Key Issues of Economic Evaluations for Health Technology Assessment in China: A Nationwide Expert Survey.

OBJECTIVES: Health technology assessment (HTA) is increasingly crucial in medicine price negotiations in China, yet prior appraisals revealed national discrepancies on key economic evaluation issues: willingness-to-pay (WTP) threshold, pricing models for multi-indication medicines, and comparator selection principles. This study aims to collect expert opinions on these issues for future HTA evaluations. METHODS: A nationwide anonymous web-based survey encompassing experts across academia, HTA, consultancy/contract research organization (CRO)/industry, service provider and payer. In 2023, a generic invitation containing a web link to the questionnaire was disseminated via WeChat using convenience and snowball sampling. Agreement rates for questionnaire views were analyzed using descriptive statistics. The relationship between participants' responses and demographics was examined using appropriate logistic models. RESULTS: 303 responses were received from experts in 34 cities. Key expert views include: a suggested base WTP threshold ranging from 0.5 to 1.5 times GDP (52.1% agreement); elevated thresholds for childhood diseases, rare diseases, end-of-life diseases, and first-in-class medicines (FICs) (>78.0% agreement); a single pricing model for multi-indication medicines (60.4% agreement); consideration of multiple medicines as comparators (79.9% agreement); and avoiding the use of centrally procured medicines as comparators for medicines with a time-to-market under three years (71.0% agreement). Participants who are service provider had lower odds of selecting higher thresholds (OR: 0.26; P<0.01) compared with responders from consultancy/CRO/industry. CONCLUSIONS: Expert views indicate the need for substantial changes in China's current HTA methods, highlighting the need for increased investment in HTA processes and expertise cultivation.

Changing inequity in health service utilization and financial burden among patients with hypertension in China: evidence from China Health and Retirement Longitudinal Study (CHARLS), 2011-2018.

BACKGROUND: China initiated a health system reform in 2009 to achieve Universal Health Coverage (UHC) by 2020. While the effectiveness of health-system reforms has been studied, equity in health-service utilization and financial burden remains underexplored. This study evaluated whether the health system reform has improved the equity in utilization and financial burden of health services among patients with hypertension in China. METHODS: We obtained data from four waves of the China Health and Retirement Longitudinal Study (CHARLS) conducted between 2011 and 2018. The main outcome variables were outpatient and inpatient service utilization rates and catastrophic health expenditure (CHE) for patients with hypertension. The Standardized Concentration Index (CI) was used to measure the changing equity in health service utilization and affordability. RESULTS: Outpatient service utilization was relatively equal among patients with varying socioeconomic statuses (SESs) (CI: 0.041 in 2011 and 0.064 in 2018). Inpatient service utilization inequity improved from CI 0.144 in 2011 to CI 0.066 in 2018. CHE incidence increased from 15.6% in 2011 to 24.2% in 2018. CI for CHE declined from -0.069 in 2011 to -0.012 in 2015 but increased to -0.063 in 2018. CONCLUSIONS: Health insurance expansion and poverty alleviation policies promoted equity in inpatient service utilization for hypertensive patients. However, the financial burden for the poor requires further attention through reimbursement policy adjustments for outpatient services in primary care settings.

Interplay between traumatic brain injury and intimate partner violence: data driven analysis utilizing electronic health records.

BACKGROUND: It is estimated that a majority of intimate partner violence (IPV) victims suffer from blunt force to the head, neck and the face area. Injuries to head and neck are among the major causes for traumatic brain injury (TBI). METHODS: In this interdisciplinary study, we aimed to characterize the key associations between IPV and TBI by mining de-identified electronic health records data with more than 12 M records between 1999 to 2017 from the IBM Explorys platform. For this purpose, we formulated a data-driven analytical framework to identify significant health correlates among IPV, TBI and six control cohorts. Using this framework, we assessed the co-morbidity, shared prevalence, and synergy between pairs of conditions. RESULTS: Our findings suggested that health effects attributed to malnutrition, acquired thrombocytopenia, post-traumatic wound infection, local infection of wound, poisoning by cardiovascular drug, alcoholic cirrhosis, alcoholic fatty liver, and drug-induced cirrhosis were highly significant at the joint presence of IPV and TBI. CONCLUSION: To develop a better understanding of how IPV is related to negative health effects, it is potentially useful to determine the interactions and relationships between symptom categories. Our results can potentially improve the accuracy and confidence of existing clinical screening techniques on determining IPV-induced TBI diagnoses.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics.

