scholarly journals Effect of the Neutralizing SARS-CoV-2 Antibody Sotrovimab in Preventing Progression of COVID-19: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Anil Gupta ◽  
Yaneicy Gonzalez-Rojas ◽  
Erick Juarez ◽  
Manuel Crespo ◽  
Jaynier Moya ◽  
...  
Keyword(s):  
High Risk ◽  
Emergency Room ◽  
Severe Disease ◽  
Neutralizing Antibody ◽  
Supplemental Oxygen ◽  
Secondary Outcome ◽  
Effective Treatment Option ◽  
Double Blind ◽  
Increased Risk ◽  
High Flow Oxygen

Importance: Older patients and those with underlying comorbidities infected with SARS-CoV-2 may be at increased risk of hospitalization and death from COVID-19. Sotrovimab is a neutralizing antibody designed for treatment of high-risk patients to prevent COVID-19 progression. Objective: To evaluate the efficacy and safety of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease. Design: Randomized, double-blind, multicenter, placebo-controlled, phase 3 study. Setting: 57 centers in 5 countries. Participants: Nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for disease progression. Intervention: Patients were randomized (1:1) to an intravenous infusion of sotrovimab 500 mg or placebo. Main Outcomes and Measures: The primary efficacy outcome was the proportion of patients with COVID-19 progression, defined as all-cause hospitalization longer than 24 hours for acute illness management or death through day 29. Key secondary outcomes included the proportion of patients with COVID-19 progression, defined as emergency room visit, hospitalization of any duration, or death, and proportion of patients developing severe/critical respiratory COVID-19 requiring supplemental oxygen. Results: Among 1057 patients randomized (sotrovimab, 528; placebo, 529), all-cause hospitalization longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) by 79% (95% CI, 50% to 91%; P<.001). Secondary outcome results further demonstrated the effect of sotrovimab in reducing emergency room visits, hospitalization of any duration, or death, which was reduced by 66% (95% CI, 37% to 81%; P<.001), and severe/critical respiratory COVID-19, which was reduced by 74% (95% CI, 41% to 88%; P=.002). No patients receiving sotrovimab required high-flow oxygen, oxygen via nonrebreather mask, or mechanical ventilation compared with 14 patients receiving placebo. The proportion of patients reporting adverse events was similar between treatment groups; sotrovimab was well tolerated, and no safety concerns were identified. Conclusions and Relevance: Among nonhospitalized patients with mild to moderate COVID-19, a single 500-mg intravenous dose of sotrovimab prevented progression of COVID-19, with a reduction in hospitalization and need for supplemental oxygen. Sotrovimab is a well-tolerated, effective treatment option for patients at high risk for severe morbidity and mortality from COVID-19.

scholarly journals Neutralizing Antibody Therapeutics for COVID-19

Viruses ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 628
Author(s):  
Aeron C. Hurt ◽  
Adam K. Wheatley
Keyword(s):  
High Risk ◽  
Neutralizing Antibodies ◽  
Controlled Trial ◽  
Antiviral Treatment ◽  
Severe Disease ◽  
Neutralizing Antibody ◽  
Supplemental Oxygen ◽  
European Medicines Agency ◽  
Global Public Health ◽  
Public Health Burden

The emergence of SARS-CoV-2 and subsequent COVID-19 pandemic has resulted in a significant global public health burden, leading to an urgent need for effective therapeutic strategies. In this article, we review the role of SARS-CoV-2 neutralizing antibodies (nAbs) in the clinical management of COVID-19 and provide an overview of recent randomized controlled trial data evaluating nAbs in the ambulatory, hospitalized and prophylaxis settings. Two nAb cocktails (casirivimab/imdevimab and bamlanivimab/etesevimab) and one nAb monotherapy (bamlanivimab) have been granted Emergency Use Authorization by the US Food and Drug Administration for the treatment of ambulatory patients who have a high risk of progressing to severe disease, and the European Medicines Agency has similarly recommended both cocktails and bamlanivimab monotherapy for use in COVID-19 patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. Efficacy of nAbs in hospitalized patients with COVID-19 has been varied, potentially highlighting the challenges of antiviral treatment in patients who have already progressed to severe disease. However, early data suggest a promising prophylactic role for nAbs in providing effective COVID-19 protection. We also review the risk of treatment-emergent antiviral resistant “escape” mutants and strategies to minimize their occurrence, discuss the susceptibility of newly emerging SARS-COV-2 variants to nAbs, as well as explore administration challenges and ways to improve patient access.

