A budget impact analysis of cost to implement a whole child health focused, family-based intervention in primary care for children with elevated BMI.

BACKGROUND: Although the cost of implementing evidence-based interventions (EBIs) is a key determinant of adoption, lack of cost information is widespread. We previously evaluated the cost of preparing to implement Family Check-Up 4 Health (FCU4Health), an individually tailored, evidence-based parenting program that takes a whole child approach, with effects on both behavioral health and health behavior outcomes, in primary care settings. This study estimates the cost of implementation, including preparation. METHODS: We assessed the cost of FCU4Health across the preparation and implementation phases spanning 32 months and 1 week (October 1, 2016-June 13, 2019) in a type 2 hybrid effectiveness-implementation study. This family-level randomized controlled trial took place in Arizona with n = 113 predominantly low-income, Latino families with children ages > 5.5 to < 13 years. Using electronic cost capture and time-based activity-driven methods, budget impact analysis from the perspective of a future FCU4Health adopting entity-namely, ambulatory pediatric care clinicians-was used to estimate the cost of implementation. Labor costs were based on 2021 Bureau of Labor Statistics Occupational Employment Statistics, NIH-directed salary cap levels or known salaries, plus fringe benefits at a standard rate of 30%. Non-labor costs were based on actual amounts spent from receipts and invoices. RESULTS: The cost of FCU4Health implementation to 113 families was $268,886 ($2380 per family). Actual per family cost varied widely, as individual tailoring resulted in families receiving a range of 1-15 sessions. The estimated cost of replicating implementation for future sites ranged from $37,636-$72,372 ($333-$641 per family). Using our previously reported preparation costs (i.e., $174,489; $1544 per family), with estimated replication costs of $18,524-$21,836 ($164-$193 per family), the total cost of delivering FCU4Health was $443,375 ($3924 per family), with total estimated replication costs of $56,160-$94,208 ($497-$834 per family). CONCLUSIONS: This study provides a baseline for costs associated with implementation of an individually tailored parenting program. Results provide critical information for decision makers and a model for future economic analysis and can be used to inform optimization thresholds for implementation and, when necessary, benchmarks for program adaptation to promote scale-up. TRIAL REGISTRATION: This trial was prospectively registered on January 6, 2017, at ClinicalTrials.gov (NCT03013309).

Patient Attribution-A Call for a System Redesign.

This Viewpoint discusses several shortcomings in patient attribution systems from the perspective of physicians and patients and proposes strategies to improve patient attribution accuracy to better advance the goals of alternative payment models.

The Prevalence of Cardiovascular Disease and Other Comorbidities Among American Indian and Alaska Native Adults with Diabetes.

AIMS: American Indians and Alaska Native (AI/ANs) peoples experience significant health disparities compared to the U.S. general population. We report comorbidities among AI/ANs with diabetes to guide efforts to improve their health status. METHODS: Drawing upon data for over 640,000 AI/ANs who used services funded by the Indian Health Service, we identified 43,518 adults with diabetes in fiscal year 2010. We reported the prevalence of comorbidities by age and cardiovascular disease (CVD) status. Generalized linear models were estimated to describe associations between CVD and other comorbidities. RESULTS: Nearly 15% of AI/AN adults had diabetes. Hypertension, CVD and kidney disease were comorbid in 77.9%, 31.6%, and 13.3%, respectively. Nearly 25% exhibited a mental health disorder; 5.7%, an alcohol or drug use disorder. Among AI/ANs with diabetes absent CVD, 46.9% had 2 or more other chronic conditions; the percentage among adults with diabetes and CVD was 75.5%. Hypertension and tobacco use disorders were associated with a 71% (95% CI for prevalence ratio: 1.63 - 1.80) and 33% (1.28 - 1.37) higher prevalence of CVD, respectively, compared to adults without these conditions. CONCLUSION: Detailed information on the morbidity burden of AI/ANs with diabetes may inform enhancements to strategies implemented to prevent and treat CVD and other comorbidities.

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

BACKGROUND: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. OBJECTIVES: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. METHODS: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. RESULTS: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. CONCLUSION: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care.

