Impact of Pre-existing Type 2 Diabetes Mellitus and Cardiovascular Disease on Healthcare Resource Utilization and Costs in Patients With COVID-19.

Background: The economic burden associated with type 2 diabetes mellitus (T2DM) and concurrent cardiovascular disease (CVD) among patients with COVID-19 is unclear. Objective: We compared healthcare resource utilization (HCRU) and costs in patients with COVID-19 and T2DM and CVD (T2DM + CVD), T2DM only, or neither T2DM nor CVD (T2DM/CVD). Methods: A retrospective observational study in COVID-19 patients using data from the Healthcare Integrated Research Database (HIRD®) was conducted. Patients with COVID-19 were identified between March 1, 2020, and May 31, 2021, and followed from first diagnosis or positive lab test to the end of health plan enrollment, end of study period, or death. Patients were assigned one of 3 cohorts: pre-existing T2DM+CVD, T2DM only, or neither T2DM/CVD. Propensity score matching and multivariable analyses were performed to control for differences in baseline characteristics. Study outcomes included all-cause and COVID-19-related HCRU and costs. Results: In all, 321 232 COVID-19 patients were identified (21 651 with T2DM + CVD, 28 184 with T2DM only, and 271 397 with neither T2DM/CVD). After matching, 6967 patients were in each group. Before matching, 46.0% of patients in the T2DM + CVD cohort were hospitalized for any cause, compared with 18.0% in the T2DM-only cohort and 6.3% in the neither T2DM/CVD cohort; the corresponding values after matching were 34.2%, 26.0%, and 21.2%. The proportion of patients with emergency department visits, telehealth visits, or use of skilled nursing facilities was higher in patients with COVID-19 and T2DM + CVD compared with the other cohorts. Average all-cause costs during follow-up were 12 324,7882, and $7277 per-patient-per-month after matching for patients with T2DM + CVD, T2DM-only, and neither T2DM/CVD, respectively. COVID-19-related costs contributed to 78%, 75%, and 64% of the overall costs, respectively. The multivariable model showed that per-patient-per-month all-cause costs for T2DM + CVD and T2DM-only were 54% and 21% higher, respectively, than those with neither T2DM/CVD after adjusting for residual confounding. Conclusion: HCRU and costs in patients were incrementally higher with COVID-19 and pre-existing T2DM + CVD compared with those with T2DM-only and neither T2DM/CVD, even after accounting for baseline differences between groups, confirming that pre-existing T2DM + CVD is associated with increased HCRU and costs in COVID-19 patients, highlighting the importance of proactive management.

Patient Perspectives on the Burden of Heart Failure with Preserved Ejection Fraction in a US Commercially Insured and Medicare Advantage Population: A Survey Study.

Background: Patient-reported health related quality of life (HRQOL) is not routinely assessed in clinical practice. Little is known about health status outcomes reported by patients with heart failure with preserved ejection fraction (HFpEF) in non-clinical trial settings. Purpose: To better understand patient burden of HFpEF in terms of HF-specific functional and symptom status, HRQOL, healthcare resource utilization (HCRU) and costs in a US-based commercial and Medicare Advantage insured population. Patients and methods: We conducted a cross-sectional survey of patients with HFpEF and linked their survey and administrative claims data. Consenting, eligible patients completed a survey that included the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and the PROMIS Global Health-10 (GH-10) questionnaire, as well as clinical and demographic questions. HF medication use, HCRU and costs during the 12-month baseline period before the survey were determined from claims data. Generalized linear regression was used to assess the associations between baseline characteristics and the KCCQ-23 overall summary score. Results: Of 598 survey respondents with survey and claims data, 54.7% were female with mean age 74.0 years. The KCCQ-23 overall summary and clinical summary scores were 64.8 and 63.0, respectively, and the GH-10 physical and mental health summary scores were 39.9 and 45.5. Factors related to lower KCCQ-23 overall summary scores were HF treatment and symptom changes during the past 4-weeks before the survey, hospital admission during the past year, low household income, high comorbidity index, and morbid obesity (BMI>40). Total all-cause healthcare costs were $38,243 during the year prior to the survey, of which 42% were HF-related. Conclusion: Patient-reported outcome measure scores indicated impairment due to HF symptoms and physical limitations in this real-world sample of patients with HFpEF, highlighting a need to assess patient-reported outcomes as well as the clinical and economic outcomes traditionally assessed by clinicians, health systems and payers.

Impact of pre-existing type 2 diabetes with and without cardiovascular disease on patients with COVID-19.