scholarly journals 491. Aerosol-Generating Medical Procedures: Transmission of SARS-CoV-2 and Emerging Viruses

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S312-S312
Author(s):  
Seth D Judson ◽  
Vincent J Munster
Keyword(s):  
High Risk ◽  
Severe Disease ◽  
Experimental Studies ◽  
Virus Transmission ◽  
Nosocomial Transmission ◽  
Medical Procedures ◽  
Emerging Viruses ◽  
Zoonotic Viruses ◽  
Increased Risk ◽  
Hospital Acquired

Abstract Background During the pandemic of coronavirus disease 2019 (COVID-19), many questions arose regarding risks for hospital-acquired or nosocomial transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Aerosol generating medical procedures (AGMPs), techniques that can generate infectious, virus-laden aerosols, could potentially amplify transmission among healthcare workers (HCWs). Thus, it was widely recommended that HCWs use airborne precautions when performing AGMPs. However, in clinical settings it is often unclear what procedures constitute AGMPs and how the risk varies by procedure or pathogen. We set out to further define AGMPs and assess the risk for nosocomial transmission of SARS-CoV-2 and other high-risk viruses via AGMPs. Methods We identified potential AGMPs and emerging viruses that were high-risk for nosocomial transmission through reviewing experimental and clinical data. Potential AGMPs were those associated with previous virus transmission or mechanically capable of transmission. High-risk viruses were defined as those that cause severe disease in humans for which limited therapies or interventions exist, are infectious via aerosols in humans or non-human primates (NHPs), found in the respiratory tract of infected humans or NHPs, and had previous evidence of nosocomial transmission. Results We identified multiple potential AGMPs, which could be divided into those that generate aerosols or induce a patient to form aerosols, as well as eight families of high-risk viruses. All of the viruses were emerging zoonotic RNA viruses. In the family Coronaviridae, we identified potential evidence for SARS-CoV-1, MERS-CoV, and SARS-CoV-2 transmission via AGMPs. SARS-CoV-1 and SARS-CoV-2 were also found to be similarly stable when aerosolized. Conclusion Multiple emerging zoonotic viruses pose a high risk for nosocomial transmission through a variety of AGMPs. Given the similar stability of SARS-CoV-2 with SARS-CoV-1 when aerosolized and prior nosocomial transmission of SARS-CoV-1 via AGMPs, we suspect that certain AGMPs pose an increased risk for SARS-CoV-2 transmission. Additional experimental studies and on-site clinical sampling during AGMPs are necessary to further risk stratify AGMPs. Disclosures All Authors: No reported disclosures

scholarly journals 688 Pediatric Obstructive Sleep Apnea (OSA) and COVID-19-Related Adverse Clinical Outcomes

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A269-A269
Author(s):  
Vaishal Shah ◽  
Nancy Foldvary-Schaefer ◽  
Lu Wang ◽  
Lara Jehi ◽  
Cynthia Pena Obrea ◽  
...  
Keyword(s):  
High Risk ◽  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Pediatric Patients ◽  
Control Design ◽  
Supplemental Oxygen ◽  
Case Control ◽  
World Health ◽  
Invasive Ventilation ◽  
High Flow Oxygen

