ABSTRACT
INTRODUCTION: Evidence suggests that an apixaban-based strategy to treat acute venous thromboembolism (VTE) in patients with End-Stage Kidney Disease (ESKD) may be safer than a warfarin-based strategy. Apixaban has an additional advantage of not requiring bridging with heparin which often necessitates long hospitalizations for patients with ESKD. We sought to determine if an apixaban-based strategy is associated with less healthcare utilization than a warfarin-based strategy. MATERIAL AND METHODS: We employed a new-user, active-comparator retrospective cohort study using inverse probability of treatment weights (IPTW) to adjust for confounding demographic and clinical variables. Patients with ESKD newly initiated on either apixaban or warfarin for an acute VTE between 2014 and 2018 in the United States Renal Data System were included. Outcomes were presence of index hospitalization, length of index hospitalization, total hospital days, total hospital days excluding index hospitalization, total emergency department (ED) visits that did not result in hospitalization, and total skilled nursing facility days. RESULTS: At six months, patients who received apixaban were less likely to have an index hospitalization, had a shorter index hospitalization (median of 4.0 vs 8.0 days, p < 0.001), and had fewer total hospital days. The IPTW and index year-adjusted incidence rate ratios of total hospital days at one, three, and six months were 0.83 (95 % confidence intervals (CI) 0.79-0.86), 0.84 (95 % CI 0.81-0.88), and 0.88 (95 % CI 0.83-0.92) for apixaban compared to warfarin. CONCLUSION: Among patients with ESKD and VTE, resource utilization for an apixaban-based strategy appears to be lower than for a warfarin-based strategy.
Subject(s)
Kidney Failure, Chronic , Venous Thromboembolism , Venous Thrombosis , Humans , United States , Warfarin/therapeutic use , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Anticoagulants/therapeutic use , Retrospective Studies , Venous Thrombosis/drug therapy , Pyridones/therapeutic use , Kidney Failure, Chronic/complications , Patient Acceptance of Health CareSubject(s)
Cardiology , Chest Pain , United States , Humans , Consensus , Chest Pain/diagnosis , Chest Pain/etiology , Chest Pain/therapy , Emergency Service, HospitalABSTRACT
BACKGROUND: Patients with end-stage kidney disease (ESKD) are at significantly increased risk for both thrombosis and bleeding relative to those with normal renal function. The optimal therapy of venous thromboembolism (VTE) in patients with ESKD is unknown. OBJECTIVE: To compare the safety and effectiveness of apixaban relative to warfarin in patients with ESKD and acute VTE. DESIGN, SETTING AND PARTICIPANTS: New-user, active-comparator retrospective United States population-based cohort with inverse probability of treatment weighting, using the United States Renal Data System data from 2014 to 2018. We included adults with ESKD on hemodialysis or peritoneal dialysis who were newly initiated on apixaban or warfarin for an acute VTE. MAIN OUTCOME AND MEASURES: The coprimary outcomes were major bleeding, recurrent VTE, and all-cause mortality within 6 months of anticoagulant initiation. Secondary outcomes were intracranial hemorrhage and gastrointestinal bleeding. The primary analyses were based on intent-to-treat defined by the first drug received and accounted for competing risks of death. Sensitivity analyses included varied follow-up time, as-treated analyses, and dose-specific apixaban subgroups. RESULTS: The apixaban and warfarin cohorts included 2302 and 9263 patients, respectively. Apixaban was associated with a lower risk of major bleeding (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.70-0.94), intracranial bleeding (HR 0.69, 95% CI 0.48-0.98), and gastrointestinal bleeding (HR 0.82, 95% CI 0.69-0.96). Recurrent VTE and all-cause mortality were not significantly different between the groups. CONCLUSION: Apixaban was associated with a lower risk of bleeding relative to warfarin when used to treat acute VTE in patients with ESKD on dialysis.
Subject(s)
Kidney Failure, Chronic , Venous Thromboembolism , Venous Thrombosis , Adult , Anticoagulants/adverse effects , Cohort Studies , Gastrointestinal Hemorrhage/drug therapy , Humans , Kidney Failure, Chronic/chemically induced , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Pyrazoles , Pyridones , Retrospective Studies , United States , Venous Thromboembolism/drug therapy , Venous Thrombosis/drug therapy , Warfarin/adverse effectsABSTRACT
Thromboembolism is a common and deadly consequence of COVID-19 infection for hospitalized patients. Based on clinical evidence pre-dating the COVID-19 pandemic and early observational reports, expert consensus and guidance documents have strongly encouraged the use of prophylactic anticoagulation for patients hospitalized for COVID-19 infection. More recently, multiple clinical trials and larger observational studies have provided evidence for tailoring the approach to thromboprophylaxis for patients with COVID-19. This document provides updated guidance for the use of anticoagulant therapies in patients with COVID-19 from the Anticoagulation Forum, the leading North American organization of anticoagulation providers. We discuss ambulatory, in-hospital, and post-hospital thromboprophylaxis strategies as well as provide guidance for patients with thrombotic conditions who are considering COVID-19 vaccination.
