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Background: Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. Methods: The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. Results: As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, −4.51% [95% CI, −5.93 to −3.10]; P P P =0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9–6.3]; P z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of −0.31 (95% CI, −0.47 to −0.14; P P =0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. Conclusions: A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02561221.

Background: LEADER trial (Liraglutide Effect and Action in Diabetes: Evaluation of CV Outcome Results) results demonstrated cardiovascular benefits for patients with type 2 diabetes mellitus at high cardiovascular risk on standard of care randomized to liraglutide versus placebo. The effect of glucagon-like peptide-1 receptor agonist liraglutide on cardiovascular events and all-cause mortality in patients with type 2 diabetes mellitus and chronic kidney disease is unknown. Liraglutide’s treatment effects in patients with and without kidney disease were analyzed post hoc. Methods: Patients were randomized (1:1) to liraglutide or placebo, both in addition to standard of care. These analyses assessed outcomes stratified by baseline estimated glomerular filtration rate (eGFR; 2 ) and baseline albuminuria. The primary outcome (composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) and secondary outcomes, including all-cause mortality and individual components of the primary composite outcome, were analyzed using Cox regression. Results: Overall, 2158 and 7182 patients had baseline eGFR 2 , respectively. In patients with eGFR 2 , risk reduction for the primary composite cardiovascular outcome with liraglutide was greater (hazard ratio [HR], 0.69; 95% CI, 0.57–0.85) versus those with eGFR ≥60 mL/min/1.73 m 2 (HR, 0.94; 95% CI, 0.83–1.07; interaction P =0.01). There was no consistent effect modification with liraglutide across finer eGFR subgroups (interaction P =0.13) and when analyzing eGFR as a continuous variable (interaction P =0.61). Risk reductions in those with eGFR 2 were as follows: for nonfatal myocardial infarction, HR, 0.74; 95% CI, 0.55–0.99 versus HR, 0.93; 95% CI, 0.77–1.13; for nonfatal stroke, HR, 0.51; 95% CI, 0.33–0.80 versus HR, 1.07; 95% CI, 0.84–1.37; for cardiovascular death, HR, 0.67; 95% CI, 0.50–0.90 versus HR, 0.84; 95% CI, 0.67–1.05; for all-cause mortality, HR, 0.74; 95% CI, 0.60–0.92 versus HR, 0.90; 95% CI, 0.75–1.07. Risk reduction for the primary composite cardiovascular outcome was not different for those with versus without baseline albuminuria (HR, 0.83; 95% CI, 0.71–0.97; and HR, 0.92; 95% CI, 0.79–1.07, respectively; interaction P =0.36). Conclusions: Liraglutide added to standard of care reduced the risk for major cardiovascular events and all-cause mortality in patients with type 2 diabetes mellitus and chronic kidney disease. These results appear to apply across the chronic kidney disease spectrum enrolled. Clinical Trial Registration: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT01179048.

Despite the known higher risk of cardiovascular disease (CVD) in individuals with type 1 diabetes mellitus (T1DM), the pathophysiology underlying the relationship between cardiovascular events, CVD risk factors, and T1DM is not well understood. Management approaches to CVD reduction have been extrapolated in large part from experience in type 2 diabetes mellitus (T2DM), despite the longer duration of disease in T1DM than in T2DM and the important differences in the underlying pathophysiology. Furthermore, the phenotype of T1DM is changing. As a result of the findings of the Diabetes Control and Complications Trial (DCCT), which compared intensive glycemic control with usual care, and its follow-up observational study, Epidemiology of Diabetes Interventions and Complications (EDIC), intensive management of diabetes mellitus (DM) has become the standard of care and has led to increasing longevity. However, our understanding of CVD in T1DM comes in large part from the previous era of less intensive glycemic control. More intensive glycemic control is associated with significant risk of weight gain, which may be magnified by the obesity epidemic. There is growing interest in better understanding the adverse effects of glycemia, the prevalence and type of lipid abnormalities in T1DM, the prognostic role of albuminuria and renal insufficiency, and the role of blood pressure (BP) in CVD. Obesity-associated metabolic abnormalities such as the proinflammatory state likely modify CVD risk in T1DM; however, the effect may be different from what is seen in T2DM. These concepts, and how they may affect management, have not been fully explored. The present review will focus on the importance of CVD in patients with T1DM. We will summarize recent observations of potential differences in the pathophysiology of T1DM compared with T2DM, particularly with regard to atherosclerosis. We will explore the implications of these concepts for treatment of CVD risk factors in patients with …

