scholarly journals Off-Label Medicines Use: Complex Problem of Modern Clinical Practice

2020 ◽  
Vol 16 (2) ◽  
pp. 324-334
Author(s):  
S. R. Gilyarevskiy
Keyword(s):  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Complex Problem ◽  
The European Union ◽  
Off Label Use ◽  
Off Label ◽  
Medicines Use ◽  
The Usa ◽  
History Of

World experience in off-label medicines use is presented in the article. Data on the history of changes in tactics and approaches to solve the problem of medicines off-label use in the USA and some European countries, as well as in the European Union as a whole, are presented. The reasons, why doctors should use medicines off-label, are discussed. The expert opinion on the conditions ensuring the maximum safety in off-label medicines use is presented. In particular, the validity of obtaining patient informed consent is discussed. The article does not apply to the Russian regulation regarding “off-label” therapy but describes the foreign practice related to off-label medicines use. In addition, the results of some recently completed randomized clinical trials evaluating the effects of direct oral anticoagulants are presented in order to demonstrate the need to clarify the effectiveness and safety of medicines used in certain clinical situations. The results of such studies clarify the indications for the drug use, which are subsequently entered into the summary of product characteristics.

scholarly journals Off-label Use of Direct Oral Anticoagulants in Patients Receiving Surgical Mechanical and Bioprosthetic Heart Valves

2021 ◽  
Vol 4 (3) ◽  
pp. e211259
Author(s):  
Ankur Kalra ◽  
Sajjad Raza ◽  
Baqir Hasan Jafry ◽  
Harley E. King ◽  
Joseph A. Lahorra ◽  
...  
Keyword(s):  
Heart Valves ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label Use ◽  
Bioprosthetic Heart Valves ◽  
Off Label ◽  
Label Use

scholarly journals Off-label Use of Direct Oral Anticoagulants Compared With Warfarin for Left Ventricular Thrombi

2020 ◽  
Vol 5 (6) ◽  
pp. 685 ◽  
Author(s):  
Austin A. Robinson ◽  
Cory R. Trankle ◽  
Grayson Eubanks ◽  
Christopher Schumann ◽  
Paul Thompson ◽  
...  
Keyword(s):  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Off Label Use ◽  
Off Label ◽  
Left Ventricular Thrombi ◽  
Label Use

scholarly journals Off-Label Use of Direct Oral Anticoagulants in Intracerebral Hemorrhage Patients With Prosthetic Valves

Stroke ◽  
2017 ◽  
Vol 48 (11) ◽  
pp. 3183-3186
Author(s):  
Seemant Chaturvedi ◽  
Carlos A. Molina ◽  
Magdy H. Selim ◽  
Hans-Christoph Diener ◽  
Stefan H. Hohnloser
Keyword(s):  
Intracerebral Hemorrhage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label Use ◽  
Off Label ◽  
Prosthetic Valves ◽  
Label Use

scholarly journals Will Direct Oral Anticoagulants Have a Chance in Prosthetic Valves?

2020 ◽  
Vol 15 ◽  
Author(s):  
Mahmoud Abdelnabi ◽  
Abdallah Almaghraby ◽  
Yehia Saleh
Keyword(s):  
Left Atrial Appendage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Off Label Use ◽  
Off Label ◽  
Prosthetic Valves ◽  
Large Sector ◽  
Abundant Data ◽  
Left Ventricular Thrombi

Although there are abundant data highlighting the safety and efficacy of direct oral anticoagulants, to date, recent guidelines have limited their use to stroke prevention in patients with non-valvular AF, as well as in the prevention and treatment of venous thromboembolism and pulmonary embolism. Encouraging data about the off-label use of direct oral anticoagulants have been shown in several other indications, such as intracardiac thrombi, left ventricular thrombi and left atrial appendage, but a large sector of patients are still not addressed, such as valvular and prosthetic patients.

scholarly journals Rivaroxaban versus warfarin for the management of left ventricle thrombus

2021 ◽  
Vol 73 (1) ◽  
Author(s):  
Monirah A. Albabtain ◽  
Yahya Alhebaishi ◽  
Ola Al-Yafi ◽  
Hatim Kheirallah ◽  
Adel Othman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Study ◽  
Left Ventricle ◽  
Surface Area ◽  
Median Time ◽  
Randomized Clinical Trials ◽  
Off Label Use ◽  
Duration Of Treatment ◽  
Off Label ◽  
Warfarin Group

