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Vorapaxar: emerging evidence and clinical questions in a new era of PAR-1 inhibition
Despite the use of therapies recommended in practice guidelines for secondary prevention in patients with atherosclerotic coronary artery disease, the residual risk for cardiovascular events remains high. Some of the residual risk is believed to result from incomplete platelet inhibition with current therapy. Vorapaxar is a first-in-class, novel antiplatelet agent that acts by antagonizing the PAR-1 receptor, inhibiting thrombin-mediated platelet activation. Vorapaxar was recently approved by the Food and Drug Administration for secondary prevention of cardiovascular events in patients with a history of myocardial infarcti...
Source: Coronary Artery Disease - September 30, 2016 Category: Cardiology Tags: Reviews in Depth Source Type: research

A Review of the Clinical Subgroup Analyses From the RE-LY Trial.
Authors: Kumar R, Rahman AM, Henry BL Abstract Dabigatran was the first direct-acting oral anticoagulant approved by the US Food and Drug Administration for prevention of stroke and systemic embolism in people with atrial fibrillation, based on data from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Over 18,000 patients with nonvalvular atrial fibrillation and a moderate-to-high risk of thromboembolic stroke were randomized to warfarin or dabigatran. With respect to the primary endpoints for efficacy and safety, dabigatran was superior to warfarin in the prevention of stroke and thro...
Source: Reviews in Cardiovascular Medicine - September 28, 2016 Category: Cardiology Tags: Rev Cardiovasc Med Source Type: research

Why 5,000 People Are Suing Over Plavix
Legal action is apparently moving forward involving lawsuits filed by thousands of people who say they suffered serious injuries by taking the once-heralded blood-thinning drug Plavix. The California Supreme Court ruled late last month that eight product liability lawsuits against Plavix manufacturer Bristol-Myers Squibb and Plavix distributor McKesson Corporation can proceed in San Francisco Superior Court. Those eight cases involved 678 plaintiffs. They may soon be joined by a multitude of other cases, involving about 5,000 plaintiffs, that have been filed around the country. There is no word yet on whether Bristol-My...
Source: Healthy Living - The Huffington Post - September 13, 2016 Category: Consumer Health News Source Type: news

Idarucizumab: Clinical Role of a Novel Reversal Agent for Dabigatran.
Authors: Teleb M, Salire K, Wardi M, Alkhateeb H, Said S, Mukherjee D Abstract Atrial fibrillation (AF), a common cardiac arrhythmia associated with increased risk of heart failure, thromboembolic phenomena and death, is a leading cause of hospitalization of adults. A major complication of atrial fibrillation is an increased risk of ischemic stroke leading to long-term disability and in severe cases, death. Historically, coumadin has been the drug of choice for chronic anticoagulation and stroke prevention in AF patients however, given the need for constant monitoring and multiple drug interactions, newer anticoagu...
Source: Cardiovascular and Hematological Disorders Drug Targets - August 3, 2016 Category: Drugs & Pharmacology Tags: Cardiovasc Hematol Disord Drug Targets Source Type: research

Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban.
Authors: Mezue K, Obiagwu C, John J, Sharma A, Yang F, Shani J Abstract Almost 800,000 new or recurrent strokes happen every year. Atrial fibrillation, the most common cardiac arrhythmia, is a major risk factor for stroke, accounting for 15-20% of ischemic strokes. Apixaban is a direct inhibitor of Factor Xa that was approved in December 2012 by the US Food and Drug Administration (FDA) for the prevention of stroke in patients with non-valvular atrial fibrillation. It is part of a family of novel oral anticoagulants (NOACs) which have the advantage over warfarin of less dosing variability, rapid onset of action and...
Source: Current Cardiology Reviews - July 29, 2016 Category: Cardiology Tags: Curr Cardiol Rev Source Type: research

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal ant...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

Severe jaundice due to intrahepatic cholestasis after initiating anticoagulation with rivaroxaban
Rivaroxaban, a highly selective direct factor Xa inhibitor, is a new oral anticoagulant approved by the US Food and Drug Administration in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Because of its efficacy and once-a-day dosing, it is commonly preferred in patients with nonvalvular atrial fibrillation and intolerance to warfarin in clinical practice. However, it can result in some adverse effects such as bleeding, rashes and liver injury. Here, we described a very rare adverse reaction of rivaroxaban, jaundice due to intrahepatic cholestasis, appeared in a 71-year-old male patien...
Source: Blood Coagulation and Fibrinolysis - February 2, 2016 Category: Hematology Tags: Case Reports Source Type: research

