Substantial Comorbidity Burden Research Articles

Prospective registry of heart failure with preserved ejection fraction in México: EDIFICE-Mx

Background and aimsHeart failure with preserved ejection fraction (HFpEF) is an increasingly common clinical syndrome, estimated to constitute approximately 50 % of all heart failure (HF) cases. Nonetheless, registries from specific geographic areas, as Latin America, are lacking. The present study aims to report the underlying causes, comorbidities, treatment patterns and outcomes of patients with HFpEF in a large cardiovascular center in Mexico City. MethodsThe present is a prospective, longitudinal, observational study, including female and male patients over 18 years of age, who presented to the emergency department, coronary care unit or outpatient department of the National Institute of Cardiology Ignacio Chavez in Mexico City with HFpEF. Patients were classified according to different phenotypes and current literature. The primary outcome was the composite total HFpEF hospitalization and all-cause mortality. ResultsWithin a median follow-up of 472 (IQR 425–518) days, total mortality was 14.56 %, with 10.68 % attributed to cardiovascular causes. HF hospitalization was 7.77 %. Atrial fibrillation showed a notable association with outcomes (adjusted HR 2.87, P = 0.028). Beta-blocker showed a non-significant trend towards benefit, while mineralocorticoid receptor antagonists (MRA) significantly influenced outcomes (adjusted HR 3.30, P = 0.018). The primary composite endpoint occurred in 19.42 % of patients, with no significant difference among phenotypes (P = 0.536). ConclusionsWe observed a substantial comorbidity burden impacting quality of life, as indicated by KCCQ scores. There was a high incidence of hard endpoints, including cardiovascular death and hospitalizations, alongside significant variability in treatment utilization. Future research should focus on elucidating individual healthcare trajectories in HFpEF patients and promoting wider adoption of evidence-based therapies.

Cross-sectional analysis of a cohort of people over 65 years of age living with HIV

IntroductionThis study aims to describe and analyze the characteristics of aged people who are living with HIV (APHIV) and evaluate their association on the comorbidities they currently have. MethodsCross-sectional analysis of APHIV under active follow-up at the Infectious Diseases Unit of the University Clinical Hospital of Santiago de Compostela. Demographic and clinical data were analyzed, along with their association with the development of comorbidities in this population. A correlation and multiple linear regression analysis were performed for this purpose. ResultsEighty-five APHIV, 65 males and 20 females, with an average age of 69 years (IQR 8) and a duration of living with HIV of 17 years (SD 7), were studied. 41% of them had their initial diagnosis with AIDS. The most common comorbidities are hypertension and dyslipidemia in 55% and 52%, respectively. 40% of APHIV take at least 5 medications. 35% have received more than 5 lines of antiretroviral treatment. At the time of analysis, all APHIV have an undetectable viral load. No significant association was observed between the number of comorbidities and various characteristics of APHIV; however, a weak correlation was noted among age, the cumulative number of antiretroviral treatments received throughout their lives, and the number of comorbidities. ConclusionsThis analysis highlights the substantial burden of comorbidities and polypharmacy experienced by APHIV. Further studies are needed to better understand the characteristics and variables influencing their development.

Análisis transversal de una cohorte de personas de más de 65 años que viven con VIH

IntroductionThis study aims to describe and analyze the characteristics of aged people who are living with HIV (APHIV) and evaluate their association on the comorbidities they currently have. MethodsCross-sectional analysis of APHIV under active follow-up at the Infectious Diseases Unit of the University Clinical Hospital of Santiago de Compostela. Demographic and clinical data were analyzed, along with their association with the development of comorbidities in this population. A correlation and multiple linear regression analysis were performed for this purpose. ResultsEighty-five APHIV, 65 males and 20 females, with an average age of 69 years (IQR: 8) and a duration of living with HIV of 17 years (SD: 7), were studied. 41% of them had their initial diagnosis with AIDS. The most common comorbidities are hypertension and dyslipidemia in 55% and 52%, respectively. 40% of APHIV take at least 5 medications. 35% have received more than 5 lines of antiretroviral treatment. At the time of analysis, all APHIV have an undetectable viral load. No significant association was observed between the number of comorbidities and various characteristics of APHIV; however, a weak correlation was noted among age, the cumulative number of antiretroviral treatments received throughout their lives, and the number of comorbidities. ConclusionsThis analysis highlights the substantial burden of comorbidities and polypharmacy experienced by APHIV. Further studies are needed to better understand the characteristics and variables influencing their development.

