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1.  Life’s Simple 7 and Incidence of Diabetes Among American Indians: The Strong Heart Family Study 
Diabetes Care  2014;37(8):2240-2245.
The American Heart Association’s recommendations for optimal health, summarized in Life’s Simple 7, have been associated with reduced risk of cardiovascular disease (CVD)-related end points, but no studies have examined the association of these goals with incident type 2 diabetes, which is associated with high risk for CVD. The purpose of this analysis was to examine the associations of Life’s Simple 7 goals with incident diabetes among American Indians, a population at high risk of cardiometabolic diseases.
Strong Heart Family Study participants without diabetes (n = 1,639) at baseline and who participated in a follow-up examination were included in the analysis. Risk scores ranging from 0 to 7 were created using physical activity, diet, BMI, smoking, blood pressure, fasting glucose, and cholesterol metrics in accordance with Life’s Simple 7 goals. Diabetes was defined using 2003 American Diabetes Association criteria, including use of insulin or oral antidiabetes medication or a follow-up fasting plasma glucose level ≥126 mg/dL. Generalized estimating equations were used to examine the association of risk scores with incident diabetes.
During a mean 5-year follow-up (range 4–8 years), we identified 210 cases of incident type 2 diabetes. Compared with participants who achieved 0–1 goals, those who achieved 2–3 or 4+ goals had lower odds of diabetes, with odds ratios = 0.40 (95% CI 0.29–0.56) and 0.11 (95% CI 0.05–0.21), respectively.
The adoption of as few as two or three Life’s Simple 7 goals is associated with a lower risk of diabetes.
PMCID: PMC4113167  PMID: 24804696
2.  Trauma-Informed Medical Care: A CME Communication Training for Primary Care Providers 
Family medicine  2015;47(1):7-14.
Trauma exposure predicts mental disorders, medical morbidity, and healthcare costs. Yet trauma-related impacts have not received sufficient attention in primary care provider (PCP) training programs. This study adapted a theory-based approach to working with trauma survivors, Risking Connection, into a 6-hour CME course, Trauma-Informed Medical Care (TI-Med), and evaluated its efficacy.
We randomized PCPs to training or wait-list (delay) conditions; waitlist groups were trained after reassessment. The primary outcome assessing newly acquired skills was a patient-centeredness score derived from Roter Interactional Analysis System ratings of 90 taped visits between PCPs and standardized patients (SPs). PCPs were Family Medicine residents (n=17) and community physicians (n=13; 83% Family Medicine specialty), from four sites in the Washington DC metropolitan area.
Immediately trained PCPs trended toward a larger increase in patient-centeredness than did the delayed PCPs (p < .09), with a moderate effect size (.66). The combined trained PCP groups showed a significant increase in patient-centeredness pre to post training, p < .01, Cohen’s D = .61.
This is a promising approach to supporting relationship-based trauma-informed care among PCPs to help promote better patient health and higher compliance with medical treatment plans.
PMCID: PMC4316735  PMID: 25646872
trauma; communication; continuing medical education; patient-centeredness
JAMA  2008;299(14):1678-1689.
Individuals with diabetes are at greatly increased risk for developing cardiovascular disease (CVD), but more aggressive targets for risk factor control have not been tested.
To compare the progression of subclinical atherosclerotic disease in diabetic adults treated to aggressive targets of low-density lipoprotein cholesterol (LDL-C) ≤ 70 mg/dL and blood pressure (BP) ≤ 115/75 mm Hg (aggressive) versus treatment to standard targets of LDL-C ≤ 100 mg/dL and BP ≤ 130/85 mm Hg (standard).
Randomized, open label, blinded-to-endpoint 3-year trial in individuals with diabetes conducted April 2003-July 2004.
Four clinical centers in southwestern Oklahoma; Phoenix, AZ; northeastern Arizona; and South Dakota.
499 American Indian men and women ≥ age 40 with type 2 diabetes and no prior CVD events.
Participants were randomized to aggressive vs. standard treatment. The same treatment algorithms were followed for both groups.
