A broad definition of morbidity and mortality costs was employed to value the productivity loss in patients with unpaid employment, economically inactive and unemployed as well as the life years after the age of retirement. Their narrow definitions were also used in sensitivity analyses, using age- and/or sex-specific employment rates. Forgone future earnings/productivity loss were discounted at 3%. Annual per-patient costs were projected to estimate the total costs of AGC at the national level with an estimated number of patients with AGC (N = 2611) in Taiwan in 2013. RESULTS: The mean age of the 82 patients was 59.3 (SD: 11.9) years, and 67.1% were male. Per-patient costs were US$26,431 for direct medical costs, US$4669 for direct non-medical costs, US$5758 for morbidity costs, and US$145,990 for mortality costs (per death). These per-patient costs were projected to incur total AGC costs of US$423 million at the national-level. Mortality costs accounted for 77.3% of the total costs, followed by direct medical costs (16.3%), morbidity costs (3.6%), and direct non-medical costs (2.9%). CONCLUSION: AGC was found to exert a significant economic burden in Taiwan, incurring US$423 million in 2013. This represents about 0.08% of the Taiwanese economy. Mortality costs appeared to be the single greatest contributor to the burden, followed by direct medical costs. Early detection and providing effective treatments will help to reduce its burden on patients, caregivers and society as a whole. A poster of this study was presented at the 2016 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, CA, USA.

OH reactivity in urban and suburban regions in Seoul, South Korea - an East Asian megacity in a rapid transition.

South Korea has recently achieved developed country status with the second largest megacity in the world, the Seoul Metropolitan Area (SMA). This study provides insights into future changes in air quality for rapidly emerging megacities in the East Asian region. We present total OH reactivity observations in the SMA conducted at an urban Seoul site (May-June, 2015) and a suburban forest site (Sep, 2015). The total OH reactivity in an urban site during the daytime was observed at similar levels (∼15 s(-1)) to those previously reported from other East Asian megacity studies. Trace gas observations indicate that OH reactivity is largely accounted for by NOX (∼50%) followed by volatile organic compounds (VOCs) (∼35%). Isoprene accounts for a substantial fraction of OH reactivity among the comprehensive VOC observational dataset (25-47%). In general, observed total OH reactivity can be accounted for by the observed trace gas dataset. However, observed total OH reactivity in the suburban forest area cannot be largely accounted for (∼70%) by the trace gas measurements. The importance of biogenic VOC (BVOCs) emissions and oxidations used to evaluate the impacts of East Asian megacity outflows for the regional air quality and climate contexts are highlighted in this study.

Functioning in patients with major depression treated with duloxetine or a selective serotonin reuptake inhibitor in East Asia.

PURPOSE: 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<0.001). This treatment difference was more apparent in the subgroup of patients with PPS at baseline. Similar patterns were also observed for SDS subscores (work, social life, and family life). CONCLUSION: Depressed patients treated with duloxetine achieved better functioning compared to those treated with SSRIs. This treatment difference was mostly driven by patients with PPS at baseline.

Real-world outcomes in patients with depression treated with duloxetine or a selective serotonin reuptake inhibitor in East Asia.

INTRODUCTION: This study compared treatment outcomes 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. METHODS: This post-hoc analysis of data from a 6-month prospective observational study involving 1,549 major depressive disorder patients without sexual dysfunction focused on a subgroup of patients from East Asia (n = 587). Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16 ), whereas quality of life (QoL) was measured using EuroQoL instruments. PPS were rated using the modified Somatic Symptom Inventory. Multiple regression analyses were performed to compare the treatment outcomes. RESULTS: Duloxetine-treated patients had higher odds of achieving remission (odds ratio = 2.578, P < 0.001) and response (odds ratio = 2.704, P < 0.001) during follow-up, compared with SSRI-treated patients. They also had lower levels of disease severity and higher levels of QoL during follow-up. A similar pattern was observed in each subgroup of patients with and without PPS at baseline, but the effects of duloxetine relative to SSRIs were in general greater in patients with PPS. DISCUSSION: Patients treated with duloxetine had better treatment outcomes in terms of remission, response, depressive symptoms, and QoL, compared with SSRIs. Treatment with duloxetine may have additional advantages for patients with concurrent PPS.

Health-related quality of life in patients with depression treated with duloxetine or a selective serotonin reuptake inhibitor in a naturalistic outpatient setting.

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<0.001). Notably, pain severity at baseline was also statistically significantly associated with poorer QoL during follow-up (P<0.001). In addition, this association was observed in the subgroup of SSRI-treated patients (P<0.001), but not in that of duloxetine-treated patients (P=0.479). CONCLUSION: Depressed patients treated with duloxetine achieved higher QoL, compared to those treated with SSRIs, possibly in part due to its moderating effect on the link between pain and poorer QoL.