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Background: Evidence from large randomized clinical trials supports the benefit of SGLT2i (sodium-glucose cotransporter-2 inhibitors) to improve cardiovascular and kidney outcomes in patients with type 2 diabetes with or at high risk for atherosclerotic cardiovascular disease or chronic kidney disease. Considering this evidence, which has been expanding since the product label indication for empagliflozin to reduce risk of cardiovascular death in 2016, clinician-level variation in the prescription of SGLT2i among US Medicare beneficiaries was evaluated.Methods: Antihyperglycemic medication prescribers were identified as those physicians and advanced practice providers prescribing metformin in Medicare part D prescriber data. In this cross-sectional study, the proportion prescribing SGLT2i was assessed overall and across specialties in 2018, with changes assessed from 2014 to 2018. SGLT2i use was compared with other second-line antihyperglycemic medication classes, sulfonylureas and DPP4is (dipeptidyl peptidase-4 inhibitors).Results: Among 232 523 unique clinicians who prescribed metformin for Medicare beneficiaries in 2018 (diabetes-treating clinicians), 45 255 (19.5%) prescribed SGLT2i. There was substantial variation across specialties-from 72% of endocrinologists to 14% of cardiologists who prescribed metformin also prescribed SGLT2i. Between 2014 and 2018, the number prescribing SGLT2i increased 5-fold from 9048 in 2014 to 45 255 in 2018. Among clinicians who prescribed both sulfonylureas and SGLT2i in 2018, SGLT2i was prescribed to a median 33 beneficiaries for every 100 prescribed sulfonylureas (interquartile range, 18-67). SGLT2i use relative to sulfonylureas increased from 19 (interquartile range, 11-34) per 100 in 2014 to 33 (interquartile range, 18-67) per 100 in 2018 (Ptrend<0.001).Conclusions: Eighty percent of clinicians prescribing metformin to Medicare beneficiaries did not prescribe SGLT2i in 2018. Moreover, sulfonylureas prescriptions were 3 times more frequent than those of SGLT2is, although a pattern of increasing uptake may portend future trends. These findings highlight a baseline opportunity to improve care and outcomes for patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

The article presents a study which examined (AMI) patients in the first 48 hours admitted to U.S. hospitals from 2000 to 2008, to identify glucose variability (GV) metrics that are most predictive of in-hospital mortality and examine whether GV provides additional prognostic information above and beyond mean blood glucose (BG). Mean BG remains an independent predictor of in-hospital death, even in models adjusting for GV and multiple patient characteristics.

The article focuses on the revised recommendations of the American Diabetes Association (ADA), American Heart Association (AHA) and the American College of Cardiology Foundation (ACCF) on aspirin therapy as a prevention strategy in people with diabetes at increased cardiovascular risk. It references findings from related studies and clinical trials. It outlines the questions considered by a group of experts convened to review and summarize the available evidence.

The article focuses on the quality assessment of comprehensive cardiometabolic care of patients suffering from type 2 diabetes in the U.S. Topics discussed include an overview of type 2 diabetes, the impact of its prevalence on its mortality and complications, and the formation of the Diabetes Collaborative Registry.

The article presents the consensus statement released by the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA) concerning inpatient glycemic control. It notes that not all hospitalized patients with hyperglycemia exhibit improved outcomes following intervention designed to reduce blood glucose (BG) levels. It examines several treatment options for glycemic control including intravenous (IV) insulin infusions and subcutaneously administered insulin.

The article presents a study which examines the glucose normalization among patients with acute myocardial infarction in the U.S. It states that high blood glucose levels on hospital admission have connection with increased mortality in patients with acute myocardial infarction. It concludes that glucose normalization after hospital admission is associated with better survival in hyperglycemic patients with acute myocardial infarction whether or not they receive insulin therapy. It highlights the need for effective strategy on intentional glucose lowering with insulin therapy.

Discusses research on the use of oral medications in treating type 2 diabetes. Results of clinical trials to determine the effects of available oral agents for type 2 diabetes on patients; Types of oral antihyperglycemic drugs approved by the U.S. Food and Drug Administration; Strategies for combining different kinds of oral medications.