Main Outcome Measures
Primary endpoint was a composite of progression of atherosclerosis as measured by common carotid artery intimal medial thickness (IMT) and clinical events. Secondary endpoints included other carotid and cardiac ultrasonographic measures.
LDL-C and systolic BP (SBP) goals for both groups were reached within 12 months and maintained to 36 months. LDL-C and SBP in the last 12 months averaged 72 and 104 mg/dL and 116 and 129 mm Hg in the aggressive and standard groups, respectively. Regression of IMT (-0.017 vs. 0.041 mm, p < .0001) and arterial mass (-0.14 vs. 1.14 mm2, p < .0001) and greater decrease in left ventricular mass (-2.4 vs. -1.3 g/m2.7, p = .05) were observed in the aggressive group. Clinical CVD events were lower than expected and did not differ between groups
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 outomes.
PMCID: PMC4243925  PMID: 18398080
4.  Sex-specific associations of nutrition with hypertension and systolic blood pressure in Alaska Natives findings from the GOCADAN study 
To examine sex-specific associations of nutritional factors with prevalent hypertension (HTN) and systolic blood pressure (SBP) in Alaska Natives. Diet is known to affect SBP, a major risk factor for cardiovascular disease.
Study design
Cross-sectional analysis of participants without diabetes in the Genetics of Coronary Artery Disease in Alaska Natives study.
Macronutrients such as fat, carbohydrate and protein and micronutrients such as sodium were investigated. HTN was defined as SBP≥140 mmHg, diastolic blood pressure≥90 mmHg and/or taking anti-HTN medication. Analyses were stratified by sex and covariates included age, body mass index (BMI), energy intake, smoking and physical activity.
Mean age was 42 years for men (n=456) and women (n=602). Men with HTN (n=106) compared to men without HTN consumed a higher proportion of calories from total (p=0.01), saturated (p<0.01) and trans fatty acid (p=0.03) fats. Women with HTN (n=99) compared to women without HTN consumed more total (p=0.03) and monounsaturated (p=0.04) fat, higher protein (p=0.02) and lower total (p<0.01) and simple (p<0.01) carbohydrates. After covariate adjustment, men not on anti-HTN medications (n=407) had significantly higher average SBP with increasing quartiles of trans fatty acid intake (p for linear trend=0.01) and sodium intake (p for linear trend=0.02). For women not on anti-HTN medications (n=528), after covariate adjustment, average SBP decreased with increasing quartiles of omega 3 fatty acid intake (p for linear trend <0.01).
Prospective evaluation of the sex-specific associations of nutritional factors with HTN and SBP on outcomes is needed along with novel interventions to lower the risk of cardiovascular disease.
PMCID: PMC4219542  PMID: 21631966
nutrition; Alaska Native; sex; systolic blood pressure; epidemiology
5.  Relationship Between Glycemic Control and Depression Among American Indians in the Strong Heart Study 
To examine the relationship between depression and glycemic control in the Strong Heart Study (SHS), a longitudinal study of cardiovascular disease in American Indians.
This cross sectional analysis focused on the relationship between depression, diabetes, and glycemic control among 2,832 individuals ≥age 15. Depression was measured by the CES-D scale and diabetes by American Diabetes Association criteria. An ordered logit regression model was used to assess whether diabetes was related to level of depression (none, mild, moderate, severe). Multiple logistic regression was used to explore the relationship between A1c and severe depression in participants with diabetes.
Rates of depression were higher in men and women with diabetes when compared to those without diabetes, respectively (p<.05). For every 1-unit increase in A1c, the odds of severe depression increased by 22% (OR 1.22, 95% CI: 1.05–1.42). Female gender (OR 2.97, 95% CI: 1.32–6.69) and BMI (OR 1.04, 95% CI: 1.00–1.08) also were significantly associated with increased risk for severe depression. Although BMI appears to be significantly associated with increased risk for severe depression, the magnitude of this effect was small.
Individuals with diabetes have higher rates of depression than those without diabetes, consistent with other populations. There is a positive relationship between severity of depression and A1c levels; men and women with severe depression have higher A1c levels than those with moderate-to-no depression.