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003-2013 using key words of "generic switching" or "substitution" was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases.

Pharmacological Prophylaxis for Venous Thromboembolism Among Hospitalized Patients With Acute Medical Illness: An Electronic Medical Records Study.

Patients hospitalized with acute medical illness have an elevated risk of venous thromboembolism (VTE). American College of Chest Physicians guidelines list various chronic illnesses, sepsis, advanced age, history of VTE, and immobility as risk factors and recommend prophylactic anticoagulation using fondaparinux, low-molecular weight heparin, or low-dose unfractionated heparin. The objectives of this study were to examine pharmacological prophylaxis against VTE among hospitalized medically ill patients and to assess demographic and clinical correlates related to VTE prophylaxis. A retrospective (1999-2010) electronic medical records study included patients aged 40 years and older hospitalized for at least 3 days, with significant medical illness or with a VTE hospitalization 30-365 days before admission. Each patient's first qualifying hospitalization was analyzed. Exclusions were if VTE treatment was started within 1 day of admission, or if warfarin (and not heparin or enoxaparin) was used. Prophylaxis was defined if the first inpatient dose of subcutaneous heparin or enoxaparin was at prophylaxis levels (lower than treatment levels). Multivariable logistic regression was used to examine factors associated with VTE prophylaxis. Among 12,980 patients, 22.1% received prophylaxis (11.8% with enoxaparin, 10.3% with heparin). VTE prophylaxis was positively associated with year of hospitalization, subcutaneous heparin in the month before admission, aspirin, self-pay status, age, and sepsis. VTE prophylaxis was negatively associated with smoking, alcohol, warfarin in the past 30 days, and primary diagnoses of stroke, infectious disease, or inflammatory bowel disease. Pharmacological VTE prophylaxis has increased significantly over the past 12 years but is still largely underused in patients hospitalized with acute medical illness. Multiple demographic, behavioral, and clinical factors are associated with inpatient VTE prophylaxis.

Pharmacologic Prophylaxis for Venous Thromboembolism Among Patients With Total Joint Replacement: An Electronic Medical Records Study.

Patients who have total hip (THR) or knee (TKR) replacement have an elevated risk of venous thromboembolism (VTE). The American College of Chest Physicians guidelines recommend prophylactic anticoagulation. The aim of the study was to examine pharmacologic prophylaxis against VTE among patients with THR or TKR and to assess demographic and clinical correlates related to VTE prophylaxis. Using 15 years of data (1995-2009) from an electronic medical record system for an inner-city public hospital in the United States, we examined pharmacologic prophylaxis against VTE and associated factors in patients after THR (n = 242) and TKR (n = 317). Before the early 2000s, aspirin was the most common prophylaxis agent (THR, 61% and TKR, 65%), and 26% of patients with THR and 19% of patients with TKR did not receive prophylaxis. Enoxaparin use has increased since 2000, and warfarin is now the most common prophylaxis agent (THR, 70% and TKR, 61%). After controlling for time period, factors associated with prophylaxis pattern included obesity, hip fracture, and the surgeon's number of years in practice. VTE prophylaxis medications in patients with total joint replacement have changed over 15 years, in trends generally consistent with the evolution of guidelines. Obesity, history of hip fracture, and physician's experience are associated with the prescription of VTE prophylaxis medications.

Estimating the future burden of cardiovascular disease and the value of lipid and blood pressure control therapies in China.

