Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data From the DELIVER and DAPA-HF Trials.

BACKGROUND: The sodium glucose cotransporter-2 inhibitors are guideline-recommended to treat heart failure across the spectrum of left ventricular ejection fraction; however, economic evaluations of adding sodium glucose cotransporter-2 inhibitors to standard of care in chronic heart failure across a broad left ventricular ejection fraction range are lacking. METHODS AND RESULTS: We conducted a US-based cost-effectiveness analysis of dapagliflozin added to standard of care in a chronic heart failure population using pooled, participant data from the DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) and DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trials. The 3-state Markov model used estimates of transitional probabilities, effectiveness of dapagliflozin, and utilities from the pooled trials. Costs estimates were obtained from published sources, including published rebates in dapagliflozin cost. Adding dapagliflozin to standard of care was estimated to produce an additional 0.53 quality-adjusted life years (QALYs) compared with standard of care alone. Incremental cost effectiveness ratios were $85 554/QALY when using the publicly reported full (undiscounted) Medicare cost ($515/month) and $40 081/QALY, at a published nearly 50% rebate ($263/month). The addition of dapagliflozin to standard of care would be of at least intermediate value (<$150 000/QALY) at a cost of <$872.58/month, of high value (<$50 000/QALY) at <$317.66/month, and cost saving at <$40.25/month. Dapagliflozin was of at least intermediate value in 92% of simulations when using the full (undiscounted) Medicare list cost in probabilistic sensitivity analyses. Cost effectiveness was most sensitive to the dapagliflozin cost and the effect on cardiovascular death. CONCLUSIONS: The addition of dapagliflozin to standard of care in patients with heart failure across the spectrum of ejection fraction was at least of intermediate value at the undiscounted Medicare cost and may be potentially of higher value on the basis of the level of discount, rebates, and price negotiations offered. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01035255 & NCT01920711.

Association of country economy and socioeconomic factors on risk factor control for primary prevention of cardiovascular disease in patients with diabetes mellitus: Insights from the DISCOVER study.

BACKGROUND: We sought to describe global patterns in achievement of risk factor control for primary prevention in patients with T2D and explore the association of country's GNI/capita with risk factor control. METHODS: The DISCOVER study is a prospective, observational study of patients with T2D from 38 countries enrolled at initiation of second-line glucose-lowering therapy. We examined achievement of risk factor control (glycosylated hemoglobin <7%, blood pressure <140/90 mmHg, prescription of a statin) at 3 years among those without optimal control at baseline. Countries were stratified by gross national income (GNI)/capita, from 2017). We examined the impact of country GNI/capita with achievement of risk factor control. FINDINGS: Our cohort included 9613 patients with T2D and without baseline cardiovascular disease (mean age 57.2 ± 8.7 years, 47.9% women). At baseline, 6354/7646 patients (83.1%) had suboptimal glucose control, 3449/9200 patients (37.5%) had suboptimal BP control, and 2800/4221 patients (66.7%) were not on an appropriate statin (sample sizes differed due to missing covariate data). Optimal control at 3 years of follow-up was achieved in 41% (glucose), 56% (blood pressure), and 29% (statins) of patients. There was significant variability in achievement of risk factor control across countries but no association between country GNI/capita with achievement of risk factor control (p > 0.08 for all). INTERPRETATION: In a global, prospective study of patients with T2D, we found that cardiovascular risk factor control achievement was suboptimal despite 3 years of follow-up in specialized health care systems. Neither country-level nor patient-level socioeconomic factors fully explained this finding.

Diabetes Care Among Older Adults Enrolled in Medicare Advantage Versus Traditional Medicare Fee-For-Service Plans: The Diabetes Collaborative Registry.