PMCID: PMC4219571  PMID: 19454372
diabetes complications; depression; Strong Heart Study
In order to effectively treat differentiated thyroid cancer (DTC) with radioiodine (RAI) it is necessary to raise serum TSH levels either endogenously by thyroid hormone withdrawal (THW) or exogenously by administration of recombinant human TSH (rhTSH). The goal of this review is to present current data on the relative efficacy and side effects profile of rhTSH-aided versus THW-aided RAI therapy for the treatment of patients with distant metastases of DTC.
We have searched the PubMed database for articles including the keywords “rhTSH”, “thyroid cancer”, and “distant metastases” published between January 1, 1996 and January 7, 2012. As references, we used clinical case series, case reports, review articles, and practical guidelines.
Exogenous stimulation of TSH is associated with better quality of life because it obviates signs and symptoms of hypothyroidism resulting from endogenous TSH stimulation. The rate of neurological complications after rhTSH and THW-aided RAI therapy for brain and spine metastases is similar. The rate of leukopenia, thrombocytopenia, xerostomia, and pulmonary fibrosis is similar after preparation for RAI treatment with rhTSH and THW. There is currently a controversy regarding RAI uptake in metastatic lesions after preparation with rhTSH versus THW, with some studies suggesting equal and some superior uptake after preparation with THW. Analysis of available retrospective studies comparing survival rates, progression free survival, and biochemical and structural response to a dosimetrically-deterrnined dose of RAI shows similar efficacy after preparation for therapy with rhTSH and THW.
The rhTSH stimulation is not presently approved by the FDA as a method of preparation for adjunctive therapy with RAI in patients with metastatic DTC. Data on rhTSH compassionate use suggest that rhTSH stimulation is as equally effective as THW as a method of preparation for dosimetry-based RAI treatment in patients with RAI-avid metastatic DTC.
PMCID: PMC4185285  PMID: 23186979
7.  Patients’ preferences for selection of endpoints in cardiovascular clinical trials 
To reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied.
To determine the preferences of patients in the design of cardiovascular trials.
Participants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process.
One hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting.
Key results
Among single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004) on a scale of 1–6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001), angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001), and stroke (4.73 vs. 2.43, p<0.001). Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%), incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers), and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect).
Patients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but it also has the potential to improve compliance with cardiovascular medications.
PMCID: PMC3937559  PMID: 24596645
Patient preferences; combined endpoints; clinical trial design; composite outcomes
8.  Estimated GFR and Incident Cardiovascular Disease Events in American Indians: The Strong Heart Study 
In populations with high prevalence of diabetes and obesity, estimating glomerular filtration rate (GFR) by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation may predict cardiovascular disease risk better than by using the Modification of Diet in Renal Disease (MDRD) Study equation.
Study design
Longitudinal cohort study comparing the association of GFR estimated using either the CKD-EPI or MDRD Study equations with incident cardiovascular disease outcomes.
Setting and participants
American Indians participating in the Strong Heart Study, a longitudinal population-based cohort with high prevalences of diabetes, cardiovascular disease, and CKD.
Predictor or factor
eGFR predicted using the CKD-EPI and MDRD Study equations.
Fatal and nonfatal cardiovascular events, consisting of coronary heart disease, stroke, and heart failure.
The association between eGFR and outcomes was explored in Cox proportional hazards models, adjusted for traditional risk factors and albuminuria; the net reclassification index and integrated discrimination improvement were determined for the CKD-EPI versus MDRD Study equations.
Among 4549 participants, diabetes was present in 45%, cardiovascular disease in 7%, and stage 3–5 CKD in 10%. Over a median of 15 years, there were 1280 cases of incident CVD, 929 of incident coronary heart disease, 305 of incident stroke, and 381 of incident heart failure. Reduced eGFR (<90 mL/min/1.73 m2) was associated with adverse events in most models. Compared with the MDRD Study equation, the CKD-EPI equation correctly reclassified 17.0% of 2,151 participants without incident CVD to a lower risk (higher eGFR) category and 1.3% (n=28) were incorrectly reclassified to a higher risk (lower eGFR) category.