BACKGROUND: Lifestyle and dietary changes reflect an ongoing epidemiological transition in China, with cardiovascular disease (CVD) playing an ever-increasing role in China's disease burden. This study assessed the burden of CVD and the potential value of lipid and blood pressure control strategies in China. METHODS: We estimated the likely burden of CVD between 2016 and 2030 and how expanded use of lipid lowering and blood pressure control medication would impact that burden in the next 15 years. Accounting for the costs of drug use, we assessed the net social value of a policy that expands the utilization of lipid and blood pressure lowering therapies in China. RESULTS: Rises in prevalence of CVD risk and population aging would likely increase the incidence of acute myocardial infarctions (AMIs) by 75 million and strokes by 118 million, while the number of CVD deaths would rise by 39 million in total between 2016 and 2030. Universal treatment of hypertension and dyslipidemia patients with lipid and blood pressure lowering therapies could avert between 10 and 20 million AMIs, between 8 and 30 million strokes, and between 3 and 10 million CVD deaths during the 2016-2030 period, producing a positive social value net of health care costs as high as $932 billion. CONCLUSIONS: In light of its aging population and epidemiological transition, China faces near-certain increases in CVD morbidity and mortality. Preventative measures such as effective lipid and blood pressure management may reduce CVD burden substantially and provide large social value. While the Chinese government is implementing more systematic approaches to health care delivery, prevention of CVD should be high on the agenda.

Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial fibrillation.

AIMS: Warfarin, a vitamin K antagonist (VKA), has been the standard of care for stroke prevention in patients with atrial fibrillation (AF). Aspirin is recommended for low-risk patients and those unsuitable for warfarin. Apixaban is an oral anticoagulant that has demonstrated better efficacy than warfarin and aspirin in the ARISTOTLE and AVERROES studies, respectively, and causes less bleeding than warfarin. We evaluated the potential cost-effectiveness of apixaban against warfarin and aspirin from the perspective of the UK payer perspective. RESULTS AND METHODS: A lifetime Markov model was developed to evaluate the pharmacoeconomic impact of apixaban compared with warfarin and aspirin in VKA suitable and VKA unsuitable patients, respectively. Clinical events considered in the model include ischaemic stroke, haemorrhagic stroke, intracranial haemorrhage, other major bleed, clinically relevant non-major bleed, myocardial infarction, cardiovascular hospitalization and treatment discontinuations; data from the ARISTOTLE and AVERROES trials and published mortality rates and event-related utility rates were used in the model. Apixaban was projected to increase life expectancy and quality-adjusted life years (QALYs) compared with warfarin and aspirin. These gains were expected to be achieved at a drug acquisition-related cost increase over lifetime. The estimated incremental cost-effectiveness ratio was £11 909 and £7196 per QALY gained with apixaban compared with warfarin and aspirin, respectively. Sensitivity analyses indicated that results were robust to a wide range of inputs. CONCLUSIONS: Based on randomized trial data, apixaban is a cost-effective alternative to warfarin and aspirin, in VKA suitable and VKA unsuitable patients with AF, respectively.

Recent advancement in integrating artificial intelligence and information technology with real-world data for clinical decision-making in China: A scoping review.

OBJECTIVE: Striking innovations and advancements have been achieved with the use of artificial intelligence and healthcare information technology being integrated into clinical real-world data. The current scoping review aimed to provide an overview of the current status of artificial intelligence-/information technology-based clinical decision support tools in China. METHODS: PubMed/MEDLINE, Embase, China National Knowledge Internet, and Wanfang data were searched for both English and Chinese literature. The gray literature search was conducted for commercially available tools. Original studies that focused on clinical decision support tools driven by artificial intelligence or information technology in China and were published between 2010 and February 2022 were included. Information extracted from each article was further synthesized by themes based on three types of clinical decision-making. RESULTS: A total of 37 peer-reviewed publications and 13 commercially available tools were included in the final analysis. Among them, 32.0% were developed for disease diagnosis, 54.0% for risk prediction and classification, and 14.0% for disease management. Chronic diseases were the most popular therapeutic areas of exploration, with particular emphasis on cardiovascular and cerebrovascular diseases. Single-center electronic medical records were the mainstream data sources leveraged to inform clinical decision-making, with internal validation being predominately used for model evaluation. CONCLUSIONS: To effectively promote the extensive use of real-world data and drive a paradigm shift in clinical decision-making in China, multidisciplinary collaboration of key stakeholders is urgently needed.

