C0135: Efficacy, Safety and Clinical Management of the New Generation Oral Anticoagulants (NOAs) in the Clinical Practice: “The Real Life Cohort Study”

2014 ◽  
Vol 133 ◽  
pp. S38
Author(s):  
P. Olivera ◽  
I. Valcarce ◽  
B. Merchan ◽  
M. Gómez ◽  
L. López-Andreoni ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Clinical Management ◽  
Oral Anticoagulants ◽  
Real Life ◽  
The Real ◽  
New Generation

Comparison Of Drugs in Patients Using New Generation Anticoagulants

2021 ◽  
Vol 6 (14) ◽  
pp. 56-67
Author(s):  
Arslan Say ◽  
Abdülkadir ÇAKMAK ◽  
Gökhan KESKİN ◽  
Erdinç PELİT ◽  
Yılmaz ÖZBAY
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Recurrent Venous Thromboembolism ◽  
Anticoagulant Drugs ◽  
History Of ◽  
The Mean ◽  
N 93 ◽  
New Generation

Aim: New generation anticoagulants rapidly find a wider area of use in the clinic due to the use problems of other oral anticoagulants. Anticoagulants such as Dabigatran, Rivaroxaban, and Apixaban with safer treatment intervals have been accepted in clinical practice guidelines and have taken their place as preferred drugs. In this study, we aimed to retrospectively examine the effects of three new-generation anticoagulant drugs on a group of patients. Material and Methods: In this retrospectively planned study, patients diagnosed with atrial fibrillation (n = 522) were divided into three groups according to the drugs used for treatment (Dabigatran, Rivaroxaban, and Apixaban). Routine blood values of the patients in each group were retrospectively scanned according to age, gender, time of drug initiation and presence of chronic disease. Results: According to the results obtained, it was found that the mean HCT, BUN, AST, ALT, MPV, Iron, and Ferritin were higher in patients using Apixaban than those using Dabigatran and Rivaroxaban drugs, but the age, average values of Hgb1 Hgb2, Hgb1, PLT, CrCl, Gfr and INR of the patients using Apixaban lower than those using Dabigatran and Rivaroxaban. The highest rate (22.5%) was found in the group of patients taking apixaban (n=93) when people taking the drugs were examined in terms of mortality. Conclusion: It has been observed that Rivaroxaban can be used more safely in patients with a history of acute cancer and thrombosis, patients with recurrent venous thromboembolism, and patients with high frailty, three drugs should be preferred instead of oral anticoagulants.

scholarly journals ISMAR-study presentation: in-hospital epidemiology and clinical management of respiratory and cardiac comorbidities in cardiac and respiratory disease units

2014 ◽  
Vol 9 ◽  
Author(s):  
Roberto Tramarin ◽  
Mario Polverino ◽  
Maurizio Volterrani ◽  
Bruna Girardi ◽  
Claudio Chimini ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Management ◽  
Real Life ◽  
Length Of Hospital Stay ◽  
Relevant Information ◽  
Hospital Epidemiology ◽  
Discharge Data ◽  
Definition Of ◽  
Current Guidelines

Background: Cardiovascular and respiratory diseases are leading causes of morbidity and their co-occurrence has important implications in mortality and other outcomes. Even the most recent guidelines do not reliably address clinical, prognostic, and therapeutic concerns due to the overlap of respiratory and cardiac diseases. Study objectives and design: In order to evaluate in the reality of clinical practice the epidemiology and the reciprocal impact of cardio-pulmonary comorbidity on the clinical management, diagnostic workup and treatment, 1,500 cardiac and 1,500 respiratory inpatients, admitted in acute and rehabilitation units, will be enrolled in a multicenter, nationwide, prospective observational study. For this purpose, each center will enroll at least 50 consecutive patients. At discharge, data analysis will be aimed at the definition of cardiac and pulmonary inpatient comorbidity prevalence, demographic characteristics, length of hospital stay, and risk factors, taking into account also procedures, pharmacological and non-pharmacological treatment, and follow up in patients with cardio-respiratory comorbidity. Conclusions: The purely observational design of the study aims to give new relevant information on the assessment and management of overlapping patients in real life clinical practice, and new insight for improvement and implementation of current guidelines on the management of individual diseases.

scholarly journals Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

2020 ◽  
Vol 10 (4) ◽  
pp. 266-276 ◽  
Author(s):  
Carlo Lavalle ◽  
Luca Di Lullo ◽  
Antonio Bellasi ◽  
Claudio Ronco ◽  
Stefano Radicchia ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Market Share ◽  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Risk Index ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Drug Reactions ◽  
Safety And Efficacy ◽  
Pharmacovigilance Database

Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.