The comorbidity profiles and medication issues of patients with multiple system atrophy: a systematic cross-sectional analysis

BackgroundMultiple system atrophy (MSA) is a complex and fatal neurodegenerative movement disorder. Understanding the comorbidities and drug therapy is crucial for MSA patients’ safety and management.ObjectivesTo investigate the pattern of comorbidities and aspects of drug therapy in MSA patients.MethodsCross-sectional data of MSA patients according to Gilman et al. (2008) diagnostic criteria and control patients without neurodegenerative diseases (non-ND) were collected from German, multicenter cohorts. The prevalence of comorbidities according to WHO ICD-10 classification and drugs administered according to WHO ATC system were analyzed. Potential drug-drug interactions were identified using AiDKlinik®.ResultsThe analysis included 254 MSA and 363 age- and sex-matched non-ND control patients. MSA patients exhibited a significantly higher burden of comorbidities, in particular diseases of the genitourinary system. Also, more medications were prescribed MSA patients, resulting in a higher prevalence of polypharmacy. Importantly, the risk of potential drug-drug interactions, including severe interactions and contraindicated combinations, was elevated in MSA patients. When comparing MSA-P and MSA-C subtypes, MSA-P patients suffered more frequently from diseases of the genitourinary system and diseases of the musculoskeletal system and connective tissue.ConclusionsMSA patients face a substantial burden of comorbidities, notably in the genitourinary system. This, coupled with increased polypharmacy and potential drug interactions, highlights the complexity of managing MSA patients. Clinicians should carefully consider these factors when devising treatment strategies for MSA patients.

Dementia and Multimorbidity Trends in Al-Baha, Saudi Arabia: An Analytical Retrospective Study Using Records-Based Data.

The prevalence of dementia is escalating significantly, posing a substantial societal burden. Currently, there exists a dearth of comprehensive health data about dementia patients in Saudi Arabia, particularly within Al-Baha City. A retrospective case-series study was undertaken to ascertain the prevalence of dementia within the populace of the Al-Baha region, Kingdom of Saudi Arabia. This investigation utilized hospital-based records encompassing individuals exhibiting symptoms or diagnosed with dementia and its related forms across the Al-Baha region. Furthermore, the study aimed to evaluate the burden of comorbidities among dementia patients and document the pharmacological therapeutic interventions administered to manage dementia and its associated concurrent health conditions. Our investigation explored the prevalence rates of various forms of dementia and the accompanying comorbidities among affected individuals. The study spanned from August 2020 to August 2023. Our study encompassed 407 patients diagnosed with Alzheimer's disease (AD), Parkinson's disease, vascular dementia (VaD), or other forms of dementia who were either admitted to or attended tertiary hospitals in Al-Baha. Assessment of the comorbidity burden was conducted using the Charlson Comorbidity Index (CCI). Our findings revealed that among these patients, 13.3% presented with AD, 23.6% with VaD, 33.4% with Parkinson's disease, 15.75% with amnesia, and 14.0% with other types of dementia. The spectrum of comorbidities observed among dementia patients encompassed various conditions, with diabetes mellitus emerging as the predominant comorbidity (19.1%), followed by hypertension (16.4%). Additionally, manifestations of depression were noted in 14% of patients, while 9.82% suffered from paralysis. Chronic conditions such as cancer, chronic obstructive pulmonary disorder (COPD), and cervical spondylosis were also observed among individuals afflicted with dementia and its varied forms. Statistically significant correlations were established between gender, age, nationality, comorbidities, and the prevalence of dementia. Therapeutic interventions in the form of pharmacological treatments were prescribed for dementia patients with comorbidities. Commonly administered medications included Amlod (6.3%), Amlodipine (6.6%), Amlor (5.8%), Aspirin (10.5%), chemotherapeutic drugs (4.4%), Glipizide (8.5%), Lantus (11.3%), Levodopa (23.5%), Metformin (7.8%), acetylcholinesterase inhibitors (6.8%), and Pulmicort (7.86%). These medications aimed to alleviate symptoms associated with dementia and its accompanying comorbidities. Our investigation underscores the substantial burden of comorbidities experienced by dementia patients. These findings offer crucial insights into the overall health status of individuals grappling with dementia, serving as a catalyst for increased awareness among clinicians and policymakers. Such awareness can drive improvements in medical care and support frameworks tailored to the specific needs of dementia patients.

FRI638 Glycemic And Cost Outcomes In Hispanic/Latino People With Type 2 Diabetes Initiating Dulaglutide Or Basal Insulin In The US