AIM: To compare adverse outcomes among COVID-19 patients with pre-existing type 2 diabetes (T2D) only, T2D and cardiovascular disease (CVD), or neither. METHODS: This retrospective cohort study used administrative claims, laboratory and mortality data from the HealthCore Integrated Research Database. Patients with COVID-19 were identified from 3 January 2020 to 31 May 2021 and stratified by the presence of T2D and CVD. Outcomes included hospitalization, intensive care unit (ICU) admission, mortality and complications following COVID-19 infection. Propensity score matching and multivariable analyses were performed. RESULTS: A total of 321 232 COVID-19 patients were identified (21 651 T2D + CVD, 28 184 T2D only, and 271 397 neither) with a mean (SD) follow-up of 5.4 (3.0) months. After matching, 6 967 patients were identified for each group, and residual baseline differences remained. Adjusted analyses showed that COVID-19 patients with T2D + CVD were 59% more probable to be hospitalized, 74% more probable to be admitted to the ICU, and had a 26% higher mortality risk than those with neither. COVID-19 patients with T2D only were 28% and 32% more probable to be admitted to the hospital and ICU than those with neither, respectively. Among all T2D + CVD patients, acute respiratory distress syndrome (31%) and acute kidney disease (24%) were observed. CONCLUSION: Our study highlights the incrementally poorer outcomes associated with pre-existing T2D + CVD in COVID-19 patients compared with those without T2D/CVD and suggests consideration of a more optimal management approach in these patients.

Real-World Treatment Patterns, Healthcare Resource Utilization, and Costs for Patients with Newly Diagnosed Systolic versus Diastolic Heart Failure.

BACKGROUND: Although the significant burden of heart failure (HF) is well recognized, the relative contributions of systolic HF versus diastolic HF are less defined. OBJECTIVE: To explore the differential burden between patients with systolic and diastolic HF in terms of treatment patterns, healthcare resource utilization (HCRU), costs, and mortality risk. METHODS: This retrospective cohort study used administrative claims data from a large US commercial health insurer integrated with mortality data. Patients newly diagnosed with HF between January 1, 2010, and June 30, 2016, were identified and grouped according to systolic HF or diastolic HF diagnosis and were followed up to 4 years after diagnosis. Treatment patterns, HCRU, costs, and mortality were compared between the 2 groups of patients. RESULTS: Overall, 46,885 patients with systolic HF and 21,854 with diastolic HF were identified and included in the study. Patients with systolic HF had less HCRU than those with diastolic HF during the first year after HF diagnosis, including hospital admissions (70.2% vs 82.4%, respectively; P <.001) and emergency department visits (30.5% vs 39.1%, respectively; P <.001). The average per-patient costs for patients with systolic HF during the 1-year follow-up were higher than for those with diastolic HF ($64,154 vs $59,652, respectively; P <.001), but lower during years 2 through 4 (approximately $23,000-$25,000 annually vs approximately $28,000-$29,000 annually; P <.001). Patients with diastolic HF had a higher adjusted hospitalization risk (odds ratio, 1.62; 95% confidence interval [CI], 1.55-1.69), but comparable adjusted costs (exponentiated estimate, 1.01; 95% CI, 0.99-1.02) and slightly lower mortality risk (hazard ratio, 0.96; 95% CI, 0.93-0.99) versus patients with systolic HF. The number of HF-related medication classes received for other diagnoses during the year preceding an HF diagnosis was associated with lower risks for hospitalization, mortality, and lower costs, with a trend in benefits toward patients with systolic HF. Of note, 21.9% of patients with systolic HF and 25% of patients with diastolic HF filled no HF-related prescriptions in the year after diagnosis. CONCLUSION: This real-world analysis confirms a high disease burden associated with HF and provides insight across the systolic HF and diastolic HF phenotypes. HF-related medication use after diagnosis was suboptimal and underscores a gap in patient care.

Clinical characteristics, patterns of lipid-lowering medication use, and health care resource utilization and costs among patients with atherosclerotic cardiovascular disease.

PURPOSE: The aim of this study was to investigate real-world patient characteristics, medication use, and health care resource utilization (HCRU) and costs among patients with clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, to examine burden of disease and unmet needs, such as potential undertreatment. PATIENTS AND METHODS: This retrospective cohort study utilized a nationally representative managed care database to identify newly diagnosed ASCVD patients between January 1, 2007, and November 30, 2012 (index = first ASCVD diagnosis date) in the USA. Patients had ≥12-month pre-index (baseline) and ≥12-month post-index (follow-up) health plan enrollment and no baseline lipid-lowering medication (LLM). Patient characteristics, LLM utilization patterns, HCRU, and costs were examined for all patients and by subgroups based on LLM use pattern and/or follow-up low-density lipoprotein cholesterol (LDL-C) levels. RESULTS: A total of 128,017 ASCVD patients were identified with a mean (SD) age of 59 (13) years, 43.1% female, and 48.8% with ≥36-month follow-up. Within 12-month follow-up, 10.6% had high-intensity statins and 56.9% had no LLM fills. Baseline mean (SD) all-cause costs were $8,852 ($25,608). At 12-month follow-up, mean (SD) all-cause and ASCVD-related costs were $31,443 ($54,040) and $20,289 ($45,159), respectively. The 36-month analyses showed similar distributions. Multivariable analyses showed that age, gender, region, health insurance type, baseline comorbidities, baseline use of specific medications, baseline lipid profiles, and index ASCVD type were significantly associated with all-cause and ASCVD-related health care costs. CONCLUSION: Patients have nonoptimal treatment for ASCVD and substantial HCRU and costs associated with residual risk. Unmet needs and cost burdens of ASCVD patients merit additional investigation.