Metformin, a biguanide, has been available in the US for the treatment of type 2 diabetes mellitus for nearly 8 years. Over this period of time, it has become the most widely prescribed antihyperglycaemic agent. Its mechanism of action involves the suppression of endogenous glucose production, primarily by the liver. Whether the drug actually has an insulin sensitising effect in peripheral tissues, such as muscle and fat, remains somewhat controversial. Nonetheless, because insulin levels decline with metformin use, it has been termed an 'insulin sensitiser'. Metformin has also been shown to have several beneficial effects on cardiovascular risk factors and it is the only oral antihyperglycaemic agent thus far associated with decreased macrovascular outcomes in patients with diabetes. Cardiovascular disease, impaired glucose tolerance and the polycystic ovary syndrome are now recognised as complications of the insulin resistance syndrome, and there is growing interest in the management of this extraordinarily common metabolic disorder. While diet and exercise remain the cornerstone of therapy for insulin resistance, pharmacological intervention is becoming an increasingly viable option. We review the role of metformin in the treatment of patients with type 2 diabetes and describe the additional benefits it provides over and above its effect on glucose levels alone. We also discuss its potential role for a variety of insulin resistant and prediabetic states, including impaired glucose tolerance, obesity, polycystic ovary syndrome and the metabolic abnormalities associated with HIV disease. [ABSTRACT FROM AUTHOR]

Context: According to package inserts, metformin is contraindicated in diabetic patients receiving drug treatment for heart failure therapy, and thiazolidinediones are not recommended in diabetic patients with symptoms of advanced heart failure. Little is known about patterns of use of these antihyperglycemic drugs in diabetic patients with heart failure. Objective: To determine the proportions of patients hospitalized with heart failure and concomitant diabetes treated with metformin or thiazolidinediones. Design: Serial cross-sectional measurements using data from retrospective medical record abstraction. Setting: Nongovernmental acute care hospitals in the United States. Patients: Two nationally representative samples of Medicare beneficiaries hospitalized with the primary diagnosis of heart failure and concomitant diabetes between April 1998 and March 1999 and between July 2000 and June 2001. Main Outcome Measures: The prescription of either metformin or a thiazolidinedione at hospital discharge. Results: In the 1998-1999 sample (n = 12 505), 7.1% of patients were discharged with a prescription for metformin, 7.2% with a prescription for a thiazolidinedione, and 13.5% with a prescription for either drug. In the 2000-2001 sample (n = 13 158), metformin use increased to 11.2%, thiazolidinedione use to 16.1%, and use of either drug to 24.4% (P<.001 for all comparisons). Similar increases were seen among patients of all age groups, all races, and both sexes. Conclusions: The use of metformin and thiazolidinediones is common and has increased rapidly in Medicare beneficiaries with diabetes and heart failure in direct contrast with explicit warnings against this practice by the Food and Drug Administration. Further studies to establish the safety and effectiveness of this practice are needed to ensure optimal care of patients with diabetes and heart failure. [ABSTRACT FROM AUTHOR]

To examine the mechanism by which metformin lowers endogenous glucose production in type 2 diabetic patients, we studied seven type 2 diabetic subjects, with fasting hyperglycemia (15.5 +/- 1.3 mmol/l), before and after 3 months of metformin treatment. Seven healthy subjects, matched for sex, age, and BMI, served as control subjects. Rates of net hepatic glycogenolysis, estimated by 13C nuclear magnetic resonance spectroscopy, were combined with estimates of contributions to glucose production of gluconeogenesis and glycogenolysis, measured by labeling of blood glucose by 2H from ingested 2H2O. Glucose production was measured using [6,6-2H2]glucose. The rate of glucose production was twice as high in the diabetic subjects as in control subjects (0.70 +/- 0.05 vs. 0.36 +/- 0.03 mmol x m(-2) min(-1), P < 0.0001). Metformin reduced that rate by 24% (to 0.53 +/- 0.03 mmol x m(-2) x min(-1), P = 0.0009) and fasting plasma glucose concentration by 30% (to 10.8 +/- 0.9 mmol/l, P = 0.0002). The rate of gluconeogenesis was three times higher in the diabetic subjects than in the control subjects (0.59 +/- 0.03 vs. 0.18 +/- 0.03 mmol x m(-2) min(-1) and metformin reduced that rate by 36% (to 0.38 +/- 0.03 mmol x m(-2) x min(-1), P = 0.01). By the 2H2O method, there was a twofold increase in rates of gluconeogenesis in diabetic subjects (0.42 +/- 0.04 mmol m(-2) x min(-1), which decreased by 33% after metformin treatment (0.28 +/- 0.03 mmol x m(-2) x min(-1), P = 0.0002). There was no glycogen cycling in the control subjects, but in the diabetic subjects, glycogen cycling contributed to 25% of glucose production and explains the differences between the two methods used. In conclusion, patients with poorly controlled type 2 diabetes have increased rates of endogenous glucose production, which can be attributed to increased rates of gluconeogenesis. Metformin lowered the rate of glucose production in these patients through a reduction in gluconeogenesis. [ABSTRACT FROM AUTHOR]

The article presents the authors' response on the comment of David R. Matthews and colleagues on the article on recommendations for insulin therapy in type 2 diabetes outlined in the American Diabetes Association's "Standard of Medical Care in Diabetes" published in the issue of "Diabetes Care" journal. They agree that there are three treatment options after basal insulin failure. They stress that misapplication of complex therapies can be harmful despite its efficacy during the research.