OBJECTIVE: Medicare Advantage (MA), Medicare's managed care program, is quickly expanding, yet little is known about diabetes care quality delivered under MA compared with traditional fee-for-service (FFS) Medicare. RESEARCH DESIGN AND METHODS: This was a retrospective cohort study of Medicare beneficiaries ≥65 years old enrolled in the Diabetes Collaborative Registry from 2014 to 2019 with type 2 diabetes treated with one or more antihyperglycemic therapies. Quality measures, cardiometabolic risk factor control, and antihyperglycemic prescription patterns were compared between Medicare plan groups, adjusted for sociodemographic and clinical factors. RESULTS: Among 345,911 Medicare beneficiaries, 229,598 (66%) were enrolled in FFS and 116,313 (34%) in MA plans (for ≥1 month). MA beneficiaries were more likely to receive ACE inhibitors/angiotensin receptor blockers for coronary artery disease, tobacco cessation counseling, and screening for retinopathy, foot care, and kidney disease (adjusted P ≤ 0.001 for all). MA beneficiaries had modestly but significantly higher systolic blood pressure (+0.2 mmHg), LDL cholesterol (+2.6 mg/dL), and HbA1c (+0.1%) (adjusted P < 0.01 for all). MA beneficiaries were independently less likely to receive glucagon-like peptide 1 receptor agonists (6.9% vs. 9.0%; adjusted odds ratio 0.80, 95% CI 0.77-0.84) and sodium-glucose cotransporter 2 inhibitors (5.4% vs. 6.7%; adjusted odds ratio 0.91, 95% CI 0.87-0.95). When integrating Centers for Medicare and Medicaid Services-linked data from 2014 to 2017 and more recent unlinked data from the Diabetes Collaborative Registry through 2019 (total N = 411,465), these therapeutic differences persisted, including among subgroups with established cardiovascular and kidney disease. CONCLUSIONS: While MA plans enable greater access to preventive care, this may not translate to improved intermediate health outcomes. MA beneficiaries are also less likely to receive newer antihyperglycemic therapies with proven outcome benefits in high-risk individuals. Long-term health outcomes under various Medicare plans requires surveillance.

Serial Assessment of High-Sensitivity Cardiac Troponin and the Effect of Dapagliflozin in Patients With Heart Failure With Reduced Ejection Fraction: An Analysis of the DAPA-HF Trial.

BACKGROUND: Circulating high-sensitivity cardiac troponin T (hsTnT) predominantly reflects myocardial injury, and higher levels are associated with a higher risk of worsening heart failure and death in patients with heart failure with reduced ejection fraction. Less is known about the prognostic significance of changes in hsTnT over time, the effects of dapagliflozin on clinical outcomes in relation to baseline hsTnT levels, and the effect of dapagliflozin on hsTnT levels. METHODS: DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) was a randomized, double-blind, placebo-controlled trial of dapagliflozin (10 mg daily) in patients with New York Heart Association class II to IV symptoms and left ventricular ejection fraction ≤40% (median follow-up, 18.2 months). hsTnT (Roche Diagnostics) was measured at baseline in 3112 patients and at 1 year in 2506 patients. The primary end point was adjudicated worsening heart failure or cardiovascular death. Clinical end points were analyzed according to baseline hsTnT and change in hsTnT from baseline to 1 year. Comparative treatment effects on clinical end points with dapagliflozin versus placebo were assessed by baseline hsTnT. The effect of dapagliflozin on hsTnT was explored. RESULTS: Median baseline hsTnT concentration was 20.0 (25th-75th percentile, 13.7-30.2) ng/L. Over 1 year, 67.9% of patients had a ≥10% relative increase or decrease in hsTnT concentrations, and 43.5% had a ≥20% relative change. A stepwise gradient of higher risk for the primary end point was observed across increasing quartiles of baseline hsTnT concentration (adjusted hazard ratio Q4 versus Q1, 3.44 [95% CI, 2.46-4.82]). Relative and absolute increases in hsTnT over 1 year were associated with higher subsequent risk of the primary end point. The relative reduction in the primary end point with dapagliflozin was consistent across quartiles of baseline hsTnT (P-interaction=0.55), but patients in the top quartile tended to have the greatest absolute risk reduction (absolute risk difference, 7.5% [95% CI, 1.0%-14.0%]). Dapagliflozin tended to attenuate the increase in hsTnT over time compared with placebo (relative least squares mean reduction, -3% [-6% to 0%]; P=0.076). CONCLUSIONS: Higher baseline hsTnT and greater increase in hsTnT over 1 year are associated with worse clinical outcomes. Dapagliflozin consistently reduced the risk of the primary end point, irrespective of baseline hsTnT levels. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03036124.

