Trends in Use of High-Cost Antihyperglycemic Drugs Among US Adults with Type 2 Diabetes.

BACKGROUND: Some antihyperglycemic drugs can reduce cardiovascular events, slow the progression of kidney disease, and prevent death, but they are more expensive than older drugs. OBJECTIVES: (1) To estimate trends in use of antihyperglycemic drugs by cost; (2) to examine use of high-cost drugs by race/ethnicity, income, and insurance status DESIGN: Cross-sectional analysis of the 2003-2018 National Health and Nutrition Examination Survey PARTICIPANTS: US adults ≥18 years with type 2 diabetes EXPOSURES: Race/ethnicity, income, and insurance status MAIN MEASURES: Low-cost noninsulin medications included any drugs that had at least one generic version approved by the Food and Drug Administration. Human regular, NPH, and premixed NPH/regular 70/30 insulins were classified as low-cost. All other noninsulin medications and insulins were considered high-cost KEY RESULTS: The sample included 7,394 patients. Prevalence of use of low-cost noninsulin drugs increased from 37% in 2003-2004 to 52% in 2017-2018. Use of high-cost noninsulin drugs decreased from 2003-2004 to 2013-2014 and then slowly increased. Use of low-cost insulin decreased from 7 to 2% while high-cost insulin rose from 4 to 16%. In multivariable analysis, non-White patients had 25-35% lower odds of receiving high-cost drugs than non-Hispanic Whites. Health insurance was associated with more than twice the odds of having high-cost drugs compared to no insurance. Patients with higher HbA1c or moderate obesity were also more likely to use high-cost drugs. Sex, income, and insurance type were not associated with receipt of high-cost drugs. CONCLUSIONS: There was a shift in utilization from high- to low-cost noninsulin drugs, but since 2013-2014 the trend has slowly reversed with increased use of newer, more expensive drug classes. High-cost insulin analogs have almost completely replaced lower cost human insulins. Disparities in receipt of diabetes drugs by race/ethnicity and insurance must be addressed to ensure that cost is not a barrier for disadvantaged populations.

The Impact of New and Renewed Restrictive State Abortion Laws on Pregnancy-Capable People with Diabetes.

PURPOSE OF REVIEW: When the Supreme Court handed down its decision in Dobbs v Jackson Women's Health Organization in June 2022, the constitutional right to abortion was no longer protected by Roe v Wade. Fifteen states now have total or near-total bans on abortion care or no clinics providing abortion services. We review how these restrictions affect the medical care of people with pregestational diabetes. RECENT FINDINGS: Of the ten states with the highest percent of adult women living with diabetes, eight currently have complete or 6-week abortion bans. People with diabetes are at high risk of diabetes-related pregnancy complications and pregnancy-related diabetes complications and are disproportionately burdened by abortion bans. Abortion is an essential part of comprehensive, evidence-based diabetes care, yet no medical society has published guidelines on pregestational diabetes that explicitly discuss the importance and role of safe abortion care. Medical societies enacting standards for diabetes care and clinicians providing diabetes care must advocate for access to abortion to reduce pregnancy-related morbidity and mortality for pregnant people with diabetes.

Phthalate exposure is associated with more rapid body fat gain in midlife women: The Study of Women's Health Across the Nation (SWAN) Multi-Pollutant Study.

Obesity is a major threat to health, but the etiology of obesity is incompletely understood. Phthalates, synthetic chemicals ubiquitous in the environment, are suspected to have obesogenic effects, but the relationship of phthalates and obesity in humans remains uncertain. We examined whether phthalate exposure was associated with body fat gain in midlife women. We analyzed data from 1369 women in the Study of Women's Health Across the Nation Multi-Pollutant Study. Eleven phthalate metabolites measured in spot urine samples at baseline (1999/2000) were standardized with covariate-adjusted creatinine. Body weight (BW), fat mass (FM) from dual-energy X-ray absorptiometry (DXA), and body fat percentage (BF%) from DXA were measured near-annually until 2016/2017. For each metabolite, linear mixed effects models with time and log2(metabolite) interactions were examined, adjusting for demographic, lifestyle, and menopause-related factors. Analyses were conducted overall and stratified by baseline obesity status. As sensitivity analyses, all analyses were repeated using a second set of metabolites measured in 2002/2003. Higher levels of all metabolites except mono-carboxy-isononyl phthalate were associated with faster increases in BF%. Per doubling of metabolite concentrations, differences in five-year BF% change ranged from 0.03 percentage point (ppt) (95% confidence interval (CI): -0.03, 0.09) for mono-isobutyl phthalate to 0.09 ppt (95% CI: 0.02, 0.16) for mono(3-carboxypropyl) phthalate. Results were similar for FM change, but associations with BW change were mostly null. In stratified analyses by baseline obesity status, positive associations were strongest in women who were normal/underweight at baseline. When metabolites from 2002/2003 were used as exposures, most associations were attenuated and not statistically significant, but they remained positive for normal/underweight women. In conclusion, phthalate metabolites were associated with more rapid body fat gain in midlife women, but our results need confirmation given attenuation of estimates in the sensitivity analyses.