Single measurements of eGFR and albuminuria at study visits.
Although eGFR based on either equation had similar associations with incident cardiovascular disease, coronary heart disease, stroke, and heart failure events, among those not having events, reclassification of participants to eGFR categories was superior using the CKD-EPI equation compared with the MDRD Study equation.
PMCID: PMC3473098  PMID: 22841159
cardiovascular disease risk; chronic kidney disease; estimated glomerular filtration rate; Strong Heart Study
9.  Association Between Fish Consumption and Nephropathy in American Indians—The Strong Heart Study 
The present study examined the association between fish consumption and nephropathy in American Indians.
In the family cohort of the Strong Heart Study, we investigated 2,261 participants with baseline examination between 2001 and 2003 and follow-up examination between 2006 and 2008. The average follow-up period was 5.4 years. We defined fish consumption as the sum of dietary intake of tuna, fried fish, and nonfried fish obtained from a validated food frequency questionnaire. Nephropathy was defined as microalbuminuria (urinary albumin–creatinine ratio [ACR]: 30 to 299 mg/g), macroalbuminuria (urinary ACR: ≥300 mg/g), or an estimated glomerular filtration rate of <60 mL/min/1.73 m2. Using regression models, we examined the association between fish consumption measured at baseline and 2 outcomes in nephropathy present at follow-up, albuminuria, or renal impairment, and change in urinary ACR or estimated glomerular filtration rate between baseline and follow-up examinations.
The prevalence of microalbuminuria, macroalbuminuria, and renal impairment was 13%, 3%, and 4%, respectively. The fish items consumed by the participants were predominantly deep-fried. We found no associations between fish consumption and any measure of nephropathy after adjusting for demographic, clinical, lifestyle, and dietary factors.
Dietary intake of predominantly fried fish was not associated with a lower risk of nephropathy in American Indians.
PMCID: PMC3688064  PMID: 21742515
10.  Radioiodine Treatment of Metastatic Thyroid Cancer: Relative Efficacy and Side Effect Profile of Preparation by Thyroid Hormone Withdrawal Versus Recombinant Human Thyrotropin 
Thyroid  2012;22(3):310-317.
To effectively treat differentiated thyroid cancer (DTC) with radioiodine (RAI) it is necessary to raise serum thyrotropin (TSH) levels either endogenously by thyroid hormone withdrawal (THW) or exogenously by administration of recombinant human TSH (rhTSH). The aim of our study was to compare the relative efficacy and side effect profile of rhTSH versus THW preparation for RAI therapy of metastatic DTC.
Fifty-six patients (31 women and 25 men) with RAI-avid distant metastases of DTC treated with either rhTSH-aided (n=15) or THW-aided RAI (n=41) and followed for 72±36.2 months were retrospectively analyzed. The groups were comparable in regard to mean size of target lesions (rhTSH vs. THW 6.4 vs. 4.8 cm, p=0.41), mean baseline thyroglobulin level (6995 vs. 5544 ng/mL, p=0.83), distribution of micronodular and macronodular pulmonary metastases (67% vs. 63%, p=0.54, 13% vs. 15% p=0.64, respectively), osseous (53% vs. 29%, p=0.09), brain (0% vs. 2%, p=0.73), and liver/kidney metastases (13% vs. 2%, p=0.61). Patients in the rhTSH group were older (rhTSH vs. THW mean 62 vs. 49 years, p=0.01), and received lower cumulative RAI dose (256 vs. 416 mCi, p=0.03), which was more frequently based on dosimetric calculations (80% vs. 46%, p=0.024). Responses to treatment were based on RECIST 1.1 criteria.