Abstract Disclosure: M. Hoog: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. J. Maldonado: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. R. Wangia-Dixon: Employee; Self; Optum Inc. Other; Self; Eli Lilly & Company. R. Halpern: Employee; Self; Optum Inc. Other; Self; Eli Lilly & Company. E. Buysman: Employee; Self; Optum Inc. Other; Self; Eli Lilly & Company. G. Gremel: Employee; Self; Optum Inc. Other; Self; Eli Lilly & Company. A. Huang: Employee; Self; Tigermed. Other; Self; Eli Lilly & Company. M. Konig: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. Hispanic/Latino (H/L) adults in the US have a greater prevalence of type 2 diabetes (T2D) and diabetes-related complications compared to non-H/L adults. Optimal glycemic control remains a challenge in H/L adults with T2D, resulting in poor health outcomes and a substantial comorbidity burden. This study compared glycemic and cost outcomes among H/L adults with T2D who initiated treatment with dulaglutide (DU) or basal insulin (BI). This retrospective cohort study used claims data from the Optum Research Database from July 2014 - March 2022 (commercial and Medicare Advantage). H/L patients with ≥1 pharmacy claim for DU or BI during the identification period (IDP), January 01, 2015 - March 31, 2021, were included. Index date was the date of first claim for DU or BI during the IDP and cohorts were assigned based on index date medication. Patients were required to have continuous enrollment during the 6-month baseline and 12-month follow-up periods; ≥1 claim with baseline T2D diagnosis; ≥1 glycated hemoglobin (HbA1c) test result each in the baseline period and 4-12 months after index date; and no injectable T2D medications at baseline. Cohorts were propensity-score matched on demographic and baseline clinical characteristics. Measures of glycemic control included change in HbA1c from baseline to 12-month follow-up, which was modelled using ordinary least squares regression (OLS) on the matched cohorts, and proportion of patients achieving the HbA1c target of <7.0%. Bootstrap sampling with 5,000 samples was used to compare total costs per 1% change in HbA1c between cohorts. The propensity-score matched cohorts comprised of 2,872 patients with 1,436 patients in each cohort (DU and BI). Most demographic and baseline characteristics were balanced between the cohorts except for age, income, office visit counts, and medical costs. Mean [standard deviation (SD)] age in the DU and BI cohorts was 59.8 [12.8] and 61.4 [12.9] years, respectively. About half of the matched population was male (DU: 54.3%; BI: 51.4%). At 12 months, the mean change from baseline in HbA1c was significantly greater in the DU cohort than BI (DU: -1.4% [1.9]; BI: -0.9% [2.1]; p<0.001) and the total cost per 1% change in HbA1c was significantly lower in the DU cohort than BI (DU: $13,768; BI: $19,128; p<0.001). The proportion of patients achieving HbA1c <7.0% at 12 months was significantly higher among patients initiating DU than BI (DU: 37.9%; BI: 22.1%; p<0. 001). Results from OLS showed that the DU cohort had a larger decrease in HbA1c compared to BI (estimate: -0.57; p<0.001). Patients initiating DU had twice the odds of achieving HbA1c <7.0% compared to BI (odds ratio: 2.19; p<0.001). DU demonstrated better glycemic outcomes and lower costs per 1% HbA1c reduction among H/L adults with T2D compared with those initiating BI. DU may be an effective therapeutic option for this vulnerable population and may help with achieving improved T2D outcomes. Presentation: Friday, June 16, 2023

Drugs with a negative impact on cognitive function (Part 1): chronic kidney disease as a risk factor.

People living with chronic kidney disease (CKD) frequently suffer from mild cognitive impairment and/or other neurocognitive disorders. This review in two parts will focus on adverse drug reactions resulting in cognitive impairment as a potentially modifiable risk factor in CKD patients. Many patients with CKD have a substantial burden of comorbidities leading to polypharmacy. A recent study found that patients seen by nephrologists were the most complex to treat because of their high number of comorbidities and medications. Due to polypharmacy, these patients may experience a wide range of adverse drug reactions. Along with CKD progression, the accumulation of uremic toxins may lead to blood-brain barrier (BBB) disruption and pharmacokinetic alterations, increasing the risk of adverse reactions affecting the central nervous system (CNS). In patients on dialysis, the excretion of drugs that depend on kidney function is severely reduced such that adverse and toxic levels of a drug or its metabolites may be reached at relatively low doses, unless dosing is adjusted. This first review will discuss how CKD represents a risk factor for adverse drug reactions affecting the CNS via (i) BBB disruption associated with CKD and (ii) the impact of reduced kidney function and dialysis itself on drug pharmacokinetics.

Diabetes in childhood cancer survivors: emerging concepts in pathophysiology and future directions.

With advancements in cancer treatment and supportive care, there is a growing population of childhood cancer survivors who experience a substantial burden of comorbidities related to having received cancer treatment at a young age. Despite an overall reduction in the incidence of most chronic health conditions in childhood cancer survivors over the past several decades, the cumulative incidence of certain late effects, in particular diabetes mellitus (DM), has increased. The implications are significant, because DM is a key risk factor for cardiovascular disease, a leading cause of premature death in childhood cancer survivors. The underlying pathophysiology of DM in cancer survivors is multifactorial. DM develops at younger ages in survivors compared to controls, which may reflect an "accelerated aging" phenotype in these individuals. The treatment-related exposures (i.e., chemotherapy, radiation) that increase risk for DM in childhood cancer survivors may be more than additive with established DM risk factors (e.g., older age, obesity, race, and ethnicity). Emerging research also points to parallels in cellular processes implicated in aging- and cancer treatment-related DM. Still, there remains marked inter-individual variability regarding risk of DM that is not explained by demographic and therapeutic risk factors alone. Recent studies have highlighted the role of germline genetic risk factors and epigenetic modifications that are associated with risk of DM in both the general and oncology populations. This review summarizes our current understanding of recognized risk factors for DM in childhood cancer survivors to help inform targeted approaches for disease screening, prevention, and treatment. Furthermore, it highlights the existing scientific gaps in understanding the relative contributions of individual therapeutic exposures and the mechanisms by which they exert their effects that uniquely predispose this population to DM following cancer treatment.