Coal mining is associated with lung cancer risk in Xuanwei, China.

BACKGROUND: Xuanwei, China, experiences some of the highest rates of lung cancer in China. While lung cancer risk has been linked to the household use of bituminous coal, no study has comprehensively evaluated the risk of lung cancer associated with the mining of this coal in Xuanwei. In Xuanwei, coal is typically extracted from underground mines, without ventilation, and transported to the surface using carts powered by manpower or electricity. METHODS: We evaluated the risk of lung cancer and working as a coal miner, in the absence of diesel exhaust exposure, in a population-based case-control study of 260 male lung cancer cases and 260 age-matched male controls with information on occupational histories. Odds ratios (ORs) and 95% confidence intervals (CIs) for working as a coal miner and years of working as a coal miner were calculated by conditional logistic regression, adjusting for potential confounders, such as smoking and household coal use. RESULTS: We observed an increased risk of lung cancer among coal miners (OR = 2.7; 95%CI = 1.3-5.6) compared to noncoal miners. Further, a dose-response relationship was observed for the risk of lung cancer and the number of years working as a coal miner (P(trend) = 0.02), with those working as miners for more than 10 years experiencing an almost fourfold increased risk (OR = 3.8; 95%CI = 1.4-10.3) compared to noncoal miners. CONCLUSIONS: These findings suggest that coal mining in Xuanwei may be a risk factor for lung cancer.

Real-World Data for Healthcare Research in China: Call for Actions.

OBJECTIVES: This study aimed to provide an overview of major data sources in China that can be potentially used for epidemiology, health economics, and outcomes research; compare them with similar data sources in other countries; and discuss future directions of healthcare data development in China. METHODS: The study was conducted in 2 phases. First, various data sources were identified through a targeted literature review and recommendations by experts. Second, an in-depth assessment was conducted to evaluate the strengths and limitations of administrative claims and electronic health record data, which were further compared with similar data sources in developed countries. RESULTS: Secondary databases, including administrative claims and electronic health records, are the major types of real-world data in China. There are substantial variations in available data elements even within the same type of databases. Compared with similar databases in developed countries, the secondary databases in China have some general limitations such as variations in data quality, unclear data usage mechanism, and lack of longitudinal follow-up data. In contrast, the large sample size and the potential to collect additional data based on research needs present opportunities to further improve real-world data in China. CONCLUSIONS: Although healthcare data have expanded substantially in China, high-quality real-world evidence that can be used to facilitate decision making remains limited in China. To support the generation of real-world evidence, 2 fundamental issues in existing databases need to be addressed-data access/sharing and data quality.

Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study.

OBJECTIVE: To investigate the existing barriers and recommendations of real-world data (RWD) standardisation for clinical research through a qualitative study on different stakeholders. DESIGN: This qualitative study involved five types of stakeholders based on five interview outlines. The data analysis was performed using the constructivist grounded theory analysis process. SETTING: Eight hospitals, four hospital system vendors, three big data companies, six medical products companies and four regulatory institutions were included. PARTICIPANTS: In total, 62 participants from 25 institutions were interviewed through purposive sampling. RESULTS: The findings showed that the lack of clinical applicability in existing terminology standards, lack of generalisability in existing research databases, and lack of transparency in existing data standardisation process were the barriers of data standardisation of RWD for clinical research. Enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency might be feasible suggestions for solving the current problems. CONCLUSIONS: Efficient and reliable data standardisation of RWD for clinical research can help generate better evidence used to support regulatory evaluation of medical products. This research suggested enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency to guide efforts in data standardisation in the future.