Clinical Characteristics and Unmet Need Among Patients with Atherosclerotic Cardiovascular Disease Stratified by Statin Use.

BACKGROUND: The American College of Cardiology (ACC)/American Heart Association (AHA) 2013 guidelines for blood cholesterol treatment recommend high-intensity statins for adults with atherosclerotic cardiovascular disease (ASCVD). Currently, little is known about the real-world patient characteristics of ASCVD, as well as the clinical and economic consequences of different treatment options for this disease. OBJECTIVES: To compare the demographic, clinical, and economic characteristics of patients with clinical ASCVD who started therapy with high-intensity statins, low-/moderate-intensity statins, or no statins in usual-care settings based on data primarily before the release of the ACC/AHA 2013 guidelines. METHODS: This retrospective, observational cohort study used claims data from US commercial health plans from January 2006 to June 2014 to identify patients with ASCVD (ie, acute coronary syndrome, coronary heart disease, ischemic stroke, or peripheral arterial disease). High-intensity, low-/moderate-intensity statin users and non-statin users were selected based on the presence of a corresponding prescription fill. The index date was defined as the first statin fill date for the statin cohorts and the earliest eligibility date for clinical ASCVD for the non-statin users group. The follow-up outcomes, including treatment patterns, cardiovascular (CV) events, and healthcare utilization and costs, were assessed after matching the high-intensity statin and low-/moderate-intensity statin initiators. RESULTS: A total of 273,308 patients with ASCVD were included in the study; of these, 104,649 were statin initiators and 168,659 non-statin users. Only 8.8% (N = 24,106) of the total population initiated high-intensity statins. Patient adherence (defined as proportion of days covered ≥80%) to statin therapy was low in the matched high-intensity statin and low-/moderate-intensity statin cohorts (27.0% vs 26.4%, respectively). Approximately 16% of the patients in either of the matched cohorts had at least 1 CV event during the available follow-up period. CONCLUSION: The low percentage of patients who initiated high-intensity statin therapy, low adherence to statin therapy, and high rates of CV events during the follow-up period suggest a substantial unmet need among patients with ASCVD in the real-world setting. The demographic and clinical heterogeneity across the cohorts suggests significant variability in physician perception of the appropriate use of statins and may provide an opportunity to improve care and health outcomes in these high-risk patients.

Clinical outcomes and medication adherence in acute coronary syndrome patients with and without type 2 diabetes mellitus: a longitudinal analysis 2006-2011.

BACKGROUND: The presence of type 2 diabetes mellitus magnifies the risks associated with acute coronary syndrome (ACS), increasing the risk of recurrent cardiovascular events (CVEs) and doubling the risk of death. Managing cardiovascular risk factors has little effect on lowering the mortality risk in patients with type 2 diabetes. OBJECTIVE: To evaluate the relationship between type 2 diabetes mellitus and subsequent CVEs and medication adherence following ACS hospitalization. METHODS: Patients with ACS were identified using ICD-9-CM codes for acute myocardial infarction or unstable angina. The risk of subsequent CVEs was assessed at 1 and 3 years after the index ACS event based on type 2 diabetes status, adjusting for baseline demographic characteristics, comorbidities, medication use, and index ACS characteristics. RESULTS: Of 140,903 patients with ACS (mean age 66.8 years, 58.6% male), 27.4% had type 2 diabetes. During follow-up, 22.0% had subsequent CVEs (26.2% type 2 diabetes, 19.0% nondiabetes). After adjusting for other covariates, type 2 diabetes was associated with increased risk of subsequent CVEs by 9.7% at 1 year and 10.2% at 3 years (both P < 0.001). Most patients were not revascularized at first recurrence after index ACS discharge (79.2% type 2 diabetes, 77.5% nondiabetes). Patients with type 2 diabetes had statistically significant higher adherence rates for antiplatelet agents at 1 year and antihypertensives at 1 and 3 years versus nondiabetes patients. Persistence was higher in the type 2 diabetes group for antihypertensives and in the nondiabetes group for antiplatelet agents and statins. CONCLUSIONS: This analysis demonstrates that patients with type 2 diabetes have a higher risk of subsequent CVEs following an initial event versus those without diabetes, despite evidence of higher treatment persistence for certain medications. Adherence rates remained suboptimal, suggesting a continuing need for patient education.