A Comparative Analysis of Functional and Patient-Reported Outcomes Following Lisfranc and Chopart Amputations in High-Risk Limb Salvage Patients

Midfoot amputations provide an opportunity for limb salvage through preservation of a weightbearing limb. However, the longevity of midfoot amputations is threatened by restrictions in surface area and risks of skin breakdown. To better inform decisions surrounding the level of amputation, we sought to compare outcomes of high-risk individuals who underwent Lisfranc or Chopart amputations. A single-center retrospective cohort study was performed from November 2013 to September 2022 of adult patients who underwent Lisfranc or Chopart amputations. Patients were stratified into cohorts based on the amputation type. Outcomes included postoperative rates of re-amputation, functional status, mortality and patient-reported outcome measures in the form of Lower Extremity Functional Scale scores. Sixty-six patients were identified; of which, 45 underwent Lisfranc amputation, and 21 underwent Chopart amputation. Median Charlson Comorbidity Index was 7, signifying a substantial comorbidity burden. By median follow-up of 14 (Interquartile range: 28) months, 31 patients (36%) progressed to higher-level amputation, and most patients were ambulatory (n=38, 58%). Overall rates of re-amputation, ambulatory status, and mortality were comparable between groups. Re-amputation to another midfoot amputation was more common among the Lisfranc cohort (n=16, 36% vs n=1, 5%), whereas re-amputation to BKA was more prevalent among the Chopart cohort (Chopart: n=7, 33% vs Lisfranc: n=7, 16%; p=.011). Average Lower Extremity Functional Scale scores were similar between groups and corresponded to a maximal function of 48%. Lisfranc and Chopart amputations have the potential to be efficacious limb salvage options in high-risk patient populations in conjunction with intraoperative biomechanical optimization and optimal preoperative patient selection.

LBSUN319 Characteristics And Treatment Patterns Of Hispanic/latino Patients Initiating First Injectable Glp-1ra Or Basal Insulin

Abstract Hispanic/Latino (H/L) adults in the United States have greater prevalence of T2D and diabetes-related complications compared to non-Hispanic/Latinos (nH/L). Optimal glycemic control remains a challenge in H/L patients, resulting in poor health outcomes and substantial burden of comorbidities. Injectable treatments, such as GLP-1RA and basal insulin, are recommended treatment options for patients with T2D-related complications. However, there is limited information on H/L patients initating these treatments. This retrospective cohort study, conducted using claims data (January 2014−February 2020), described demographics, baseline clinical characteristics and treatment patterns of H/L and nH/L patients with T2D initiating first injectable GLP-1RA or basal insulin. Adult commerical or Medicare Advantage enrollees with ≥1 pharmacy claim for injectable GLP-1RA or basal insulin were included. Index date was the date of first claim for GLP-1RA or basal insulin (January 2015−August 2019); with a 6 months post-index follow-up period. Patients with any injected T2D medications during 12-month baseline period were excluded. Patients were categorized as H/L and nH/L groups from race/ethnicity data. Subsets of patients with ≥2 claims for index GLP-1RAs or ≥3 claims for basal insulin, or with baseline and follow-up A1C values, were analyzed for index medication dose escalation and A1C, respectively. Data were presented descriptively as counts and percentages for categorical variables; means and standard deviations (SD) for continuous variables. The study sample included 9,088 H/L and 52,030 nH/L patients with T2D; 46.8% and 49.5% initiated GLP-1RAs in the H/L and nH/L groups, respectively. Mean (SD) age was 58.3 (13.7) and 61.8 (12.7) years in H/L and nH/L groups, respectively. A majority of H/L (60.6%) and nH/L (52.6%) patients had commercial insurance. The most common comorbidities in H/L and nH/L were hypertension (71.5% and 79.1%), dyslipidemia (68.6% and 71.3%), and obesity (20. 0% and 22.3%), respectively. Mean baseline A1C for H/L and nH/L subset with ≥1 A1C value was 9. 04% and 8.79%, respectively; 14.3% of H/L and 16.8% of nH/L had baseline A1C < 7. 0%. Dose escalation of index medication occured in 37.1% of H/L and 40. 0% of nH/L groups. Patients who discontinued index treatment were 55.4% and 47.3% of H/L and nH/L groups, respectively. Our findings suggest that demographics, comorbidities and treatment patterns varied for H/L and nH/L patients initiating a first injectable treatment. This includes a numerically lower proportion of the H/L group initiating GLP-1RA. Understanding the characteristics of H/L patients may help guide management of T2D in this high-risk population and improve treatment outcomes. Future research on optimizing treatments in H/L patients with T2D could provide additional insight and potentially prevent early manifestation of complications in this group. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