Cost-effectiveness of carotid artery stenting vs endarterectomy: A simulation.

OBJECTIVE: Clinical trials conducted before the introduction of modern medical management to prevent stroke demonstrated that carotid endarterectomy (CEA) and carotid artery stenting (CAS) prevent stroke following transient ischemic attack (TIA). We compared the cost-effectiveness of CEA, CAS, and modern medical management in two secular settings of medical management in individuals with incident TIA and type 2 diabetes. METHODS: Using simulation modeling, our base-case analyses were performed from the healthcare sector perspective over a 20-year time horizon with an annual 3% discount rate applied to both costs and quality-adjusted life years (QALYs). Outcomes depended on age, sex, biomarkers associated with cardiovascular risk, and treatment effects based on a validated model of type 2 diabetes. Our simulation population was drawn from the National Health and Nutrition Examination Survey (NHANES) 2014 cohort. Costs for modern medical management were based on average wholesale prices, and revascularization costs were derived from published literature. One-way and probabilistic sensitivity analyses were conducted. RESULTS: Compared to all other strategies, historical medical management plus CEA was either cost-saving or cost-effective at a threshold of $100,000 per QALY gained. Modern medical management was cost-effective compared to historical medical management without revascularization at a $100,000 acceptability threshold. However, both revascularization approaches (plus medical management) were cost-saving compared to modern medical management alone. CONCLUSION: Among individuals requiring carotid revascularization, carotid endarterectomy is the cost-effective strategy to treat individuals with type 2 diabetes following a TIA. For individuals for whom revascularization is contraindicated, modern medical therapy is cost-effective.

Per- and polyfluoroalkyl substances and incident diabetes in midlife women: the Study of Women's Health Across the Nation (SWAN).

AIMS/HYPOTHESIS: Diabetogenic effects of per- and polyfluoroalkyl substances (PFAS) have been suggested. However, evidence based on prospective cohort studies is limited. We examined the association between serum PFAS concentrations and incident diabetes in the Study of Women's Health Across the Nation Multi-Pollutant Study (SWAN-MPS). METHODS: We included 1237 diabetes-free women aged 45-56 years at baseline (1999-2000) who were followed up to 2017. At each follow-up visit, women with incident diabetes were identified by the presence of one or more of the following conditions: (1) use of a glucose-lowering medication at any visit; (2) fasting glucose ≥7 mmol/l on two consecutive visits while not on steroids; and (3) any two visits with self-reported diabetes and at least one visit with fasting blood glucose ≥7 mmol/l. Serum concentrations of 11 PFAS were quantified by online solid-phase extraction-HPLC-isotope dilution-tandem MS. Seven PFAS with high detection rates (>96%) (n-perfluorooctanoic acid [n-PFOA], perfluorononanoic acid [PFNA], perfluorohexane sulfonic acid [PFHxS], n-perfluorooctane sulfonic acid [n-PFOS], sum of perfluoromethylheptane sulfonic acid isomers [Sm-PFOS], 2-[N-methyl-perfluorooctane sulfonamido] acetic acid [MeFOSAA] and 2-[N-ethyl-perfluorooctane sulfonamido] acetic acid) were included in data analysis. Cox proportional hazards models were used to compute HRs and 95% CIs. Quantile-based g-computation was used to evaluate the joint effects of PFAS mixtures. RESULTS: After adjustment for race/ethnicity, site, education, smoking status, alcohol consumption, total energy intake, physical activity, menopausal status and BMI, the HR (95% CI) comparing the lowest with the highest tertile was 1.67 (1.21, 2.31) for n-PFOA (ptrend = 0.001), 1.58 (1.13, 2.21) for PFHxS (ptrend = 0.003), 1.36 (0.97, 1.90) for Sm-PFOS (ptrend = 0.05), 1.85 (1.28, 2.67) for MeFOSAA (ptrend = 0.0004) and 1.64 (1.17, 2.31) for the sum of four common PFAS (n-PFOA, PFNA, PFHxS and total PFOS) (ptrend = 0.002). Exposure to seven PFAS as mixtures was associated with an HR of 2.62 (95% CI 1.12, 6.20), comparing the top with the bottom tertiles for all seven PFAS. CONCLUSIONS/INTERPRETATION: This study suggests that PFAS may increase diabetes risk in midlife women. Reduced exposure to these 'forever and everywhere chemicals' may be an important preventative approach to lowering population-wide diabetes risk.

