scholarly journals Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER

2021 ◽  
Author(s):  
Gary E. Raskob ◽  
Alex C. Spyropoulos ◽  
Theodore E. Spiro ◽  
Wentao Lu ◽  
Zhong Yuan ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Number Needed To Treat ◽  
Medical Illness ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Post Discharge ◽  
Medically Ill ◽  
Vein Thrombosis ◽  
Medically Ill Patients ◽  
Critical Site

Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post‐Discharge Venous Thrombo‐Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel‐group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all‐cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63–0.97], P =0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36; P =0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade‐off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT00571649 and NCT02111564.

scholarly journals Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients

2020 ◽  
Vol 75 (25) ◽  
pp. 3140-3147 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Walter Ageno ◽  
Gregory W. Albers ◽  
C. Gregory Elliott ◽  
Jonathan L. Halperin ◽  
...  
Keyword(s):  
Thromboembolic Events ◽  
Post Discharge ◽  
Medically Ill ◽  
Medically Ill Patients

scholarly journals Identification and Outcomes of Hospitalized Medically Ill Patients Who Are Candidates for Extended Duration Thromboprophylaxis

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e344-e350
Author(s):  
Craig I. Coleman ◽  
Gregory Piazza ◽  
Veronica Ashton ◽  
Thomas J. Bunz ◽  
Alex C. Spyropoulos
Keyword(s):  
High Risk ◽  
Gastroduodenal Ulcer ◽  
Medical Illness ◽  
Additional Risk Factor ◽  
Index Hospitalization ◽  
Post Discharge ◽  
Medically Ill ◽  
Hospitalization Costs ◽  
Extended Duration ◽  
Medically Ill Patients

Abstract Background Extended duration thromboprophylaxis (ET) for approximately 30 days can effectively and safely reduce venous thromboembolism (VTE) risk in appropriately selected medically ill patients. We sought to estimate the proportion of hospitalized medically ill patients potentially qualifying for ET and assess their post-discharge clinical and economic outcomes using a large claims database. Methods Using MarketScan claims from January 2012 to September 2018, we identified medically ill patients hospitalized with a primary diagnosis of heart failure, respiratory insufficiency, ischemic stroke, infection, or inflammatory disease and ≥1-additional risk factor for VTE. Patients < 40 years old, a length-of-stay < 3 or >30 days, receiving oral anticoagulation prior to index hospitalization or having an indication for full-dose anticoagulation were excluded, as were patients deemed high-risk for bleeding due to active, in-hospital treated cancer, gastroduodenal ulcer or bleeding within the prior 3 months, bronchiectasis, pulmonary cavitation or hemorrhage, or dual antiplatelet therapy use. Results We identified 2,782,988 patients ≥40 years of age and admitted for a high-risk medical illness. Of these, 724,531 patients (26.0%) were identified as ET candidates. Patients' VTE risk appeared highest in the first 30 days post-discharge (1,532/724,531, 0.2%). Adjusted post-index hospitalization costs (2018 US$) for patients with a VTE within 30 days were higher than those without VTE (Δ = $32,623 at 30 days, Δ = $43,325 at 90 days, Δ = $53,668 at 365 days; p < 0.001 for all). Conclusion Post-discharge VTE in high-risk patients with medical illness is associated with substantially increased costs.

scholarly journals Risk of Severe Bleeding With Extended Rivaroxaban to Prevent Venous Thromboembolism in Acute Medically Ill Patients With Bronchiectasis

2021 ◽  
Vol 27 ◽  
pp. 107602962110533
Author(s):  
Concetta Lipardi ◽  
C. Gregory Elliott ◽  
Chiara L. Sugarmann ◽  
Lloyd Haskell ◽  
Alex C. Spyropoulos ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Pulmonary Hemorrhage ◽  
Severe Bleeding ◽  
Medical Illness ◽  
Medically Ill ◽  
Subcutaneous Enoxaparin ◽  
Pulmonary Bleeding ◽  
Post Hoc ◽  
Medically Ill Patients