Assessing the cost-effectiveness of sodium-glucose cotransporter-2 inhibitors in type 2 diabetes mellitus: A comprehensive economic evaluation using clinical trial and real-world evidence.

AIMS: The economic burden of diabetes is driven by the management of vascular complications. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated reductions in cardiovascular and renal complications, including hospitalization for heart failure (HHF) and renal disease progression, in randomized clinical trials. The objective of this study was to evaluate the cost-effectiveness of the SGLT2i class versus standard of care in type 2 diabetes mellitus (T2DM), using evidence from both clinical trial and real-world studies. METHODS: An established T2DM model was adapted to use contemporary outcomes evidence from real-world studies and randomized controlled trial evaluations of SGLT2i, and extrapolated over a lifetime for HHF, myocardial infarction, stroke, end-stage renal disease and all-cause mortality. The economic analysis considered adults with T2DM, with and without established cardiovascular disease, and was conducted over a lifetime from the perspective of the health care payer in the United Kingdom, United States and China, discounted at country-specific rates. RESULTS: SGLT2i were consistently associated with increased treatment costs, reduced complication costs and gains in quality-adjusted life years driven by differences in projected life expectancy, cardiovascular and microvascular morbidity and weight loss. SGLT2i were estimated to be cost-saving or cost-effective at relevant thresholds for the overall population in the United Kingdom, United States and China, with cost-effectiveness being the greatest in higher risk subgroups. CONCLUSIONS: The findings highlight the need to take into account cost savings from reducing common, morbid and preventable T2DM complications when considering the cost of diabetes medications.

Eligibility of patients with type 2 diabetes for sodium-glucose co-transporter-2 inhibitor cardiovascular outcomes trials: An assessment using the Diabetes Collaborative Registry.

Generalizability of findings from cardiovascular outcomes trials (CVOTs) to patients with type 2 diabetes (T2D) in clinical practice is unknown. We assessed the proportions of patients in the Diabetes Collaborative Registry who would have met enrolment criteria for pivotal CVOTs of sodium-glucose co-transporter-2 inhibitors (SGLT-2is): EMPA-REG OUTCOME, CANVAS, DECLARE and VERTIS CV. In 172 643 patients, mean [standard deviation (SD)] age and HbA1c were 68.1 (11.8) years and 7.8% (2.2), respectively; 56.8% of patients were men and SGLT-2i use was 4.4%. Atherosclerotic cardiovascular disease (ASCVD) prevalence was 64.3% and mean 10-year ASCVD risk was 28.6% in patients without ASCVD. Proportions of patients eligible for CVOTs ranged from 26% (EMPA-REG OUTCOME) to 44% (DECLARE); 48% of patients were ineligible for all CVOTs. Mean (SD) ASCVD risk was 25.4% (22.6), 32.1% (20.6) and 37.7% (19.4) in patients eligible for no, one or two CVOTs, respectively. SGLT-2i use was low in patients eligible for no CVOTs (3.5%) and at least one CVOT (5.2%). In conclusion, applicability of CVOT results to patients with T2D in clinical practice varies based on trial eligibility criteria.