Diabetes is a chronic, progressively worsening disease associated with a variety of microvascular and macrovascular complications. Cardiovascular disease (CVD) is the main cause of death in these patients.1,2 During the past decade, numerous drugs have been introduced for the treatment of type 2 diabetes that, used in monotherapy or in combination therapy, are effective in lowering blood glucose to achieve glycemic goals and in reducing diabetes-related end-organ disease. Two such drugs, rosiglitazone and pioglitazone, belong to the class called thiazolidinediones (TZDs).3 Troglitazone, the first agent of this class to be approved, was effective in controlling glycemia but was removed from the market because of serious liver toxicity. Both rosiglitazone and pioglitazone are indicated either as monotherapy or in combination with a sulfonylurea, metformin, or insulin when diet, exercise, and a single agent do not result in adequate glycemic control4 (package insert Avandia [rosiglitazone maleate; GlaxoSmithKline] and Actos5 [pioglitazone hydrochloride; Takeda Pharmaceuticals]). In addition to lowering blood glucose, both drugs may benefit cardiovascular parameters, such as lipids, blood pressure, inflammatory biomarkers, endothelial function, and fibrinolytic status.6,7 These beneficial effects of TZDs on glycemia and cardiovascular risk factors have made them attractive agents in patients with type 2 diabetes who are at high risk for CVD. There is a growing recognition, however, that edema can occur in patients treated with either drug. Because people with diabetes are at increased risk for CVD and many have preexisting heart disease, the edema that sometimes accompanies the use of a TZD can be cause for concern, as it may be a harbinger or sign of congestive heart failure (CHF). An analysis of Medicare beneficiaries hospitalized with the diagnosis of diabetes and CHF indicated that the number of these patients discharged on TZDs had increased from 7.2% to 16.2% over a …

Background: Compared with studies on achieving a single goal of either glycated hemoglobin (HbA1c) or low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM), the clinical benefits of dual-goal achievement (LDL-C Methods: Newly diagnosed adult T2DM patients with ≥2 measures of LDL-C and HbA1c were identified in the Veterans Integrated Services Network 16 data warehouse (01/2004-06/2010). A logistic regression model was used to identify factors associated with dual-goal achievement during 7-12 months following the index date (first HbA1c recorded within three months of the first T2DM diagnosis). Factors included demographics and 0-6 month dual-goal achievement, as well as diabetes-related comorbidities, medications, surgeries, and healthcare utilization, all measured during the 1-year period surrounding the index date. Multivariate Cox proportional hazards models were used to assess the association between time-varying goal achievement status and post-index date clinical outcomes, including microvascular complications (retinopathy, nephropathy, and neuropathy), cardiovascular-related complications (cardiovascular death, stroke, or myocardial infarction) and acute coronary syndromes (ACS). Results: A total of 16,829 T2DM patients were included in the study. Factors associated with an increased likelihood of dual-goal achievement include older age, higher Charlson Comorbidity Index (CCI), prior dual-goal achievement, diagnosis of ketoacidosis or hypersmolarity, and lipid-lowering drug use. Conversely, patients with prior diagnoses of retinopathy, neuropathy, and congestive heart failure, as well as prior insulin use were less likely to achieve both goals. Compared with failure to achieve either goal, achieving only LDL-C goal was associated with a lower risk of cardiovascular-related complications (HR:0.76; 95% CI:0.71-0.81) and ACS (HR:0.76; 95% CI:0.67-0.86), while achieving only HbA1C goal was associated with a lower risk of microvascular complications (HR:0.73; 95% CI:0.71-0.74), cardiovascular-related complications (HR:0.80; 95% CI:0.74-0.87) and ACS (HR:0.66; 95% CI:0.60-0.72). Dual-goal achievement was associated with additional reduction in risk of microvascular complications (HR: 0.69; 95% CI: 0.63-0.76) vs. only LDL-C goal achievement, but had similar risk to achieving HbA1c goal alone. Conclusions: Older age, higher CCI, prior dual-goal achievement, and lipid-lowering drug use were associated with a greater likelihood of dual-goal achievement. Dual-goal achievement in newly diagnosed T2DM patients is associated with decreased risks of microvascular complications than those with only LDL-C goal achievement.

