Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans.

This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans.

Achieving Value by Risk Stratification With Machine Learning Model or Clinical Risk Score in Acute Upper Gastrointestinal Bleeding: A Cost Minimization Analysis.

INTRODUCTION: We estimate the economic impact of applying risk assessment tools to identify very low-risk patients with upper gastrointestinal bleeding who can be safely discharged from the emergency department using a cost minimization analysis. METHODS: We compare triage strategies (Glasgow-Blatchford score = 0/0-1 or validated machine learning model) with usual care using a Markov chain model from a US health care payer perspective. RESULTS: Over 5 years, the Glasgow-Blatchford score triage strategy produced national cumulative savings over usual care of more than $2.7 billion and the machine learning strategy of more than $3.4 billion. DISCUSSION: Implementing risk assessment models for upper gastrointestinal bleeding reduces costs, thereby increasing value.

Validation of Biomechanical Computed Tomography for Fracture Risk Classification in Metastatic Hormone-sensitive Prostate Cancer.

BACKGROUND: Guidelines recommend dual-energy x-ray absorptiometry (DXA) screening to assess fracture risk and benefit from antiresorptive therapy in men with metastatic hormone-sensitive prostate cancer (mHSPC) on androgen deprivation therapy (ADT). However, <30% of eligible patients undergo DXA screening. Biomechanical computed tomography (BCT) is a radiomic technique that measures bone mineral density (BMD) and bone strength from computed tomography (CT) scans. OBJECTIVE: To evaluate the (1) correlations between BCT- and DXA-assessed BMD, and (2) associations between BCT-assessed metrics and subsequent fracture. DESIGN, SETTING, AND PARTICIPANTS: A multicenter retrospective cohort study was conducted among patients with mHSPC between 2013 and 2020 who received CT abdomen/pelvis or positron emission tomography/CT within 48 wk before ADT initiation and during follow-up (48-96 wk after ADT initiation). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used univariate logistic regression to assess the associations between BCT measurements and the primary outcomes of subsequent pathologic and nonpathologic fractures. RESULTS AND LIMITATIONS: Among 91 eligible patients, the median ([interquartile range) age was 67 yr (62-75), 44 (48.4%) were White, and 41 (45.1%) were Black. During the median follow-up of 82 wk, 17 men (18.6%) developed a pathologic and 15 (16.5%) a nonpathologic fracture. BCT- and DXA-assessed femoral-neck BMD T scores were strongly correlated (R2 = 0.93). On baseline CT, lower BCT-assessed BMD (odds ratio [OR] 1.80, 95% confidence interval or CI [1.10, 3.25], p = 0.03) was associated with an increased risk of a pathologic fracture. Lower femoral strength (OR 1.63, 95% CI [0.99, 2.71], p = 0.06) was marginally associated with an increased risk of a pathologic fracture. Neither BMD (OR 1.52, 95% CI [0.95, 2.63], p = 0.11) nor strength (OR 1.14, 95% CI [0.75, 1.80], p = 0.57) was associated with a nonpathologic fracture. BCT identified nine (9.9%) men eligible for antiresorptive therapy, of whom four (44%) were not treated. Limitations include low fracture numbers resulting in lower power to detect fracture associations. CONCLUSIONS: Among men diagnosed with mHSPC, BCT assessments were strongly correlated with DXA, predicted subsequent pathologic fracture, and identified additional men indicated for antiresorptive therapy. PATIENT SUMMARY: We assess whether biomechanical computer tomography (BCT) from routine computer tomography (CT) scans can identify fracture risk among patients recently diagnosed with metastatic prostate cancer. We find that BCT and dual-energy x-ray absorptiometry-derived bone mineral density are strongly correlated and that BCT accurately identifies the risk for future fracture. BCT may enable broader fracture risk assessment and facilitate timely interventions to reduce fracture risk in metastatic prostate cancer patients.

Management of Prostate Cancer in Older Adults.