Metals and risk of incident metabolic syndrome in a prospective cohort of midlife women in the United States.

Exposure to metals may contribute to the development of metabolic syndrome (MetS); however, evidence from midlife women who are at greater risk of cardiometabolic disease is limited. We assessed the associations of 15 urinary metal concentrations with incident MetS in a prospective cohort of midlife women in the United States. The study population included 947 White, Black, Chinese and Japanese women, aged 45-56 years, free of MetS at baseline (1999-2000), who participated in the Study of Women's Health Across the Nation Multi-Pollutant Study. Fifteen metals were detected in almost all participants urine samples using inductively coupled plasma mass spectrometry at the baseline. Incident MetS was identified annually through 2017 as having at least three of the following five components: high blood pressure, impaired fasting glucose, abdominal obesity, high triglycerides, and poor high-density lipoprotein cholesterol. We used the Cox proportional hazards models to investigate the associations between individual metals and MetS incidence. The adjusted hazard ratios (HR) (95% CI) for MetS in associations with each doubling of urinary metal concentration were 1.14 (1.08, 1.23) for arsenic, 1.14 (1.01, 1.29) for cobalt, and 1.20 (1.06, 1.37) for zinc. We further evaluated the associations between metal mixtures and MetS using the elastic net penalized Cox model and summarized the results into the environmental risk score (ERS). Arsenic, barium, cobalt, copper, nickel, antimony, thallium, and zinc had positive weights, and cadmium, cesium, mercury, molybdenum, lead, and tin had negative weights in the construction of the ERS. The adjusted HR of MetS comparing 75th vs. 25th percentiles of the ERS was 1.45 (1.13, 1.87). These findings support the view that arsenic, cobalt, zinc, as well as metal mixtures, might influence the risks of incident MetS in midlife women.

[Integrating hypertension and diabetes management in primary health care settings: HEARTS as a toolIntegrando o manejo da hipertensão e do diabetes na atenção primária à saúde: uso do HEARTS como instrumento]. / HEARTS como herramienta para integrar el manejo de la hipertensión y la diabetes en los entornos de atención primaria de salud.

Hypertension and diabetes are modifiable cardiovascular disease (CVD) risk factors that contribute to nearly one-third of all deaths in the Americas Region each year (2.3 million deaths). Despite advances in the detection and clinical management of hypertension and diabetes, there are substantial gaps in their implementation globally and in the Region. The considerable overlap in risk factors, prognosis, and treatment of hypertension and diabetes creates a unique opportunity for a unified implementation model for management at the population level. This report highlights one such high-profile effort, the Pan American Health Organization's "HEARTS in the Americas" program, based on the World Health Organization's HEARTS Technical Package for Cardiovascular Disease Management in Primary Health Care. The HEARTS program aims to improve the implementation of preventive CVD care in primary health systems using six evidence-based, pragmatic components: Healthy-lifestyle counseling, Evidence-based protocols, Access to essential medicines and technology, Risk-based CVD management, Team-based care, and Systems for monitoring. To date, HEARTS implementation projects have focused primarily on hypertension given that it is the leading modifiable CVD risk factor and can be treated cost-effectively. The objective of this report is to describe opportunities for integration of diabetes clinical care and policy within the HEARTS hypertension framework. A substantial global burden of disease could be averted with integrated primary care management of these conditions. Thus, there is an urgency in applying lessons from HEARTS to close these implementation gaps and improve the integrated detection, treatment, and control of diabetes and hypertension.