Risk Score to Predict Need for Intensive Care in Initially Hemodynamically Stable Adults With Non-ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: Intensive care unit (ICU) use for initially stable patients presenting with non-ST-segment-elevation myocardial infarction (NSTEMI) varies widely across hospitals and minimally correlates with severity of illness. We aimed to develop a bedside risk score to assist in identifying high-risk patients with NSTEMI for ICU admission. METHODS AND RESULTS: Using the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry linked to Medicare data, we identified patients with NSTEMI aged ≥65 years without cardiogenic shock or cardiac arrest on presentation. Complications requiring ICU care were defined as subsequent development of cardiac arrest, shock, high-grade atrioventricular block, respiratory failure, stroke, or death during the index hospitalization. We developed and validated a model and integer risk score (Acute Coronary Treatment and Intervention Outcomes Network (ACTION) ICU risk score) that uses variables present at hospital admission to predict requirement for ICU care. Of 29 973 patients with NSTEMI, 4282 (14%) developed a complication requiring ICU-level care, yet 12 879 (43%) received care in an ICU. Signs or symptoms of heart failure, initial heart rate, initial systolic blood pressure, initial troponin, initial serum creatinine, prior revascularization, chronic lung disease, ST-segment depression, and age had statistically significant associations with requirement for ICU care after adjusting for other risk factors. The ACTION ICU risk score had a C-statistic of 0.72. It identified 11% of patients as having very high risk (>30%) of developing complications requiring ICU care and 49% as having low likelihood (<10%) of requiring an ICU. CONCLUSIONS: The ACTION ICU risk score quantifies the risk of initially stable patients with NSTEMI developing a complication requiring ICU care, and could be used to more effectively allocate limited ICU resources.

Burden of cardio-renal-metabolic conditions in adults with type 2 diabetes within the Diabetes Collaborative Registry.

We examined the prevalence of cardio-renal-metabolic (CaReMe) conditions and their combinations among 530 747 adults with type 2 diabetes in a USA-based outpatient registry of 271 primary care, cardiology and endocrinology offices. We evaluated the following CaReMe conditions: hypertension, hyperlipidaemia, coronary artery disease (CAD), chronic kidney disease (CKD), cerebrovascular disease, peripheral artery disease, atrial fibrillation, heart failure, and gout or hyperuricaemia; prevalence estimates were adjusted based on the distribution of diabetes by age in the US population in 2015. We found that it was uncommon for patients to have isolated type 2 diabetes without other CaReMe conditions, with only 6.4% having no other CaReMe conditions and 51% having ≥3 other CaReMe conditions. The most prevalent individual conditions were hypertension (83%), hyperlipidemia (81%), CAD (32%) and CKD (20%), and the most common combinations included various groupings of hypertension, hyperlipidaemia, atherosclerotic cardiovascular disease and CKD. Older age, male sex and tobacco use were each associated with increased numbers of CaReMe conditions. These findings highlight the clinical need for novel treatment strategies for diabetes that address both glycaemia and coexisting disease states.

Rates of myocardial infarction and stroke in patients initiating treatment with SGLT2-inhibitors versus other glucose-lowering agents in real-world clinical practice: Results from the CVD-REAL study.

The multinational, observational CVD-REAL study recently showed that initiation of sodium-glucose co-transporter-2 inhibitors (SGLT-2i) was associated with significantly lower rates of death and heart failure vs other glucose-lowering drugs (oGLDs). This sub-analysis of the CVD-REAL study sought to determine the association between initiation of SGLT-2i vs oGLDs and rates of myocardial infarction (MI) and stroke. Medical records, claims and national registers from the USA, Sweden, Norway and Denmark were used to identify patients with T2D who newly initiated treatment with SGLT-2i (canagliflozin, dapagliflozin or empagliflozin) or oGLDs. A non-parsimonious propensity score was developed within each country to predict initiation of SGLT-2i, and patients were matched 1:1 in the treatment groups. Pooled hazard ratios (HRs) and 95% CIs were generated using Cox regression models. Overall, 205 160 patients were included. In the intent-to-treat analysis, over 188 551 and 188 678 person-years of follow-up (MI and stroke, respectively), there were 1077 MI and 968 stroke events. Initiation of SGLT-2i vs oGLD was associated with a modestly lower risk of MI and stroke (MI: HR, 0.85; 95%CI, 0.72-1.00; P = .05; Stroke: HR, 0.83; 95% CI, 0.71-0.97; P = .02). These findings complement the results of the cardiovascular outcomes trials, and offer additional reassurance with regard to the cardiovascular effects of SGLT-2i, specifically as it relates to ischaemic events.

Recent trends in the prevalence of type 2 diabetes and the association with abdominal obesity lead to growing health disparities in the USA: An analysis of the NHANES surveys from 1999 to 2014.