The article discusses citizen petition to the U.S. Food and Drug Administration (FDA) to change prescribing guidelines. It says that the First Amendment to the U.S. Constitution guarantees the right of the people...to petition the Government for a remedy of grievances. It adds that individuals have the right to address their concerns by directly petitioning the FDA when it comes to the control of drugs and protection of public health.

Background: The implementation of preventive therapies among patients with stroke remains inadequately explored, especially when compared with patients with myocardial infarction (MI), despite sharing similar vascular risk profiles. We tested the hypothesis that participants with a history of stroke have a worse cardiovascular prevention profile in comparison to participants with MI., Methods and Results: In cross-sectional analyses within the UK Biobank and All of Us Research Program, involving 14 760 (9193 strokes, 5567 MIs) and 7315 (2948 strokes, 4367 MIs) participants, respectively, we evaluated cardiovascular prevention profiles assessing low-density lipoprotein (<100 mg/dL), blood pressure (systolic, <140 mm Hg; and diastolic, <90 mm Hg), statin and antiplatelet use, and a cardiovascular prevention score that required meeting at least 3 of these criteria. The results revealed that, within the UK Biobank, patients with stroke had significantly lower odds of meeting all the preventive criteria compared with patients with MI: low-density lipoprotein control (odds ratio [OR], 0.73 [95% CI, 0.68-0.78]; P <0.001), blood pressure control (OR, 0.63 [95% CI, 0.59-0.68]; P <0.001), statin use (OR, 0.45 [95% CI, 0.42-0.48]; P <0.001), antiplatelet therapy use (OR, 0.30 [95% CI, 0.27-0.32]; P <0.001), and cardiovascular prevention score (OR, 0.42 [95% CI, 0.39-0.45]; P <0.001). Similar patterns were observed in the All of Us Research Program, with significant differences across all comparisons ( P <0.05), and further analysis suggested that the odds of having a good cardiovascular prevention score were influenced by race and ethnicity as well as neighborhood deprivation levels (interaction P <0.05 in both cases)., Conclusions: In 2 independent national cohorts, patients with stroke showed poorer cardiovascular prevention profiles and lower adherence to guideline-directed therapies compared with patients with MI. These findings underscore the need to explore the reasons behind the underuse of secondary prevention in vulnerable stroke survivors.

Diabetes is a heterogeneous disease that affects 9% of the world's population (11% in the United States). The consequences of diabetes for the brain are severe; it nearly doubles a person's risk of stroke and is a major contributor to risk for cerebral small vessel disease and dementia. These effects on the brain are in addition to peripheral neuropathy, retinopathy, nephropathy, and coronary heart disease. In this article, we explain the treatments that can prevent or mitigate its harmful effects and propose a role for neurologists and other neurology clinicians in managing patients during routine care.

Acute Heart failure (AHF) is among the most frequent causes of hospitalization in the United States, contributing to substantial health care costs, morbidity, and mortality. Inpatient initiation of guideline-directed medical therapy (GDMT) is recommended for patients with heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death or HF hospitalization. However, underutilization of GDMT prior to discharge is pervasive, representing a valuable missed opportunity to optimize evidence-based care. The PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failure tests the effectiveness of an electronic health record embedded clinical decision support system that informs providers during hospital management about indicated but not yet prescribed GDMT for eligible AHF patients with HFrEF. PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failureis an open-label, multicenter, pragmatic randomized controlled trial of 1,012 patients hospitalized with HFrEF. Eligible patients randomized to the intervention group are exposed to a tailored best practice advisory embedded within the electronic health record that alerts providers to prescribe omitted GDMT. The primary outcome is an increase in the proportion of additional GDMT medication classes prescribed at the time of discharge compared to those in the usual care arm., Competing Interests: Disclosures JH, TO, JM are employees of AstraZeneca. RJR is a consultant for Alexion, Amgen, AstraZeneca, Boehringer Ingelheim, Janssen, Johnson & Johnson, PhaseBio, and Portola. RD does executive teaching for Sanofi Consumer Health care. SEI has served on clinical trial committees and advisory boards for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk. He has served as a consultant to Merck, Pfizer, Lexicon, vTv Therapeutics, Esperion and Abbott and has delivered lectures supported by Boehringer Ingelheim and AstraZeneca. TA is consultant for Sanofi-Aventis, Amgen, Cytokinetics. He has research funding from Boehringer Ingelheim, AstraZeneca, Cytokinetics, and Relypsa. NRD works under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures used for public reporting and pay for performance programs. He reports research grants and consulting for Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Novartis, SCPharmaceuticals, and Vifor. The remaining authors have nothing to disclose., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Heart failure with reduced ejection fraction (HFrEF) is one of the most common chronic illnesses in the United States and carries significant risk of morbidity and mortality. Use of guideline-directed medical therapy (GDMT) for patients with HFrEF has been shown to dramatically improve outcomes, but adoption of these treatments remains generally low. Possible explanations for poor GDMT uptake include lack of knowledge about recommended management strategies and provider reluctance due to uncertainties regarding application of said guidelines to real-world practice. One way to overcome these barriers is by harnessing the electronic health record (EHR) to create patient-centered "best practice alerts" (BPAs) that can guide clinicians to prescribe appropriate medical therapies. If found to be effective, these low-cost interventions can be rapidly applied across large integrated healthcare systems. The PRagmatic Trial Of Messaging to Providers about Treatment of Heart Failure (PROMPT-HF) trial is a pragmatic, cluster randomized controlled trial designed to test the hypothesis that tailored and timely alerting of recommended GDMT in heart failure (HF) will result in greater adherence to guidelines when compared with usual care. PROMPT-HF has completed enrollment of 1,310 ambulatory patients with HFrEF cared for by 100 providers who were randomized to receive a BPA vs usual care. The BPA alerted providers to GDMT recommended for their patients and displayed current left ventricular ejection fraction (LVEF) along with the most recent blood pressure, heart rate, serum potassium and creatinine levels, and estimated glomerular filtration rate. It also linked to an order set customized to the patient that suggests medications within each GDMT class not already prescribed. Our goal is to examine whether tailored EHR-based alerting for outpatients with HFrEF will lead to higher rates of GDMT at 30 days post randomization when compared with usual care. Additionally, we are assessing clinical outcomes such as hospital readmissions and death between the alert versus usual care group. Trial Registration: Clinicaltrials.gov NCT04514458., (Copyright © 2021. Published by Elsevier Inc.)