Abstract Introduction The relationship of OSA and human coronavirus (COVID-19) in the pediatric population is unknown. We postulate that OSA is associated with SARS-CoV-2 positivity and with adverse COVID-19 outcomes in children. Methods A retrospective review of 120 consecutive patients (&lt;18 years) with prior polysomnogram (PSG) and COVID-19 testing from the Cleveland Clinic COVID-19 registry was conducted. Using a case control design of SARS-CoV-2 positive and negative pediatric patients, we examined COVID-19 and pre-existing OSA (dichotomized AHI≥1) using logistic (OR,95%CI) regression and as continuous measures: AHI, oxygen(SpO2) nadir, %time SpO2&lt;90%) using linear regression(beta+/-SE). In those positive for SARS-CoV-2(cases only), we assessed the association of OSA and World Health Organization(WHO) COVID-19 clinical outcome composite score (hospitalization, requiring supplemental oxygen, non-invasive ventilation/high-flow oxygen, invasive ventilation/ECMO or death) using Wilcoxon rank sum test for ordinal data. Results Cases (n=36) were 11.8±4.4 years, 61% male, 27.8% black and 88.9% with OSA, while 85.7% of controls (n=84) had OSA. OSA was not associated with increased SARS-CoV-2 positivity: OR=1.33(0.40, 4.45,p=0.64). No significant difference between cases and controls for mean AHI 3.7(1.5,6.0) vs 3.5(1.5,7.1),p=0.91,SpO2 nadir 88.6±5.4 vs 89.1±4.4,p=0.58,%time SpO2&lt;90% 0.05[0.00,1.00) vs 0.10 (0.00,1.00, p=0.65) respectively was noted. WHO-7 COVID-19 clinical outcome did not meet statistical significance in relation to OSA due to the low event frequency (p=0.49). Of note, those with OSA vs without OSA had a higher WHO-7 outcome score of 2 vs 0 and prevalence of hospitalization: 12.5 vs 0% respectively. Of hospitalized patients, the following was observed: 23% had moderate/severe OSA vs 4.3% mild OSA, 50% required supplemental oxygen and 25% required intubation/invasive ventilation. No deaths or readmissions were reported. High risk conditions included: 75% obesity, 50% asthma, 25% sickle cell disease and 25% hypoplastic left heart. Conclusion In this first report of which we are aware focused on COVID-19 in pediatric OSA, we use a case control design leveraging COVID-19 and sleep laboratory registries. Albeit not statistically significant, pediatric patients with OSA had a higher percentage of worse clinical outcomes. Larger network studies are needed to clarify whether poorer COVID-19 outcomes may be attributable to OSA or modulated via high risk health conditions. Support (if any):

scholarly journals Early elevation of FIB-4 liver fibrosis score is associated with adverse outcomes among patients with COVID-19

2020 ◽  
Author(s):  
Fangfei Xiang ◽  
Jing Sun ◽  
Po-Hung Chen ◽  
Peijin Han ◽  
Haipeng Zheng ◽  
...  
Keyword(s):  
Regression Models ◽  
Cox Regression ◽  
Early Stage ◽  
Severe Disease ◽  
High Flow ◽  
Adverse Outcomes ◽  
Prolonged Hospitalization ◽  
Severe Stage ◽  
Increased Risk ◽  
High Flow Oxygen