33777 Comorbidities and treatment patterns in pemphigus: A retrospective US claims database study

Objective: We evaluated comorbidities and treatment patterns in patients with pemphigus in the United States (US). Methods: This retrospective cohort study used data from the US Optum Clinformatics claims database between May 1, 2000 and December 31, 2020. Comorbidities in the pemphigus cohort were compared with the non-pemphigus cohort, matched (1:1) on age and gender, for up to 4 years after the index date (first pemphigus diagnosis). Multivariable models (also adjusted on propensity score matched [PSM] model) were used to estimate hazard ratios (HRs). Results: Overall, 1391 patients with pemphigus (ICD-9 and ICD-10 codes) were identified (mean [SD] age: 63.7 [17.9] years; females: 57%). Pemphigus patients had increased risk of developing hypertension (HR [95%CI]:1.15 [1.04–1.26]), osteoporosis (HR [95% CI]:1.36 [1.13–1.62]), Cushing’s syndrome (HR [95% CI]:7.93 [2.25–27.94]), gastroesophageal reflux (HR [95% CI] :1.23 [1.08–1.40]), muscle weakness (HR [95% CI]:1.32 [1.13–1.53]), hematological abnormalities (HR [95%CI]:1.19 [1.05–1.35]), and infections (HR [95% CI]:1.16 [1.06–1.27]) compared with the nonpemphigus cohort. Similar results were observed in PSM models. Approximately 24% of patients did not receive any systemic treatment during the 4-year follow-up period. After the initial diagnosis of pemphigus, most patients received corticosteroids (60%) or immunosuppressants (15%), while <1% patients received intravenous immune globulin. Among those treated with immunosuppressants, 14% patients received rituximab, while others received conventional immunosuppressants. Conclusions: These results suggest that pemphigus is associated with substantial comorbidity burden. These comorbidities are potentially associated with the use of corticosteroids and immunosuppressants, suggesting the need for better treatment options for these patients.

Contemporary outpatient management of patients with worsening heart failure with reduced ejection fraction: Rationale and design of the CHART-HF study

Patients with heart failure with reduced ejection fraction (HFrEF) and worsening HF events (WHFE) represent a distinct subset of patients with a substantial comorbidity burden, greater potential for intolerance to medical therapy, and high risk of subsequent death, hospitalization and excessive healthcare costs. Although multiple therapies have been shown to be efficacious and safe in this high-risk population, there are limited real-world data regarding factors that impact clinical decision-making when initiating or modifying therapy. Likewise, prior analyses of US clinical practice support major gaps in medical therapy for HFrEF and few medication changes during longitudinal follow-up, yet granular data on reasons why clinicians do not initiate or up-titrate guideline-directed medication are lacking. We designed the CHART-HF study, an observational study of approximately 1,500 patients comparing patients with and without WHFE (WHFE defined as receipt of intravenous diuretics in the inpatient, outpatient, or emergency department setting) who had an index outpatient visit in the US between 2017 and 2019. Patient-level data on clinical characteristics, clinical outcomes, and therapy will be collected from 2 data sources: a single integrated health system, and a national panel of cardiologists. Furthermore, clinician-reported rationale for treatment decisions and the factors prioritized with selection and optimization of therapies in real-world practice will be obtained. To characterize elements of clinician decision-making not documented in the medical record, the panel of cardiologists will review records of patients seen under their care to explicitly note their primary reason for initiating, discontinuing, and titrating medications specific medications, as well as the reason for not making changes to each medication during the outpatient visit. Results from CHART-HF have the potential to detail real-world US practice patterns regarding care of patients with HFrEF with versus without a recent WHFE, to examine clinician-reported reasons for use and non-use of guideline-directed medical therapy, and to characterize the magnitude and nature of clinical inertia toward evidence-based medication changes for HFrEF.

Cardiac amyloidosis: a changing epidemiology with open challenges

Cardiac amyloidosis (CA) is increasingly diagnosed due to the advancements made in diagnostics and therapeutics in the last decades, particularly in the field of transthyretin-related CA. Studies that have used bone scintigraphy for screening at-risk conditions have shown that about one out of ten patients with heart failure with preserved ejection fraction (HFpEF), aortic stenosis undergoing valve replacement, or hypertrophic cardiomyopathy (HCM) diagnosed later in life might have an underlying or concomitant CA. At the same time, the epidemiology of these conditions is also rapidly evolving. HFpEF has become the leading form of heart failure, and HFpEF patients are increasingly cared for in non-cardiology settings due to their older age and substantial burden of comorbidities. Aortic stenosis is increasingly treated percutaneously at earlier stages of the disease, determining a significant gain in survival. Hypertrophic cardiomyopathy is nowadays mostly diagnosed in middle-aged adults with near-normal life expectancy, with a greater chance of misdiagnosing CA as HCM or of an overlap between the two conditions. In all these contexts, the therapeutic and prognostic implications of diagnosing CA will have to be further investigated. Meanwhile, the diagnostic workup of patients with suspected CA should always be completed with the systematic exclusion of a plasma cell dyscrasia, the acquisition of tomographic imaging at bone scintigraphy, and the completion of genetic testing for transthyretin-related forms.

COVID-19 Vaccination Effectiveness Against Infection or Death in a National U.S. Health Care System : A Target Trial Emulation Study.