Pediatric ventricular assist devices.
Authors: Adachi I, Burki S, Zafar F, Morales DL Abstract The domain of pediatric ventricular assist device (VAD) has recently gained considerable attention. Despite the fact that, historically, the practice of pediatric mechanical circulatory support (MCS) has lagged behind that of adult patients, this gap between the two groups is narrowing. Currently, the Berlin EXCOR VAD is the only pediatric-specific durable VAD approved by the U.S Food and Drug Administration (FDA). The prospective Berlin Heart trial demonstrated a successful outcome, either bridge to transplantation (BTT), or in rare instances, bridge to reco...
Source: Journal of Thoracic Disease - January 24, 2016 Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research

Reversing the effects of the new anti-clotting drugs
The oral anticoagulant warfarin (Coumadin) became available for prescription in 1954. This anti-clotting drug commanded national attention when President Dwight Eisenhower received the drug as part of his treatment following a heart attack. No other oral anticoagulant was successfully developed and marketed in the United States until 2010. Warfarin is a dangerous drug. Along with insulin, it is responsible for the most emergency hospitalizations due to adverse drug reactions. Whereas insulin causes low blood sugar, warfarin is notorious for the complication of major bleeding. Warfarin is plagued by hundreds of drug-drug an...
Source: New Harvard Health Information - December 9, 2015 Category: Consumer Health News Authors: Samuel Z. Goldhaber, MD Tags: Drugs and Supplements Health Heart Health Hypertension and Stroke anti-clotting coumadin deep-vein-thrombosis DVT Source Type: news

An evidence-based review of edoxaban and its role in stroke prevention in patients with nonvalvular atrial fibrillation
Tushar Acharya, Prakash Deedwania Division of Cardiology, Department of Internal Medicine, University of California, San Francisco, Fresno, CA, USA Abstract: Atrial fibrillation is the most common arrhythmia in the elderly. It is responsible for significant morbidity and mortality from cardioembolic complications like stroke. As a result, atrial fibrillation patients are risk-stratified using the CHADS2 or CHA2DS2-VASc scoring systems. Those at intermediate-to-high risk have traditionally been treated with therapeutic anticoagulation with warfarin for stroke prevention. Although effective, warfarin use is fraught with mult...
Source: Core Evidence - April 27, 2015 Category: Drugs & Pharmacology Tags: Core Evidence Source Type: research

Problems in addition to stroke and bleeding after left atrial appendage closure
We read the article by Waksman et al. about the discussions between the US Food and Drug Administration (FDA) and the sponsor regarding approval of the WATCHMAN-device for interventional left atrial appendage closure (LAAC).[1] We would like to stimulate the discussion by the following contribution: LAAC is primarily intended as an alternative for stroke prevention in patients with atrial fibrillation (AF) in whom oral anticoagulation (OAC) is not possible because of contraindications about a high bleeding risk.
Source: The American Journal of Cardiology - April 24, 2015 Category: Cardiology Authors: Claudia Stöllberger, Josef Finsterer, Birke Schneider Source Type: research

The new oral anticoagulants: clinical use and reversal agent development
Warfarin has been the centre of oral anticoagulant therapy for over 60 years. Recent development of new oral anticoagulants (NOACs) has provided a safe and effective alternative for stroke prevention in patients with atrial fibrillation and for prevention of venous thromboembolism. Determination of their use in acute coronary syndrome has been hampered by increases in bleeding events in most large trials, especially when used with antiplatelet therapy. NOACs have equal or superior efficacy and safety profiles compared to warfarin, fewer drug interactions; no dietary restrictions; predictable responses that eliminates moni...
Source: ISBT Science Series - April 13, 2015 Category: Hematology Authors: J. Costin, J. Ansell, S. Bakhru, B. Laulicht, S. Steiner Tags: Invited Review Source Type: research

Novel oral anticoagulants and reversal agents: Considerations for clinical development
This article reflects the views of the authors and should not be construed to represent FDA's views or policies.
Source: American Heart Journal - April 8, 2015 Category: Cardiology Source Type: research

Novel Oral Anticoagulants (NOAC) and Reversal Agents: Considerations for Clinical Development
This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.
Source: American Heart Journal - April 3, 2015 Category: Cardiology Source Type: research

The Left Atrial Appendage: Target for Stroke Reduction in Atrial Fibrillation.
Abstract A patient with atrial fibrillation (AF) has a greater than 5% annual risk of major stroke, a 5-fold increase compared to the general population. While anticoagulation remains the standard stroke prevention strategy, the nature of lifelong anticoagulation inevitably carries an increased risk of bleeding, increased stroke during periods of interruption, increased cost, and significant lifestyle modification. Many patients with atrial fibrillation have had their left atrial appendage (LAA) ligated or excised by surgeons during cardiac surgery, a decision based largely on intuition and with no clear evidence ...
Source: Methodist DeBakey Cardiovascular Journal - April 1, 2015 Category: Cardiology Authors: Ramlawi B, Abu Saleh WK, Edgerton J Tags: Methodist Debakey Cardiovasc J Source Type: research

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