Hipertensão e diabetes são fatores de risco modificáveis para doenças cardiovasculares (DCV) que contribuem para quase um terço de todas as mortes na Região das Américas a cada ano (2,3 milhões de mortes). Apesar dos avanços na detecção e no manejo clínico da hipertensão e do diabetes, existem lacunas importantes em sua implementação mundialmente e na região. A sobreposição considerável de fatores de risco, prognóstico e tratamento da hipertensão e do diabetes cria uma oportunidade única para um modelo de implementação unificado para o manejo dessas doenças em nível populacional. Este relatório destaca um desses esforços de alto nível, o programa "HEARTS nas Américas" da Organização Pan-Americana da Saúde, baseado no Pacote Técnico HEARTS da Organização Mundial da Saúde para o manejo de DCV na atenção primária à saúde. O programa HEARTS visa melhorar a implementação de cuidados preventivos de DCV nos sistemas de atenção primária utilizando seis componentes pragmáticos e baseados em evidências: Hábitos saudáveis (aconselhamento a pacientes), protocolos baseados em Evidências, Acesso a medicamentos e tecnologias essenciais, manejo das DCV baseado em Risco, Trabalho de equipe como base para a atenção e Sistemas de monitoramento. Até hoje, os projetos de implementação do HEARTS têm se concentrado principalmente na hipertensão, considerando que é o principal fator de risco modificável de DCV e pode ser tratada de forma custo-efetiva. O objetivo deste relatório é descrever as oportunidades de integração do manejo clínico e de políticas para o diabetes dentro da estrutura HEARTS de manejo da hipertensão. Uma importante carga global de doença poderia ser evitada com o manejo integrado dessas duas afecções na atenção primária. Assim, há uma urgência na aplicação das lições de HEARTS para fechar estas lacunas de implementação e melhorar a detecção, o tratamento e o controle integrados do diabetes e da hipertensão.

Integrating hypertension and diabetes management in primary health care settings: HEARTS as a tool.

Hypertension and diabetes are modifiable cardiovascular disease (CVD) risk factors that contribute to nearly one-third of all deaths in the Americas Region each year (2.3 million deaths). Despite advances in the detection and clinical management of hypertension and diabetes, there are substantial gaps in their implementation globally and in the Region. The considerable overlap in risk factors, prognosis, and treatment of hypertension and diabetes creates a unique opportunity for a unified implementation model for management at the population level. This report highlights one such high-profile effort, the Pan American Health Organization's "HEARTS in the Americas" program, based on the World Health Organization's HEARTS Technical Package for Cardiovascular Disease Management in Primary Health Care. The HEARTS program aims to improve the implementation of preventive CVD care in primary health systems using six evidence-based, pragmatic components: Healthy-lifestyle counseling, Evidence-based protocols, Access to essential medicines and technology, Risk-based CVD management, Team-based care, and Systems for monitoring. To date, HEARTS implementation projects have focused primarily on hypertension given that it is the leading modifiable CVD risk factor and can be treated cost-effectively. The objective of this report is to describe opportunities for integration of diabetes clinical care and policy within the HEARTS hypertension framework. A substantial global burden of disease could be averted with integrated primary care management of these conditions. Thus, there is an urgency in applying lessons from HEARTS to close these implementation gaps and improve the integrated detection, treatment, and control of diabetes and hypertension.

La hipertensión y la diabetes son los factores de riesgo modificables de las enfermedades cardiovasculares asociados a casi un tercio de todas las muertes en la Región de las Américas cada año (2,3 millones). A pesar de los avances en la detección y el manejo clínico de la hipertensión y la diabetes, existen brechas sustanciales en la implementación a nivel regional y mundial. El considerable solapamiento en los factores de riesgo, el pronóstico y el tratamiento de la hipertensión y la diabetes crea una oportunidad única para un modelo unificado de implementación para el manejo a nivel poblacional. En este informe se pone de relieve una iniciativa importante de este tipo, el programa HEARTS en las Américas de la Organización Panamericana de la Salud, basado en el paquete técnico HEARTS para el manejo de las enfermedades cardiovasculares en la atención primaria de salud. El programa HEARTS tiene como objetivo mejorar la implementación de la atención preventiva de las enfermedades cardiovasculares en los sistemas de atención primaria de salud mediante seis componentes pragmáticos basados en la evidencia: Hábitos y estilos de vida saludables: asesoramiento para los pacientes; Evidencia: protocolos basados en la evidencia; Acceso a medicamentos y tecnologías esenciales; Riesgo cardiovascular: manejo de las enfermedades cardiovasculares basado en el riesgo; Trabajo en equipos; y Sistemas de monitoreo. Hasta la fecha, los proyectos de implementación de HEARTS se han centrado principalmente en la hipertensión, dado que es el principal factor de riesgo modificable de las enfermedades cardiovasculares y puede tratarse de una manera costo-eficaz. El objetivo de este informe es describir las oportunidades para la integración de la política y la atención clínica en el marco HEARTS para la hipertensión. Se podría evitar una significativa carga mundial de enfermedad con un manejo integrado de la atención primaria de estos problemas de salud. Por lo tanto, existe una urgencia en la aplicación de las enseñanzas de HEARTS para salvar estas brechas en la implementación y mejorar la detección, el tratamiento y el control integrados de la diabetes y la hipertensión.