Subject(s)
COVID-19 , Venous Thromboembolism , Anticoagulants/therapeutic use , COVID-19 Vaccines , Humans , Pandemics , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & controlABSTRACT
OBJECTIVE: To examine the healthcare economic burden of atrial fibrillation (AF) patients treated with factor Xa inhibitor (FXaI) anticoagulants who were hospitalized in the US with a major bleed (MB). METHODS: Adult AF patients treated with FXaIs and hospitalized with an MB were selected from MarketScan databases (1 January 2015-30 April 2018). Patients were grouped into cohorts based on type of MB: intracranial hemorrhage (ICH), gastrointestinal (GI), other types of MB. Healthcare costs in 2019 USD were evaluated for index hospitalizations and during a variable follow-up period in unadjusted and adjusted analyses. RESULTS: Of the overall AF patient population treated with FXaIs and hospitalized with an MB (n = 7,577), 9.9% had ICH (mean age: 77.9 years; 58% male), 55.9% had GI (mean age: 76.8 years; 52% male), and 34.2% had other types of MB (mean age: 74.4 years; 61% male). Mean index hospitalization costs for ICH, GI, and other type of MB were $54,163, $26,901, and $36,645, respectively; from adjusted analyses, patients with ICH vs. GI spent 1.6 more days in the hospital; mean cost was $15,630 higher. Patients with other types of MB vs. GI spent 0.6 more days in the hospital; mean cost was $5,859 higher. Index hospitalization cost in addition to total all-cause healthcare costs incurred in the follow-up period were $34,522 higher per ICH patient and $11,584 higher per other type of MB patient vs. a GI MB patient. LIMITATIONS: Since this study was a retrospective observational study using a claims database analysis, a causal relationship between treatment with FXaIs and MB events cannot be established. CONCLUSIONS: Although all of the evaluated MB types were associated with high hospitalization costs, ICH was associated with the most substantial short- and long-term healthcare economic burden.
Subject(s)
Atrial Fibrillation , Stroke , Adult , Aged , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Factor Xa Inhibitors/adverse effects , Female , Health Care Costs , Hemorrhage , Hospitalization , Humans , Male , Retrospective StudiesABSTRACT
INTRODUCTION: Direct-acting oral anticoagulants (DOACs) are associated with risk of major bleeding. This study evaluated the incremental healthcare economic burden of patients with atrial fibrillation (AF) treated with DOACs and hospitalized with a major bleed (MB). METHODS: Adult patients with AF treated with DOACs and hospitalized with MB or no MB hospitalizations during January 1, 2015-April 30, 2018 were extracted from MarketScan claims databases. The index date was defined as the first MB hospitalization for patients with MB and a random date during DOAC usage for patients without MB. Healthcare resource utilization and costs were evaluated for index hospitalizations of patients with MB and during the 6-month period prior to index dates and a variable follow-up period of 1-12 months for both patients with and those without MB. Multivariable regression analyses were performed to evaluate the incremental burden of MB vs. non-MB status on all-cause hospital days and healthcare costs. RESULTS: Of the overall AF patient population using DOACs (N = 152,305), 7577 (5.0%) had a hospitalization for MB. Greater proportions of those who had an MB hospitalization were older and female compared to patients without MB (mean age 76.1 vs. 70.1 years; 44.1% vs. 40.5% female, respectively). For index MB hospitalizations, mean length of stay (LOS) was 5.3 days and cost was $32,938. In adjusted analyses, patients with MB had 3.6 more hospital days, $10,609 higher inpatient cost, $9613 higher outpatient medical cost, and $18,910 higher total healthcare costs for all causes per patient during follow-up (all p < 0.001). Including index MB hospitalization costs in the follow-up, all-cause total adjusted healthcare costs were almost two times higher for patients with vs. without MB ($96,590 vs. $49,091, p < 0.001). CONCLUSIONS: Among a large US nationally representative sample of patients with AF treated with DOACs, the cost of MB hospitalization was substantial. Furthermore, healthcare costs following MB events were nearly 40% higher compared to those of patients with AF without an MB.