The Family Check-Up 4 Health (FCU4Health) is an adaptation of the Family Check-Up (FCU) for delivery in primary care settings. While maintaining the original FCU's focus on parenting and child behavioral health, we added content targeting health behaviors. This study evaluated whether the adapted FCU maintained positive effects on parenting (positive behavior support, limit setting, parental warmth) and child behavioral health (self-regulation, conduct problems, emotional problems). Pediatric (6-12 years) primary care patients with a BMI ≥ 85th%ile (n = 240) were recruited from primary care clinics in Phoenix. Children were 75% Latino, 49% female, and 73% Medicaid recipients. This type 2 effectiveness-implementation hybrid trial compared families randomized to FCU4Health (n = 141) or usual care (n = 99). FCU4Health was delivered over a period of 6 months. This study focuses on a priori secondary outcomes included parenting and child behavioral health targets of the original FCU, assessed at baseline and 3, 6, and 12 months. Significant improvements were found for the FCU4Health condition, compared to usual care, in parenting from baseline to the 3-month assessment [ß = .17 (.01; .32)]. Parenting predicted improvements in child self-regulation at 6-months [ß = .17 (.03; .30)], which in turn predicted reductions in conduct problems [ß = - .38 (- .51; - .23)] and emotional problems [ß = - .24 (- .38; - .09)] at 12 months. Ethnicity and language of delivery (English or Spanish) did not moderate these effects. The FCU4Health can improve parenting and child behavioral health outcomes when delivered in primary care.Trial Registration Trial registration number: NCT03013309 ClinicalTrials.gov.

Sex Differences in Diabetes Prevalence, Comorbidities, and Health Care Utilization among American Indians Living in the Northern Plains.

BACKGROUND: The American Indian (AI) population experiences significant diet-related health disparities including diabetes and cardiovascular disease (CVD). Owing to the relatively small sample size of AIs, the population is rarely included in large national surveys such as the NHANES. This exclusion hinders efforts to characterize potentially important differences between AI men and women, track the costs of these disparities, and effectively treat and prevent these conditions. OBJECTIVE: We examined the sex differences in diabetes prevalence, comorbidity experience, health care utilization, and treatment costs among AIs within a Northern Plains Indian Health Service (IHS) service unit. METHODS: We assessed data from a sample of 11,144 persons using an IHS service unit in the Northern Plains region of the United States. Detailed analyses were conducted for adults (n = 7299) on prevalence of diabetes by age and sex. We described sex differences in comorbidities, health care utilization, and treatment costs among the adults with diabetes. RESULTS: In our sample, adult men and women had a similar prevalence of diabetes (10.0% and 11.0%, respectively). The prevalence of CVD among men and women with diabetes was 45.7% and 34.0%, respectively. Among adults with diabetes, men had a statistically higher prevalence of hypertension and substance use disorders than women. The men were statistically less likely to have a non-substance use mental health disorder. Although men had higher utilization and costs for hospital inpatient services than women, the differences were not statistically significant. CONCLUSIONS: In this AI population, there were differences in comorbidity profiles between adult men and women with diabetes, which have differential mortality and cost consequences. Appropriate diabetes management addressing gender-specific comorbidities, such as substance use disorders for men and non-substance use mental health disorders for women, may help reduce additional comorbidities or complications to diabetes.

Translating evidence-based parenting programs for primary care: Stakeholder recommendations for sustainable implementation.

AIMS: To translate evidence-based programs (EBP) for a new setting, attention must be given to the characteristics of the intervention and the local setting, as well as evidence that is compelling to decision-makers. This paper describes the history of a partnership and stakeholder recommendations to inform the adaptation of an EBP for primary care. METHODS: We established a community advisory board (CAB) consisting of stakeholders with expertize in primary care delivery. A thematic analysis was conducted with fieldnotes and transcriptions from CAB meetings and regular meetings with participating clinics. RESULTS: We found that (a) parenting programs with a focus on behavioral and physical health are appropriate for this setting, (b) variability in the structure of primary care means implementation must be tailorable, and (c) financial and organizational outcomes are compelling for decision-makers. CONCLUSION: Factors related to the content and structure of evidence-based programs are uniquely related to distinct implementation outcomes of interest to key stakeholders.