AIM: To assess whether the secular trends in type 2 diabetes prevalence differ between abdominally obese and non-obese individuals. METHODS: Data from the National Health and Nutrition Examination Surveys (NHANES) were used to estimate the prevalence of type 2 diabetes and abdominal obesity among individuals aged ≥20 years in the USA from 1999/2000 to 2013/2014, after standardization to the age, sex and ethnicity population distribution estimates on January 1, 2014, as published by the US Census Bureau. RESULTS: The prevalence of abdominal obesity in the US population increased from 47.4% (95% confidence interval [CI] 42.6-52.2) in 1999/2000 to 57.2% (95% CI 55.9-58.5) in 2013/2014. A significant increase was observed in all age groups: 20 to 44, 45 to 64, and ≥65 years. The prevalence of type 2 diabetes has also increased from 8.8% (95% CI 7.2-10.4) in 1999/2000 to 11.7% (95% CI 10.9-12.6) in 2013/2014, with no substantial change in trend over the recent years. However, the increase in the prevalence of type 2 diabetes was limited to individuals with abdominal obesity, and more specifically to individuals aged ≥45 years with abdominal obesity, with no significant change in prevalence in the non-obese group and in individuals aged <45 years. CONCLUSION: These findings highlight the critical importance of abdominal obesity-both as a likely key contributor to the continuing epidemic of type 2 diabetes in the USA and as a priority target for public health interventions.

Quality of Care of the Initial Patient Cohort of the Diabetes Collaborative Registry®.

BACKGROUND: Although guidelines and performance measures exist for patients with diabetes mellitus, achievement of these metrics is not well known. The Diabetes Collaborative Registry® (DCR) was formed to understand the quality of diabetes mellitus care across the primary and specialty care continuum in the United States. METHODS AND RESULTS: We assessed the frequency of achievement of 7 diabetes mellitus-related quality metrics and variability across the Diabetes Collaborative Registry® sites. Among 574 972 patients with diabetes mellitus from 259 US practices, median (interquartile range) achievement of the quality metrics across the practices was the following: (1) glycemic control: 19% (5-47); (2) blood pressure control: 80% (67-88); (3) angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers in patients with coronary artery disease: 62% (51-69); (4) nephropathy screening: 62% (53-71); (5) eye examination: 0.7% (0.0-79); (6) foot examination: 0.0% (0.0-2.3); and (7) tobacco screening/cessation counseling: 86% (80-94). In hierarchical, modified Poisson regression models, there was substantial variability in meeting these metrics across sites, particularly with documentation of glycemic control and eye and foot examinations. There was also notable variation across specialties, with endocrinology practices performing better on glycemic control and diabetes mellitus foot examinations and cardiology practices succeeding more in blood pressure control and use of angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers. CONCLUSIONS: The Diabetes Collaborative Registry® was established to document and improve the quality of outpatient diabetes mellitus care. While target achievement of some metrics of cardiovascular risk modification was high, achievement of others was suboptimal and highly variable. This may be attributable to fragmentation of care, lack of ownership among various specialists concerning certain domains of care, incomplete documentation, true gaps in care, or a combination of these factors.

Shifting Paradigms in the Medical Management of Type 2 Diabetes: Reflections on Recent Cardiovascular Outcome Trials.

An important challenge in the management of patients with type 2 diabetes is cardiovascular disease (CVD) prevention. While it is well established that intensive glycemic control prevents the onset and slows the progression of certain microvascular complications, such a strategy utilized in multiple clinical trials over the past few decades has failed to show a similar benefit with regard to cardiovascular events, including mortality. Despite this, a major hope has been the discovery of glucose-lowering medications that simultaneously improve cardiovascular outcomes. Over the past year and a half, four randomized clinical trials (involving empagliflozin, pioglitazone, liraglutide, and semaglutide) have reported important benefits in preventing adverse cardiovascular outcomes in patients with or at risk for type 2 diabetes and established CVD. On the basis of these landmark trials, we propose that a paradigm shift in the management of patients with type 2 diabetes, specifically in those with prior macrovascular disease. A transition from current algorithms based primarily on hemoglobin A1c values to a more comprehensive strategy additionally focused on CVD prevention seems warranted.