Hipertensão e diabetes são fatores de risco modificáveis para doenças cardiovasculares (DCV) que contribuem para quase um terço de todas as mortes na Região das Américas a cada ano (2,3 milhões de mortes). Apesar dos avanços na detecção e no manejo clínico da hipertensão e do diabetes, existem lacunas importantes em sua implementação mundialmente e na região. A sobreposição considerável de fatores de risco, prognóstico e tratamento da hipertensão e do diabetes cria uma oportunidade única para um modelo de implementação unificado para o manejo dessas doenças em nível populacional. Este relatório destaca um desses esforços de alto nível, o programa "HEARTS nas Américas" da Organização Pan-Americana da Saúde, baseado no Pacote Técnico HEARTS da Organização Mundial da Saúde para o manejo de DCV na atenção primária à saúde. O programa HEARTS visa melhorar a implementação de cuidados preventivos de DCV nos sistemas de atenção primária utilizando seis componentes pragmáticos e baseados em evidências: Hábitos saudáveis (aconselhamento a pacientes), protocolos baseados em Evidências, Acesso a medicamentos e tecnologias essenciais, manejo das DCV baseado em Risco, Trabalho de equipe como base para a atenção e Sistemas de monitoramento. Até hoje, os projetos de implementação do HEARTS têm se concentrado principalmente na hipertensão, considerando que é o principal fator de risco modificável de DCV e pode ser tratada de forma custo-efetiva. O objetivo deste relatório é descrever as oportunidades de integração do manejo clínico e de políticas para o diabetes dentro da estrutura HEARTS de manejo da hipertensão. Uma importante carga global de doença poderia ser evitada com o manejo integrado dessas duas afecções na atenção primária. Assim, há uma urgência na aplicação das lições de HEARTS para fechar estas lacunas de implementação e melhorar a detecção, o tratamento e o controle integrados do diabetes e da hipertensão.

Perfluoroalkyl and polyfluoroalkyl substances and body size and composition trajectories in midlife women: the study of women's health across the nation 1999-2018.

BACKGROUND/OBJECTIVES: Perfluoroalkyl and polyfluoroalkyl substances (PFAS) have been suggested as obesogens but epidemiologic evidence is limited. We examined associations of serum PFAS concentrations with longitudinal trajectories of weight, waist circumference (WC), fat mass, and proportion fat in midlife women. SUBJECTS/METHODS: This study included 1,381 midlife women, with a total of 15,000 repeated measures from the multi-racial/ethnic Study of Women's Health Across the Nation between 1999 and 2018. The average follow-up was 14.9 (range: 0-18.6) years. Body size (objectively measured weight and WC) and body composition from dual-energy X-ray absorptiometry were assessed at near-annual visits. Linear mixed models with piecewise linear splines were utilized to model non-linear trajectories of body size and composition. RESULTS: After multivariable adjustment, PFAS concentrations were positively associated with weight, WC, fat mass, and proportion fat at baseline and during follow-up. Comparing the highest to the lowest tertiles of PFAS concentrations, adjusted geometric mean weight was 73.9 kg vs. 69.6 kg for PFOS (P < 0.0001), and 74.0 vs. 69.4 kg for linear PFOA (P < 0.0001) at baseline. Women with the highest tertile of PFOS had an annual increase rate of 0.33% (95% CI: 0.27%, 0.40%) in weight, compared to the lowest tertile with 0.10% (95% CI: 0.04%, 0.17%) (P < 0.0001). PFOS was also significantly related to higher increase rates in WC (difference = 0.12% per year, P = 0.002) and fat mass (difference = 0.25% per year, P = 0.0002). EtFOSAA and MeFOSAA showed similar effects to PFOS. Although PFHxS was not related to body size or fat at baseline, PFHxS was significantly associated with accelerated increases in weight (P < 0.0001), WC (P = 0.003), fat mass (P < 0.0001), and proportion fat (P = 0.0009). No significant results were found for PFNA. CONCLUSIONS: Certain PFAS were positively associated with greater body size and body fat, and higher rates of change over time. PFAS may be an underappreciated contributing factor to obesity risk.

Urinary metals and adipokines in midlife women: The Study of Women's Health Across the nation (SWAN).