Background: Patients with type 2 diabetes and atherosclerotic cardiovascular disease are at high clinical risk. We assessed the effect of the sodium-glucose co-transporter-2 inhibitor, empagliflozin, on total cardiovascular events and admissions to hospital in the EMPA-REG OUTCOME trial., Methods: The EMPA-REG OUTCOME trial was a randomised, double-blind, non-inferiority trial of patients (aged ≥18 years) with type 2 diabetes and atherosclerotic cardiovascular disease done between August, 2010, and April, 2015. Participants were randomly assigned (1:1:1) to empagliflozin 10 mg or 25 mg, or placebo. The primary outcome was major adverse cardiovascular events: a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction. As prespecified, the effects of pooled empagliflozin versus placebo were assessed on total (first plus recurrent) events of major adverse cardiovascular events, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, and admission to hospital for heart failure. We also did post-hoc analyses on additional cardiovascular and admission to hospital outcomes. We used statistical models that preserve randomisation and account for correlation of recurrent events, including negative binomial regression, as prespecified for the primary analyses. The EMPA-REG OUTCOME trial is registered with ClinicalTrials.gov, NCT01131676, and is closed to accrual., Findings: In the EMPA-REG OUTCOME trial, 7020 patients were randomly assigned and treated with empagliflozin 10 mg (n=2345), empagliflozin 25 mg (n=2342), or placebo (n=2333) and followed up for a median of 3·2 years (IQR 2·2 to 3·6) in the pooled empagliflozin group and 3·1 years (2·2 to 3·5) in the placebo group. Analysing total (first plus recurrent) events, empagliflozin versus placebo reduced the risk of major adverse cardiovascular events (rate ratio [RR] 0·78 [95% CI 0·67 to 0·91]; p=0·0020; 12·88 [95% CI 3·74 to 22·02] events prevented per 1000 patient-years); fatal or non-fatal myocardial infarction (0·79 [0·62 to 0·998]; p=0·049; 4·97 [-0·68 to 10·61] events prevented per 1000 patient-years); the composite of fatal or non-fatal myocardial infarction, or coronary revascularisation (0·80 [0·67 to 0·95]; p=0·012; 11·65 [1·25 to 22·05] events prevented per 1000 patient-years); admission to hospital for heart failure (0·58 [0·42 to 0·81]; p=0·0012; 9·67 [3·07 to 16·28] events prevented per 1000 patient-years); and all-cause admission to hospital (0·83 [0·76 to 0·91]; p<0·0001; 50·41 [26·20 to 74·63] events prevented per 1000 patient-years). For outcomes significantly reduced with empagliflozin, risk reductions were numerically larger for total events than for first events. Total fatal or non-fatal stroke was not significantly different between treatment groups (RR 1·10 [95% CI 0·82 to 1·49]; p=0·52)., Interpretation: Empagliflozin reduced the total burden of cardiovascular complications and all-cause admission to hospital in patients with type 2 diabetes and atherosclerotic cardiovascular disease., Funding: The Boehringer Ingelheim and Lilly Alliance., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Although cardiologists have long treated patients with coronary artery disease (CAD) and concomitant type 2 diabetes mellitus (T2DM), T2DM has traditionally been considered just a comorbidity that affected the development and progression of the disease. Over the past decade, a number of factors have shifted that have forced the cardiology community to reconsider the role of T2DM in CAD. First, in addition to being associated with increased cardiovascular risk, T2DM has the potential to affect a number of treatment choices for CAD. In this document, we discuss the role that T2DM has in the selection of testing for CAD, in medical management (both secondary prevention strategies and treatment of stable angina), and in the selection of revascularization strategy. Second, although glycemic control has been recommended as a part of comprehensive risk factor management in patients with CAD, there is mounting evidence that the mechanism by which glucose is managed can have a substantial impact on cardiovascular outcomes. In this document, we discuss the role of glycemic management (both in intensity of control and choice of medications) in cardiovascular outcomes. It is becoming clear that the cardiologist needs both to consider T2DM in cardiovascular treatment decisions and potentially to help guide the selection of glucose-lowering medications. Our statement provides a comprehensive summary of effective, patient-centered management of CAD in patients with T2DM, with emphasis on the emerging evidence. Given the increasing prevalence of T2DM and the accumulating evidence of the need to consider T2DM in treatment decisions, this knowledge will become ever more important to optimize our patients' cardiovascular outcomes.