Intensive Care Unit Utilization and Mortality Among Medicare Patients Hospitalized With Non-ST-Segment Elevation Myocardial Infarction.

Importance: Intensive care unit (ICU) utilization may have important implications for the care and outcomes of patients with non-ST-segment elevation myocardial infarction (NSTEMI). Objectives: To examine interhospital variation in ICU utilization in the United States for older adults with hemodynamically stable NSTEMI and outcomes associated with ICU utilization among patients with low, moderate, or high mortality risk. Design, Setting, and Participants: This study was a retrospective analysis of 28 018 Medicare patients 65 years or older admitted with NSTEMI to 346 hospitals participating in the Acute Coronary Treatment and Intervention Outcomes Network (ACTION)-Get With the Guidelines from April 1, 2011, through December 31, 2012. Patients with cardiogenic shock or cardiac arrest on presentation were excluded. Data analysis was performed from May 7 through October 8, 2015. Exposures: Hospitals with high (>70% of patients with NSTEMI treated in an ICU during the index hospitalization), intermediate (30%-70%), or low (<30%) ICU utilization. Main Outcomes and Measures: Thirty-day mortality. Results: Of 28 018 patients with NSTEMI 65 years or older (median age, 77 years [interquartile range, 71-84 years]; female, 13 055 [46.6%]; nonwhite race, 3931 [14.0%]), 11 934 (42.6%) had an ICU stay. The proportion of patients with NSTEMI treated in the ICU varied across hospitals (median, 38%; interquartile range, 26%-54%), but no significant differences were found in hospital or patient characteristics among high, intermediate, or low ICU utilization hospitals. Compared with high ICU utilization hospitals, low or intermediate ICU utilization hospitals were only marginally more selective of higher-risk patients, as determined by ACTION in-hospital mortality risk score or initial troponin level. The median ACTION risk score for patients treated in the ICU at low and intermediate ICU utilization hospitals was 34 compared with 33 for patients not treated in the ICU; at high ICU utilization hospitals, the median ACTION mortality risk score was 33 for patients treated in the ICU and 34 for patients not treated in the ICU. Thirty-day mortality rates did not significantly differ based on hospital ICU utilization (high vs low: 8.7% vs 8.7%; adjusted odds ratio, 0.91; 95% CI, 0.76-1.08; intermediate vs low: 9.6% vs 8.7%; adjusted odds ratio, 1.06; 95% CI, 0.94-1.20). The association between hospital ICU utilization and mortality did not change when considered among patients with ACTION risk scores greater than 40, 30 to 40, and less than 30 (adjusted interaction P = .86). Conclusions and Relevance: Utilization of the ICU for older patients with NSTEMI varied significantly among hospitals. This variability was not explained by hospital characteristics or driven by patient risk. Mortality after myocardial infarction did not significantly differ among high, intermediate, or low ICU utilization hospitals.

Discontinuation of antihyperglycemic therapy after acute myocardial infarction: medical necessity or medical error?

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.

Relationship between glycosylated hemoglobin assessment and glucose therapy intensification in patients with diabetes hospitalized for acute myocardial infarction.

OBJECTIVE: To evaluate the relationship between A1C and glucose therapy intensification (GTI) in patients with diabetes mellitus (DM) hospitalized for acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS: A1C was measured as part of routine care (clinical A1C) or in the core laboratory (laboratory A1C, results unavailable to clinicians). GTI predictors were identified using hierarchical Poisson regression. RESULTS: Of 1,274 patients, 886 (70%) had clinical A1C and an additional 263 had laboratory A1C measured. Overall, A1C was <7% in 419 (37%), 7-9% in 415 (36%), and >9% in 315 patients (27%). GTI occurred in 31% of patients and was more frequent in those with clinical A1C both before (34 vs. 24%, P < 0.001) and after multivariable adjustment (relative risk 1.34 [95% CI 1.12-1.62] vs. no clinical A1C). CONCLUSIONS: Long-term glucose control is poor in most AMI patients with DM, but only a minority of patients undergo GTI at discharge. Inpatient A1C assessment is strongly associated with intensification of glucose-lowering therapy.