Background Limited prior data suggest that pre-existing liver disease was associated with adverse outcomes among patients with COVID-19. FIB-4 is a noninvasive index of readily available laboratory measurements that represents hepatic fibrosis. The association of FIB-4 with COVID-19 outcomes has not been previously evaluated. Methods FIB-4 was evaluated at admission in a cohort of 267 patients admitted with early-stage COVID-19 confirmed through RT-PCR. Hazard of ventilator use and of high-flow oxygen was estimated using Cox regression models controlled for covariates. Risk of progress to severe cases and of death/prolonged hospitalization (>30 days) were estimated using logistic regression models controlled for same covariates. Results Forty-one (15%) patients progressed to severe cases, 36 (14%) required high-flow oxygen support, 10 (4%) required mechanical ventilator support, and 1 died. Patients with high FIB-4 score (>3.25) were more likely to be older with pre-existing conditions. FIB-4 between 1.45-3.25 was associated with over 5-fold (95% CI: 1.2-28) increased hazard of high-flow oxygen use, over 4-fold (95% CI: 1.5-14.6) increased odds of progress to severe stage, and over 3-fold (95% CI: 1.4-7.7) increased odds of death or prolonged hospitalization. FIB-4>3.25 was associated with over 12-fold (95% CI: 2.3-68. 7) increased hazard of high-flow oxygen use and over 11-fold (95% CI: 3.1-45) increased risk of progress to severe disease. All associations were independent of sex, number of comorbidities, and inflammatory markers (D-dimer, C-reactive protein). Conclusions FIB-4 at early-stage of COVID-19 disease had an independent and dose-dependent association with adverse outcomes during hospitalization. FIB-4 provided significant prognostic value to adverse outcomes among COVID-19 patients.

scholarly journals Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS

2020 ◽  
Vol 41 (37) ◽  
pp. 3533-3545 ◽  
Author(s):  
Usman Baber ◽  
George Dangas ◽  
Dominick Joseph Angiolillo ◽  
David Joel Cohen ◽  
Samin Kumar Sharma ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
High Risk ◽  
Acute Coronary Syndromes ◽  
Clinical Presentation ◽  
Coronary Intervention ◽  
Secondary Outcome ◽  
Bleeding Events ◽  
Double Blind ◽  
Percutaneous Coronary ◽  
Coronary Syndromes

Abstract Aims  The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and results  We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36–0.61; P &lt; 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54–1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74–1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61–1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). Conclusion  Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. Trial registration Clinicaltrials.gov identifier: NCT02270242.

P2773Evaluation of the bleeding prediction score VTE-BLEED for predicting recurrent VTE

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F A Klok ◽  
E Presles ◽  
C Tromeur ◽  
S Barco ◽  
S V Konstantinides ◽  
...  
Keyword(s):  
High Risk ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Low Risk ◽  
Potential Yield ◽  
Double Blind ◽  
Increased Risk ◽  
Risk Patients ◽  
Recurrent Vte ◽  
Post Hoc

Abstract Introduction VTE-BLEED is a validated score for identification of patients at a 3 to 5-fold increased risk of major bleeding during extended anticoagulation for venous thromboembolism (VTE; table 1). It is unknown whether VTE-BLEED high-risk patients also have an increased risk for recurrent VTE, which would limit the potential usefulness of the score. Methods This was a post-hoc analysis of the randomised double-blind placebo-controlled PADIS-PE trial, in which patients with a first unprovoked pulmonary embolism (PE) initially treated for 6 months were randomised to receive an additional 18-month of warfarin versus placebo. Primary outcome of the current analysis was recurrent VTE during 2-year follow-up after anticoagulant discontinuation, i.e. after the initial 6-month treatment in the placebo arm and after 24 months of anticoagulation in the active treatment arm. This rate, adjusted on study treatment allocation, was compared between patients in the high- versus low-risk VTE-BLEED group. Results In complete case analysis (n=308; 82.4% of total population), 89 (28.9%) patients were classified as VTE-BLEED high risk. A total of 44 VTE events occurred after anticoagulant discontinuation during 668 patient-years. The cumulative incidence of recurrent VTE was 16.4% (95% CI 10.0–26.1%; 14 events) and 14.6% (95% CI 10.4–20.3%; 30 events) in the high-risk and low-risk VTE-BLEED groups, respectively, for an adjusted Hazard Ratio of 1.16 (95% CI 0.62–2.19; Figure 1). Figure 1 Conclusion In this study, patients with unprovoked PE classified at high risk of major bleeding by VTE-BLEED did not have a higher incidence of recurrent VTE after cessation of anticoagulant therapy, supporting the potential yield of the score for making management decisions on the optimal duration of anticoagulant therapy.