Objective: In 2016, the U.S. Food and Drug Administration (FDA) revised metformin's label to permit use in patients with mild-moderate chronic kidney disease. We sought to determine whether this change was associated with increased reports of metformin-associated lactic acidosis (MALA) to the FDA's Adverse Event Reporting System (FAERS)., Research Design and Methods: Publicly available FAERS reports were analyzed., Results: MALA reports increased from 521 in 2015 to 1,939 in 2018. After restriction to U.S. reports, absolute and relative increase in MALA reports was less, from 111 to 243. The proportionate reporting ratio (PRR), a measure adjusted for rates of other adverse event reports, was stable., Conclusions: The increased reports deserve attention, but the PRR's stability and FAERS's known limitations, including lack of a denominator or control group, do not permit the conclusion that U.S. MALA rates have increased. Further study with more robust data sources is needed., (© 2019 by the American Diabetes Association.)

In 2008, the US Food and Drug Administration (FDA) issued a guidance to industry statement concerning evaluation of the cardiovascular (CV) safety of new antihyperglycaemic therapies for type 2 diabetes. Fifteen CV outcome trials assessing three novel classes of antihyperglycaemic therapies, DPP-4 inhibitors, GLP-1 receptor agonists and SGLT-2 inhibitors, were completed by the end of 2018 and several others are ongoing. In addition, one comparative insulin trial also has been completed. None of these trials reported an increase in risk for major adverse CV events (MACE), and six agents have demonstrated CV benefits. This experience has led to the first FDA-approved indications for antihyperglycaemic medications to reduce the risk of CV death (empagliflozin) and to reduce the risk of MACE (liraglutide, canagliflozin), both indications specific to patients with established atherosclerotic cardiovascular disease (ASCVD). Because of the aggregate results from dedicated CV outcomes trials conducted in response to the FDA guidance statement, the contemporary paradigm for treatment of patients with type 2 diabetes has evolved substantially. However, the guidance has substantially increased the cost of developing new medications to address this important disease that afflicts hundreds of millions of adults worldwide, with reduction in quality of life as well as in life expectancy. The cost burden of drug development of medications proven effective that may directly impact cost to patients and to their insurers might be alleviated by modifications to the present guidance statement. These include areas of trial design, aspects of trial operation, expansion of composite outcomes to include broader component CV outcomes and continued evolution of analytic methodology. The guidance statement will benefit from consideration of a number of modifications to support continued innovation and, of course, the safety of marketed medications for type 2 diabetes. However, the requirement to assess each new antihyperglycaemic medication in at least one large-scale standard randomized clinical outcomes trial should remain, so that clinicians can be reassured about the favourable efficacy/safety profiles of the medications they prescribe., (© 2019 John Wiley & Sons Ltd.)