The real-life effectiveness of psychosocial therapies on social autonomy in schizophrenia patients: Results from a nationwide cohort study in France

2017 ◽  
Vol 247 ◽  
pp. 97-104 ◽  
Author(s):  
Aminata Ali ◽  
Arnaud Carre ◽  
Massimiliano Orri ◽  
Mathieu Urbach ◽  
Caroline Barry ◽  
...  
Keyword(s):  
Cohort Study ◽  
Real Life ◽  
Life Effectiveness ◽  
The Real ◽  
Social Autonomy

Mo1896 The Real-Life Experience of Vedolizumab Efficacy and Safety in Crohn's Disease: A Prospective Observational Multicenter Cohort Study

2016 ◽  
Vol 150 (4) ◽  
pp. S810
Author(s):  
Aurelien Amiot ◽  
Jean-charles Grimaud ◽  
Xavier Treton ◽  
Jerome Filippi ◽  
Benjamin Pariente ◽  
...  
Keyword(s):  
Cohort Study ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Life Experience ◽  
Real Life ◽  
Efficacy And Safety ◽  
Multicenter Cohort Study ◽  
The Real ◽  
Multicenter Cohort

scholarly journals Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis

2021 ◽  
Vol 17 (4) ◽  
pp. 584-593
Author(s):  
S. R. Gilyarevsky
Keyword(s):  
Clinical Trials ◽  
Big Data ◽  
Clinical Practice ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Hierarchy Of Evidence

The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed. 

scholarly journals Direct oral anticoagulants in patients with antiphospholipid syndrome: a cohort study

Lupus ◽  
2019 ◽  
Vol 29 (1) ◽  
pp. 37-44 ◽  
Author(s):  
K Malec ◽  
E Broniatowska ◽  
A Undas
Keyword(s):  
Cohort Study ◽  
Antiphospholipid Syndrome ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Double Positive ◽  
Increased Risk ◽  
Long Term Follow Up

Objectives Despite controversies, direct oral anticoagulants (DOACs) are increasingly used in antiphospholipid syndrome (APS). We investigated the safety and efficacy of DOACs versus vitamin K antagonists (VKAs) in real-life consecutive APS patients. Patients and methods In a cohort study of 176 APS patients, which included 82 subjects who preferred DOACs or had unstable anticoagulation with VKAs, we recorded venous thromboembolism (VTE), cerebrovascular ischemic events or myocardial infarction, along with major bleeding or clinically relevant non-major bleeding (CRNMB). Results APS patients were followed for a median time of 51 (interquartile range 43–63) months. Patients on DOACs and those on VKAs were similar with regard to baseline characteristics. APS patients treated with DOACs had increased risk of recurrent thromboembolic events and recurrent VTE alone compared with those on VKAs (hazard ratio (HR) = 3.98, 95% confidence interval (CI): 1.54–10.28, p = 0.004 and HR = 3.69, 95% CI: 1.27–10.68, p = 0.016, respectively) with no differences between rivaroxaban and apixaban or single- or double-positive and triple-positive APS. Thromboembolism on DOACs was associated with older age (median 52 versus 42 years, p = 0.008) and higher global APS score (median 13 versus 8.5, p = 0.013). Patients on DOACs had increased risk of major bleeding or CRNMB (HR = 3.63, 95% CI: 1.53–8.63, p = 0.003), but rates of gastrointestinal bleeds (HR = 3.36, 95% CI: 0.70–16.16, p = 0.13) and major bleeds or CRNMB other than heavy menstrual bleeding (HR = 2.45, 95% CI: 0.62–9.69, p = 0.2) were similar in both treatment groups. Conclusion During long-term follow-up of real-life APS patients, DOACs are less effective and less safe as VKAs in the prevention of thromboembolism.

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