Little is known about real-world COVID-19 vaccine effectiveness (VE) in racially and ethnically diverse, elderly populations with high comorbidity burden. To determine the effectiveness of messenger RNA COVID-19 vaccines. Target trial emulation study comparing newly vaccinated persons with matched unvaccinated controls. U.S. Department of Veterans Affairs health care system. Among persons receiving care in the Veterans Affairs health care system (n=5766638), those who received at least 1 dose of the Moderna or Pfizer-BioNTech COVID-19 vaccine from 11 December 2020 to 25 March 2021 (n=2099871) were matched to unvaccinated controls in a 1:1 ratio according to demographic, clinical, and geographic characteristics. Follow-up for SARS-CoV-2 infection or SARS-CoV-2-related death, defined as death within 30 days of infection, began after the vaccination date or an identical index date for the matched unvaccinated controls and continued until up to 30 June 2021. Vaccine effectiveness against SARS-CoV-2 infection or SARS-CoV-2-related death. Vaccinated and unvaccinated groups were well matched; both were predominantly male (92.9% vs. 93.4%), had advanced age (mean, 68.7 years in both groups), had diverse racial and ethnic distribution (for example, Black: 17.3% vs. 17.0%, Hispanic: 6.5% vs. 6.1%), and had substantial comorbidity burden. Vaccine effectiveness 7 or more days after the second vaccine dose was 69% (95% CI, 67% to 70%) against SARS-CoV-2 infection and 86% (CI, 82% to 89%) against SARS-CoV-2-related death and was similar when follow-up was extended to 31 March versus 30 June. Vaccine effectiveness against infection decreased with increasing age and comorbidity burden. Predominantly male population and lack of data on SARS-CoV-2 variants. In an elderly, diverse, high-comorbidity population, COVID-19 VE against infection was substantially lower than previously reported, but VE against death was high. Complementary infection mitigation efforts remain important for pandemic control, even with vaccination. U.S. Department of Veterans Affairs.

Examining the Usefulness of the Charlson Comorbidity Index to Predict Early Mortality in Patients with Acute Myeloid Leukaemia

Background and aims: Acute myeloid leukaemia (AML) is a relatively rare haematological malignancy which is the most common acute leukaemia in adults. Patients with AML often have a substantial comorbidity burden. Consequently, different scores are used in clinical practice to predict outcomes in patients with multiple comorbidities. The Charlson Comorbidity Index (CCI), calculated based on 19 different medical conditions, weighs the comorbidities to measure a patient's burden of disease. Previous publications have suggested that the CCI may be useful in determining survival in AML patients. However, the CCI is not in routine use in Ireland for assessing patients with AML. In this study we examined the usefulness of the CCI to predict early mortality in AML patients, drawing on data from the Extended Blood Cancer Registration (EBCR) in Ireland.Methods: The EBCR was undertaken by National Cancer Registry Ireland registrars trained by consultant haematologists and deployed in national centres. Data collection began in 2017 and continued to 2019; 141 AML patients underwent extended data registration. Comorbidities were identified by ICD-9 codes and chart review. Kaplan Meier curves and Cox regression analyses were used to determine the usefulness of the CCI to predict early mortality in AML patients.Results: Of the 141 AML patients, 82% were between 50 and 70 years of age and 84 had died by 31/12/2019 (median survival time = 289.0 days). The median survival time for patients in the lowest tertile of the CCI was 498.5 days, compared to 246.0 and 116.5 days for subjects in tertiles 2 and 3, respectively (Figure 1. Log rank P-value <.001). In Cox regression analysis, a dose-response relationship was observed, with patients in the highest CCI tertile displaying a greater risk (HR = 4.90, 95% CI: 2.79-8.63) of mortality compared to subjects in tertile 2 (HR = 2.74, 95% CI: 1.64-4.57) and tertile 1 (reference). However, this relationship was attenuated, and non-significant, in analyses which adjusted for age at diagnosis and in a further multivariable model.Conclusions: Although results demonstrate a strong relationship between the CCI and early mortality in AML patients, our findings suggest that the CCI provides little or no additional prognostic information beyond that which is obtained from age at AML diagnosis alone. This study highlights the importance of validating risk assessment tools in order to determine their potential usefulness in a clinical setting and emphasise the importance of weighing in the treatment decision making paradigm.The Blood Cancer Network Ireland (BCNI) thank the Science Foundation of Ireland (SFI) and the Irish Cancer Society (ICS) for funding (2015-2021).We also thank our colleagues in the National Cancer Registry Ireland for assistance, advice and guidance. [Display omitted] DisclosuresQuinn: Takeda: Honoraria. O'Dwyer: Bristol Myers Squibb: Research Funding; Janssen: Consultancy; ONK Therapeutics: Current Employment, Current equity holder in publicly-traded company, Membership on an entity's Board of Directors or advisory committees. Szegezdi: ONK Therapeutics: Research Funding.

