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Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.
Abstract Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framewor...
Source: Circulation - November 17, 2020 Category: Cardiology Authors: Kaul S, Stockbridge N, Butler J Tags: Circulation Source Type: research

‘Ten Commandments’ of the EHRA Guide for the Use of NOACs in AF
Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF), and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. In 2013, the first “EHRA Practical Guide” was published to provide practical guidance for situations; an update was published in 2015. Below ...
Source: European Heart Journal - April 21, 2018 Category: Cardiology Source Type: research

Factors associated with non –vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
Conclusions In contemporary clinical practice, up to three-fourths of patients with new-onset AF are now initially treated with a NOAC for stroke prevention. Those selected for NOAC treatment had lower stroke and bleeding risk profiles, were more likely treated by cardiologists, and had higher socioeconomic status. Trial registration clinicaltrials.gov Identifier: NCT01701817
Source: American Heart Journal - April 25, 2017 Category: Cardiology Source Type: research

Factors Associated with Non-vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients with New-Onset Atrial Fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
Conclusions In contemporary clinical practice up to three-fourths of patients with new-onset AF are now initially treated with a NOAC for stroke prevention. Those selected for NOAC treatment had lower stroke and bleeding risk profiles, were more likely treated by cardiologists and had higher socioeconomic status. Trial Registration clinicaltrials.gov Identifier: NCT01701817
Source: American Heart Journal - April 4, 2017 Category: Cardiology Source Type: research

Direct oral anticoagulant use in nonvalvular atrial fibrillation with valvular heart disease: a systematic review
In conclusion, subanalyses of DOAC landmark AF trials revealed that dabigatran, rivaroxaban, and apixaban may be safely used in AF patients with certain types of VHD: aortic stenosis, aortic regurgitation, and mitral regurgitation. More evidence is needed before routinely recommending these agents for patients with bioprosthetic valves or mild mitral stenosis. Patients with moderate to severe mitral stenosis or mechanical valves should continue to receive warfarin, as these patients were excluded from all landmark AF trials.
Source: Clinical Cardiology - December 21, 2016 Category: Cardiology Authors: Ryan E. Owens, Rajesh Kabra, Carrie S. Oliphant Tags: Reviews Source Type: research

How to define valvular atrial fibrillation?
Abstract Atrial fibrillation (AF) confers a substantial risk of stroke. Recent trials comparing vitamin K antagonists (VKAs) with non-vitamin K antagonist oral anticoagulants (NOACs) in AF were performed among patients with so-called "non-valvular" AF. The distinction between "valvular" and "non-valvular" AF remains a matter of debate. Currently, "valvular AF" refers to patients with mitral stenosis or artificial heart valves (and valve repair in North American guidelines only), and should be treated with VKAs. Valvular heart diseases, such as mitral regurgitation, aortic stenosis (AS) and aortic insufficiency, do...
Source: Archives of Cardiovascular Diseases - July 13, 2015 Category: Cardiology Authors: Fauchier L, Philippart R, Clementy N, Bourguignon T, Angoulvant D, Ivanes F, Babuty D, Bernard A Tags: Arch Cardiovasc Dis Source Type: research