Variability in asthma quality and costs in children with different Medicaid insurance plans in Maricopa County.

OBJECTIVE: To describe the variation in asthma quality and costs among children with different Medicaid insurance plans. METHODS: We used 2013 data from the Center for Health Information and Research, which houses a database that includes individuals who have Medicaid insurance in Arizona. We analyzed children ages 2-17 years-old who lived in Maricopa County, Arizona. Asthma medication ratio (AMR, a measure of appropriate asthma medication use), outpatient follow-up within 2 weeks after asthma-related hospitalization (a measure of continuity of care), asthma-related hospitalizations, and all emergency department (ED) visits were the primary quality metrics. Direct costs were reported in 2013 $US dollars. We used one-way analysis of variance to compare the health plans for AMR and per member cost (total, ER, and hospital), and the chi-squared test for the outpatient follow-up measure. We used coefficient of variation to identify variation of each measure across all individuals in the study. RESULTS: In 2013, 90,652 children in Maricopa County were identified as having asthma. The average patient-weighted AMR for children with persistent asthma was 0.35, well short of the goal of ≥0.70, and only 36% of hospitalized asthma patients had outpatient follow-up within 2 weeks of hospitalization. AMR, total costs, and ED costs varied significantly (p <.0001) when comparing health plans while hospital costs and outpatient follow-up showed no significant variation. CONCLUSIONS: Targeting appropriate medication use for asthma may help reduce variation, improve outcomes, and increase healthcare value for children with asthma and Medicaid insurance in the US.

The costs of treating American Indian adults with diabetes within the Indian Health Service.

OBJECTIVES: We examined the costs of treating American Indian adults with diabetes within the Indian Health Service (IHS). METHODS: We extracted demographic and health service utilization data from the IHS electronic medical reporting system for 32 052 American Indian adults in central Arizona in 2004 and 2005. We derived treatment cost estimates from an IHS facility-specific cost report. We examined chronic condition prevalence, medical service utilization, and treatment costs for American Indians with and without diabetes. RESULTS: IHS treatment costs for the 10.9% of American Indian adults with diabetes accounted for 37.0% of all adult treatment costs. Persons with diabetes accounted for nearly half of all hospital days (excluding days for obstetrical care). Hospital inpatient service costs for those with diabetes accounted for 32.2% of all costs. CONCLUSIONS: In this first study of treatment costs within the IHS, costs for American Indians with diabetes were found to consume a significant proportion of IHS resources. The findings give federal agencies and tribes critical information for resource allocation and policy formulation to reduce and eventually eliminate diabetes-related disparities between American Indians and Alaska Natives and other racial/ethnic populations.

Relationship of glycemia control to lipid and blood pressure lowering and atherosclerosis: the SANDS experience.

OBJECTIVES: Cardiovascular disease prevention for patients with type 2 diabetes is accomplished through hypertension and dyslipidemia management. Although studies have established strategies for lowering low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP), none have examined whether glycemia influences ability to achieve lipid and BP targets. This post hoc analysis from the Stop Atherosclerosis in Native Diabetics Study examines the role of baseline glycemia in achieving standard and aggressive targets and outcomes after 36 months. METHODS: Diabetic individuals aged > 40 years with no cardiovascular events (n = 499) were randomized to aggressive versus standard targets for LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and systolic BP (SBP). Management algorithms were used for both groups. Carotid ultrasound and echocardiography were performed at baseline and after 36 months. RESULTS: No differences were observed in baseline hemoglobin A1c between treatment groups nor any significant change in A1c after 36 months in either group. Baseline A1c, however, was significantly and negatively related to achieving LDL-C (P = .007), non-HDL-C (P = .03) and SBP targets (P = .007) and to changes in LDL-C (P = .007), non-HDL-C (P = .03) and SBP (P = .001) in both groups. Baseline A1c failed to predict progression of carotid intima medial thickness (CIMT) (P = .42) or left ventricular mass index (LVMI) (P = .10), nor was it related to the effects of lipid and BP lowering on CIMT and LVMI over 36 months. CONCLUSIONS: In diabetic adults with no cardiovascular disease events, A1c was negatively associated with ability to achieve LDL-C, non-HDL-C and SBP goals but was not independently related to treatment-associated changes in CIMT or LVMI over 36 months.