Adjusted by age rates of complete response (CR), stable disease (SD), progressive disease (PD), and progression free survival (PFS) were not different between the groups (rhTSH vs. THW CR hazard ratio [HR] 0.97, 95% CI 0.08–11.42, p=0.982; SD HR 3.22, 95% CI 0.79–13.18, p=0.104, PD HR 0.26, 95% CI 0.52–1.26, p=0.094; PFS HR 0.41, 95% CI 0.14–1.23, p=0.112). The only independent risk factor for nonresponding to treatment and presentation with PD was age (HR 1.06, 95% CI 1.02–1.11, p=0.008). Age was also an independent factor affecting PFS (HR 1.04 for each year, 95% CI 1.02–1.07, p=0.001). Rates of leukopenia, thrombocytopenia, xerostomia, and restrictive pulmonary disease after RAI were not significantly different (rhTSH vs. THW 30% vs. 28%, p=0.61, 10% vs. 0%, p=0.37, 0% vs. 12%, p=0.20, 0% vs. 2%, p=0.73, respectively).
Patients with metastatic DTC prepared with rhTSH achieve comparable benefit of RAI therapy as those treated after THW.
PMCID: PMC4162434  PMID: 22313411
11.  Uric Acid, Hypertension, and CKD among Alaska Eskimos—the Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) Study 
It is unknown what role uric acid may play in the increasing cardiovascular disease (CVD) among Alaska Eskimos. Uric acid is associated with both hypertension (HTN) and chronic kidney disease (CKD). We analyzed 1078 Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) participants. Estimated glomerular filtration rate (eGFR) was calculated from serum creatinine measures using the MDRD equation. CKD was defined by an eGFR of <60ml/min/1.73m2. We adjusted for age, sex, education, diabetes, hypertension (or eGFR), obesity, lipids, and smoking status; 7% (n=75) had prevalent CKD. eGFR decreased with increasing tertiles of serum uric acid. (p<0.001) Uric acid was independently associated with prevalent CKD (Adjusted Odds Ratio [OR] and 95% confidence interval [CI] of 2.04 (1.62–2.56), respectively). 21% (n=230) had prevalent HTN; Uric acid was independently associated with prevalent HTN (Adjusted OR 1.2, 95% CI 1.1–1.5). Uric acid is independently associated with prevalent CKD and HTN in this population.
PMCID: PMC3507473  PMID: 22277138
Alaska Eskimos; chronic kidney disease; epidemiology; hypertension; uric acid
12.  Relationship of Glycemia Control to Lipid and Blood Pressure Lowering and Atherosclerosis: the SANDS Experience 
Cardiovascular disease (CVD) 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 (SANDS) examines the role of baseline glycemia in achieving standard and aggressive targets and outcomes after 36 months.
Diabetic individuals >age 40 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.
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=0.007), non-HDL-C (p=0.03), and SBP targets (p=0.007) and to changes in LDL-C (p=0.007), non-HDL-C (p=0.03), and SBP (p=0.001) in both groups. Baseline A1c failed to predict progression of carotid intima medial thickness (CIMT) (p=0.42) or left ventricular mass index (LVMI) (p=0.10), nor was it related to the effects of lipid and BP lowering on CIMT and LVMI over 36 months.
In diabetic adults with no CVD 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.
PMCID: PMC3222781  PMID: 21775166
LDL-C; A1c; cardiovascular disease; carotid arteries; diabetes
13.  Impact of subspecialty elective exposures on outcomes on the American board of internal medicine certification examination 
BMC Medical Education  2012;12:94.
The American Board of Internal Medicine Certification Examination (ABIM-CE) is one of several methods used to assess medical knowledge, an Accreditation Council for Graduate Medical Education (ACGME) core competency for graduating internal medicine residents. With recent changes in graduate medical education program directors and internal medicine residents are seeking evidence to guide decisions regarding residency elective choices. Prior studies have shown that formalized elective curricula improve subspecialty ABIM-CE scores. The primary aim of this study was to evaluate whether the number of subspecialty elective exposures or the specific subspecialties which residents complete electives in impact ABIM-CE scores.
ABIM-CE scores, elective exposures and demographic characteristics were collected for MedStar Georgetown University Hospital internal medicine residents who were first-time takers of the ABIM-CE in 2006–2010 (n=152). Elective exposures were defined as a two-week period assigned to the respective subspecialty. ABIM-CE score was analyzed using the difference between the ABIM-CE score and the standardized passing score (delta-SPS). Subspecialty scores were analyzed using percentage of correct responses. Data was analyzed using GraphPad Prism version 5.00 for Windows.