Aim: To investigate multiple risk factor target attainment in adults with diabetes mellitus (DM) for atherosclerotic cardiovascular disease (ASCVD) prevention and the predictors of such attainment in a contemporary DM registry., Methods: In the US Diabetes Collaborative Registry we identified patients who were at target for glycated haemoglobin (HbA1c; < 53 mmol/mol (7%) or < 64 mmol/mol (8%) if with ASCVD), LDL cholesterol (< 2.6 mmol/L (100 mg/dL) or < 1.8 mmol/L (70 mg/dL) 1.8 if with ASCVD) and blood pressure (BP; <140/90 mmHg and < 130/80 mmHg as an alternate), and who had non-smoking status, by sex, race and history of ASCVD. Multiple logistic regression was used to examine predictors of target attainment., Results: In 74 393 patients with DM who had available data (mean age 69.0 years, 41.0% women), overall target attainment for HbA1c, BP, LDL cholesterol and non-smoking status was 73.6%, 69.0% (40.3% for BP <130/80 mmHg), 48.6% and 85.2%, respectively. Only 21.6% (13.0% with BP <130/80 mmHg) were at target for all four measures, and the proportions were higher in men (23.6%) versus women (18.6%) and in white people (22.5%) versus African-American people (14.7%) and people of other races (20.8%; P < 0.01). A total of 62.4% were on a moderate-/high-intensity statin. Age (≥65 years: odds ratio [OR] 1.9, 95% confidence interval [CI] 1.7-2.0; and 55-64 years: OR 1.3, 95% CI 1.2-1.4 vs. <55 years), male sex (OR 1.3, 95% CI 1.3-1.4), white race (OR 1.4, 95% CI 1.3-1.5), middle or high income (ORs 1.1, 95% CI 1.1-1.2 or 1.4, 95% CI 1.4-1.5, respectively) were associated, and depression (OR 0.9, 95% CI 0.8-1.0) was inversely associated with meeting all four targets (all P = 0.01 to P < 0.001)., Conclusions: In our US registry of patients with DM, only one in five patients were achieving comprehensive risk factor control. Multifactorial interventions will be necessary to optimize ASCVD risk factor control., (© 2019 John Wiley & Sons Ltd.)

Background: Although practice guidelines stress individualization of glucose management in patients with type 2 diabetes (T2D), the extent to which providers take patient factors into account when selecting medications is not well known., Methods: Diabetes Collaborative Registry (DCR) is an outpatient diabetes registry including primary care, cardiology, and endocrinology practices. T2D medications were grouped as those which may be suboptimal for key patient subgroups, and we examined patient factors associated with use of these agents using hierarchical, multivariable Poisson models., Results: In DCR, 157,551 patients from 374 US practices were prescribed a glucose-lowering medication. Patients with morbid obesity were more likely treated with medications prone to cause weight gain (relative rate [RR] 1.09, 95% CI 1.07-1.11). Older patients were more likely to be treated with medications with increased risk of hypoglycemia (RR 1.04 per 5 years, 95% CI 1.04-1.05). Patients with CKD 4/5 were less likely to be treated with agents with known risk in patients with advanced CKD (RR 0.74, 95% CI 0.71-0.77). Patients with coronary artery disease were no more or less likely to be treated with medications with potential cardiovascular safety issues (RR 0.99, 95% CI 0.96-1.01)., Conclusions: We observed some targeted use of glucose-lowering therapies in certain subgroups but also identified potential opportunities for better personalization of treatment. Data sources such as the DCR can highlight potential areas for improving targeted approaches to pharmacologic therapy in order to optimize selection of patients most likely to benefit (and least likely to be harmed) from treatments., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: A writing committee of the Planning Research in Inpatient Diabetes (PRIDE) group has written this consensus article on behalf of the group in response to a specific request for input from the Centers for Medicare and Medicaid Services (CMS). The purpose of this article is to respond to the March 13, 2015 statement from that agency regarding plans to enforce prohibition of the off-label use of point of care (POC) capillary blood glucose monitor (BGM) testing in most critically ill patients. The article discusses: 1) how POC BGM testing is currently regulated; 2) how POC BGM testing is currently used in the United States; and 3) how POC BGM testing can be safely and effectively regulated in the future through cooperation between the clinician, laboratory, regulatory, industry, and patient communities., Participants: Nine members of PRIDE volunteered to write the statement on behalf of the entire group., Evidence: Descriptions of current medical practice for critically ill patients were derived from the experience of the authors. Descriptions of the performance of various methods for measuring glucose levels for intensive insulin therapy came from a literature review., Consensus Process: Eleven questions were developed by the PRIDE writing group. After extensive electronic and telephone discussion, the article was written and reviewed by all nine authors and then reviewed by two outside experts in the care of critically ill patients. All suggestions by the authors and the outside experts were incorporated., Conclusions: Although the CMS is attempting to protect patients with abnormal glycemic control from harm due to inaccurate POC fingerstick capillary BGM testing, their plan will result in more harm than good. A moratorium on enforcement of the prohibition of off-label use of POC capillary BGM testing is needed.