Achieving lipid targets in adults with type 2 diabetes: the Stop Atherosclerosis in Native Diabetics Study.

BACKGROUND: Although lipid management in diabetes is standard practice, goals often are neither met nor maintained. Strategies for achieving lower targets have not been explored. The Stop Atherosclerosis in Native Diabetics Study randomized patients with diabetes to standard versus aggressive lipid and blood pressure goals for 36 months. OBJECTIVE: To report strategies used to achieve and maintain lipid goals and to report adverse events (AEs). METHODS: Adults with type 2 diabetes and no history of cardiovascular disease (N = 499) were randomized to standard (low-density lipoprotein cholesterol [LDL-C] ≤ 100 mg/dL, non-high-density lipoprotein cholesterol [non-HDL-C] ≤ 130 mg/dL) or aggressive (LDL-C ≤ 70 mg/dL, non-HDL-C ≤ 100 mg/dL) targets. An algorithm was started with statin monotherapy, with intestinally acting agents added as required to reach LDL-C targets.Triglyceride [TG]-lowering agents were next used to reach non-HDL-C goals. Lipid management was performed by mid-level practitioners, with physician consultation, by the use of point-of-care lipid determinations. RESULTS: On average, both groups achieved the LDL-C and non-HDL-C goals within 12 months and maintained them throughout the study. At 36 months, mean (SD) LDL-C and non-HDL-C were 72 (24) and 102 (29) mg/dL in the aggressive group (AGG) and 104 (20) and 138 (26) mg/dL, respectively, in the standard group (STD); systolic blood pressure targets were 115 and 130 mmHg, respectively. A total of 68% of participants reached target LDL-C for greater than 50% of the visits and 46% for greater than 75% of visits. At 36 months, the AGG averaged 1.5 lipid lowering medications and the STD 1.2. Statins were used in 91% and 68% of the AGG and STD; ezetimibe by 31% and 10%; fibrates by 8% and 18%. No serious AEs were observed; AEs occurred in 18% of the AGG and 14% of the STD. CONCLUSION: Standard and aggressive lipid targets can be safely maintained in diabetic patients. Standardized algorithms, point-of-care lipid testing, and nonphysician providers facilitate care delivery.

Cost-effectiveness of lower targets for blood pressure and low-density lipoprotein cholesterol in diabetes: the Stop Atherosclerosis in Native Diabetics Study (SANDS) .

BACKGROUND: The Stop Atherosclerosis in Native Diabetics Study (SANDS) reported cardiovascular benefit of aggressive versus standard treatment targets for both low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in diabetic individuals. OBJECTIVE: In this analysis, we examined within trial cost-effectiveness of aggressive targets of LDL-C ≤70 mg/dL and systolic BP ≤115 mmHg versus standard targets of LDL-C ≤100 mg/dL and systolic BP ≤130 mmHg. DESIGN: Randomized, open label blinded-to-endpoint 3-year trial. DATA SOURCES: SANDS clinical trial database, Quality of Wellbeing survey, Centers for Medicare and Medicaid Services, Wholesale Drug Prices. TARGET POPULATION: American Indians ≥ age 40 years with type 2 diabetes and no previous cardiovascular events. TIME HORIZON: April 2003 to July 2007. PERSPECTIVE: Health payer. INTERVENTIONS: Participants were randomized to aggressive versus standard groups with treatment algorithms defined for both. OUTCOME MEASURES: Incremental cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Compared with the standard group, the aggressive group had slightly lower costs of medical services (-$116) but a 54% greater cost for BP medication ($1,242) and a 116% greater cost for lipid-lowering medication ($2,863), resulting in an increased cost of $3,988 over 3 years. Those in the aggressively treated group gained 0.0480 quality-adjusted life-years (QALY) over the standard group. When a 3% discount rate for costs and outcomes was used, the resulting cost per QALY was $82,589. RESULTS OF SENSITIVITY ANALYSIS: The use of a 25%, 50%, and 75% reduction in drug costs resulted in a cost per QALY of $61,329, $40,070, and $18,810, respectively. LIMITATIONS: This study was limited by use of a single ethnic group and by its 3-year duration. CONCLUSIONS: Within this 3-year study, treatment to lower BP and LDL-C below standard targets was not cost-effective because of the cost of the additional medications required to meet the lower targets. With the anticipated availability of generic versions of the BP and lipid-lowering drugs used in SANDS, the cost-effectiveness of this intervention should improve. Published by Elsevier Inc on behalf of the National Lipid Association.