Abstract Background Rivaroxaban has been recently introduced for the management of non-valvular intra-cardiac thrombosis with variable results. We aimed to compare the results of the off-label use of rivaroxaban versus warfarin in the management of patients with left ventricle (LV) thrombus. This research is a retrospective study conducted on 63 patients who had LV thrombus from January to December 2016. We compared patients treated with warfarin (n=35) to patients who had rivaroxaban (n=28), and study outcomes were time to thrombus resolution, bleeding, stroke, and mortality. Results The median duration of treatment was 9.5 (25th-75th percentiles: 6-32.5) months for rivaroxaban and 14 (3-41) months for warfarin. Thrombus resolution occurred in 24 patients in the warfarin group (68.6%) and 20 patients in the rivaroxaban group (71.4%). The median time to resolution in the warfarin group was 9 (4-20) months and 3 (2-11.5) months in the rivaroxaban group. Thrombus resolution was significantly faster in patients on rivaroxaban (p= 0.019). Predictors of thrombus resolution were thrombus surface area (HR: 1.21; CI 95% (1.0-1.46); p= .048) and the use of rivaroxaban (HR: 1.92; CI 95% (1.01-3.65); p= 0.048). There was no difference in stroke, bleeding, and mortality between both groups. Conclusion Rivaroxaban was as effective and safe as warfarin in managing patients with left ventricle thrombus. Larger randomized clinical trials are recommended to confirm our findings.

scholarly journals A Case Series of Direct Oral Anticoagulants Use in Post-Infarction Left Ventricular Thrombus

2021 ◽  
Vol 33 (4) ◽  
pp. 19-23
Author(s):  
Tarique S. Chachar ◽  
Nooraldaem Yousif ◽  
Khurshid Ahmed ◽  
Tajammul Hussain ◽  
Haitham Amin
Keyword(s):  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Case Series ◽  
Left Ventricular ◽  
Left Ventricular Thrombus ◽  
Off Label Use ◽  
Mortality And Morbidity ◽  
Ventricular Thrombus ◽  
Current Guidelines

Left ventricular thrombus (LVT) is a known complication of acute myocardial infarction (AMI). Vitamin K antagonists such as Warfarin showed a reduction in associated mortality and morbidity and are indicated as anticoagulants of choice in current guidelines. Since their approval for clinical use, there has been a dramatic increase in off-label use of direct oral anti-coagulants (DOAC) for LVT. In this case series, the authors share their successful experience with DOAC in the treatment of LVT.

scholarly journals Recommendations on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation (Based on 2018 European Heart Rhythm Association Practical Guide)

Kardiologiia ◽  
2019 ◽  
Vol 59 (5) ◽  
pp. 68-79
Author(s):  
L. V. Popova ◽  
T. B. Kondratieva ◽  
M. B. Aksenova ◽  
T. V. Khlevchuk ◽  
M. Z. Kanevskaya
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Heart Rhythm ◽  
Vitamin K Antagonist ◽  
Advanced Liver Disease ◽  
Clinical Variants

Non-vitamin K antagonist oral anticoagulants (NOACs) – direct oral anticoagulants – are getting the ever-broadening use in clinical practice. However, many problems related to optimal use of NOACs in specific clinical situations remain unresolved. European Heart Rhythm Association in April 2018 issued the renovated recommendations on the use of NOACs in patients with atrial fibrillation. The authors of recommendations presented some specific clinical variants for which they formulated practical advices based on the evidence obtained in randomized clinical trials. They also outlined the indications for use of NOACs, formulated practical start-program and scheme of subsequent follow-up management of patients taking NOACs. Recommendations contain information on pharmacokinetics of NOACs and their interactions with other drugs, consideration of feasibility of NOACs use in patients with chronic renal insufficiency or advanced liver disease. Many other practical problems are covered as well.  

scholarly journals Off-Label Use of New Oral Anticoagulants

Stroke ◽  
2014 ◽  
Vol 45 (7) ◽  
pp. 2158-2159
Author(s):  
Carlos A. Molina ◽  
Magdy H. Selim
Keyword(s):  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Off Label Use ◽  
Off Label ◽  
Label Use
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