BACKGROUND: Information on the associations between metal exposures and adipokines in human populations is limited and results are inconsistent. We evaluated the associations between metals and adipokines. METHODS: Urinary concentrations of 15 metals (arsenic, barium, cadmium, cobalt, cesium, copper, mercury, manganese, molybdenum, nickel, lead, antimony, tin, thallium, and zinc) were measured in 1999-2000 among 1228 women of the Study of Women's Health Across the Nation Multi-Pollutant Study. Serum adipokines including high molecular weight (HMW)-adiponectin, leptin, and soluble leptin receptor (sOB-R) were measured at the follow-up visit (2002-2003). Linear regression models with adaptive elastic-net (AENET) were fit to identify metals associated with adipokines and to compute estimated percent changes in adipokines for one standard deviation increase in log-transformed urinary metal concentrations. RESULTS: After adjustment for confounders, urinary molybdenum was associated with a 5.54% higher level (95% CI: 1.36%, 9.90%), whereas cadmium was associated with a 4.53% lower level (95% CI: -8.17%, -0.76%) of HMW-adiponectin. Urinary molybdenum was also associated with a 5.95% lower leptin level (95% CI: -10.15%, -1.56%) and a 2.98% (95% CI: 0.69%, 5.32%) higher sOB-R level. Urinary cesium and lead were associated with a 3.58% (95% CI: -6.06%, -1.03%) and a 2.53% (95% CI: -4.80%, -0.21%) lower level of sOB-R, respectively. CONCLUSIONS: Our findings suggest that molybdenum was associated with favorable profiles of HMW-adiponectin, leptin, and sOB-R. Exposures to cadmium, cesium, and lead were associated with adverse adipokine profiles.

Incidence of ESKD Among Native Hawaiians and Pacific Islanders Living in the 50 US States and Pacific Island Territories.

RATIONALE & OBJECTIVE: Native Hawaiians and Pacific Islanders (NHPI) have been reported to have the highest rates of incident end-stage kidney disease (ESKD) compared with other races in the United States. However, these estimates were likely biased upward due to the exclusion of nearly half the NHPI population that reports multiple races in the US Census. We sought to estimate the incidence rate of ESKD, including individuals reporting multiple races, and describe the clinical characteristics of incident cases by race and location. STUDY DESIGN: Health care database study. SETTING & PARTICIPANTS: US residents of the 50 states and 3 Pacific Island territories of the United States whose ESKD was recorded in the US Renal Data System (USRDS) between 2007 and 2016, as well as US residents recorded in the 2010 Census. PREDICTORS: Age, sex, race, body mass index, primary cause of ESKD, comorbid conditions, estimated glomerular filtration rate, pre-ESKD nephrology care, and hemoglobin A1c level among ESKD cases. OUTCOME: Initiation of maintenance dialysis or transplantation for kidney failure. ANALYTICAL APPROACH: Crude ESKD incidence rates (cases/person-years) were estimated using both single- and multiple-race reporting. RESULTS: Even after inclusion of multirace reporting, NHPI had the highest ESKD incidence rate among all races in the 50 states (921 [95% CI, 904-938] per million population per year)-2.7 times greater than whites and 1.2 times greater than blacks. Also using multirace reporting, the NHPI ESKD incident rate in the US territories was 941 (95% CI, 895-987) per million population per year. Diabetes was listed as the primary cause of ESKD most frequently for NHPI and American Indians/Alaska Natives. Sensitivity analysis adjusting for age and sex demonstrated greater differences in rates between NHPI and other races. Diabetes was the primary cause of ESKD in 60% of incident NHPI cases. Patients with ESKD living in the territories had received less pre-ESKD nephrology care than had patients living in the 50 states. LIMITATIONS: Different methods of race classification in the USRDS versus the US Census. CONCLUSIONS: NHPI living in the 50 US states and Pacific territories had the highest rates of ESKD incidence compared with other races. Further research and efforts are required to understand the reasons for and define how best to address this racial disparity.

Evaluating the Ability of Economic Models of Diabetes to Simulate New Cardiovascular Outcomes Trials: A Report on the Ninth Mount Hood Diabetes Challenge.

OBJECTIVES: The cardiovascular outcomes challenge examined the predictive accuracy of 10 diabetes models in estimating hard outcomes in 2 recent cardiovascular outcomes trials (CVOTs) and whether recalibration can be used to improve replication. METHODS: Participating groups were asked to reproduce the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Calibration was performed and additional analyses assessed model ability to replicate absolute event rates, hazard ratios (HRs), and the generalizability of calibration across CVOTs within a drug class. RESULTS: Ten groups submitted results. Models underestimated treatment effects (ie, HRs) using uncalibrated models for both trials. Calibration to the placebo arm of EMPA-REG OUTCOME greatly improved the prediction of event rates in the placebo, but less so in the active comparator arm. Calibrating to both arms of EMPA-REG OUTCOME individually enabled replication of the observed outcomes. Using EMPA-REG OUTCOME-calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately. Applying canagliflozin HRs directly provided the best fit. CONCLUSIONS: The Ninth Mount Hood Diabetes Challenge demonstrated that commonly used risk equations were generally unable to capture recent CVOT treatment effects but that calibration of the risk equations can improve predictive accuracy. Although calibration serves as a practical approach to improve predictive accuracy for CVOT outcomes, it does not extrapolate generally to other settings, time horizons, and comparators. New methods and/or new risk equations for capturing these CV benefits are needed.