Cardiovascular disease risk factor control as primary prevention in patients with type 2 diabetes mellitus has changed substantially in the past few years. The purpose of this scientific statement is to review the current literature and key clinical trials pertaining to blood pressure and blood glucose control, cholesterol management, aspirin therapy, and lifestyle modification. We present a synthesis of the recent literature, new guidelines, and clinical targets, including screening for kidney and subclinical cardiovascular disease for the contemporary management of patients with type 2 diabetes mellitus., (© 2015 American Heart Association, Inc.)

Unlabelled: Hyperglycemia is common in the hospital in-patient setting and is associated with adverse outcomes. Healthcare professionals (HCPs) often fail to use best practices established to manage this condition or to coordinate care among team members., Objectives: The objective of the Hyperglycemia Grand Rounds (HGR) continuing education initiative was to improve knowledge levels in a team setting, leading to improved clinical competence, evidence-based behaviors, and improved patient care., Methods: To achieve that goal, a four-module seminar series was presented to HCPs on-site in a "Grand Rounds" format at healthcare institutions across the United States. Outcomes data included satisfaction, learning, impact, and intent-to-implement measures at event time and at follow-up. At the site level, detailed questionnaires assessed skill gaps and expected outcomes from administrators at the time the modules were scheduled and the impact after modules were completed. Demographic information allowed identification of HCPs receiving maximum benefits; data on barriers to implementation are reported., Results: Seventy-eight percent of participants self-reported a positive impact on competence, performance, or patient outcomes. Forty percent of learners said they intended to make specific changes in practices. Eighty-two percent of administrators confirmed expected changes in their health system. The follow-up study concurred with the initial findings., Conclusion: The HGR was an effective program in improving self-reported competence amongst attendees that could potentially lead to improved care. This descriptive report summarizes outcomes from 1 year of educational efforts to more than 2000 healthcare professionals.

Importance: The increasing intensity of diabetes mellitus management over the past decade may have resulted in lower rates of hyperglycemic emergencies but higher rates of hospital admissions for hypoglycemia among older adults. Trends in these hospitalizations and subsequent outcomes are not known., Objective: To characterize changes in hyperglycemia and hypoglycemia hospitalization rates and subsequent mortality and readmission rates among older adults in the United States over a 12-year period, and to compare these results according to age, sex, and race., Design, Setting, and Patients: Retrospective observational study using data from 33,952,331 Medicare fee-for-service beneficiaries 65 years or older from 1999 to 2011., Main Outcomes and Measures: Hospitalization rates for hyperglycemia and hypoglycemia, 30-day and 1-year mortality rates, and 30-day readmission rates., Results: A total of 279,937 patients experienced 302,095 hospitalizations for hyperglycemia, and 404,467 patients experienced 429,850 hospitalizations for hypoglycemia between 1999 and 2011. During this time, rates of admissions for hyperglycemia declined by 38.6% (from 114 to 70 admissions per 100,000 person-years), while admissions for hypoglycemia increased by 11.7% (from 94 to 105 admissions per 100,000 person-years). In analyses designed to account for changing diabetes mellitus prevalence, admissions for hyperglycemia and hypoglycemia declined by 55.2% and 9.5%, respectively. Trends were similar across age, sex, and racial subgroups, but hypoglycemia rates were 2-fold higher for older patients (≥75 years) when compared with younger patients (65-74 years), and admission rates for both hyperglycemia and hypoglycemia were 4-fold higher for black patients compared with white patients. The 30-day and 1-year mortality and 30-day readmission rates improved during the study period and were similar after an index hospitalization for either hyperglycemia or hypoglycemia (5.4%, 17.1%, and 15.3%, respectively, after hyperglycemia hospitalizations in 2010; 4.4%, 19.9%, and 16.3% after hypoglycemia hospitalizations)., Conclusions and Relevance: Hospital admission rates for hypoglycemia now exceed those for hyperglycemia among older adults. Although admissions for hypoglycemia have declined modestly since 2007, rates among black Medicare beneficiaries and those older than 75 years remain high. Hospital admissions for severe hypoglycemia seem to pose a greater health threat than those for hyperglycemia, suggesting new opportunities for improvement in care of persons with diabetes mellitus.