Advancing the development of real-world data for healthcare research in China: challenges and opportunities.

Various real-world data (RWD) sources have emerged in China with the intention of generating real-world evidence (RWE) that can be used in clinical and regulatory decision-making. Despite these efforts, significant barriers remain that hinder high-quality healthcare research. A workshop with 30 representatives from healthcare research agencies, technology companies focused on healthcare big data and pharmaceutical companies was held in December 2020 to identify strategies to overcome the barriers associated with the usability and quality of RWD in China. Across all sectors, examples of barriers identified included inconsistencies in terminology and non-standardised coding practices; the absence of longitudinal data; the absence of transparent data processing and validation practices; and the inability to access and share RWD. While cutting-edge technological innovations and data solutions provided powerful tools, the development of collaborative and synergistic research networks across multiple stakeholders is key to generate accessible, high-quality RWD in China. RWD has the potential to provide clinical, regulatory and reimbursement decision-makers with critical insights that can improve healthcare delivery in China. However, barriers to its access, collection and use must be addressed to generate RWE to guide healthcare stakeholders.

Medication adherence: a call for action.

Poor adherence to efficacious cardiovascular-related medications has led to considerable morbidity, mortality, and avoidable health care costs. This article provides results of a recent think-tank meeting in which various stakeholder groups representing key experts from consumers, community health providers, the academic community, decision-making government officials (Food and Drug Administration, National Institutes of Health, etc), and industry scientists met to evaluate the current status of medication adherence and provide recommendations for improving outcomes. Below, we review the magnitude of the problem of medication adherence, prevalence, impact, and cost. We then summarize proven effective approaches and conclude with a discussion of recommendations to address this growing and significant public health issue of medication nonadherence.

A large observational study of cardiovascular outcomes associated with atorvastatin or simvastatin therapy in hypertensive patients without prior cardiovascular disease.

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.6 mg/d) and 23,786 simvastatin users (mean dose 28.6 mg/d), and followed a median 1.5 years for the occurrence of a first CV event. The crude CV event rates were 2.81 and 3.92 per 100 person-years for atorvastatin and simvastatin, respectively [unadjusted hazard ratio (HR): 0.73; 95% confidence interval (CI): 0.68-0.78, P < 0.001]. After adjusting for clinical and demographic confounders, use of atorvastatin was associated with fewer CV events compared with simvastatin (HR: 0.91; 95% CI: 0.84-0.98, P = 0.009). However, the lipid-lowering efficacy of the 2 statins could not be assessed as patient lipid data were unavailable. In conclusion, hypertensive patients without cardiovascular disease who initiated atorvastatin (10 or 20 mg/d) had a significantly lower risk of subsequent CV events compared with those who initiated simvastatin at doses of similar potency (20 or 40 mg/d). As with all observational studies, the study is subject to certain limitations, and the findings should be regarded as hypothesis generating.

Determining initial and follow-up costs of cardiovascular events in a US managed care population.

BACKGROUND: Cardiovascular (CV) events are prevalent and expensive worldwide both in terms of direct medical costs at the time of the event and follow-up healthcare after the event. This study aims to determine initial and follow-up costs for cardiovascular (CV) events in US managed care enrollees and to compare to healthcare costs for matched patients without CV events. METHODS: A 5.5-year retrospective matched cohort analysis of claims records for adult enrollees in ~90 US health plans. Patients hospitalized for first CV event were identified from a database containing a representative sample of the commercially-insured US population. The CV-event group (n = 29,688) was matched to a control group with similar demographics but no claims for CV-related events. Endpoints were total direct medical costs for inpatient and outpatient services and pharmacy (paid insurance amount). RESULTS: Overall, mean initial inpatient costs were US dollars ($) 16,981 per case (standard deviation [SD] = $20,474), ranging from $6,699 for a transient ischemic attack (mean length of stay [LOS] = 3.7 days) to $56,024 for a coronary artery bypass graft (CABG) (mean LOS = 9.2 days). Overall mean health-care cost during 1-year follow-up was $16,582 (SD = $34,425), an excess of $13,792 over the mean cost of matched controls. This difference in average costs between CV-event and matched-control subjects was $20,862 and $26,014 after two and three years of follow-up. Mean overall inpatient costs for second events were similar to those for first events ($17,705/case; SD = $22,703). The multivariable regression model adjusting for demographic and clinical characteristics indicated that the presence of a CV event was positively associated with total follow-up costs (P < 0.0001). CONCLUSIONS: Initial hospitalization and follow-up costs vary widely by type of CV event. The 1-year follow-up costs for CV events were almost as high as the initial hospitalization costs, but much higher for 2- and 3-year follow-up.