The majority of men with prostate cancer are diagnosed when they are older than 65 years; however, clinical trial participants are disproportionately younger and more fit than the real-world population treated in typical clinical practices. It is, therefore, unknown whether the optimal approach to prostate cancer treatment is the same for older men as it is for younger and/or more fit men. Short screening tools can be used to efficiently assess frailty, functional status, life expectancy, and treatment toxicity risk. These risk assessment tools allow for targeted interventions to increase a patient's reserve and improve treatment tolerance, potentially allowing more men to experience the benefit of the significant recent treatment advances in prostate cancer. Treatment plans should also take into consideration each patient's individual goals and values considered within their overall health and social context to reduce barriers to care. In this review, we will discuss evidence-based risk assessment and decision tools for older men with prostate cancer, highlight intervention strategies to improve treatment tolerance, and contextualize these tools within the current treatment landscape for prostate cancer.

Bone Health in Prostate Cancer Survivors: Recent Lessons and Opportunities for Improvement.

Prostate cancer survivors face an elevated lifetime risk of fracture due to factors that include older age, bony metastases, and use of androgen deprivation therapy in the curative setting, which increases the risk of osteoporosis and fracture. Management of bone health is critical to prevent fracture and other bone-related complications; however, routine bone health screening is seldom performed and is inadequate. In this mini-review, we discuss optimal bone health management for prostate cancer survivors who have received curative-intent therapy. We also discuss areas for future improvement. PATIENT SUMMARY: This mini-review discusses the importance of bone health for prostate cancer survivors who had nonmetastatic disease, steps to improve bone health, and areas for improvement.

Assessment of US Pharmacies Contracted With Health Care Institutions Under the 340B Drug Pricing Program by Neighborhood Socioeconomic Characteristics.

This cross-sectional study assesses pharmacy participation in the 340B Drug Pricing Program following the 2010 expansion and the extent to which growth has occurred in socioeconomically disadvantaged neighborhoods.

Guideline discordant care in patients with metastatic germ cell tumors.

INTRODUCTION: Despite high curability, patients with metastatic germ cell tumors (GCT) in the United States general population persistently face inferior outcomes compared with those treated in specialty referral centers. We characterized guideline discordant management in patients with metastatic GCT who experienced relapse after first-line chemotherapy and compared those who were initially treated in community practices vs. academic referral centers. PATIENTS/METHODS: Retrospective analysis of 53 patients with relapsed GCT between 2005 and 2018. First-line GCT management was assessed against the National Comprehensive Cancer Network guidelines. Guideline discordant management, predictors of discordance, and associations with outcomes were assessed. RESULTS: Of 53 patients with relapsed GCT, 34% received guideline discordant care in the first-line setting. Guideline discordant care was more prevalent in patients initially treated in community practices (12/30, 40%) vs. those initially treated in academic centers (3/22, 14%), though in multivariate logistic regression, this difference was not statistically significant (odds ratio: 4.07, P = 0.08). Most patients in community settings who received guideline discordant care were undertreated (10/12, 83%). There were 3 major reasons for guideline discordant care: (1) failure to resect residual masses after chemotherapy (27%, 4/15), (2) mismanagement of chemotherapy-related adverse events (27%, 4/15), and (3) under staging at diagnosis, resulting either insufficient chemotherapy regimen intensity (13%, 2/15) and/or inappropriately receiving primary surgical resection for metastatic disease (20%, 3/15). CONCLUSION: Under treatment was identified in nearly half of patients initially treated in a community setting who later developed relapsed GCT. Referral to specialized centers for a second opinion should be considered for all metastatic GCT patients in the first-line setting and all patients with post-chemotherapy residual disease. More effective methods should be developed to facilitate second opinions from expert centers in the United States.

Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors.