Cardiovascular disease is the leading cause of morbidity and mortality for patients with type 2 diabetes mellitus (T2DM), accounting for two thirds of patient deaths. In addition to traditional cardiovascular risk factors, hyperglycemia and multiple other factors associated with T2DM such as obesity, insulin resistance, and inflammation play significant roles in cardiovascular disease risk.1 Patients with diabetes mellitus have derived less benefit from multiple preventive and interventional advances. Indeed, in the Bypass Angioplasty Revascularization Investigation (BARI) trial, angioplasty appeared to provide very little benefit for patients with diabetes mellitus,2 a finding supported by a meta-analysis of randomized interventional trials,3 although modern revascularization techniques with the use of drug-eluting stents were not yet widely utilized. Therefore, the questions addressed in the BARI 2 Diabetes (BARI 2D) trial are of particular importance in determining optimal treatments to prevent mortality and major cardiovascular events in patients with T2DM and stable ischemic heart disease. Both prompt revascularization compared with intensive medical therapy alone or with delayed revascularization, and insulin-sensitization compared with insulin-provisional therapeutic strategies were evaluated in 2368 patients over 5 years with the use of a 2×2 randomized factorial trial design.4 With recognition of the cardiovascular benefits of optimal management of diabetes mellitus and cardiovascular risk factors in patients with diabetes mellitus,5 the BARI 2D study was performed with guideline-driven targets for lipids, blood pressure, and aspirin use. First, in a comparison of prompt revascularization with intensive medical therapy alone or with delayed revascularization, similar survival (88.3% versus 87.8%; P =0.97) and freedom from cardiovascular event rates (77.2% versus 75.9%; P =0.70) were demonstrated. However, a high proportion (42%) of subjects initially randomized to medical intervention received delayed revascularization. These findings extend those of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, in which an …

The mission of many organizations is the optimal care to those with or at risk for developing CVD (primary and secondary prevention). Over the past two decades, there have been dramatic increases in knowledge concerning specific risk factors in atherosclerosis, hypertension, thrombosis, and other forms of vascular dysfunction. Clinical trials have proven that strategies aimed at the appropriate detection and modification of risk factors can slow progression of atherosclerosis, diabetes mellitus, and hypertension and reduce the occurrence of clinical cardiovascular events in both primary and secondary prevention settings. More recently, it has been shown that atherosclerosis can be stabilized or even modestly reversed. Finally, a new and growing knowledge base of molecular genetics applied to the study of the cardiovascular system has potential relevance to the clinical practice of preventive cardiovascular medicine. Despite the fact that clinical outcomes can be improved by promotion of favorable life habits and behaviors and by the proper use of drug treatment, the application of primary and secondary preventive interventions in clinical practice is not optimal. Prevention of CVD in both the primary and secondary prevention setting, while dominantly the responsibility of the primary care provider, is increasingly challenged given this ever expanding new knowledge as well as the ongoing problems related to adherence to recommendations. New knowledge in the area of pre-clinical disease detection has presented increasingly challenging scenarios to primary care healthcare providers relative to the decisions regarding the need for further risk stratification and aggressive medical regimens. Furthermore, increasingly complex patients are surviving with CVD, many of whom can benefit from advanced knowledge and expertise with regard to risk factor management and rehabilitation that is beyond traditional general primary and cardiology practitioner's scope of practice. The prevention of cardiovascular morbidity and mortality is a shared responsibility among all health professionals involved in the care of people at risk of developing cardiovascular disease. This document is directed at those individuals seeking expertise at a leadership level in this field, and includes opportunities for formal training and alternative routes to competence and maintenance of competence in prevention of cardiovascular disease (Table 2), and educational resources for acquisition and maintenance of competence in the prevention of cardiovascular disease (Table 3). To address the expanding fund of knowledge in the area and to ensure that an adequately trained force of preventive cardiovascular leaders will be available to primary care providers, as well as provide a pool of providers with expertise in running rehabilitation and other programs designed to address the ongoing issue of adherence, the formulation of clinical competency criteria for the cardiovascular preventive specialist is needed. These competency criteria are expected to address issues of expert clinical and scientific leadership, specialty patient care and consultation, and directorship of primary and secondary preventive cardiac programs. Of note and similar to other subspecialty areas of medicine, cardiovascular preventive specialists will have varying areas of expertise and will not necessarily achieve all the outlined areas of competencies. These clinical competency criteria in the area of specialty treatment and prevention of CVD are needed given the current setting of a rapidly growing field of knowledge ranging from molecular and cellular mechanisms to clinical outcomes in order to translate into improved patient care. Table 2 Opportunities for Formal Training and Alternative Routes to Competence and Maintenance of Competence in Prevention of Cardiovascular Disease Table 3 Educational Resources for Acquisition and Maintenance of Competence in the Prevention of Cardiovascular Disease C. Noel Bairey Merz, MD, FACC, FAHA Chair, ACCF/AHA/ACP Clinical Competence Statement on Prevention of CVD

The American Heart Association (AHA) and the American Diabetes Association (ADA) have each published guidelines for cardiovascular disease prevention: The ADA has issued separate recommendations for each of the cardiovascular risk factors in patients with diabetes, and the AHA has shaped primary and secondary guidelines that extend to patients with diabetes. This statement will attempt to harmonize the recommendations of both organizations where possible but will recognize areas in which AHA and ADA recommendations differ.