Subject(s)
Anticoagulants/economics , Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/economics , Factor Xa Inhibitors/economics , Factor Xa Inhibitors/therapeutic use , Health Care Costs/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/epidemiology , Female , Hemorrhage/chemically induced , Hospitalization/economics , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Patient Acceptance of Health Care/statistics & numerical data , Retrospective Studies , United States/epidemiology , Young AdultABSTRACT
OBJECTIVE: To address gaps in the data comparing non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin among patients with nonvalvular atrial fibrillation (NVAF) and diabetes. PATIENTS AND METHODS: A retrospective study was conducted on patients with NVAF and diabetes newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, through September 30, 2015, with Medicare data from the US Centers for Medicare & Medicaid Services and 4 other US commercial claims databases. One-to-one propensity score matching was completed between NOACs and warfarin and between NOACs in each database, and the results were pooled. Cox proportional hazards models were used to evaluate the risk of stroke/systemic embolism (SE) and major bleeding (MB). RESULTS: A total of 154,324 patients were included in the 6 matched cohorts, with a mean follow-up time of 6 to 8 months. Compared with warfarin, apixaban (hazard ratio [HR], 0.67; 95% CI, 0.57-0.77) and rivaroxaban (HR, 0.79; 95% CI, 0.71-0.89) were associated with a lower risk of stroke/SE; dabigatran (HR, 0.84; 95% CI, 0.67-1.07) was associated with a similar risk of stroke/SE. Apixaban (HR, 0.60; 95% CI, 0.56-0.65) and dabigatran (HR, 0.78; 95% CI, 0.69-0.88) were associated with a lower risk of MB; rivaroxaban (HR, 1.02; 95% CI, 0.94-1.10) was associated with a similar risk of MB compared with warfarin. Compared with dabigatran and rivaroxaban, apixaban was associated with a lower risk of MB. Compared with rivaroxaban, dabigatran was associated with a lower risk of MB. CONCLUSION: This study-the largest observational study to date of patients with NVAF and diabetes taking anticoagulants-found that NOACs were associated with variable rates of stroke/SE and MB compared with warfarin. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03087487.
Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/complications , Diabetes Complications/complications , Embolism/prevention & control , Stroke/prevention & control , Warfarin/administration & dosage , Administration, Oral , Anticoagulants/adverse effects , Embolism/epidemiology , Embolism/etiology , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Retrospective Studies , Risk Assessment , Stroke/epidemiology , Stroke/etiology , Treatment Outcome , Warfarin/adverse effectsABSTRACT
Coronavirus disease 2019 (COVID-19) is a viral infection that can, in severe cases, result in cytokine storm, systemic inflammatory response and coagulopathy that is prognostic of poor outcomes. While some, but not all, laboratory findings appear similar to sepsis-associated disseminated intravascular coagulopathy (DIC), COVID-19- induced coagulopathy (CIC) appears to be more prothrombotic than hemorrhagic. It has been postulated that CIC may be an uncontrolled immunothrombotic response to COVID-19, and there is growing evidence of venous and arterial thromboembolic events in these critically ill patients. Clinicians around the globe are challenged with rapidly identifying reasonable diagnostic, monitoring and anticoagulant strategies to safely and effectively manage these patients. Thoughtful use of proven, evidence-based approaches must be carefully balanced with integration of rapidly emerging evidence and growing experience. The goal of this document is to provide guidance from the Anticoagulation Forum, a North American organization of anticoagulation providers, regarding use of anticoagulant therapies in patients with COVID-19. We discuss in-hospital and post-discharge venous thromboembolism (VTE) prevention, treatment of suspected but unconfirmed VTE, laboratory monitoring of COVID-19, associated anticoagulant therapies, and essential elements for optimized transitions of care specific to patients with COVID-19.
Subject(s)
Anticoagulants/therapeutic use , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Venous Thromboembolism/prevention & control , COVID-19 , Coronavirus Infections/complications , Heparin/therapeutic use , Humans , Pandemics , Patient Discharge , Patient Transfer , Pneumonia, Viral/complications , Thrombolytic Therapy , Venous Thromboembolism/virology , WarfarinABSTRACT
Warfarin is a recommended therapy to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF). The objectives of this study were to identify potential factors associated with warfarin persistence and evaluate the impact of warfarin persistence on health-care resource utilization and costs among patients with NVAF in the United States. Patients (≥18 years) with ≥1 inpatient or ≥2 outpatient diagnoses of AF without valvular disease were identified from an electronic medical record database (January 1, 2004, to January 31, 2015). The patients with NVAF were grouped into 2 cohorts-persistent with warfarin therapy and not persistent (warfarin discontinuation in <365 days). A multivariable regression was used to identify potential predictors of warfarin persistence. Health-care costs were evaluated during a 12-month follow-up period for study cohorts. Among the study population, 52%, (n = 4086) were persistent with warfarin therapy and 48% (n = 3722) were not. Patients with NVAF with higher Charlson comorbidity index and CHADS2 scores versus those with scores of 0 were more likely to demonstrate persistence with warfarin therapy. After adjusting for patient characteristics, patients with NVAF persistent with warfarin therapy versus those who were not were 30% less likely to be hospitalized during the follow-up period ( P < .001). Additionally, total all-cause health-care costs (US $2183, P < .001) and stroke-related costs (US $788, P < .001) were significantly lower among patients persistent with warfarin therapy versus those who were not. Patients with NVAF who have greater comorbidity and stroke risk are more likely to be persistent with warfarin therapy. Patients with NVAF who are persistent with warfarin therapy versus those who are not have lower all-cause and stroke-related health-care costs.