BACKGROUND: The Controlled Study of Lanreotide Antiproliferative Response in Neuroendocrine Tumors (CLARINET) trial showed prolonged progression-free survival in patients initially treated with lanreotide versus placebo. We evaluated the cost-effectiveness of upfront lanreotide versus active surveillance with lanreotide administered after progression in patients with metastatic enteropancreatic neuroendocrine tumors (NETs), both of which are treatment options recommended in NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors. METHODS: We developed a Markov model calibrated to the CLARINET trial and its extension. We based the active surveillance strategy on the CLARINET placebo arm. We calculated incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). We modeled lanreotide's cost at $7,638 per 120 mg (average sales price plus 6%), used published utilities (stable disease, 0.77; progressed disease, 0.61), adopted a healthcare sector perspective and lifetime time horizon, and discounted costs and benefits at 3% annually. We examined sensitivity to survival extrapolation and modeled octreotide long-acting release (LAR) ($6,183 per 30 mg). We conducted one-way, multiway, and probabilistic sensitivity analyses. RESULTS: Upfront lanreotide led to 5.21 QALYs and a cost of $804,600. Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained. Reducing lanreotide's price by 95% (to $370) or 85% (to $1,128) per 120 mg would allow upfront lanreotide to reach ICERs of $100,000/QALY or $150,000/QALY. Across a range of survival curve extrapolation scenarios, pricing lanreotide at $370 to $4,000 or $1,130 to $5,600 per 120 mg would reach ICERs of $100,000/QALY or $150,000/QALY, respectively. Our findings were robust to extensive sensitivity analyses. The ICER modeling octreotide LAR is $482,700/QALY gained. CONCLUSIONS: At its current price, lanreotide is not cost-effective as initial therapy for patients with metastatic enteropancreatic NETs and should be reserved for postprogression treatment. To be cost-effective as initial therapy, the price of lanreotide would need to be lowered by 48% to 95% or 27% to 86% to reach ICERs of $100,000/QALY or $150,00/QALY, respectively.

Multi-dimensional characterisation of global food supply from 1961-2013.

Food systems are increasingly globalized and interdependent and diets around the world are changing. Characterising national food supplies and how they have changed can inform food policies that ensure national food security, support access to healthy diets and enhance environmental sustainability. Here, we analysed data for 171 countries on availability of 18 food groups from the United Nations Food and Agriculture Organization to identify and track multi-dimensional food supply patterns from 1961 to 2013. Four predominant food group combinations were identified that explained almost 90% of cross-country variance in food supply: animal source and sugar; vegetable; starchy root and fruit; and seafood and oilcrops. South Korea, China and Taiwan experienced the largest changes in food supply over the past five decades, with animal source foods and sugar, vegetables, and seafood and oilcrops all becoming more abundant components of food supply. In contrast, in many Western countries, the supply of animal source foods and sugar declined. Meanwhile, there was remarkably little change in food supply in countries in the sub-Saharan Africa region. These changes have led to a partial global convergence in national supply of animal source foods and sugar, and a divergence in vegetables, and seafood and oilcrops. Our analysis has generated a novel characterisation of food supply that highlights the interdependence of multiple food types in national food systems. A better understanding of how these patterns have evolved and will continue to change is needed to support the delivery of healthy and sustainable food system policies.

Evaluating the Role of Past Clinical Information on Risk Adjustment.

OBJECTIVE: The objective of this study was to evaluate whether incorporating historical clinical information beyond 1 year improves risk adjustment. DATA SOURCES: Administrative data from the Department of Veterans Affairs and Medicare (for veterans concurrently enrolled in Medicare) for fiscal years (FYs) 2011-2015. STUDY DESIGN: We regressed total annual costs on Medicare hierarchical condition category indicators and risk scores for FY 2015 in both a concurrent and a prospective model using 5-fold cross-validation. Regressions were repeated incorporating clinical information from FY 2011 to 2015. Model fit was appraised using R and mean squared predictive error (MSPE). DATA COLLECTION: All veterans affairs users (n=3,254,783) with diagnostic information FY 2011-2015. PRINCIPAL FINDINGS: In a concurrent model, adding additional years of historical clinical information (FY 2011-2014) did not result in substantive gains in fit (R from 0.671 to 0.673) or predictive capability (MSPE from 1956 to 1950). In a prospective model, adding additional years of historical clinical information also did not result in substantive gains in fit (R from 0.334 to 0.344) or predictive capability (MSPE from 3988 to 3940). CONCLUSION: Incorporating historical clinical information yielded no material gain in risk adjustment fit.