Background: Elevated blood glucose is associated with higher mortality in patients with acute myocardial infarction (AMI). Although clinical guidelines recommend targeted glucose control in this group, clinical trials have yielded inconclusive results. Our objective was to understand how this lack of evidence impacts the management of severe hyperglycemia in routine practice., Methods: We examined insulin use among 4,297 AMI admissions with a mean hospitalization blood glucose of ≥200 mg/dL across 55 US hospitals from 2000 to 2008. Temporal trends and interhospital variation in 2 measures of insulin use during hospitalization-any (subcutaneous, intravenous [IV], short acting, long acting) and IV insulin-were examined using hierarchical Poisson regression models., Results: Of the 4,297 admissions, 2,618 (61%) received any insulin and 538 (13%) received IV insulin. After multivariable adjustment, a slight increase in insulin use was observed per admission year (relative risk [RR] 1.06, 95% CI 1.01-1.11). There was a modest (albeit nonsignificant) increase in IV insulin use seen before May 2004 (RR 1.18, 95% CI 0.96-1.47), with no significant change thereafter (RR 0.99, 95% CI 0.92-1.09). Marked variability in insulin use was observed across hospitals (median rate ratio 1.5 [any insulin] and 1.8 [IV insulin]), which did not change over time., Conclusions: Insulin use among patients with AMI and severe hyperglycemia has remained low over the past decade, with substantial and persistent interhospital variation. These observations reflect marked clinical uncertainty with regard to glucose management in AMI, underscoring the imperative for a definitive clinical trial in this field., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: A national Medicare database indicated that one in eight older patients with diabetes was discharged off all antihyperglycemic therapy (AHT) following acute myocardial infarction (AMI). This practice was associated with increased one-year mortality, but the reasons for stopping AHT were not known. A study was conducted to determine whether such practice might be due to medical necessity (that is, a new contraindication) or oversight--in which case a quality improvement opportunity might exist., Methods: Some 327 diabetic patients were identified who were hospitalized with AMI during a one-year period at an academic medical center and an affiliated community hospital. Detailed chart reviews were conducted on the 217 patients with AMI as a principal diagnosis who were admitted on AHT (insulin, 81). Twenty-five patients (11.5%) were discharged off AHT, 24 (96%) of whom received some AHT in the hospital, mostly as insulin sliding scale. One patient's (4%) AHT was stopped because of a change in care goals, a second developed recurrent hypoglycemia, and a third had entirely normal in-hospital blood glucose after AHT discontinuation. The remaining 22 patients (88%) were categorized as being discharged off AHT without justification. The demographic/clinical characteristics of those discharged on versus off AHT were similar, except for better left ventricular ejection fraction (LVEF) in the latter., Conclusions: The percentage of diabetic patients discharged off AHT following AMI was nearly identical to that in a national database (approximately one out of eight). No clear reason for this practice could be found in nearly 90% of the cases, suggesting that it may often constitute a medical error for a growing population of diabetic patients with ischemic heart disease.

Gender differences in cardiovascular outcomes were compared in asymptomatic men and women with type 2 diabetes (T2DM) in the Detection of Ischemia in Asymptomatic Diabetics (DIAD) study. Of 1123 participants, 290 men and 271 women were randomised to screening with stress myocardial perfusion imaging (MPI); 311 men and 251 women were randomised to no screening. Follow-up was 4.8±0.9 years for the occurrence of cardiac events (CE; cardiac death or non-fatal myocardial infarction). The frequency of abnormal screening was similar in men (24%) and women (19%), (p=0.2), although women trended to have smaller MPI abnormalities. CE rates were lower in women than men (1.7% vs. 3.8%, p=0.04). No CEs occurred in 17 high-risk (UKPDS risk engine) women, whereas 14 (11.2%) occurred in 125 high-risk men. Asymptomatic women with T2DM have significantly better cardiac outcomes than their male counterparts and represent a subgroup for which screening for coronary artery disease does not appear warranted.

Background: Patients with diabetes are frequently admitted for acute myocardial infarction (AMI) on antihyperglycemic agents but may be discharged without glucose-lowering therapy. We examined the frequency of this practice and evaluated the associated outcomes of readmission and mortality., Methods and Results: We conducted a retrospective study of 24 953 Medicare beneficiaries with diabetes discharged after hospitalization for AMI. We examined the frequency of discontinuation of antihyperglycemic agents on discharge among those patients admitted on a diabetic regimen. The independent association between discharge on versus off antihyperglycemic therapy and outcomes at 1 year was assessed in multivariable Cox proportional hazards models, adjusting for patient, physician, and hospital variables. The primary outcome was time to death within 1 year of discharge; secondary outcomes were time to first rehospitalization within 1 year for AMI, heart failure, and all causes. There were 8751 patients admitted on at least 1 antihyperglycemic agent who met our inclusion/exclusion criteria. Of these, 7581 (86.6%) were discharged on antihyperglycemic therapy and 1170 (13.4%) were discharged off antihyperglycemic therapy. After multivariable analysis, as compared with those whose diabetes therapy was continued at discharge, patients who were not prescribed a glucose-lowering agent had higher 1-year mortality rate (hazard ratio, 1.29; 95% confidence interval, 1.15 to 1.45). Readmission rates did not differ significantly between the 2 groups (hazard ratio, 0.95; 95% confidence interval, 0.87 to 1.03)., Conclusions: In older patients with diabetes after AMI, discontinuation of antihyperglycemic therapy is common and associated with higher mortality rates. The reasons behind this practice as well as the specific effects of hyperglycemia after AMI merit further study.