Background: Bronchiectasis is a chronic inflammation of the bronchi with recurrent infections and hemoptysis. The MAGELLAN study compared oral rivaroxaban, 10 mg once daily (QD), for 35 ± 4 days with subcutaneous enoxaparin 40 mg QD for 10 ± 4 days followed by placebo for 25 ± 4 days to prevent venous thromboembolism in patients hospitalized with an acute medical illness. MAGELLAN included a subset of patients with bronchiectasis. In a post hoc analysis, we evaluated the incidence and severity of pulmonary bleeding in patients with bronchiectasis who were hospitalized for an acute medical illness. This analysis included MAGELLAN patients diagnosed with bronchiectasis at baseline. Patients were evaluated by treatment group for International Society on Thrombosis and Haemostasis major bleeding, non-major clinically relevant (NMCR) bleeding, and the composite of the 2 (ie, clinically relevant bleeding). Results: Medically ill patients with bronchiectasis were randomized to rivaroxaban (n = 60) or enoxaparin/placebo (n = 61). There were 2 fatal pulmonary bleeds and 1 fatal gastrointestinal bleed in the rivaroxaban arm and no fatal or major bleeding in the enoxaparin/placebo arm. The incidence of major bleeding was 5% in the rivaroxaban arm. One NMCR bleed occurred in the rivaroxaban arm and 2 NMCR bleeds occurred in the enoxaparin/placebo arm. The incidence of clinically relevant bleeding was 6.7% versus 3.3% in the rivaroxaban and enoxaparin/placebo groups, respectively (relative risk = 2.06 [95% confidence interval: 0.351-12.046]). Conclusion: In-patients hospitalized with bronchiectasis and an acute medical illness, clinically relevant bleeding, including fatal pulmonary hemorrhage, occurs more frequently with extended rivaroxaban thromboprophylaxis than with enoxaparin followed by placebo.

scholarly journals Extended thromboprophylaxis for medically ill patients with cancer: a systemic review and meta-analysis

2021 ◽  
Vol 5 (8) ◽  
pp. 2055-2062
Author(s):  
Soravis Osataphan ◽  
Rushad Patell ◽  
Thita Chiasakul ◽  
Alok A. Khorana ◽  
Jeffrey I. Zwicker
Keyword(s):  
Meta Analysis ◽  
Thromboembolic Events ◽  
Medically Ill ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Extended Duration ◽  
Medically Ill Patients

Abstract Hospitalized medically ill patients with cancer are at increased risk of both venous thromboembolism and bleeding. The safety and efficacy of extended thromboprophylaxis in patients with cancer are unclear. We conducted a systematic review and meta-analysis of the literature using of MEDLINE, EMBASE, and the Cochrane CENTRAL databases to identify cancer subgroups enrolled in randomized controlled trials evaluating extended thromboprophylaxis following hospitalization. The primary outcomes were symptomatic and incidental venous thromboembolic events and hemorrhage (major hemorrhage and clinically relevant nonmajor bleeding). Four randomized controlled trials reported the outcomes of extended thromboprophylaxis in 3655 medically ill patients with active or history of cancer. The rates of venous thromboembolic events were similar between the extended-duration and standard-duration groups (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.61-1.18; I2 = 0%). However, major and clinically relevant nonmajor bleeding occurred significantly more frequently in the extended-duration thromboprophylaxis group (OR, 2.10; 95% CI, 1.33-3.35; I2 = 8%). Extended thromboprophylaxis in hospitalized medically ill patients with cancer was not associated with a reduced rate of venous thromboembolic events but was associated with increased risk of hemorrhage. This study protocol was registered on PROSPERO as #CRD42020209333.

Abstract P36: Venous Thromboembolism Prophylaxis in Hospitalized Medically Ill Patients

2011 ◽  
Vol 4 (suppl_2) ◽  
Author(s):  
Trudy Pendergraft ◽  
Montserrat Vera-Llonch ◽  
Alex Kartashov ◽  
Xianchen C Liu ◽  
Hemant Phatak ◽  
...  
Keyword(s):  
High Risk ◽  
Venous Catheter ◽  
Intermittent Pneumatic Compression ◽  
Nursing Home Admission ◽  
Thromboembolism Prophylaxis ◽  
Post Discharge ◽  
Vte Prophylaxis ◽  
Medically Ill ◽  
C Statistic ◽  
Medically Ill Patients