Cost-effectiveness of a fixed-dose combination pill for secondary prevention of cardiovascular disease in China, India, Mexico, Nigeria, and South Africa: a modelling study.

BACKGROUND: Fewer than 25% of patients with atherosclerotic cardiovascular disease in countries of low and middle income (LMICs) use guideline-directed drugs for secondary prevention. A fixed-dose combination polypill might improve cardiovascular outcomes by increasing prescription rates and adherence, but the cost-effectiveness of this approach is uncertain. METHODS: We developed microsimulation models to assess the cost-effectiveness of a polypill containing aspirin, lisinopril, atenolol, and simvastatin for secondary prevention of atherosclerotic cardiovascular disease compared with current care in China, India, Mexico, Nigeria, and South Africa. We modelled baseline use of secondary prevention drugs on the Prospective Urban Rural Epidemiological study. In the intervention arm, we assumed that patients currently prescribed any prevention drug for atherosclerotic cardiovascular disease would receive the polypill instead, which would improve adherence by 32% (from a meta-analysis of two randomised trials in LMICs). We assessed the cost-effectiveness of the polypill at prices in the public sector and on the retail market. Key outcomes were major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) over a 5-year period and the incremental cost-effectiveness ratio (ICER) from the perspective of the health-care sector and a lifetime analytical horizon. We assumed a cost-effectiveness threshold equal to each country's per capita gross domestic product (GDP) per disability-adjusted life-year (DALY) averted. In sensitivity analyses, we examined the population health effect achievable by increasing the uptake of the polypill in the eligible population. FINDINGS: Among adults aged 30-84 years with established atherosclerotic cardiovascular disease, adoption of the polypill for secondary prevention compared with current care was projected to avert 40-54 major adverse cardiovascular events for every 1000 patients treated for 5 years and produce between three and ten additional serious adverse events. Assuming public-sector pharmaceutical prices, the ICER of the polypill compared with current care over a lifetime analytical horizon was Int$168 (95% UI 55 to 337) per DALY averted in China, $154 (57 to 289) in India, $88 (15 to 193) in Mexico, $364 (147 to 692) in Nigeria, and $64 (cost-saving to 203) in South Africa, amounting to 0·4-6·2% of the per capita GDP in these countries. The ICER of the polypill compared with current care increased to 3·3-14·6% of the per capita GDP at retail market pharmaceutical prices. Use of the polypill at current rates of prescription of secondary prevention drugs would produce modest health benefits, reducing DALYs from atherosclerotic cardiovascular disease among patients with established disease by 3·1-10·1% over 10 years. Increasing use to 50% or 75% of the eligible population would produce substantially larger health gains (up to 24·3% atherosclerotic cardiovascular disease DALYs averted). INTERPRETATION: The polypill is projected to be cost-effective compared with current care for secondary prevention of atherosclerotic cardiovascular disease in China, India, Mexico, Nigeria, and South Africa, particularly if it is made available at public-sector pricing. However, achieving meaningful improvements in cardiovascular health will require simultaneous investments in health infrastructure to increase the uptake of the polypill among patients with established atherosclerotic cardiovascular disease. FUNDING: Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Hellman Family Foundation, Department of Veterans Affairs, and University of California at San Francisco.

Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Multiply Relapsed or Refractory Adult Large B-Cell Lymphoma.