Racial differences in prediabetes prevalence by test type for the US pediatric and adult population: NHANES 1999-2016.

BACKGROUND: Previous studies have shown that US estimates of prediabetes or diabetes differ depending on test type, fasting plasma glucose (FPG) vs hemoglobin A1c (HbA1c). Given age, race, and test differences reported in the literature, we sought to further examine these differences in prediabetes detection using a nationally representative sample. METHODS: Using the National Health and Nutrition Examination Survey (NHANES) 1999-2016, individuals were identified as having prediabetes with an HbA1c of 5.7% to 6.4% or a FPG of 100 to 125 mg/dL. We excluded individuals with measurements in the diabetic range. We ran generalized estimating equation logistic regressions to examine the relationship between age, race, and test type with interactions, controlling for sex and body mass index. We compared the difference in predicted prediabetes prevalence detected by impaired fasting glycemia (IFG) vs HbA1c by race/ethnicity among children and adults separately using adjusted Wald tests. RESULTS: The absolute difference in predicted prediabetes detected by IFG vs HbA1c was 19.9% for white adolescents, 0% for black adolescents, and 20.1% for Hispanic adolescents; 21.4% for white adults, -1.2% for black adults, and 19.2% for Hispanic adults. Using adjusted Wald tests, we found the absolute differences between black vs white and black vs Hispanic individuals to be significant, but, not between Hispanic and white individuals among children and adults separately. CONCLUSIONS: These observations highlight differences in test performance among racial/ethnic groups. Our findings corroborate the need for further studies to determine appropriate HbA1c cutoff levels for diagnosis of prediabetes by age group and race.

A CROSS-SECTIONAL STUDY OF THE ASSOCIATION BETWEEN THE 1-HOUR ORAL GLUCOSE TOLERANCE TEST AND THE METABOLIC SYNDROME IN A HIGH-RISK SAMPLE WITH IMPAIRED FASTING GLUCOSE.

Objective: The aim of this study was to evaluate the association between the 1-hour oral glucose tolerance test (OGTT) (≥155 mg/dL) and metabolic syndrome (MS) in a sample with previous impaired fasting glucose (IFG). Methods: Three hundred and twenty four Peruvian subjects with a history of IFG ≥100 mg/dL were selected for a cross-sectional study. They underwent a 75 g OGTT and were assigned to different groups according to the result. We evaluated the association between 1-hour OGTT and MS. Results: The mean age was 56.5 ± 12.6 years and 191 (61.5%) were female. During the OGTT, we found 28 (8.6%) subjects with diabetes, 74 (22.8%) with IGT, and 222 (68.5%) with a normal glucose tolerance test with a 2-hour glucose <140 mg/dL (NGT). In the NGT group, 124 (38.3%) had 1-hour glucose levels <155 mg/dL, while 98 (30.2%) had 1-hour glucose levels ≥155 mg/dL. Evaluating the association between the 1-hour value in the OGTT and MS, we found that subjects with a 1-hour glucose ≥155 mg/dL were more than twice as likely to have MS as those with a 1-hour glucose <155 mg/dL (odds ratio = 2.64, 95% confidence interval: 1.52 to 4.57). In addition, body mass index, fasting glycemia, triglycerides, and waist circumferences were significantly higher in subjects with 1-hour glucose levels ≥155 mg/dL compared to those with 1-hour glucose levels <155 mg/dL (P<.05). Conclusion: Among subjects with IFG, performing an OGTT was helpful to identify subjects with 1-hour glucose levels ≥155 mg/dL and NGT who were significantly more likely to have MS and a worse cardiometabolic risk profile. Abbreviations: AST = aspartate aminotransferase; BMI = body mass index; CI = confidence interval; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; LDL = low-density lipoprotein; MS = metabolic syndrome; NGT = normal glucose tolerance; OGTT = oral glucose tolerance test; OR = odds ratio; T2DM = type 2 diabetes; TG = triglycerides.

Projecting ESRD Incidence and Prevalence in the United States through 2030.