Background: Many hospitalized medically ill patients are at risk of VTE, during admission and after discharge. Risk factors include prior VTE, older age, immobility, obesity, heart or respiratory failure, and cancer. ACCP guidelines recommend use of low-molecular weight heparin (LMWH) or unfractionated heparin (UFH), and mechanical prophylaxis otherwise, in high-risk patients. VTE prophylaxis may be underutilized, however. Methods: Using a database linking admission records from >150 US hospitals to health insurance claims, we identified all persons, aged >=40 years, hospitalized from 2003 to 2008 and at high risk of VTE (based on ACCP guidelines). We excluded patients who: (1) underwent surgery; (2) were hospitalized in prior 30 days; (3) were treated for VTE in prior 30 days; (4) had hypercoagulability at admission; and (5) received LMWH, UFH, or fondaparinux (FOND) at therapeutic dosages on hospital day 1 or 2. We examined use of VTE prophylaxis during hospital admission and post-discharge. Results: We identified 35,606 patients who met all study entry criteria. Mean age was 67 years. Only 17.9% of study subjects received in-hospital VTE prophylaxis, most frequently LMWH (10.1%), intermittent pneumatic compression (4.5%), warfarin (2.9%), and/or stockings (2.0%). Prophylaxis use exceeded 25% only in patients with history (>30 days) of VTE and those admitted from nursing homes. Very few patients (1.7%) received post-discharge VTE prophylaxis; use was limited to LMWH. While there were several significant predictors of VTE prophylaxis (nursing home admission [odds ratio, 2.15; 95% confidence interval 1.91-2.42], central venous catheter placement [1.76; 1.60-1.94], ischemic stroke [1.68; 1.54-1.84] obesity [1.58; 1.47-1.70], and prior VTE [1.57; 1.24-1.99]), model discrimination was relatively poor (c statistic = 0.61). Conclusion: VTE prophylaxis is under-utilized in high-risk hospitalized medically ill patients, during initial admission and following hospital discharge.

scholarly journals Depression and Internal Medicine

2013 ◽  
pp. 49-57
Author(s):  
Domenico Panuccio
Keyword(s):  
Quality Of Life ◽  
Mood Disorders ◽  
Chronic Obstructive ◽  
Medical Illness ◽  
Obstructive Pulmonary Disease ◽  
Medically Ill ◽  
Antidepressant Use ◽  
Medically Ill Patients ◽  
Pituitary Adrenal Axis

BACKGROUND Depression is 2-4 times more frequent in medically ill patients than in the general population, it significantly undermines the quality of life and makes prognosis worse in terms of morbidity and mortality. Nevertheless the majority of cases are not recognized or appropriately treated. A growing body of evidence suggests that mood disorders and many medical illnesses are linked in a bidirectional way by several biological mechanisms. Autonomic function changes, hyperactivity of the hypothalamic-pituitary-adrenal axis, increases in plasma cortisol, elevated levels of proinflammatory cytokines, increased platelet activation and hypercoagulability, all of them occur in patients with depression and all of them are causal factors in development and progression of atherothrombotic lesions or they are implicated in the pathogenesis of neoplasm and other illness such as chronic pain, chronic obstructive pulmonary disease, rheumatoid arthritis and so on. CONCLUSIONS Although antidepressant use has not been shown to reduce mortality rates in patients with medical illness, it alleviates depression, improves the quality of life and reduces morbidity. Clinicians should be aware of this association and should make an effort in detecting and treating not only biological illness but also mood disorders.

New paradigms in venous thromboprophylaxis of medically ill patients

2017 ◽  
Vol 117 (09) ◽  
pp. 1662-1670 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Gary E. Raskob
Keyword(s):  
Large Scale ◽  
Population Based ◽  
Medical Patients ◽  
Post Discharge ◽  
Patient Centered ◽  
Medically Ill ◽  
Risk Assessment Models ◽  
Net Clinical Benefit ◽  
Medically Ill Patients ◽  
Review Current

SummaryAcutelly-ill hospitalised medical patients are at risk of venous thromboembolism (VTE), both in-hospital and in the immediate post-discharge period, and mortality from VTE is thought to be particularly high in this patient population. However, despite previous mandates from international antithrombotic guidelines such as those of the American College of Chest Physicians (ACCP) for the “universal” use of thromboprophylaxis in hospitalised medical patients, global audits suggest that implementation of thromboprophylaxis continues to be challenging because of the perceived higher risk of bleeding and lower risk of VTE than that reported in clinical trials. Recent population-based studies also reveal that a “universal” hospital-only thromboprophylactic strategy does not reduce the community burden of VTE from this population, which may constitute nearly one quarter of the attributable risk of VTE. Lastly, four large randomised placebo-controlled trials of extended thromboprophylaxis have failed to show a definitive net clinical benefit in hospitalised medical patients. Recent large-scale efforts in deriving and validating scored VTE and bleed risk assessment models (RAMs) have been completed in the medically-ill population. In addition, an elevated D-dimer as a new biomarker to identify at-VTE risk medically ill patients has also undergone prospective evaluation. This paper will review current concepts of VTE and bleed risk in hospitalised medical patients, both in the hospital as well as the post-hospital discharge period, and will discuss new paradigms of thromboprophylaxis in this population using an individualised, patient-centered approach.