PURPOSE: Two anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapies are approved for diffuse large B-cell lymphoma, axicabtagene ciloleucel (axi-cel) and tisagenlecleucel; each costs $373,000. We evaluated their cost effectiveness. METHODS: We used a decision analytic Markov model informed by recent multicenter, single-arm trials to evaluate axi-cel and tisagenlecleucel in multiply relapsed/refractory, adult, diffuse large B-cell lymphoma from a US health payer perspective over a lifetime horizon. Under a range of plausible long-term effectiveness assumptions, each therapy was compared with salvage chemoimmunotherapy regimens and stem-cell transplantation. Main outcomes were undiscounted life years, discounted lifetime costs, discounted quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (3% annual discount rate). Sensitivity analyses explored uncertainty. RESULTS: In an optimistic scenario, assuming a 40% 5-year progression-free survival (PFS), axi-cel increased life expectancy by 8.2 years at $129,000/QALY gained (95% uncertainty interval, $90,000 to $219,000). At a 30% 5-year PFS, improvements in life expectancy were more modest (6.4 years) and expensive ($159,000/QALY gained [95% uncertainty interval, $105,000 to $284,000]). In an optimistic scenario, assuming a 35% 5-year PFS, tisagenlecleucel increased life expectancy by 4.6 years at $168,000/QALY gained (95% uncertainty interval, $105,000 to $414,000/QALY). At a 25% 5-year PFS, improvements in life expectancy were smaller (3.4 years) and more expensive ($223,000/QALY gained [95% uncertainty interval, $123,000 to $1,170,000/QALY]). Administering CAR-T to all indicated patients would increase US health care costs by approximately $10 billion over 5 years. Price reductions to $250,000 and $200,000, respectively, or payment only for initial complete response (at current prices) would allow axi-cel and tisagenlecleucel to cost less than $150,000/QALY, even at 25% PFS. CONCLUSION: At 2018 prices, it is possible that both CAR-T therapies meet a less than $150,000/QALY threshold. This depends on long-term outcomes compared with chemoimmunotherapy and stem-cell transplantation, which are uncertain. Widespread adoption would substantially increase non-Hodgkin lymphoma health care costs. Price reductions or payment for initial response would improve cost effectiveness, even with modest long-term outcomes.

Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Relapsed or Refractory Pediatric B-Cell Acute Lymphoblastic Leukemia.

PURPOSE: The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel was recently approved to treat relapsed or refractory pediatric acute lymphoblastic leukemia. With a one-time infusion cost of $475,000, tisagenlecleucel is currently the most expensive oncologic therapy. We aimed to determine whether tisagenlecleucel is cost effective compared with currently available treatments. METHODS: Markov modeling was used to evaluate tisagenlecleucel in pediatric relapsed or refractory acute lymphoblastic leukemia from a US health payer perspective over a lifetime horizon. The model was informed by recent multicenter, single-arm clinical trials. Tisagenlecleucel (under a range of plausible long-term effectiveness) was compared with blinatumomab, clofarabine combination therapy (clofarabine, etoposide, and cyclophosphamide), and clofarabine monotherapy. Scenario and probabilistic sensitivity analyses were used to explore uncertainty. Main outcomes were life-years, discounted lifetime costs, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (3% discount rate). RESULTS: With an assumption of a 40% 5-year relapse-free survival rate, tisagenlecleucel increased life expectancies by 12.1 years and cost $61,000/QALY gained. However, at a 20% 5-year relapse-free survival rate, life-expectancies were more modest (3.8 years) and expensive ($151,000/QALY gained). At a 0% 5-year relapse-free survival rate and with use as a bridge to transplant, tisagenlecleucel increased life expectancies by 5.7 years and cost $184,000/QALY gained. Reduction of the price of tisagenlecleucel to $200,000 or $350,000 would allow it to meet a $100,000/QALY or $150,000/QALY willingness-to-pay threshold in all scenarios. CONCLUSION: The long-term effectiveness of tisagenlecleucel is a critical but uncertain determinant of its cost effectiveness. At its current price, tisagenlecleucel represents reasonable value if it can keep a substantial fraction of patients in remission without transplantation; however, if all patients ultimately require a transplantation to remain in remission, it will not be cost effective at generally accepted thresholds. Price reductions would favorably influence cost effectiveness even if long-term clinical outcomes are modest.

The global cardiovascular risk transition: associations of four metabolic risk factors with national income, urbanization, and Western diet in 1980 and 2008.