BACKGROUND: Population rates of obesity, hypertension, diabetes, age, and race can be used in simulation models to develop projections of ESRD incidence and prevalence. Such projections can inform long-range planning for ESRD resources needs. METHODS: We used an open compartmental simulation model to estimate the incidence and prevalence of ESRD in the United States through 2030 on the basis of wide-ranging projections of population obesity and ESRD death rates. Population trends in age, race, hypertension, and diabetes were on the basis of data from the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey and the US Census. RESULTS: The increase in ESRD incidence rates within age and race groups has leveled off and/or declined in recent years, but our model indicates that population changes in age and race distribution, obesity and diabetes prevalence, and ESRD survival will result in a 11%-18% increase in the crude incidence rate from 2015 to 2030. This incidence trend along with reductions in ESRD mortality will increase the number of patients with ESRD by 29%-68% during the same period to between 971,000 and 1,259,000 in 2030. CONCLUSIONS: The burden of ESRD will increase in the United States population through 2030 due to demographic, clinical, and lifestyle shifts in the population and improvements in RRT. Planning for ESRD resource allocation should allow for substantial continued growth in the population of patients with ESRD. Future interventions should be directed to preventing the progression of CKD to kidney failure.

Risk of Progression of Nonalbuminuric CKD to End-Stage Kidney Disease in People With Diabetes: The CRIC (Chronic Renal Insufficiency Cohort) Study.

BACKGROUND: Reduced glomerular filtration rate (GFR) in the absence of albuminuria is a common manifestation of chronic kidney disease (CKD) in diabetes. However, the frequency with which it progresses to end-stage kidney disease (ESKD) is unknown. STUDY DESIGN: Multicenter prospective cohort study. SETTING & PARTICIPANTS: We included 1,908 participants with diabetes and reduced GFR enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study in the United States. PREDICTORS: Urinary albumin and protein excretion. OUTCOMES: Incident ESKD, CKD progression (ESKD or ≥50% reduction in estimated GFR [eGFR] from baseline), and annual rate of decline in kidney function. MEASUREMENTS: ESKD was ascertained by self-report and by linkage to the US Renal Data System. We used Cox proportional hazards modeling to estimate the association of albuminuria and proteinuria with incident ESKD or CKD progression and linear mixed-effects models to assess differences in eGFR slopes among those with and without albuminuria. RESULTS: Mean eGFR at baseline was 41.2mL/min/1.73m2. Normal or mildly increased 24-hour urinary albumin excretion (<30mg/d) at baseline was present in 28% of participants, but in only 5% of those progressing to ESKD. For those with baseline normal or mildly increased albuminuria, moderately increased albuminuria (albumin excretion, 30-299mg/d), and 2 levels of severely increased albuminuria (albumin excretion, 300-999 and ≥1,000mg/d): crude rates of ESKD were 7.4, 34.8, 78.7, and 178.7 per 1,000 person-years, respectively; CKD progression rates were 17.0, 61.4, 130.5, and 295.1 per 1,000 person-years, respectively; and annual rates of eGFR decline were -0.17, -1.35, -2.74, and -4.69mL/min/1.73m2, respectively. LIMITATIONS: We were unable to compare the results with healthy controls. CONCLUSIONS: In people with diabetes with reduced eGFRs, the absence of albuminuria or proteinuria is common and carries a much lower risk for ESKD, CKD progression, or rapid decline in eGFR compared with those with albuminuria or proteinuria. The rate of eGFR decline in normoalbuminuric CKD was similar to that reported for the general diabetic population.

Computer Modeling of Diabetes and Its Transparency: A Report on the Eighth Mount Hood Challenge.

OBJECTIVES: The Eighth Mount Hood Challenge (held in St. Gallen, Switzerland, in September 2016) evaluated the transparency of model input documentation from two published health economics studies and developed guidelines for improving transparency in the reporting of input data underlying model-based economic analyses in diabetes. METHODS: Participating modeling groups were asked to reproduce the results of two published studies using the input data described in those articles. Gaps in input data were filled with assumptions reported by the modeling groups. Goodness of fit between the results reported in the target studies and the groups' replicated outputs was evaluated using the slope of linear regression line and the coefficient of determination (R2). After a general discussion of the results, a diabetes-specific checklist for the transparency of model input was developed. RESULTS: Seven groups participated in the transparency challenge. The reporting of key model input parameters in the two studies, including the baseline characteristics of simulated patients, treatment effect and treatment intensification threshold assumptions, treatment effect evolution, prediction of complications and costs data, was inadequately transparent (and often missing altogether). Not surprisingly, goodness of fit was better for the study that reported its input data with more transparency. To improve the transparency in diabetes modeling, the Diabetes Modeling Input Checklist listing the minimal input data required for reproducibility in most diabetes modeling applications was developed. CONCLUSIONS: Transparency of diabetes model inputs is important to the reproducibility and credibility of simulation results. In the Eighth Mount Hood Challenge, the Diabetes Modeling Input Checklist was developed with the goal of improving the transparency of input data reporting and reproducibility of diabetes simulation model results.