Catatonia in the medically ill: Differences and parallels in etiology, phenomenology and management

2021 ◽  
pp. 009121742199407
Author(s):  
Fernando Espi Forcen ◽  
Matteo Respino ◽  
Joshua Eloge ◽  
Meghan Baldwin ◽  
Katrina Burns ◽  
...  
Keyword(s):  
Mental Disorder ◽  
Medical Condition ◽  
Clinical Manifestations ◽  
Response To Treatment ◽  
Medical Illness ◽  
Major Depressive ◽  
Chi Square ◽  
Medically Ill ◽  
Psychomotor Symptoms ◽  
Medically Ill Patients

Objective Catatonia is a disorder characterized by psychomotor symptoms. The etiology, symptomatology, response and outcome of catatonia in the medically ill has not been vigorously studied. Those who have catatonia associated with another mental disorder versus. catatonic disorder due to another medical condition may differ. The aim of this study is to study the causes, phenomenology and outcomes of medically ill patients with catatonia and explore differences among those who have catatonia associated with psychiatric illness vs. systemic medical illness. Method We studied the incidence of catatonic symptoms in medically hospitalized patients to identify any apparent differences in clinical manifestations due to distinctive etiologies. Specifically, we assessed if there are differences between those who had catatonia associated with another mental disorder versus those with catatonic disorder due to another medical condition in their phenomenology, management and likelihood of response to treatment. Results Of our 40 patients, 18 patients (45%) had catatonia associated with another mental disorder, 17 (42.5%) had catatonic disorder due to another medical condition, and in 5 patients (12.5%) the cause of catatonia was not identified. The most common catatonic symptoms regardless of etiology in our medically ill were mutism, followed by rigidity, and immobility. Bipolar disorder, schizophrenia, major depressive disorder, metabolic abnormalities, anti NMDAR encephalitis were the most frequent causes of catatonia in our medically ill patients. Compared to subjects with catatonic disorder due to another medical condition, those with catatonia associated with another mental disorder had more frequent mannerisms (Chi-square = 4.27; p = 0.039), waxy flexibility (Chi-square = 11.0; p < 0.01), and impulsivity (Chi-square = 4.12, p = 0.042). Nonsignificant trends were noted for posturing (Chi-square = 3.74, p = 0.053), perseveration (Chi-square = 3.37, p = 0.067), and stereotypy (Chi-square = 2.91, p = 0.088) also being more frequent in catatonia associated with a psychiatric cause. Discussion Our data supports phenomenological differences between medical and psychiatric causes of catatonia in the medically ill.

scholarly journals The IL-6 antagonist tocilizumab is associated with worse depression and related symptoms in the medically ill

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jennifer M. Knight ◽  
Erin S. Costanzo ◽  
Suraj Singh ◽  
Ziyan Yin ◽  
Aniko Szabo ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Primary Outcome ◽  
Medical Illness ◽  
Hematopoietic Stem ◽  
Medically Ill ◽  
Graft Versus Host ◽  
Efficacious Treatment ◽  
Increased Risk ◽  
Medically Ill Patients ◽  
Baseline Covariates

AbstractBecause medical illness is associated with increased inflammation and an increased risk for treatment-resistant major depressive disorder, anti-cytokine therapy may represent a novel, and especially efficacious, treatment for depression. We hypothesized that blockade of the interleukin (IL)-6 signaling pathway with tocilizumab would decrease depression and related symptomatology in a longitudinal cohort of allogeneic hematopoietic stem cell transplantation (HCT) patients, a medically ill population with a significant inflammation and psychopathology. Patients undergoing allogeneic HCT received either a single dose of tocilizumab one day prior to HCT (n = 25), or HCT alone (n = 62). The primary outcome included depressive symptoms at 28 days post HCT; anxiety, fatigue, sleep, and pain were assessed at pretreatment baseline and days +28, +100, and +180 post HCT as secondary outcomes. Multivariate regression demonstrated that preemptive treatment with tocilizumab was associated with significantly higher depression scores at D28 vs. the comparison group (β = 5.74; 95% CI 0.75, 10.73; P = 0.03). Even after adjustment for baseline depressive symptoms, propensity score, and presence of acute graft-versus-host disease (grades II–IV) and other baseline covariates, the tocilizumab-exposed group continued to have significantly higher depression scores compared to the nonexposed group at D28 (β = 4.73; 95% CI 0.64, 8.81; P = 0.02). Despite evidence that IL-6 antagonism would be beneficial, blockade of the IL-6 receptor with tocilizumab among medically ill patients resulted in significantly more—not less—depressive symptoms.

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