BACKGROUND: It is commonly assumed that cardiovascular disease risk factors are associated with affluence and Westernization. We investigated the associations of body mass index (BMI), fasting plasma glucose, systolic blood pressure, and serum total cholesterol with national income, Western diet, and, for BMI, urbanization in 1980 and 2008. METHODS AND RESULTS: Country-level risk factor estimates for 199 countries between 1980 and 2008 were from a previous systematic analysis of population-based data. We analyzed the associations between risk factors and per capita national income, a measure of Western diet, and, for BMI, the percentage of the population living in urban areas. In 1980, there was a positive association between national income and population mean BMI, systolic blood pressure, and total cholesterol. By 2008, the slope of the association between national income and systolic blood pressure became negative for women and zero for men. Total cholesterol was associated with national income and Western diet in both 1980 and 2008. In 1980, BMI rose with national income and then flattened at ≈Int$7000; by 2008, the relationship resembled an inverted U for women, peaking at middle-income levels. BMI had a positive relationship with the percentage of urban population in both 1980 and 2008. Fasting plasma glucose had weaker associations with these country macro characteristics, but it was positively associated with BMI. CONCLUSIONS: The changing associations of metabolic risk factors with macroeconomic variables indicate that there will be a global pandemic of hyperglycemia and diabetes mellitus, together with high blood pressure in low-income countries, unless effective lifestyle and pharmacological interventions are implemented.

National, regional, and global trends in adult overweight and obesity prevalences.

BACKGROUND: Overweight and obesity prevalence are commonly used for public and policy communication of the extent of the obesity epidemic, yet comparable estimates of trends in overweight and obesity prevalence by country are not available. METHODS: We estimated trends between 1980 and 2008 in overweight and obesity prevalence and their uncertainty for adults 20 years of age and older in 199 countries and territories. Data were from a previous study, which used a Bayesian hierarchical model to estimate mean body mass index (BMI) based on published and unpublished health examination surveys and epidemiologic studies. Here, we used the estimated mean BMIs in a regression model to predict overweight and obesity prevalence by age, country, year, and sex. The uncertainty of the estimates included both those of the Bayesian hierarchical model and the uncertainty due to cross-walking from mean BMI to overweight and obesity prevalence. RESULTS: The global age-standardized prevalence of obesity nearly doubled from 6.4% (95% uncertainty interval 5.7-7.2%) in 1980 to 12.0% (11.5-12.5%) in 2008. Half of this rise occurred in the 20 years between 1980 and 2000, and half occurred in the 8 years between 2000 and 2008. The age-standardized prevalence of overweight increased from 24.6% (22.7-26.7%) to 34.4% (33.2-35.5%) during the same 28-year period. In 2008, female obesity prevalence ranged from 1.4% (0.7-2.2%) in Bangladesh and 1.5% (0.9-2.4%) in Madagascar to 70.4% (61.9-78.9%) in Tonga and 74.8% (66.7-82.1%) in Nauru. Male obesity was below 1% in Bangladesh, Democratic Republic of the Congo, and Ethiopia, and was highest in Cook Islands (60.1%, 52.6-67.6%) and Nauru (67.9%, 60.5-75.0%). CONCLUSIONS: Globally, the prevalence of overweight and obesity has increased since 1980, and the increase has accelerated. Although obesity increased in most countries, levels and trends varied substantially. These data on trends in overweight and obesity may be used to set targets for obesity prevalence as requested at the United Nations high-level meeting on Prevention and Control of NCDs.

The age associations of blood pressure, cholesterol, and glucose: analysis of health examination surveys from international populations.