Two steps forward, one step back: 50 years of societal value from LDL-C-lowering therapies.

OBJECTIVES: To assess the evolving landscape of low-density lipoprotein cholesterol-lowering therapies (LLTs) and quantify their effect on cardiovascular disease (CVD)-related mortality and morbidity. STUDY DESIGN: Secondary data came from LLT clinical trials and 1999-2014 National Health and Nutrition Examination Survey (NHANES) data. 1996-2016 Medical Expenditure Panel Survey (MEPS) data were used to estimate LLT spending. Nonfatal CVD events prevented by LLTs were calculated from clinical trials and NHANES. The value of nonfatal events prevented was calculated as the product of event treatment costs and the number of events prevented. The value of mortality reduction was calculated as the product of a value of a life-year and the life expectancy gain from LLTs. This was compared with LLT spending estimated using MEPS. METHODS: Total LLT expenditures were calculated based on MEPS LLT utilization and expenditure data. Values of prevented hospitalizations, prevented CVD events, and other LLT utilization-related outcomes were pulled from the published literature. RESULTS: Combined, statins and ezetimibe prevented 2.8 million nonfatal heart attacks and 1.7 million nonfatal strokes from 1999 to 2014. Statin use generated $2.6 trillion in societal value through CVD deaths avoided from 1987 to 2014, and 85% accrued to patients. CONCLUSIONS: LLTs have yielded significant societal value, and the majority of this value has accrued to patients.

Switching from atorvastatin to simvastatin in patients at high cardiovascular risk: effects on low-density lipoprotein cholesterol.

Since generic simvastatin became available in the United States in 2006, approximately one million patients have switched from atorvastatin to simvastatin. We examined the association between switching from atorvastatin to simvastatin and changes in low-density lipoprotein cholesterol (LDL-C) levels in clinical practice. We compared atorvastatin-treated patients at high cardiovascular risk who switched to simvastatin between June 2006 and July 2007 with randomly selected matched patients who remained on atorvastatin and evaluated changes in LDL-C and percentage of patients reaching LDL-C less than 100 mg/dL. Of patients who switched from atorvastatin to simvastatin, the majority were excluded as a result of lack of LDL-C measurements, leaving 383 patients in the analysis. Among these, 122 (31.9%) switched to a simvastatin dose that was less than therapeutically equivalent to their prior atorvastatin dose. Compared with control subjects, switched patients were less likely to reach an LDL-C less than 100 mg/dL (68.4% versus 74.0%; odds ratio, 0.76; 95% confidence interval, 0.59-0.99; P = 0.041) and had higher measured LDL-C (91.4 versus 87.2 mg/dL; P = 0.009). Switched patients who were not prescribed a higher milligram dose of simvastatin were significantly less likely to reach an LDL-C less than 100 mg/dL (62.3% versus 74.0%; odds ratio, 0.55; 95% confidence interval, 0.36-0.84; P = 0.006) and had higher LDL-C (95.1 versus 87.2 mg/dL; P = 0.002) than control subjects. A large proportion of patients who switch from atorvastatin to simvastatin are prescribed doses that are not therapeutically equivalent, and these patients were significantly less likely to meet LDL-C treatment goals compared with patients who remained on atorvastatin.