Racial disparities in health status: a comparison of the morbidity among American Indian and U.S. adults with diabetes.

OBJECTIVE: American Indians and Alaska Natives are 2.3 times more likely to have diabetes than are individuals in the U.S. general population. The objective of this study was to compare morbidity among American Indian and U.S. adults with diabetes. RESEARCH DESIGN AND METHODS: We extracted demographic and health service utilization data for an adult American Indian population aged 18-64 years (n = 30,121) served by the Phoenix Service Unit from the Indian Health Service clinical reporting system. Similar data for a U.S. population (n = 1,500,002) with commercial health insurance, matched by age and sex to the American Indian population, were drawn from the MartketScan Research Database. We used Diagnostic Cost Groups to identify medical conditions for which each individual was treated and to assign a risk score to quantify his or her morbidity burden. We compared the prevalence of comorbidities and morbidity burden of American Indian and U.S. adults with diabetes. RESULTS: American Indians with diabetes had significantly higher rates of hypertension, cerebrovascular disease, renal failure, lower-extremity amputations, and liver disease than commercially insured U.S. adults with diabetes (P < 0.05). The American Indian prevalence rates were 61.2, 6.9, 3.9, 1.8, and 7.1%, respectively. The morbidity burden among the American Indian with diabetes exceeded that of the insured U.S. adults with diabetes by 50%. CONCLUSIONS: The morbidity burden associated with diabetes among American Indians seen at the Phoenix Service Unit far exceeded that of commercially insured U.S. adults. These findings point to the urgency of enhancing diabetes prevention and treatment services for American Indians/Alaska Natives to reduce diabetes-related disparities.

Effects of metformin and weight loss on serum alanine aminotransferase activity in the diabetes prevention program.

Nonalcoholic fatty liver disease (NAFLD) is associated with obesity, insulin resistance, and impaired glucose tolerance. We investigated whether metformin or changes in metabolic measurements (weight, fasting plasma glucose (FPG), or fasting insulin (FI)) improved serum alanine aminotransferase (ALT) activity, as a marker for NAFLD, in the Diabetes Prevention Program (DPP). From 1996 to 1999, 2,153 participants without marked elevations of serum ALT at baseline were randomized (1,081 to placebo, 1,072 to metformin) and treated for an average of 3.2 years. ALT increased during the first 2 years of the study, and was slightly but significantly lower in the participants randomized to metformin. In regression models adjusted for sex, baseline age, FPG, and FI, these differences remained significant, but disappeared after adjustment for weight, FPG, and FI changes at each examination. The 3-year cumulative incidence for development of abnormal ALT concentrations was not significantly different ((mean +/- s.e.) 21.4 +/- 1.4% and 24.6 +/- 1.4%, P = 0.11) in the metformin vs. placebo groups but was lower in individuals in both groups that lost more weight by the end of year 1 (metformin: 19.4 +/- 2.4% vs. 27.5 +/- 3.7%, for highest vs. lowest quartile of weight loss; placebo: 18.7 +/- 3.4% vs. 28.8 +/- 2.6%). Over 3 years of follow-up in persons at high risk for development of diabetes, serum ALT was consistently lower in those treated with metformin compared with placebo. This effect was mediated by weight loss, indicating that the effects of metformin therapy on ALT is via its effects on weight.

Safety and feasibility of achieving lower systolic blood pressure goals in persons with type 2 diabetes: the SANDS trial.

The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (< or =115/75 mm Hg vs < or =130/80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/dL, aggressive systolic blood pressure-lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus.