BACKGROUND: The age association of cardiovascular disease may be in part because its metabolic risk factors tend to rise with age. Few studies have analyzed age associations of multiple metabolic risks in the same population, especially in nationally representative samples. We examined worldwide variations in the age associations of systolic blood pressure (SBP), total cholesterol (TC), and fasting plasma glucose (FPG). METHODS AND RESULTS: We used individual records from 83 nationally or subnationally representative health examination surveys in 52 countries to fit a linear model to risk factor data between ages 30 and 64 years for SBP and FPG, and between 30 and 54 years for TC. We report the cross-country variation of the slope and intercept of this relationship. We also assessed nonlinear associations in older ages. Between 30 and 64 years of age, SBP increased by 1.7 to 11.6 mm Hg per 10 years of age, and FPG increased by 0.8 to 20.4 mg/dL per 10 years of age in different countries and in the 2 sexes. Between 30 and 54 years of age, TC increased by 0.2 to 22.4 mg/dL per 10 years of age in different surveys and in the 2 sexes. For all risk factors and in most countries, risk factor levels rose more steeply among women than among men, especially for TC. On average, there was a flattening of age-SBP relationship in older ages; TC and FPG age associations reversed in older ages, leading to lower levels in older ages than in middle ages. CONCLUSIONS: The rise with age of major metabolic cardiovascular disease risk factors varied substantially across populations, especially for FPG and TC. TC rose more steeply in high-income countries and FPG in the Oceania countries, the Middle East, and the United States. The SBP age association had no specific income or geographical pattern.

National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants.

BACKGROUND: Data for trends in glycaemia and diabetes prevalence are needed to understand the effects of diet and lifestyle within populations, assess the performance of interventions, and plan health services. No consistent and comparable global analysis of trends has been done. We estimated trends and their uncertainties in mean fasting plasma glucose (FPG) and diabetes prevalence for adults aged 25 years and older in 199 countries and territories. METHODS: We obtained data from health examination surveys and epidemiological studies (370 country-years and 2·7 million participants). We converted systematically between different glycaemic metrics. For each sex, we used a Bayesian hierarchical model to estimate mean FPG and its uncertainty by age, country, and year, accounting for whether a study was nationally, subnationally, or community representative. FINDINGS: In 2008, global age-standardised mean FPG was 5·50 mmol/L (95% uncertainty interval 5·37-5·63) for men and 5·42 mmol/L (5·29-5·54) for women, having risen by 0·07 mmol/L and 0·09 mmol/L per decade, respectively. Age-standardised adult diabetes prevalence was 9·8% (8·6-11·2) in men and 9·2% (8·0-10·5) in women in 2008, up from 8·3% (6·5-10·4) and 7·5% (5·8-9·6) in 1980. The number of people with diabetes increased from 153 (127-182) million in 1980, to 347 (314-382) million in 2008. We recorded almost no change in mean FPG in east and southeast Asia and central and eastern Europe. Oceania had the largest rise, and the highest mean FPG (6·09 mmol/L, 5·73-6·49 for men; 6·08 mmol/L, 5·72-6·46 for women) and diabetes prevalence (15·5%, 11·6-20·1 for men; and 15·9%, 12·1-20·5 for women) in 2008. Mean FPG and diabetes prevalence in 2008 were also high in south Asia, Latin America and the Caribbean, and central Asia, north Africa, and the Middle East. Mean FPG in 2008 was lowest in sub-Saharan Africa, east and southeast Asia, and high-income Asia-Pacific. In high-income subregions, western Europe had the smallest rise, 0·07 mmol/L per decade for men and 0·03 mmol/L per decade for women; North America had the largest rise, 0·18 mmol/L per decade for men and 0·14 mmol/L per decade for women. INTERPRETATION: Glycaemia and diabetes are rising globally, driven both by population growth and ageing and by increasing age-specific prevalences. Effective preventive interventions are needed, and health systems should prepare to detect and manage diabetes and its sequelae. FUNDING: Bill & Melinda Gates Foundation and WHO.

National, regional, and global trends in systolic blood pressure since 1980: systematic analysis of health examination surveys and epidemiological studies with 786 country-years and 5·4 million participants.