Subject(s)
Atrial Fibrillation/drug therapy , Delivery of Health Care/economics , Warfarin/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/economics , Costs and Cost Analysis , Databases, Factual , Delivery of Health Care/statistics & numerical data , Female , Humans , Male , Middle Aged , Regression Analysis , Stroke/economics , United States , Warfarin/economics , Young AdultABSTRACT
The increasing prevalence of infections due to multidrug-resistant (MDR) gram-negative bacteria constitutes a serious threat to global public health due to the limited treatment options available and the historically slow pace of development of new antimicrobial agents. Infections due to MDR strains are associated with increased morbidity and mortality and prolonged hospitalization, which translates to a significant burden on healthcare systems. In particular, MDR strains of Enterobacteriaceae (especially Klebsiella pneumoniae and Escherichia coli), Pseudomonas aeruginosa, and Acinetobacter baumannii have emerged as particularly serious concerns. In the United States, MDR strains of these organisms have been reported from hospitals throughout the country and are not limited to a small subset of hospitals. Factors that have contributed to the persistence and spread of MDR gram-negative bacteria include the following: overuse of existing antimicrobial agents, which has led to the development of adaptive resistance mechanisms by bacteria; a lack of good antimicrobial stewardship such that use of multiple broad-spectrum agents has helped perpetuate the cycle of increasing resistance; and a lack of good infection control practices. The rising prevalence of infections due to MDR gram-negative bacteria presents a significant dilemma in selecting empiric antimicrobial therapy in seriously ill hospitalized patients. A prudent initial strategy is to initiate treatment with a broad-spectrum regimen pending the availability of microbiological results allowing for targeted or narrowing of therapy. Empiric therapy with newer agents that exhibit good activity against MDR gram-negative bacterial strains such as tigecycline, ceftolozane-tazobactam, ceftazidime-avibactam, and others in the development pipeline offer promising alternatives to existing agents.
Subject(s)
Acinetobacter baumannii/drug effects , Anti-Bacterial Agents/therapeutic use , Enterobacteriaceae Infections/drug therapy , Escherichia coli/drug effects , Klebsiella pneumoniae/drug effects , Pseudomonas aeruginosa/drug effects , Acinetobacter baumannii/growth & development , Acinetobacter baumannii/pathogenicity , Boronic Acids/therapeutic use , Drug Resistance, Multiple, Bacterial/drug effects , Drug Resistance, Multiple, Bacterial/physiology , Drug Therapy, Combination , Enterobacteriaceae Infections/microbiology , Enterobacteriaceae Infections/pathology , Escherichia coli/growth & development , Escherichia coli/pathogenicity , Heterocyclic Compounds, 1-Ring/therapeutic use , Hospitals , Humans , Klebsiella pneumoniae/growth & development , Klebsiella pneumoniae/pathogenicity , Meropenem , Pseudomonas aeruginosa/growth & development , Pseudomonas aeruginosa/pathogenicity , Sisomicin/analogs & derivatives , Sisomicin/therapeutic use , Tetracyclines/therapeutic use , Thienamycins/therapeutic useABSTRACT
PURPOSE: The Clinical Decision Aid was created to assist in selecting anticoagulant therapies for patients with nonvalvular atrial fibrillation. The aid incorporates a patient's absolute risk for stroke and bleeding, relative stroke risk reduction, and increase in relative bleeding risk to identify the agent with the lowest net risk. We describe theoretical implications of utilizing the aid at a US managed care population level. METHODS: This retrospective study used claims data from a large US managed care database including enrollees in commercial and Medicare Advantage plans. The distribution of patients across each possible combination of scores on the HAS-BLED scale (evidence of hypertension, abnormal renal or liver function, stroke, bleeding, labile INR, age >65 years, and drugs or alcohol abuse or dependence) and the CHA2DS2-VASc scale (CHADS2 [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism] with additional nonmajor stroke risk factors, including age 65-74 years, female sex, and vascular disease) was generated. We assessed the correlation between the HAS-BLED and CHA2DS2-VASc scores and derived the optimal treatment options based on various bleeding ratios. FINDINGS: Data from 48,260 patients were included in the analysis. The MAPD subset had a higher mean HAS-BLED score (2.17 vs 1.39; P < 0.001) and a higher mean CHA2DS2-VASc score (3.35 vs 2.05; P < 0.001) than did the commercial subset. Pearson coefficients suggested a moderate to strong positive correlation between the HAS-BLED and CHA2DS2-VASc scores among the commercial (0.730; P < 0.001) and MAPD (0.568; P < 0.001) enrollees. Based on a 2:1 bleeding-to-stroke risk ratio, 70.50% of patients would be recommended treatment with apixaban; 25.86%, no treatment; 3.62%, acetylsalicylic acid; and 0.01%, dabigatran 150 mg, if the Clinical Decision Aid were to be used for anticoagulant treatment selection. IMPLICATIONS: Evidence-based clinical decision-making tools utilizing risk assessment for recommending a treatment may be valuable for not only health care providers but also health care payers in optimizing care at the population level.
Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Decision Support Techniques , Aged , Aspirin/therapeutic use , Dabigatran/therapeutic use , Databases, Factual , Female , Hemorrhage/chemically induced , Humans , Male , Managed Care Programs , Middle Aged , Pyrazoles/therapeutic use , Pyridones/therapeutic use , Retrospective Studies , Risk Factors , Stroke/etiology , United StatesABSTRACT
The prevalence of skin and soft tissue infections (SSTIs) has been increasing in the United States. These infections are associated with an increase in hospital admissions. Hospitalists play an increasingly important role in the management of these infections and need to use hospital resources efficiently and effectively. When available, observation units are useful for treating low-risk patients who do not require hospital admission. Imaging tools may help to exclude abscesses and necrotizing soft tissue infections; however, surgical exploration remains the principal means of diagnosing necrotizing soft tissue infections. The most common pathogens that cause SSTIs are streptococci and Staphylococcus aureus. Methicillin-resistant S aureus (MRSA) is a prevalent pathogen, and concerns are increasing regarding the unclear distinctions between community-acquired and hospital-acquired MRSA. Other less frequent pathogens that cause SSTIs include Enterococcus species, Escherichia coli, Klebsiella species, Enterobacter species, and Pseudomonas aeruginosa. Cephalexin and clindamycin are suitable options for infections caused by streptococcal species and methicillin-susceptible S aureus. The increasing resistance of S aureus and Streptococcus pyogenes to erythromycin limits its use in these infections, and better alternatives are available. Parenteral cefazolin, nafcillin, or oxacillin can be used in hospitalized patients with nonpurulent cellulitis caused by streptococci and methicillin-susceptible S aureus. When oral MRSA therapy is indicated, clindamycin, doxycycline, trimethoprim-sulfamethoxazole, or linezolid is appropriate. Vancomycin, linezolid, daptomycin, tigecycline, telavancin, and ceftaroline fosamil are intravenous options that should be used in MRSA infections that require patient hospitalization. In the treatment of patients with SSTIs, hospitalists are at the forefront of providing proper patient care that reduces hospital costs, duration of therapy, and therapeutic failures. This review updates guidelines on the management of SSTIs with a focus on infections caused by S aureus, particularly MRSA, and outlines the role of the hospitalist in the effective management of SSTIs.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Community-Acquired Infections/epidemiology , Skin Diseases, Bacterial/drug therapy , Soft Tissue Infections/drug therapy , Community-Acquired Infections/drug therapy , Global Health , Hospitalists , Humans , Morbidity/trends , Skin Diseases, Bacterial/epidemiology , Soft Tissue Infections/epidemiologyABSTRACT
Community-acquired bacterial pneumonia (CABP) is an important health care concern in the United States and worldwide, and is associated with significant morbidity, mortality, and health care expenditure. Streptococcus pneumoniae is the most frequent causative pathogen of CABP. Other common pathogens include Staphylococcus aureus, Haemophilus influenzae, Enterobacteriaceae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. However, in clinical practice, the causative pathogen of CABP is most often not identified. Therefore, a common treatment approach for patients hospitalized with CABP is empiric antibiotic therapy with a ß-lactam in combination with a macrolide, respiratory fluoroquinolones, or tetracyclines. An increase in the incidence of S. pneumoniae that is resistant to frequently used antibiotics, including ß-lactams, macrolides, and tetracyclines, provides a challenge for the physician when selecting empiric antimicrobial therapy. When patients with CABP do not respond to initial therapy, they must be adequately reevaluated with further diagnostic testing, change in antimicrobial regimen, and/or transfer of the patient to a higher level of care. The role of hospital medicine physicians is crucial in treating patients who are hospitalized with CABP. An important focus of hospitalists is to provide care improvement in a way that addresses both patient and hospital needs. It is essential that the hospitalist provides best possible patient care, including adherence to quality measures, optimizing the patient's hospital length of stay, and arranging adequate post-discharge care in an effort to prevent readmission and provide appropriate ongoing outpatient care.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Hospitalists , Hospitalization , Pneumonia, Bacterial/drug therapy , Community-Acquired Infections/diagnosis , Community-Acquired Infections/drug therapy , Community-Acquired Infections/microbiology , Diagnosis, Differential , Drug Resistance, Bacterial , Drug Therapy, Combination , Hospitalists/standards , Humans , Pneumonia, Bacterial/diagnosis , Pneumonia, Bacterial/microbiology , Pneumonia, Pneumococcal/diagnosis , Pneumonia, Pneumococcal/drug therapy , Pneumonia, Pneumococcal/microbiology , Pneumonia, Staphylococcal/diagnosis , Pneumonia, Staphylococcal/drug therapy , Pneumonia, Staphylococcal/microbiology , Quality Indicators, Health Care , Severity of Illness Index , Treatment OutcomeABSTRACT
