Background: Racial and ethnic minority groups have been disproportionately affected by the US coronavirus disease 2019 (COVID-19) pandemic; however, nationwide data on COVID-19 outcomes stratified by race/ethnicity and adjusted for clinical characteristics are sparse. This study analyzed the impacts of race/ethnicity on outcomes among US patients with COVID-19. Methods: This was a retrospective observational study of patients with a confirmed COVID-19 diagnosis in the electronic health record from 01 February 2020 through 14 September 2020. Index encounter site, hospitalization, and mortality were assessed by race/ethnicity (Hispanic, non-Hispanic Black [Black], non-Hispanic White [White], non-Hispanic Asian [Asian], or Other/unknown). Associations between racial/ethnic categories and study outcomes adjusted for patient characteristics were evaluated using logistic regression. Findings: Among 202,908 patients with confirmed COVID-19, patients from racial/ethnic minority groups were more likely than White patients to be hospitalized on initial presentation (Hispanic: adjusted odds ratio 1¢690, 95% CI 1¢620À1¢763; Black: 1¢810, 1¢743À1¢880; Asian: 1¢503, 1¢381À1¢636) and during follow-up (Hispanic: 1¢700, 1¢638À1¢764; Black: 1¢578, 1¢526À1¢633; Asian: 1¢391, 1¢288À1¢501). Among hospitalized patients, adjusted mortality risk was lower for Black patients (0¢881, 0¢809À0¢959) but higher for Asian patients (1¢205, 1¢000À1¢452). Interpretation: Racial/ethnic minority patients with COVID-19 had more severe disease on initial presentation than White patients. Increased mortality risk was attenuated by hospitalization among Black patients but not Asian patients, indicating that outcome disparities may be mediated by distinct factors for different groups. In addition to enacting policies to facilitate equitable access to COVID-19Àrelated care, further analyses of disaggregated population-level COVID-19 data are needed.

Background Patients with acute coronary syndrome (ACS) are recognized by guidelines as remaining at high risk for adverse outcomes. Evidence from contemporary, representative ACS populations in a clinical practice setting is necessary to identify subgroups and strategies for improving patient outcomes. We aimed to describe event rates and risk factors in an ACS population over prolonged follow‐up for cardiovascular end points. Methods and Results We identified 239 234 patients in the Optum Research Database (57.2% men; mean [standard deviation] age, 69.2 [12.2] years) with evidence of an ACS hospitalization (index ACS) during January 1, 2005 through December 30, 2018. Subgroups were based on index ACS event (myocardial infarction/unstable angina and revascularization status) and the Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention. The 5‐year event rate for the primary end point representing nonfatal myocardial infarction, nonfatal ischemic stroke, and cardiovascular death was 33.4% (95% CI, 33.1%–33.7%; P <0.001). The risk of experiencing the primary end point was ≈6‐fold higher immediately after discharge (≈40.9% annualized risk) as compared with the period 1+ years after hospitalization (≈6.4% annualized risk). Among subgroups, the 5‐year primary end point event rate was highest for myocardial infarction without revascularization and a Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention ≥4, at 47.9% (95% CI, 47.3%–48.4%; P <0.001) and 56.7% (95% CI, 55.9%–57.4%; P <0.001), respectively. Conclusions Patients with ACS remain at very high risk of experiencing recurrent cardiovascular events, particularly early after discharge, with identifiable subgroups at multifold higher risk of specific clinical end points.