scholarly journals POS1233 USE OF BARICITINIB AND TOCILIZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE COVID-19 IN HOSPITALIZED PATIENTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 899.3-900
Author(s):  
D. X. Xibille Friedmann ◽  
S. M. Carrillo Vazquez
Keyword(s):  
Hospital Stay ◽  
Demographic Data ◽  
Severe Disease ◽  
Clinical Status ◽  
Supplemental Oxygen ◽  
Janus Kinase ◽  
Oral Drug ◽  
Assisted Mechanical Ventilation ◽  
Non Invasive ◽  
High Flow Oxygen

Background:SARS-CoV2 infection and COVID-19 associated pneumonia are associated to a dysregulated inflammatory response known as cytokine storm and the use of cytokine inhibitors, especially those targeting IL-6, has been proposed as a therapeutic alternative in these patients. Janus Kinase (JAK) inhibitors in combination to the antiviral Remdesivir have shown evidence of reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen or noninvasive ventilation1.Objectives:To describe the outcomes associated with the use of Tocilizumab (TCZ) and Baricitinib (Bari) in patients hospitalized for COVID-19.Methods:Descriptive study nested in a cohort. Patients from the General Hospital of Cuernavaca who were hospitalized due to COVID-19 associated pneumonia and/or respiratory failure requiring supplemental oxygen or invasive/non-invasive assisted mechanical ventilation (AMV) were analyzed. All patients had a positive RT-PCR upon hospital admission, sampled under standardized conditions. The clinical and demographic data of the patients upon hospitalization were obtained from the instrument on a specific platform (SISVER) used on a national basis. Severe disease was considered as the need for any type of AMV. TCZ was used at 400-600 mg in two infusions (baseline and at 72 hours), Bari at 4 mg daily for 14 days. The outcomes were the need for AMV, death, or discharge. A p≤ 0.05 was considered statistically significant.Results:Data from 404 SARS-CoV2 positive patients were analyzed. 269 (65.9%) were men. The mean age of the patients was 57.5 years (18-94; SD 15.3). 59.6% of the patients had one or more comorbidities (Diabetes and Hypertension in most cases [31.8%]). 22.8% of the patients had a history of current or previous smoking. Mean hospital stay was 7.4 days (1-36; SD 5.9). 15.9% of the patients required invasive or non-invasive AMV. 11 patients were treated with TCZ and 30 patients received treatment with Baricitinib. 5 of the 11 patients with TCZ required AMV (all but one were intubated), but only 6 of the 30 (20%) with Bari required AMV (all except one received CPAP). The use of Baricitinib was correlated with a reduction in the use of AMV (p 0.01). 6 patients with TCZ were discharged due to improvement and 5 died. In the case of Bari, 19 improved and were discharged and 11 died, significantly correlating with lower mortality (p 0.05). The use TCZ was not associated with a reduced hospitalization (50% remained hospitalized for more than 10 days) but patients receiving Baricitinib had significantly shorter hospital stays (86.6% had a hospital stay of less than 10 days) than those receiving TCZ (p<0.0001).Conclusion:The patients that were treated with Baricitinib and required AMV most often improved with non-invasive CPAP while the majority of the patients under AMV receiving TCZ were treated with an invasive mode, although this was due in part to the fact that TCZ can be employed intravenously and is more practical for intubated patients in whom oral drug administration is limited. Baricitinib was significantly associated with a better outcome (hospital discharge due to improvement) and a significantly shorter hospital stay.References:[1]Kalil, A.C.; Patterson, T.F.; Mehta, A.K.; Tomashek, K.M.; Wolfe, C.R.; Ghazaryan, V.; Marconi, V.C.; Ruiz-Palacios, G.M.; Hsieh, L.; Kline, S.; et al. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N. Engl. J. Med. 2020.Acknowledgements:Thanks to B. Flores and M. Hernandez for their help with data collection.Disclosure of Interests:Daniel Xavier Xibille Friedmann Speakers bureau: Lilly, Abbvie, Paid instructor for: Lilly, Abbvie, Consultant of: Pfizer, Lilly, Sandra Miriam Carrillo Vazquez Speakers bureau: Roche, Novartis, Paid instructor for: Roche, Janssen, Consultant of: Roche, Janssen

scholarly journals Effect of Antioxidants on the Occurrence of Pre-eclampsia in Women at Increased Risk