BACKGROUND: Patients with nonvalvular atrial fibrillation (NVAF) are at increased risk for stroke and bleeding events, but bleeding as an outcome has not been extensively studied in this patient population. OBJECTIVES: The goal of this study was to estimate the incidence of bleeding events among patients with NVAF enrolled in managed care, investigate the relationships between bleeding incidence and bleeding and stroke risks, and estimate health care costs for patients who had a major bleeding event. METHODS: Adults with commercial insurance or Medicare Advantage coverage and health care claims related to AF between January 2005 and June 2009 but with no evidence of valvular disease were included in this retrospective claims data analysis. Baseline stroke risk (CHADS2 [Congestive Heart Failure, Hypertension, Age >75 Years, Diabetes Mellitus, and Prior Stroke or Transient Ischemic Attack]) and bleeding risk (HAS-BLED [Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratios, Elderly, Drugs/Alcohol]) were estimated. Bleeding events were identified during the variable follow-up period, which lasted from the date of the first qualifying AF visit until the earlier of death, disenrollment from the health plan, or June 30, 2010. Bleeding events were classified as major, serious nonmajor, or minor. Health care costs for patients with major bleeding events were calculated. RESULTS: Among 48,260 patients with NVAF (mean age, 67 years), 34% had an incident bleeding event during a mean (SD) follow-up period of 802 (540) days. Incidence rates for bleeding events of any severity and major events were 29.6 and 10.4 per 100 patient-years, respectively. Bleeding incidence rates increased with greater CHADS2 and HAS-BLED risk scores. All-cause health care costs for patients during a major bleeding event averaged $16,830. Average costs per patient with a major event increased from approximately $52 per day in the prebleeding period to approximately $63 per day in the postbleeding period. Costs for patients who did not experience a major bleeding event averaged approximately $38 per day. CONCLUSIONS: Bleeding incidence among patients with NVAF in a real-world setting was high and increased with greater stroke and bleeding risk scores. Health care costs for patients with major bleeding events were elevated. All rights reserved.
Subject(s)
Atrial Fibrillation/complications , Atrial Fibrillation/economics , Hemorrhage/economics , Hemorrhage/epidemiology , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/drug therapy , Health Care Costs , Humans , Incidence , Insurance Claim Review , Male , Managed Care Programs , Medicare , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/economics , Stroke/epidemiology , United States , Young AdultABSTRACT
BACKGROUND: Stroke prevention is a goal of atrial fibrillation (AF) management, but discontinuation of warfarin anticoagulation therapy is common. OBJECTIVE: To investigate the association between warfarin discontinuation and hospitalization for stroke among nonvalvular AF (NVAF) patients enrolled in managed care. METHODS: Patients with NVAF who initiated warfarin therapy from January 2005 through June 2009 were included. Warfarin discontinuation was defined as a supply gap >60 days without evidence of International Normalized Ratio measurements. Follow-up, which was a variable time period from warfarin initiation until the earlier of death, disenrollment from the health plan, or June 30, 2010, was divided into periods of warfarin treatment and discontinuation. Stroke events were identified based on claims for inpatient stays with a primary diagnosis of stroke or transient ischemic attack. Cox proportional hazards models were constructed to assess the relationship between warfarin discontinuation and incident stroke while adjusting for baseline demographics, stroke and bleeding risk, and comorbidities, as well as time-dependent antiplatelet use, stroke, and bleeding events in the previous warfarin treatment period. RESULTS: Among warfarin initiators with NVAF (N = 16,253), 51.4% discontinued warfarin therapy at least once during a mean follow-up of 668 days. Stroke risk was significantly greater during warfarin discontinuation periods compared with therapy periods (hazard ratio = 1.60; 95% CI, 1.35-1.90; P < 0.001). CONCLUSIONS: More than half of patients on warfarin had treatment gaps or discontinued therapy. Therapy gaps were associated with increased stroke risk.
Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Ischemic Attack, Transient/etiology , Medication Adherence , Stroke/etiology , Warfarin/administration & dosage , Warfarin/adverse effects , Adolescent , Adult , Aged , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Female , Hospitalization/economics , Humans , Male , Managed Care Programs/economics , Middle Aged , Risk Factors , Stroke/economics , Time Factors , Young AdultABSTRACT
Thromboprophylaxis with oral anticoagulants (OACs) is an important but underused element of atrial fibrillation (AF) treatment. Reduction of stroke risk with anticoagulants comes at the price of increased bleeding risk. Patients with AF receiving anticoagulants require heightened attention with transition from one care setting to another. Patients presenting for emergency care of anticoagulant-related bleeding should be triaged for the severity and source of the bleeding using appropriate measures, such as discontinuing the OAC, administering vitamin K, when appropriate, to reverse warfarin-induced bleeding, or administering clotting factors for emergent bleeding. Reversal of OACs in patients admitted to the hospital for surgery can be managed similarly to patients with bleeding, depending on the urgency of the surgical procedure. Patients with AF who are admitted for conditions unrelated to AF should be assessed for adequacy of stroke risk prophylaxis and bleeding risk. Newly diagnosed AF should be treated in nearly all patients with either warfarin or a newer anticoagulant. Patient education is critically important with all anticoagulants. Close adherence to the prescribed regimen, regular international normalized ratio testing for warfarin, and understanding the stroke risk conferred by both AF and aging are goals for all patients receiving OACs. Detailed handoff from the hospitalist to the patient's primary care physician is required for good continuity of care. Monitoring by an anticoagulation clinic is the best arrangement for most patients. The elderly, or particularly frail or debilitated patients who are transferring to long-term care, need a detailed transfer of information between settings, education for the patient and family, and medication reconciliation. Communication and coordination of care among outpatient, emergency, inpatient, and long-term care settings are vital for patients with AF who are receiving anticoagulants to balance stroke prevention and bleeding risk.
Subject(s)
Aftercare , Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Continuity of Patient Care , Administration, Oral , Aged , Benzimidazoles/pharmacology , Benzimidazoles/therapeutic use , Dabigatran , Drug Monitoring , Drug Substitution , Emergencies , Hemorrhage/prevention & control , Humans , Morpholines/pharmacology , Morpholines/therapeutic use , Patient Education as Topic , Rivaroxaban , Stroke/prevention & control , Thiophenes/pharmacology , Thiophenes/therapeutic use , Warfarin/pharmacology , Warfarin/therapeutic use , beta-Alanine/analogs & derivatives , beta-Alanine/pharmacology , beta-Alanine/therapeutic useABSTRACT
BACKGROUND: Current clinical practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel or prasugrel for patients with acute coronary syndrome (ACS). Ticagrelor, an experimental antiplatelet therapy, has been shown to be associated with significantly higher rates of dyspnea than clopidogrel in clinical trials. Patients with ACS presenting with dyspnea require additional medical attention to rule out possible heart failure or other serious diagnoses. This study used real-world data to quantify the direct medical costs of dyspnea among patients with a history of ACS. OBJECTIVE: To determine the clinical and economic impact of a dyspnea episode for patients with a history of ACS using commercial and Medicare supplemental claims data. METHODS: Patients with an emergency room (ER) visit with a primary diagnosis of dyspnea (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] diagnosis code, 786.0x) in 2008 or 2009 were identified using Thomson Reuters MarketScan(®) Research Databases. Patients were required to have 6 months of continuous medical enrollment prior to an ER visit and a history of ACS (ie, ≥ 1 inpatient claim, ≥ 1 ER visit, or ≥ 2 outpatient claims, with an ICD-9-CM diagnosis code for ACS [410.xx or 411.1x] in any position on the outpatient claim during either the baseline period or on the index date). An episode of dyspnea was defined as all ER and outpatient services on the day of an ER claim with a primary diagnosis of dyspnea, and any inpatient admissions occurring on the day of or day following the ER visit. Procedure utilization and expenditures were evaluated for the ER visit and associated outpatient services, as well as the proportion of ER visits that led to an inpatient stay. Costs were allowed charges (ie, provider payment plus member cost-share) adjusted to 2009 US constant dollars. RESULTS: A total of 8433 ER visits for dyspnea were identified during 2008 to 2009 from these databases of approximately 74 million beneficiaries. The average cost per dyspnea episode was $6958, of which $1621 were outpatient costs associated with the ER visit (standard deviation, $3269). Along with physician services, assessment of dyspnea often included electrocardiogram (71.3%), chest radiograph (75.9%), and, occasionally, a B-type natriuretic peptide test (14.9%) or chest computed axial tomography scan (12.2%). More than one-fourth (25.8%) of dyspnea ER visits preceded an inpatient stay, with an average cost of $20 693 per patient. CONCLUSIONS: Dyspnea is a significant event associated with high medical resource utilization and hospital costs. Ticagrelor, an experimental antiplatelet agent not yet available on the market, has been shown to be associated with significantly higher rates of dyspnea than clopidogrel in clinical trials. Considering that the increased risk of dyspnea for ticagrelor is well documented, these costs may be important to health plan decision-makers when evaluating costs associated with each antiplatelet therapy.