BACKGROUND: Data for trends in blood pressure are needed to understand the effects of its dietary, lifestyle, and pharmacological determinants; set intervention priorities; and evaluate national programmes. However, few worldwide analyses of trends in blood pressure have been done. We estimated worldwide trends in population mean systolic blood pressure (SBP). METHODS: We estimated trends and their uncertainties in mean SBP for adults 25 years and older in 199 countries and territories. We obtained data from published and unpublished health examination surveys and epidemiological studies (786 country-years and 5·4 million participants). For each sex, we used a Bayesian hierarchical model to estimate mean SBP by age, country, and year, accounting for whether a study was nationally representative. FINDINGS: In 2008, age-standardised mean SBP worldwide was 128·1 mm Hg (95% uncertainty interval 126·7-129·4) in men and 124·4 mm Hg (123·0-125·9) in women. Globally, between 1980 and 2008, SBP decreased by 0·8 mm Hg per decade (-0·4 to 2·2, posterior probability of being a true decline=0·90) in men and 1·0 mm Hg per decade (-0·3 to 2·3, posterior probability=0·93) in women. Female SBP decreased by 3·5 mm Hg or more per decade in western Europe and Australasia (posterior probabilities ≥0·999). Male SBP fell most in high-income North America, by 2·8 mm Hg per decade (1·3-4·5, posterior probability >0·999), followed by Australasia and western Europe where it decreased by more than 2·0 mm Hg per decade (posterior probabilities >0·98). SBP rose in Oceania, east Africa, and south and southeast Asia for both sexes, and in west Africa for women, with the increases ranging 0·8-1·6 mm Hg per decade in men (posterior probabilities 0·72-0·91) and 1·0-2·7 mm Hg per decade for women (posterior probabilities 0·75-0·98). Female SBP was highest in some east and west African countries, with means of 135 mm Hg or greater. Male SBP was highest in Baltic and east and west African countries, where mean SBP reached 138 mm Hg or more. Men and women in western Europe had the highest SBP in high-income regions. INTERPRETATION: On average, global population SBP decreased slightly since 1980, but trends varied significantly across regions and countries. SBP is currently highest in low-income and middle-income countries. Effective population-based and personal interventions should be targeted towards low-income and middle-income countries. FUNDING: Funding Bill & Melinda Gates Foundation and WHO.

National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9·1 million participants.

BACKGROUND: Excess bodyweight is a major public health concern. However, few worldwide comparative analyses of long-term trends of body-mass index (BMI) have been done, and none have used recent national health examination surveys. We estimated worldwide trends in population mean BMI. METHODS: We estimated trends and their uncertainties of mean BMI for adults 20 years and older in 199 countries and territories. We obtained data from published and unpublished health examination surveys and epidemiological studies (960 country-years and 9·1 million participants). For each sex, we used a Bayesian hierarchical model to estimate mean BMI by age, country, and year, accounting for whether a study was nationally representative. FINDINGS: Between 1980 and 2008, mean BMI worldwide increased by 0·4 kg/m(2) per decade (95% uncertainty interval 0·2-0·6, posterior probability of being a true increase >0·999) for men and 0·5 kg/m(2) per decade (0·3-0·7, posterior probability >0·999) for women. National BMI change for women ranged from non-significant decreases in 19 countries to increases of more than 2·0 kg/m(2) per decade (posterior probabilities >0·99) in nine countries in Oceania. Male BMI increased in all but eight countries, by more than 2 kg/m(2) per decade in Nauru and Cook Islands (posterior probabilities >0·999). Male and female BMIs in 2008 were highest in some Oceania countries, reaching 33·9 kg/m(2) (32·8-35·0) for men and 35·0 kg/m(2) (33·6-36·3) for women in Nauru. Female BMI was lowest in Bangladesh (20·5 kg/m(2), 19·8-21·3) and male BMI in Democratic Republic of the Congo 19·9 kg/m(2) (18·2-21·5), with BMI less than 21·5 kg/m(2) for both sexes in a few countries in sub-Saharan Africa, and east, south, and southeast Asia. The USA had the highest BMI of high-income countries. In 2008, an estimated 1·46 billion adults (1·41-1·51 billion) worldwide had BMI of 25 kg/m(2) or greater, of these 205 million men (193-217 million) and 297 million women (280-315 million) were obese. INTERPRETATION: Globally, mean BMI has increased since 1980. The trends since 1980, and mean population BMI in 2008, varied substantially between nations. Interventions and policies that can curb or reverse the increase, and mitigate the health effects of high BMI by targeting its metabolic mediators, are needed in most countries. FUNDING: Bill & Melinda Gates Foundation and WHO.