2015 ◽  
Vol 1 (1) ◽  
Author(s):  
Mahmoud. A. Sultan - Hassan Salim - Y. Elmesallawy - E.A.Elt
Keyword(s):  
High Risk ◽  
Gestational Age ◽  
Uterine Artery ◽  
Resistance Index ◽  
Secondary Outcome ◽  
Control Group ◽  
High Risk Population ◽  
Elevated Liver Enzymes ◽  
Increased Risk ◽  
Pai 1

The objective of this work is: Asses the potential benefit of antioxidant supplementation on the occurrence of preeclampsia at high risk women. Patients and Methods: The number of primigravida women's collected was " 294" with gestational age ranged from 18-22 wks. .from (294) prim gravida cases ,(25) women were identified as being at increased risk of pre-eclampsia by abnormal Doppler wave form in either uterine artery at 18-22 weeks' gestation ( defined as a resistance index < 95th centile for gestation or the presence of an early diastolic notch ) , Another (25) women with history in the preceding pregnancy of pre-eclampsia, eclampsia or HELLP (Hemolysis, elevated liver enzymes, low platelets ) . -Total number of eligible participants were, (50) cases. Design and procedure: Cases divided randomly into two groups each 25 cases one group received tablets of 1000 mg vitamin C, (Cevitil efferecent. EPICO) + 400 iu of vitamin E (E-Viton 400 pharco). Venous blood for measurement of PAI-1 and PAI-2, The primary outcome measure was the ratio PAI-1 / PAI-2 and the secondary outcome prospectively according to guidelines of international society for the study of hypertension in pregnancy. Results: Doppler screening was done on, 294 prim gravidae with gestational age ranged from 18-22 weeks; only 42 women showed abnormal Doppler study so asked to come for rescanning at 24 weeks' gestation. 31 out of 42 patients (75%) have persistent abnormal study. The remainders of the 42 women (25%) were withdrawn from the study at 24 wks.' gestation because they have normal uterine-artery scan. Development of mild preeclampsia was statistically lower (p<0.5) in the study than that in the control group. However, development of sever preeclampsia or superimposed preeclampsia was statistically insignificant between both groups. PAI-1 was significantly increased in women developed preeclampsia more than normotensive (167±71.2, 113.8±35.6ng/ml respectively) with P=0.03 IN contrast PAI-2 was significantly decreased in women developed preeclampsia less than normotensive (105±34.9, 181.1±67.9ng/ml respectively) with P=0.018. Conclusion: Treatment and prevention trials of preeclampsia have been disappointing to date. However, this study has suggested causal links between oxidative stress and the development of preeclampsia indicate that may be a role for antioxidant vitamins in the prevention of preeclampsia. a high- risk population can be successfully identified on the basis of uterine-artery Doppler screening and pervious history of the disease.

scholarly journals Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial

2017 ◽  
Vol 117 (11) ◽  
pp. 2135-2145 ◽  
Author(s):  
Alok Khorana ◽  
Saroj Vadhan-Raj ◽  
Nicole Kuderer ◽  
Ted Wun ◽  
Howard Liebman ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Factor Xa ◽  
Routine Care ◽  
Bleeding Events ◽  
Double Blind ◽  
Primary Brain Tumours ◽  
Incidental Pulmonary Embolism ◽  
Increased Risk ◽  
Ambulatory Patients