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Introduction: Immune Thrombocytopenia (ITP) is a disease of immune-mediated destruction of platelets and suppression of platelet production. ITP has been historically treated with corticosteroids and/or immune globulins as first-line agents. There are several second-line treatments available, should patients fail to respond to initial therapy or relapse after it is tapered. These include eltrombopag, romiplostim, rituximab and splenectomy. This study utilized a national electronic health record (EHR) database to begin to explore the real world treatment patterns of the aforementioned second-line (index) therapies. Methods: Utilizing the Optum EHR database, we identified patients who initiated their first second-line treatment (i.e. the index treatment) with eltrombopag, romiplostim, rituximab or splenectomy from Jan. 1, 2009 to Sep. 30, 2016 for primary or unspecified ITP. Patients included in the analysis had the following characteristics: 18 years or older; previous treatment with corticosteroids and/or immune globulin products; active in the database for at least 6 months prior to and 12 months post initiation of the index treatment. Outcomes that were evaluated after initiation of the index treatment included: (1) Duration of therapy for eltrombopag and romiplostim; (2) Proportion of patients who started a subsequent line of treatment after their index treatment; (3) Treatment free duration between the end of the index treatment and start of a subsequent line of treatment; and (4) Proportion of patients using a first-line medication (corticosteroids and/or immune globulin) during treatment with eltrombopag and romiplostim. Chi-square and t-tests were used for statistical analysis. Results: 2,047 patients met the inclusion criteria and used an index treatment as follows: eltrombopag, N=110 (5.4%); romiplostim, N=189 (9.2%); rituximab, N=1488 (72.7%); splenectomy, N=260 (12.7%). The mean age was 60.8 years (standard deviation [SD]: 17.4), with 52.4% female and mean Charlson comorbidity score of 2.1 (SD: 2.1). Treatment duration was 481 days for eltrombopag versus 346 days for romiplostim (p=0.033). The proportion of patients who started a subsequent line of treatment after their index treatment ranged from 41% for rituximab to 49% for splenectomy (p=0.071). Treatment free duration between the end of the index treatment and start of a subsequent treatment ranged from a mean of 248 days for romiplostim to 575 days for splenectomy (p<0.001). The proportion of patients who did not use first-line medications during treatment with eltrombopag and romiplostim were similar (24% vs. 17%, p=0.157). See Table 1 below for details. Conclusions: In this dataset, rituximab was the predominant second-line treatment. Patients receiving eltrombopag had a greater treatment duration compared to romiplostim. As expected, a greater treatment free duration was observed with splenectomy and rituximab, though mean treatment free duration after treatment with romiplostim and eltrombopag was surprisingly long (248-270 days). Despite the longer duration off treatment following splenectomy and rituximab, a similar percentage of patients across all index treatments ultimately required a subsequent line of therapy. Further research is required to better understand the differences in real world treatment patterns among these cohorts. Disclosures Said: Novartis: Employment. Lal:Optum: Employment. Nezami:Novartis Pharmaceuticals: Employment. Andrade:Optum: Employment. Graves:Novartis: Employment. Roy:Novartis: Employment. Cuker:Spark Therapeutics: Research Funding; Kedrion: Membership on an entity's Board of Directors or advisory committees; Synergy: Consultancy; Genzyme: Consultancy.

IMPORTANCEThe Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins. OBJECTIVE To estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment. DESIGN, SETTING, AND PARTICIPANTSAn in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with