Effectiveness and safety of medication adjustments by nurse case managers to control hyperglycemia.

PURPOSE: The purpose of this study was to determine the safety and effectiveness of implementing standing orders for nurse case managers to adjust antihyperglycemic medications. METHODS: A retrospective cohort design was used to assess outcomes in American Indian and Alaska Native people who received case management and medication adjustment and those who received only standard primary care. Patients with diabetes and evidence of keeping regular follow-up appointments for diabetes care (N = 2345) who all had baseline A1C >or= 7.0% were divided into 3 mutually exclusive groups for analysis: (1) those seen only by primary care providers (PCP; n = 1574); (2) those seen by nurse case managers (NCM; in addition to primary care) for diabetes education services only (n = 711); and (3) those who, in addition to a PCP and NCM visit, had medications adjusted by the nurse case managers (MA; n = 60). Outcome variables were number of visits with documentation of hypoglycemia (safety) and rate of A1C change (effectiveness). RESULTS: Documented hypoglycemia occurred more frequently with more intensive treatment. The MA group experienced the greatest rate of hypoglycemic events. The difference in hypoglycemia incidence between the groups was significant, but the number of events was small. Glycemic control improved most rapidly in the MA group, even after adjusting for potentially confounding variables. CONCLUSIONS: In this setting, hypoglycemia occurs infrequently in all groups, but at higher rates with more intensive treatment. Nurse case management, whether with or without medication adjustment, is effective in improving short-term glucose control.

PREVENTION OF ATHEROSCLEROSIS WITH LDL-C LOWERING - LIPOPROTEIN CHANGES AND INTERACTIONS: THE SANDS STUDY.

BACKGROUND: Lowering low-density lipoprotein cholesterol (LDL-C) with statins reduces atherosclerosis. LDL and high-density lipoprotein (HDL) are commonly measured by their cholesterol content, but non-HDL cholesterol, LDL particle number (LDL-P), or total apolipoprotein B (apoB) may better predict cardiovascular risk. Few studies have examined relations among lipoprotein levels and composition before and after interventions to lower LDL-C and non-HDL-C. OBJECTIVE: To measure changes in carotid artery intimal media thickness (CIMT) and lipid concentration and composition during 36 months of statin therapy. METHODS: Analyses were conducted on 418 diabetic individuals, with complete data and no prior cardiovascular events, who were randomized to aggressive (AG) versus standard (STD) treatment for LDL-C, non-HDL-C, and systolic blood pressure (SBP) as part of the Stop Atherosclerosis in Native Diabetics Study (SANDS). RESULTS: The AG group achieved average LDL-C and non-HDL-C of 71mg/dL and 100mg/dL and a decrease in CIMT. No significant interactions were observed between treatment effect and initial levels of LDL-C, non-HDL-C, HDL-C, triglycerides, apoB, or LDL-P. Decreases in LDL-C (p<.005) and non-HDL-C (p<.001) were independently correlated with CIMT regression in the AG group. Changes in apoB and LDL-P showed borderline correlations with CIMT regression (p=.07 and p=.09). CONCLUSIONS: In diabetic adults with no prior cardiovascular events, treatment to current targets for lipids and SBP reduces atherosclerosis progression and when more aggressive targets are met, atherosclerosis regresses. The aggressive targets for LDL-C and non-HDL-C appeared to be the main determinants of CIMT regression and were more predictive of this outcome than changes in LDL-P or apoB.

Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes: the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial.

OBJECTIVES: This secondary analysis from the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial examines the effects of lowering low-density lipoprotein cholesterol (LDL-C) with statins alone versus statins plus ezetimibe on common carotid artery intima-media thickness (CIMT) in patients with type 2 diabetes and no prior cardiovascular event. BACKGROUND: It is unknown whether the addition of ezetimibe to statin therapy affects subclinical atherosclerosis. METHODS: Within an aggressive group (target LDL-C 40 years of age receiving statins plus ezetimibe versus statins alone. The CIMT changes in both aggressive subgroups were compared with changes in the standard subgroups (target LDL-C

Chronic liver disease among two American Indian patient populations in the southwestern United States, 2000-2003.