Incremental cardiovascular costs and resource use associated with diabetes: an assessment of 29,863 patients in the US managed-care setting.

BACKGROUND: Patients with type 2 diabetes are at increased risk of cardiovascular events, and there is an associated economic burden attached to this risk. We conducted a retrospective claims database analysis to evaluate incremental cardiovascular costs in diabetic versus non-diabetic patients hospitalized for a cardiovascular event. METHODS: Patients hospitalized for a cardiovascular event between January 1, 2001 and June 30, 2005 were identified from a large US managed-care population. Diabetic patients were identified by evidence of type 2 diabetes in the 12 months prior to the index hospitalization. Direct medical costs and resource use - including inpatient expenditures (for the index and first recurrent hospitalizations), as well as outpatient, laboratory, and pharmacy expenditures (during the 3-year follow-up period) - were determined for patients with or without diabetes. RESULTS: Of the 29,863 patients identified with a cardiovascular hospitalization, 5,501 patients (18.4%) had a history of diabetes in the pre-index period (mean age, 57.8 years; 42.1% female). The overall mean follow-up period was 22.8 months. The incidence of subsequent cardiovascular events in the first year of follow-up was significantly higher for patients with diabetes compared with non-diabetic patients for all types of cardiovascular events except angina. Compared with non-diabetic patients, patients with diabetes had similar mean direct medical costs per patient for the index cardiovascular hospitalization ($17,435 versus $16,917; P = 0.09), and the first recurrent cardiovascular hospitalization ($18,488 versus $17,481; P = 0.2), yet higher mean total direct medical costs per patient for cardiovascular events during follow-up years (Year 1: $8,805 versus $6,982; Year 2: $13,860 versus $10,056; Year 3: $16,149 versus $12,163; all P < or = 0.0002). The cost difference between diabetic and non-diabetic patients remained significant after adjusting for age, gender and other potential confounders in multivariate regression analysis. The mean (SD) total period of inpatient cardiovascular hospitalization after 3 years of follow-up was 3.3 (12.4) days for patients with diabetes compared with 1.8 (5.8) days for non-diabetic patients (P < 0.0001). CONCLUSION: Diabetic patients hospitalized for a cardiovascular event incur higher costs for cardiovascular care than their non-diabetic counterparts. This analysis of the incremental cardiovascular cost and resource use provides the basis for greater accuracy and precision when modeling the economic value of initiatives aimed at reducing cardiovascular morbidity in patients with diabetes mellitus.

Variation in lung cancer risk by smoky coal subtype in Xuanwei, China.

Lung cancer rates in Xuanwei County have been among the highest in China for both males and females and have been causally associated with exposure to indoor smoky (bituminous) coal emissions that contain very high levels of polycyclic aromatic hydrocarbons. There are numerous coal mines across the County. Although lung cancer risk is strongly associated with the use of smoky coal as a whole, variation in risk by smoky coal subtype has not been characterized as yet. We conducted a population-based case-control study of 498 lung cancer cases and 498 controls, individually matched to case subjects on age (+/-2 years) and sex to examine risk by coal subtype. Odds ratios (ORs) and 95% confidence intervals (CIs) for coal subtype were calculated by conditional logistic regression, adjusting for potential confounders. Overall, smoky coal use was positively and statistically significantly associated with lung cancer risk, when compared with the use of smokeless coal or wood (OR = 7.7, 95% CI = 4.5-13.3). Furthermore, there was a marked heterogeneity in risk estimates for specific subtypes of smoky coal (test for heterogeneity: p = 5.17 x 10(-10)). Estimates were highest for coal of the Laibin (OR = 24.8, 95% CI = 12.4-49.6) and Longtan (OR = 11.6, 95% CI = 5.0-27.2) coal types and lower for coal from other subtypes. These findings strongly suggest that in Xuanwei and elsewhere, the carcinogenic potential of coal combustion products can exhibit substantial local variation by specific coal source.