AbstractVenous thromboembolism (VTE) is a frequent complication of cancer associated with morbidity, mortality, increased hospitalizations and higher health care costs. Cancer patients at increased risk for VTE can be identified using a validated risk assessment score, and the incidence of VTE can be reduced in high-risk settings using anticoagulation. Rivaroxaban is a potent, oral, direct, factor Xa inhibitor approved for the prevention and treatment of thromboembolic events, including VTE. CASSINI is a double-blind, randomized, parallel-group, multicentre study comparing rivaroxaban with placebo in adult ambulatory patients with various cancers who are initiating systemic cancer therapy and are at high risk of VTE (Khorana score ≥ 2). Patients with primary brain tumours or those at risk for bleeding are excluded. Approximately 700 patients will be randomized 1:1 to rivaroxaban 10 mg daily or placebo for up to 6 months if there is no evidence of VTE from compression ultrasonography (CU) during screening or from routine care imaging within 30 days prior to randomization. Mandatory CU will also be performed at weeks 8 and 16 (±7 days), and at study end (±3 days). The primary efficacy hypothesis is that anticoagulation with rivaroxaban reduces the composite of objectively confirmed symptomatic or asymptomatic, lower-extremity, proximal deep-vein thrombosis (DVT); symptomatic, upper-extremity DVT; symptomatic or incidental pulmonary embolism; and VTE-related death compared with placebo. The primary safety objective is to assess major bleeding events (Clinical trial information: NCT02555878).

Abstract 4101: The Effect of Dronaderone on Hospitalizations in Patients with Atrial Fibrillation. Results from the ATHENA Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Christian Torp-Pedersen ◽  
Richard L Page ◽  
Stuart J Conolly ◽  
Harry J Crijns ◽  
Martin van Eickels ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Heart Association ◽  
Persistent Atrial Fibrillation ◽  
Left Ventricular ◽  
Hazard Ratio ◽  
Exclusion Criterion ◽  
Secondary Outcome ◽  
Double Blind ◽  
Increased Risk ◽  
The Impact

The ATHENA study has demonstrated that dronaderone reduces a combined endpoint of cardiovascular hospitalizations and cardiovascular death in patients with paroxysmal or persistent atrial fibrillation or flutter (AF). Two previous studies have demonstrated dronaderone to reduce risk of AF recurrence. Here we examine the impact of dronaderone on hospitalizations. ATHENA is a double-blind, placebo controlled parallel group study. Eligible patients needed to have documented AF as well as documented sinus rhythm within 6 months year prior to randomization. Patients further needed to document increased risk by an age above 75 years or an age above 70 years and additionally either diabetes, prior stroke, hypertension, reduced left ventricular function or an enlarged left atrium. New York heart association class IV was an exclusion criterion. Randomized patients received dronaderone 400 mig bid or matching placebo. Mean follow-up was 21 months. The primary outcome was cardiovascular hospitalization or death. Cardiovascular hospitalization was a secondary outcome. There were 675 first cardiovascular hospitalizations on dronaderone and 859 on placebo, hazard ratio 0.75 (95% cl 0.67– 0.82, p<0.001). The main reasons for first hospitalization on dronaderone/placebo were: AF 296/457, ischemic heart disease 93/102, heart failure 78/92. Overall there were 438/511 cardiovascular hospitalizations not related to AF/AFL, hazard ratio 0.86 (0.75– 0.97, p=0.02). There were 516/533 non-cardiovascular hospitalizations, hazard ratio 0.98 (0.87–1.11, p=0.8). Examining total hospitalization burden (cardiovascular and non-cardiovascular) there were 9995 nights in hospital on dronaderone and 13986 on placebo, a reduction of 28% (p<0.001). For cardiovascular hospitalizations the number of nights were 5875/9073, a reduction of 35% (p<0.001). In patients with paroxysmal or persistent AF dronaderone substantially reduces the risk of cardiovascular hospitalization and substantially reduces total hospitalization burden.

Sign in / Sign up

Export Citation Format

Share Document