Paired elective exposure and ABIM-CE scores were available in 131 residents. There was no linear correlation between ABIM-CE mean delta-SPS and the total number of electives or the number of unique elective exposures. Residents with ≤14 elective exposures had higher ABIM-CE mean delta-SPS than those with ≥15 elective exposures (143.4 compared to 129.7, p=0.051). Repeated electives in individual subspecialties were not associated with significant difference in mean ABIM-CE delta-SPS.
This study did not demonstrate significant positive associations between individual subspecialty elective exposures and ABIM-CE mean delta-SPS score. Residents with ≤14 elective exposures had higher ABIM-CE mean delta-SPS than those with ≥15 elective exposures suggesting there may be an “ideal” number of elective exposures that supports improved ABIM-CE performance. Repeated elective exposures in an individual specialty did not correlate with overall or subspecialty ABIM-CE performance.
PMCID: PMC3480921  PMID: 23057635
Resident education; Gender; Elective; Subspecialty; Graduate medical education
Hypertension  2011;58(3):367-371.
The relative impacts of lowering blood pressure vs. lowering low-density lipoprotein cholesterol on regression of ventricular and arterial mass have not been systematically examined. Changes in left ventricular mass and arterial mass (common carotid artery cross-sectional area) following 36 months of simultaneous lowering of systolic blood pressure and low-density lipoprotein cholesterol were examined in the SANDS trial of standard vs. aggressive low-density lipoprotein cholesterol and blood pressure targets in American Indians with type 2 diabetes. The two treatment groups were combined to examine changes in left ventricular and arterial mass over a spectrum of achieved blood pressure and lipid levels. Among the combined group of 413 SANDS participants, systolic blood pressure, low-density lipoprotein cholesterol and left ventricular mass were all significantly reduced, whereas arterial mass significantly increased, following 36 months of therapy (p<0.001 for all). In linear regression models, a decrease in arterial mass was significantly related to achieved systolic blood pressure and, to a lesser extent, achieved low-density lipoprotein cholesterol, following adjustment for important covariates. Left ventricular mass progressively decreased with lower achieved levels of systolic blood pressure, independent of baseline levels of left ventricular mass. In conclusion, achieved levels of systolic blood pressure are important determinants of the extent of regression of arterial and ventricular mass during prolonged therapy in diabetic individuals. Achieved levels of low-density lipoprotein cholesterol influence regression of arterial but not ventricular mass. Our findings suggest there is no threshold of systolic blood pressure below which regression of cardiovascular target organ damage cannot be achieved.
PMCID: PMC3167150  PMID: 21788602
hypertrophy/remodeling; atherosclerosis; target organ damage
Journal of clinical lipidology  2010;4(5):435-443.
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 (SANDS) randomized patients with diabetes to standard versus aggressive lipid and blood pressure goals for 36 months.
To report strategies used to achieve and maintain lipid goals and to report adverse events (AEs).
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 started with statin monotherapy, adding intestinally acting agents 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, using point-of-care lipid determinations.
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. 68% of participants reached target LDL-C for >50% of the visits and 46% for >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 adverse events (SAEs) were observed; AEs occurred in 18% of the AGG and 14% of the STD.
Standard and aggressive lipid targets can be safely maintained in diabetic patients. Standardized algorithms, point-of-care lipid testing, and non-physician providers facilitate care delivery.
PMCID: PMC2976563  PMID: 21076630
lipids; blood pressure; carotid artery intima media thickness; cardiovascular disease; American Indians
16.  Trauma, Depression, and Comorbid PTSD/Depression in a Community Sample of Latina Immigrants 
Trauma exposure is frequently overlooked as a risk factor for psychiatric morbidity among studies with Latinos. The purpose of this study was to examine the relationships among trauma history, immigration-related factors, and mental health status among Latina immigrants. The current study used baseline data from a randomized clinical trial for the treatment of depression (Miranda et al., 2006) of 64 women with comorbid PTSD and depression, 69 with depression-only, and 61 with no Axis I mental disorder. Sixty-four percent of the sample was Central American and 75% percent reported trauma exposure. Multinomial logit analysis suggested fewer years in the US was associated with worse mental health status. Having a non-married marital status was also associated with worse mental health. Reporting four or more types of traumatic events was associated with an increase in the probability of comorbidity. These findings have important implications for future research and clinical practice.