Subject(s)
Acute Coronary Syndrome/complications , Acute Coronary Syndrome/drug therapy , Dyspnea/economics , Dyspnea/etiology , Platelet Aggregation Inhibitors/therapeutic use , Aged , Aged, 80 and over , Aspirin/therapeutic use , Clopidogrel , Costs and Cost Analysis , Diagnostic Techniques and Procedures , Drug Therapy, Combination , Emergency Service, Hospital/economics , Emergency Service, Hospital/statistics & numerical data , Female , Humans , Insurance Claim Review/statistics & numerical data , Male , Middle Aged , Piperazines/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Prasugrel Hydrochloride , Thiophenes/therapeutic use , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic useABSTRACT
Hyponatremia (typically defined as serum sodium level < 135 mEq/L) is a common electrolyte abnormality among hospitalized patients. Whether present at admission or acquired during hospitalization, hyponatremia is associated with higher mortality and longer hospital stays. Failure to adequately investigate and treat hyponatremia may also be associated with adverse outcomes. The presence and severity of clinical symptoms largely depend on the rate and extent of the decline in serum sodium; rapid or large decreases may cause serious neurologic complications. The approach to treatment depends on the presence and severity of symptoms, the timing of their onset, the underlying etiology, and the patient's volume status. Patients with euvolemic or hypervolemic hyponatremia usually have inappropriately elevated levels of arginine vasopressin, which stimulates water reabsorption even in the presence of low serum osmolality. Tolvaptan is an orally active, selective V2-receptor antagonist that blocks the effects of arginine vasopressin in the renal collecting duct to promote aquaresis without increasing sodium or potassium excretion; as a result, it increases serum sodium in a controlled manner. Tolvaptan offers a mechanism-based treatment option for patients with euvolemic or hypervolemic hyponatremia who have serum sodium levels < 125 mEq/L or persistent symptoms resistant to fluid restriction.
Subject(s)
Antidiuretic Hormone Receptor Antagonists , Benzazepines/therapeutic use , Hospitalization , Hyponatremia/drug therapy , Arginine Vasopressin/antagonists & inhibitors , Diagnosis, Differential , Humans , Hyponatremia/diagnosis , Hyponatremia/etiology , Hypovolemia/complications , Quality Indicators, Health Care , Severity of Illness Index , Time Factors , TolvaptanABSTRACT
Clinical trials of anticoagulants often exclude special populations. We assessed the proportion of special populations in real-world orthopedic surgery and the incidence of venous thromboembolism (VTE)-related outcomes. Data on patients with hip (n = 11 483) or knee replacement (n = 19 390) were extracted from IMS' PharMetrics Patient-Centric Database. There was high prevalence of patients aged ≥75 years (20.3%), CYP3A4-inhibitor use (21.5%), and chronic warfarin use (9.5%). Venous thromboembolism events were increased with each increasing year of age (hip: odds ratio [OR] 1.02, 95% confidence interval [CI] = 1.01-1.03; knee: OR 1.01, 95%CI = 1.00-1.02) and chronic warfarin use (hip: OR 1.56, 95%CI = 1.13-2.17; knee: OR 1.33, 95%CI = 1.03-1.72); in hip patients with renal insufficiency (OR1.61, 95%CI=1.11-2.36); and in knee patients with atrial fibrillation (OR 1.41, 95%CI = 1.06-1.88). Major bleeding was higher in hip patients with hepatic impairment (OR 21.99, 95%CI = 2.04-236.62), each increasing year of age (OR 1.08, 95%CI = 1.01-1.15), and chronic warfarin use (OR 7.11, 95%CI = 1.16-43.46). Special populations are prevalent in real-world orthopedic surgery, which may impact VTE-related outcomes.
Subject(s)
Orthopedic Procedures/adverse effects , Venous Thromboembolism/prevention & control , Aged , Female , Humans , Male , Postoperative Complications/prevention & control , Risk Factors , Treatment Outcome , United StatesABSTRACT
Studies investigating racial differences in the prevalence of venous thromboembolism (VTE) have generally been conducted on a limited scale. This analysis measured VTE prevalence across racial groups in a population of US Medicaid enrollees from 2002 to 2005. Records for patients aged ≥ 18 years with VTE between January 1, 2002 and December 31, 2005 were retrieved from the MarketScan® Multi-State Medicaid Database from Thomson Reuters. Patients were classified as having VTE in each calendar year by the presence of a VTE diagnosis on an inpatient claim or ≥ 1 outpatient claim with VTE diagnosis plus evidence of anticoagulant use. Patients dually eligible for Medicaid and Medicare were excluded. Logistic regression was used to calculate the odds of VTE. An average of 4.5 million Medicaid enrollees were study eligible in each calendar year, 72.2% of which had deep-vein thrombosis, 22.5% pulmonary embolism, and 5.3% had both. Patients were mainly Caucasian (46.8%), African-American (26.0%), and Hispanic (14.1%). VTE prevalence per 100,000 enrollees was highest in African-American males (584 in 2002-784 in 2005), followed by Caucasian males (457-643), Caucasian females (335-446), and African-American females (348-444). Hispanic males (94-149) and females (93-154) had lower prevalence of VTE. African-Americans had a significantly higher probability of having a VTE event than Caucasians (adjusted odds ratio 1.04, 95% confidence interval 1.00-1.07, P = 0.036). VTE prevalence increased over the study period and was highest in African-American males. More coordinated efforts are required to improve VTE awareness and prevention across all racial and ethnic groups.