Epidemiology, Etiology, and Treatment of Gastroparesis: Real-World Evidence From a Large US National Claims Database

Although gastroparesis carries a considerable health care and patient burden, associated epidemiological data are limited. To provide new real-world evidence for gastroparesis, we estimated disease prevalence, and investigated patient demographics and disease etiology in a large US claims database. This retrospective, cross-sectional analysis used de-identified, longitudinal patient-level enrollment and billing data for adults from the Optum Clinformatics Data Mart database, a large US national administrative health insurance claims database. Prevalence was age-, sex-, and geographical region-standardized using the 2018 US census. Descriptive analyses of demographic and clinical variables and underlying disease etiologies were performed. The overall standardized prevalence of gastroparesis was 267.7 (95% confidence interval [CI] 264.8-270.7) per 100,000 US adults, whereas prevalence of "definite" gastroparesis (individuals diagnosed within 3 months of gastric emptying scintigraphy testing with persistent symptoms for more than 3 months) was 21.5 (95% CI 20.6-22.4) per 100,000 persons. Patients with gastroparesis had an overall Charlson Comorbidity Index score of 4.2, indicating substantial comorbidity burden. The most frequently documented comorbidities were chronic pulmonary disease (46.4%), diabetes with chronic complication (37.3%), and peripheral vascular disease (30.4%). Patients most commonly had a diabetic etiology (57.4%; type 1, 5.7% and type 2, 51.7%), followed by postsurgical (15.0%), drug-induced (11.8%), and idiopathic (11.3%) etiologies. New evidence is provided regarding the prevalence, patient demographics, and etiology of gastroparesis in the US general population. Wider availability of reliable objective gastric emptying measures and further education of medical professionals in recognizing and diagnosing gastroparesis would benefit future studies and improve understanding of disease epidemiology.

Real-World Burden of Comorbidities in US Patients with AL Amyloidosis

Introduction: Amyloidlight chain (AL) amyloidosis is a rare, progressive, and typically fatal disease caused by extracellular deposition of misfolded immunoglobulin light chains (LCs). The toxic LC aggregates and deposited fibrils (amyloid) in AL lead to progressive failure of vital organs, including the heart, kidneys, and nervous system. The objective of this study was to estimate the burden of comorbidities among patients with AL amyloidosis in a real-world setting.Methods: This was a retrospective, cross-sectional study using 2007-2015 data from the Truven MarketScan® Commercial and Medicare Supplemental claims databases. As there is no diagnosis code specific to AL amyloidosis, the following algorithm was used to identify patients. For each calendar year (CY), adult patients ≥18 years old with AL amyloidosis were identified if they (1) had at least one inpatient claim or two outpatient claims consistent with AL amyloidosis [International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes: 277.30 or 277.39; International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes: E85.4x, E85.8x, or E85.9x] in any diagnosis field and (2) received AL-specific treatments (eg, chemotherapy, hematopoietic stem cell transplant [HSCT]) on or after the first AL amyloidosis diagnosis in the study period. Full-year enrollment was not required after exploratory analyses suggested most patients with partial year enrollment likely died during the year. Descriptive statistics were reported by CY and overall. Some patients may have been included in multiple CYs at different points in the course of their disease. All analyses were done using SAS®.Results: A total of 7,326 patients with AL amyloidosis were included in the study period (between 368 and 1,080 unique patients per year). The mean (SD) age of the total population with AL amyloidosis was 63.6 (12.1) years old and 45% were female. All US regions were represented. The most common AL-related comorbidities were renal disease (39.3%), congestive heart failure (33.2%), and moderate or severe liver disease (28.6%). Other common comorbidities include hyperlipidemia (45.7%), moderate or severe liver disease (28.6%), any malignancy/lymphoma/leukemia excluding multiple myeloma (23.4%), monoclonal gammopathy of undetermined significance (19.6%), diabetes without chronic complications (18.3%), hypothyroidism (17.7%), and hypotension (16.2%). At least one claim with a diagnosis of multiple myeloma was identified in 38.9% of patients. The burden of comorbidities increased over time (eg, the mean (SD) of Charlson Comorbidity Index: 4.2 (3.2) in 2007 and 4.6 (3.2) in 2015.Conclusions: Patients with AL amyloidosis have a substantial burden of comorbidities. Many of the observed comorbidities, including congestive heart failure, renal disease, and liver disease, likely represent manifestations of the disease process. In summary, our current study is the first comprehensive report of the real-world burden of comorbidities in a large US population with AL amyloidosis. Physician awareness of these comorbidities may lead to better diagnosis, disease management, and treatment of AL amyloidosis. DisclosuresQuock:Prothena Biosciences Inc: Employment, Other: Stockholder. Yan:Partnership for Health Analytic Research, LLC: Employment. Chang:Partnership for Health Analytic Research, LLC: Employment. Broder:Partnership for Health Analytic Research, LLC: Employment.

Combined Pulmonary Fibrosis Emphysema: Role of Cigarette Smoking and Pulmonary Hypertension in a Rural Cohort.