PMCID: PMC2850073  PMID: 20376305
Latino; Latina; Immigrant; Trauma; PTSD; Depression; Comorbidity; Hispanic
Journal of clinical lipidology  2010;4(3):165-172.
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.
In this analysis, we examined within trial cost-effectiveness of aggressive targets of LDL-C ≤70 mg/dL and systolic blood pressure (SBP) ≤115 mmHg vs. standard targets of LDL-C ≤100 mg/dL and SBP ≤130 mmHg.
Randomized, open label blinded-to-endpoint 3-year trial.
Data Sources
SANDS clinical trial database, Quality of Wellbeing (QWB) survey, Centers for Medicare and Medicaid Services, Wholesale Drug Prices.
Target Population
American Indians ≥ age 40 years with type 2 diabetes and no prior cardiovascular events.
Time Horizon
April 2003-July 2007.
Health payer.
Participants were randomized to aggressive vs. 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% higher cost for BP medication ($1,242) and a 116% higher 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. Using a 3% discount rate for costs and outcomes, the resulting cost per QALY was $82,589.
Results of Sensitivity Analysis
Using a 25%, 50%, and 75% reduction in drug costs resulted in a cost per QALY of $61,329, $40,070, and $18,810, respectively.
This study was limited by use of a single ethnic group and by its 3-year duration.
Within this 3-year study, treatment to lower BP and LDL-C below standard targets was not cost-effective due to 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, cost-effectiveness of this intervention should improve.
PMCID: PMC2885818  PMID: 20563294
Journal of clinical lipidology  2009;3(5):322-331.
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.
To measure changes in carotid artery intimal media thickness (CIMT) and lipid concentration and composition during 36 months of statin therapy.
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).
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).
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.
PMCID: PMC2805908  PMID: 20161568
atherosclerosis; cardiovascular disease; carotid arteries; cholesterol; lipoproteins
This secondary analysis from the Stop Atherosclerosis in Native Diabetics Study examines the effects of lowering low-density lipoprotein cholesterol (LDL-C) with statins alone versus statins plus ezetimibe (E) on common carotid artery intimal medial thickness (CIMT) in patients with type 2 diabetes and no prior cardiovascular event.
It is unknown whether the addition of E to statin therapy affects subclinical atherosclerosis.
Within an aggressive group (target LDL-C ≤70mg/dL; non-high-density lipoprotein [non-HDL]-C ≤<100 mg/dL; systolic blood pressure [SBP] ≤115mmHg), change in CIMT over 36mos was compared in diabetic individuals >40 yrs receiving statins plus E versus statins alone. CIMT changes in both aggressive subgroups were compared with changes in the standard subgroups (target LDL-C ≤<100mg/dL; non-HDL-C ≤ 130 mg/dL; SBP ≤130mmHg).
Mean (95%CI) LDL-C was reduced by 31 (23, 37)mg/dL and 32 (27, 38)mg/dL in the aggressive group receiving statins plus E and statins alone, respectively, compared with changes of 1 (−3, 6) mg/dL in the standard group (p<0.0001 vs both aggressive subgroups. Within the aggressive group, mean IMT at 36mos regressed from baseline similarly in the E (−.025 [−05,.003] mm) and non-E subgroups (−.012 [−.03,.008] mm) but progressed in the standard treatment arm (0.039 [0.02, 0.06] mm), intergroup p<0.0001.
Reducing LDL-C to aggressive targets resulted in similar regression of CIMT in patients who attained equivalent LDL-C reductions from a statin alone or statin plus E. CIMT increased in those achieving standard targets.
PMCID: PMC2854549  PMID: 19095139
ezetimibe; CIMT; atherosclerosis

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