GOALS: To determine the etiologies of chronic liver disease among American Indians. BACKGROUND: American Indians are disproportionately affected by chronic liver disease, yet little is known about its underlying etiologies in this group. STUDY: We conducted a cross-sectional prevalence study at medical centers serving American Indian populations in Arizona and California. Patients' records were reviewed to identify those with chronic liver disease (ICD-9 code for chronic liver disease or 2 abnormal liver tests > or = 6 mo apart). ICD-9 codes and laboratory findings were abstracted to determine etiologies. RESULTS: Of the 30,698 American Indian patients seen at the Arizona center during 2000 to 2002, 1496 (4.9%) had chronic liver disease, including 268/1496 (17.9%) with decompensated cirrhosis. Etiologies included alcohol (621; 41.5%), hepatitis C (103; 6.9%), both (136; 9.1%), or nonalcoholic fatty liver disease (191; 12.8%). Among alcohol-related liver disease patients tested for hepatitis C, 32.2% were positive. Of the 6074 American Indian patients seen at the California center during 2002 to 2003, 344 (5.7%) had chronic liver disease, including 45/344 (13.1%) with decompensated cirrhosis. Etiologies included alcohol (57; 16.6%) hepatitis C (83; 24.1%), and both (42; 12.2%). In one-third of chronic liver disease patient at the 2 centers, no etiology could be identified; 30% to 45% had not been tested for hepatitis C. CONCLUSIONS: Alcohol-related liver disease and hepatitis C were the most commonly identified etiologies among these American Indian patients with chronic liver disease in clinical care. Identifying American Indian and Alaska Native patients with chronic liver disease and providing treatment are critical for reducing disease burden.

Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial.

CONTEXT: Individuals with diabetes are at increased risk for cardiovascular disease (CVD), but more aggressive targets for risk factor control have not been tested. OBJECTIVE: To compare progression of subclinical atherosclerosis in adults with type 2 diabetes treated to reach aggressive targets of low-density lipoprotein cholesterol (LDL-C) of 70 mg/dL or lower and systolic blood pressure (SBP) of 115 mm Hg or lower vs standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower. DESIGN, SETTING, AND PARTICIPANTS: A randomized, open-label, blinded-to-end point, 3-year trial from April 2003-July 2007 at 4 clinical centers in Oklahoma, Arizona, and South Dakota. Participants were 499 American Indian men and women aged 40 years or older with type 2 diabetes and no prior CVD events. INTERVENTIONS: Participants were randomized to aggressive (n=252) vs standard (n=247) treatment groups with stepped treatment algorithms defined for both. MAIN OUTCOME MEASURES: Primary end point was progression of atherosclerosis measured by common carotid artery intimal medial thickness (IMT). Secondary end points were other carotid and cardiac ultrasonographic measures and clinical events. RESULTS: Mean target LDL-C and SBP levels for both groups were reached and maintained. Mean (95% confidence interval) levels for LDL-C in the last 12 months were 72 (69-75) and 104 (101-106) mg/dL and SBP levels were 117 (115-118) and 129 (128-130) mm Hg in the aggressive vs standard groups, respectively. Compared with baseline, IMT regressed in the aggressive group and progressed in the standard group (-0.012 mm vs 0.038 mm; P < .001); carotid arterial cross-sectional area also regressed (-0.02 mm(2) vs 1.05 mm(2); P < .001); and there was greater decrease in left ventricular mass index (-2.4 g/m(2.7) vs -1.2 g/m(2.7); P = .03) in the aggressive group. Rates of adverse events (38.5% and 26.7%; P = .005) and serious adverse events (n = 4 vs 1; P = .18) related to blood pressure medications were higher in the aggressive group. Clinical CVD events (1.6/100 and 1.5/100 person-years; P = .87) did not differ significantly between groups. CONCLUSIONS: Reducing LDL-C and SBP to lower targets resulted in regression of carotid IMT and greater decrease in left ventricular mass in individuals with type 2 diabetes. Clinical events were lower than expected and did not differ significantly between groups. Further follow-up is needed to determine whether these improvements will result in lower long-term CVD event rates and costs and favorable risk-benefit outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00047424.