BackgroundDisease heterogeneity in idiopathic pulmonary fibrosis (IPF) often complicates the systematic study of disease, management of patients and clinical investigations.ObjectiveTo describe combined pulmonary fibrosis emphysema (CPFE) phenotype in a rural Appalachian IPF cohort with the highest smoking rates in the United States.MethodsCPFE patients (n = 60) in a developed IPF cohort (n = 153) were characterized. Groups (CPFE vs IPF without emphysema) were categorized based on the predominant HRCT patterns of UIP (n = 109). Demographics, clinical variables, and treatment details were recorded. Kaplan–Meier survival and multivariate logistic regression analysis were performed.ResultsThe prevalence of CPFE in our IPF cohort was 45% (n = 49). The CPFE group was younger (73.9 vs 78.2), had a more extensive smoking history (93.9% vs 53.3%) with greater mean smoking pack years (49.09 vs 15.39) and had lower percentage predicted DLCO on presentation (38.35 vs 51.09) compared to IPF without emphysema group. Both groups shared equivalent higher burden of comorbidities, including pulmonary hypertension (PH) (46.9% vs 33.3%). One-fifth of patients were prescribed antifibrotics and only a subset (5%) of patients underwent lung transplantation. There was a non-significant trend towards reduced survival in CPFE (p = 0.076). Smoking status and DLCO predicted CPFE in our cohort. Body mass index (BMI), PH, and pirfenidone use were significant predictors of mortality.ConclusionCPFE was highly prevalent in our rural IPF cohort. In contrast to previous studies, CPFE group was older and had higher female (approx. 30%) occurrence. A greater exposure to cigarette smoke and reduced DLCO at diagnosis predicted CPFE. Lower BMI and PH predicted higher mortality whereas use of pirfenidone improved survival in our cohort. This study highlights a complex interaction of cigarette smoking, advanced fibrosis of UIP, PH and potential utility of antifibrotic agents in CPFE phenotype. Substantial burden of comorbidities, older age, and the limited utilization of advanced therapeutics in the cohort emphasize the challenges faced by rural Appalachian patients.

Seasonal burden of National Emergency Department visits due to hidradenitis suppurativa

Seasonal burden of National Emergency Department visits due to hidradenitis suppurativa

Clinical Burden and Practice Patterns in Patients With Chronic Hypoparathyroidism in the United States (US): A Claims Data Analysis Using Surgery-Based Criteria

Objectives: Significant knowledge gaps exist regarding the clinical burden and practice patterns associated with chronic hypoparathyroidism (cHP). This study assessed the clinical burden and practice patterns in patients with cHP identified using surgery-based criteria. Methods: This retrospective cohort study was conducted using a large (130 million individuals) US claims database, the HealthVerity Closed Payer Claim Medical and Pharmacy database (Private Source 20) from Oct 2014 to Dec 2019. The patient eligibility criteria for the surgery-based method included the presence of a procedure claim of either parathyroidectomy, complete or partial thyroidectomy, or neck dissection, followed by a HP diagnosis claim (6–15 months apart) with a subsequent second HP diagnosis claim at any time point, and with continuous enrollment for 15 months before the index date (the date of the first qualifying HP diagnosis claim) and ≥6 months after. Patients were followed one year before the surgery and up to two years after the index date. Patient characteristics, comorbidities, laboratory testing and treatment patterns were descriptively analyzed. Results: A total of 1,406 patients met the eligibility criteria, among which 1,184 patients had complete data for 1-year follow-up. The mean age was 52.1 + 16.4 (SD) years, and 83.2% were females. The mean time between surgery and qualifying HP diagnosis claim was 8.7 + 2.3 (SD) months, and 115 patients (8.2%) had a HP diagnosis prior to surgery. During the 1-year follow-up, the most common comorbidities were cancer (54.2%, of which 49% were thyroid cancers), hypertension (49.7%), hypocalcemia (47.1%), chronic pulmonary disease (21.9%), diabetes (21.7%), cardiac arrhythmias (18.4%), CKD stage 3–5 (11.3%), osteoporosis (9.8%), and neuropsychiatric disorders, including anxiety (23.9%), depressive disorders (21.8%), and sleep-wake disorders (20.9%). Most cHP patients were monitored for lab values. These included serum calcium (93.2%), eGFR/creatinine (86.2%), 25-Hydroxy Vitamin D (66.5%), intact PTH (63.0%), serum magnesium (40.9%), serum phosphorous (38.4%), bone mineral density (9.8%), and 24h-urine calcium (8.4%) during the 1-year follow up. Also within the 1-year follow-up, 66.9% of patients had a prescription claim for thyroid replacement therapy, 51.6% for calcitriol, 13.3% for ergocalciferol, and 5.5 % for PTH. Conclusion: This cHP population, identified using surgery-based criteria, largely consists of patients with a recent diagnosis, and had a substantial comorbidity burden that aligned with the monitoring patterns. Already at this early stage of cHP, kidney function appears to be a key concern and may be important when considering therapeutic intervention. These data are consistent with our findings from a larger cHP population identified in the same database using a diagnosis-based approach.