Recovery from hospital-acquired anemia after acute myocardial infarction and effect on outcomes.

New-onset, hospital-acquired anemia (HAA) during acute myocardial infarction (AMI) is independently associated with poor outcomes. The patterns of recovery from HAA after AMI and their association with mortality and health status are unknown. In the prospective 24-center Translational Research Investigating Underlying disparities in acute myocardial infarction Patients' Health Status (TRIUMPH) registry, we identified 530 patients with AMI and HAA (defined as normal hemoglobin at admission with the development of anemia by discharge) who had a repeat, protocol-driven hemoglobin measurement at 1 month after discharge. The 1-month measures were used to define persistent (persistent anemia) and transient (anemia resolved) HAA. The patients' health status was assessed at 1, 6, and 12 months after AMI using the Short-Form 12 Physical Component Summary, and the health status of patients with persistent and transient HAA was compared using multivariate repeated measures regression analysis. Mortality was compared using the log-rank test and proportional hazards regression analysis. Overall, 165 patients (31%) developed persistent HAA. The adjusted mean Short-Form 12 Physical Component Summary scores at the follow-up visit were significantly lower in those with persistent HAA than in those with transient HAA (-2.0 points, 95% confidence interval -3.6 to -0.3; p = 0.02). During a median follow-up of 36 months, the crude mortality (13% vs 5%, p = 0.002) and multivariate-adjusted mortality (hazard ratio 2.08, 95% confidence interval 1.02 to 4.21, p = 0.04) was greater in patients with persistent HAA. In conclusion, HAA persists 1 month after discharge in nearly 1 of 3 patients and is associated with worse health status and greater mortality. Additional investigation is needed to understand whether HAA prevention, recognition, and treatment, particularly among those with persistent HAA, will improve outcomes.

Trends in length of stay and short-term outcomes among Medicare patients hospitalized for heart failure, 1993-2006.

CONTEXT: Whether decreases in the length of stay during the past decade for patients with heart failure (HF) may be associated with changes in outcomes is unknown. OBJECTIVE: To describe the temporal changes in length of stay, discharge disposition, and short-term outcomes among older patients hospitalized for HF. DESIGN, SETTING, AND PARTICIPANTS: An observational study of 6,955,461 Medicare fee-for-service hospitalizations for HF between 1993 and 2006, with a 30-day follow-up. MAIN OUTCOME MEASURES: Length of hospital stay, in-patient and 30-day mortality, and 30-day readmission rates. RESULTS: Between 1993 and 2006, mean length of stay decreased from 8.81 days (95% confidence interval [CI], 8.79-8.83 days) to 6.33 days (95% CI, 6.32-6.34 days). In-hospital mortality decreased from 8.5% (95% CI, 8.4%-8.6%) in 1993 to 4.3% (95% CI, 4.2%-4.4%) in 2006, whereas 30-day mortality decreased from 12.8% (95% CI, 12.8%-12.9%) to 10.7% (95% CI, 10.7%-10.8%). Discharges to home or under home care service decreased from 74.0% to 66.9% and discharges to skilled nursing facilities increased from 13.0% to 19.9%. Thirty-day readmission rates increased from 17.2% (95% CI, 17.1%-17.3%) to 20.1% (95% CI, 20.0%-20.2%; all P < .001). Consistent with the unadjusted analyses, the 2005-2006 risk-adjusted 30-day mortality risk ratio was 0.92 (95% CI, 0.91-0.93) compared with 1993-1994, and the 30-day readmission risk ratio was 1.11 (95% CI, 1.10-1.11). CONCLUSION: For patients admitted with HF during the past 14 years, reductions in length of stay and in-hospital mortality, less marked reductions in 30-day mortality, and changes in discharge disposition accompanied by increases in 30-day readmission rates were observed.

Discontinuation of antihyperglycemic therapy and clinical outcomes after acute myocardial infarction in older patients with diabetes.

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.