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INTRODUCTION: Immune Thrombocytopenia (ITP) is a disease of immune-mediated destruction of platelets and suppression of platelet production. ITP has been historically treated with corticosteroids and/or immune globulins as first-line agents. There are several second-line treatments available, should patients fail to respond to initial treatment or relapse after it is tapered. This study utilizes a national electronic health record (EHR) database to understand clinical outcomes with use of second-line treatments including: thrombopoietin receptor agonists (specifically, eltrombopag and romiplostim), rituximab, and splenectomy. METHODS: Utilizing the Optum EHR database, we identified patients who initiated a second-line treatment from Jan. 1, 2009 to Sep. 30, 2016 for primary or unspecified ITP. Additionally, patients included in the analysis had the following characteristics: 18 years or older; previous treatment with corticosteroids or immune globulin products; and active in the database for at least 6 months prior to and 12 months post initiation of a second-line treatment. Evaluated outcomes included: (1) platelet counts; (2) bleeding related episodes (BREs); and (3) thrombotic events (TEs), including stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, and pulmonary embolism. All outcomes were evaluated over the 12-month period following the initiation of second-line treatment. BREs and TEs were defined using ICD codes, collapsed to first three characters, indicating a form of bleeding or thrombotic events. Chi-square test and t-test were used to evaluate differences among the four treatment cohorts (eltrombopag, romiplostim, rituximab, and splenectomy). RESULTS: 2,047 patients met the inclusion criteria and used the second-line treatments as follows: eltrombopag, N=110 (5.4%); romiplostim, N=189 (9.2%); rituximab, N=1,488 (72.7%); splenectomy, N=260 (12.7%). The mean age was 60.8 years (standard deviation [SD]: 17.4), with 52.4% female and mean Charlson comorbidity score of 2.1 (SD: 2.1). Compared with platelet counts at the initiation of second-line treatments (collected within +/- 14 days of initiation of second-line treatments), mean platelet counts achieved during the 12 months post initiation of a second-line treatment increased in all treatment cohorts, ranging from an increase of 63,000/μL for rituximab to an increase of 157,000/μL for splenectomy. Mean platelet counts achieved during the 12 months post initiation of a second-line treatment differed significantly across treatment cohorts, ranging from 102,000/μL for eltrombopag to 240,000/μL for splenectomy (p<0.001) (Table 1). The proportion of patients who experienced BREs differed across the treatment cohorts, ranging from 25.5% for eltrombopag to 36.5% for romiplostim (p=0.038) (Table 2). Most common BREs observed included acute posthemorrhagic anemia, GI hemorrhage, hematuria, hemoptysis and hemorrhage, and rectal hemorrhage. TEs were observed in all treatment cohorts ranging from 11.6% for eltrombopag to 15.7% for splenectomy (p=0.744). (Table 2). CONCLUSIONS: This retrospective real world evidence study compares mean platelet response and burden of both BREs and TEs in ITP patients treated with different second-line treatments. Although there were significant differences in mean platelet counts achieved with the second-line treatments, TEs were observed with similar incidence across all treatments. Patients who received splenectomy had the highest mean platelet counts and also the highest proportion of patients who experienced TEs, though differences in TEs did not reach statistical significance. Incidence proportion of patients with BREs was lower in patients treated with eltrombopag than in patients treated with other second-line treatments. Such differences in outcomes may be useful when selecting treatment in the second-line setting. Disclosures Said: Novartis Pharmaceuticals Corporation: Employment. Lal:Optum: Employment. Andrade:Optum: Employment. Nezami:Novartis Pharmaceuticals: Employment. Graves:Novartis: Employment. Roy:Novartis: Employment. Cuker:Kedrion: Membership on an entity's Board of Directors or advisory committees; Synergy: Consultancy; Genzyme: Consultancy; Spark Therapeutics: Research Funding.

BACKGROUND:Necrotizing soft tissue infections (NSTIs) are an acute surgical condition with high morbidity and mortality. Timely identification, resuscitation, and aggressive surgical management have significantly decreased inpatient mortality. However, reduced inpatient mortality has shifted the burden of disease to long-term mortality associated with persistent organ dysfunction. METHODS:We performed a combined analysis of NSTI patients from the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections randomized-controlled interventional trial (ATB-202) and comprehensive administrative database (ATB-204) to determine the association of persistent organ dysfunction on inpatient and long-term outcomes. Persistent organ dysfunction was defined as a modified Sequential Organ Failure Assessment (mSOFA) score of 2 or greater at Day 14 (D14) after NSTI diagnosis, and resolution of organ dysfunction defined as mSOFA score of 1 or less. RESULTS:The analysis included 506 hospitalized NSTI patients requiring surgical debridement, including 247 from ATB-202, and 259 from ATB-204. In both study cohorts, age and comorbidity burden were higher in the D14 mSOFA ≥2 group. Patients with D14 mSOFA score of 1 or less had significantly lower 90-day mortality than those with mSOFA score of 2 or higher in both ATB-202 (2.4% vs. 21.5%; p < 0.001) and ATB-204 (6% vs. 16%: p = 0.008) studies. In addition, in an adjusted covariate analysis of the combined study data sets D14 mSOFA score of 1 or lesss was an independent predictor of lower 90-day mortality (odds ratio, 0.26; 95% confidence interval, 0.13-0.53; p = 0.001). In both studies, D14 mSOFA score of 1 or less was associated with more favorable discharge status and decreased resource utilization. CONCLUSION:For patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality. Promoting the resolution of acute organ dysfunction after NSTI should be considered as a target for investigational therapies to improve long-term outcomes after NSTI.