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All-Cause Mortality and Cardiovascular Outcomes With Non-Vitamin K Oral Anticoagulants Versus Warfarin in Patients With Heart Failure in the Food and Drug Administration Adverse Event Reporting System
Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes. Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAE...
Source: American Journal of Therapeutics - November 1, 2019 Category: Drugs & Pharmacology Tags: Original Research Source Type: research

Oral anticoagulation in emergency department patients: high rates of off-label doses,no difference in bleeding rates
Patients with oral anticoagulation constitute an increasing proportion in the present medical routine.1 The approval of the first direct oral anticoagulant (DOAC) dabigatran by the U.S. food and drug administration in 2010 for the purpose of stroke prevention in patients with non-valvular atrial fibrillation revolutionized the therapy strategies of this entity since the Vitamin-K antagonists (VKA) warfarin, phenprocoumon and acenocoumarol had been the only available oral anticoagulants for decades.
Source: The American Journal of Medicine - October 23, 2019 Category: General Medicine Authors: Corinne M. Eschler, Bertram K. Woitok, Georg-Christian Funk, Philipp Walter, Volker Maier, Aristomenis K. Exadaktylos, Gregor Lindner Tags: Clinical Research Study Source Type: research

Making Sense of Nutraceuticals in China
The Chinese nutraceutical market is considered the third largest in the world after the US and Japan, or the fourth largest if Europe is counted as a single market.Despite strong fundamentals and high rates of annual growth, though, the Chinese market remains some way from realizing its true potential. Its evolution is muddied by ambiguities around what nutraceuticals actually are and how they should be managed.The result has been polarization between over-zealous regulation of so-called health foods, and a grey market where products have skirted approval procedures through questionable positioning or by exploiting alterna...
Source: EyeForPharma - February 10, 2017 Category: Pharmaceuticals Authors: Marc Yates Source Type: news

In the Raw: To Cook or Not to Cook?
Imagine never again savoring the smell of baking cakes or charbroiled steak. Could you? Why would you? Yet some people worldwide are turning away not only from meat and processed food, but also from cooking. Welcome to the raw food diet. As the Standard American Diet becomes more fat-laden, sugar-sated, and processed, the prevalence of metabolic disorders, obesity, type 2 diabetes, and cardiovascular disease (CVD) are soaring. According to the Centers for Disease Control and Prevention (CDC), obesity now affects nearly 35 percent of the population of the United States, over 29 million people have been diagnosed with t...
Source: Healthy Living - The Huffington Post - August 4, 2016 Category: Consumer Health News Source Type: news

3 reasons your child shouldn’t go “gluten-free” (unless your doctor says so)
Follow me at @drClaire There is a puzzling and worrisome new phenomenon that I am seeing as a pediatrician: parents who are putting their children on gluten-free diets. It’s puzzling because in the vast majority of cases it isn’t necessary — and it’s worrisome because, although parents are doing it because they think it’s healthy, a gluten-free diet can be very unhealthy for children. Gluten is a protein found in wheat, rye, barley, and some other grains. It’s in bread and other baked goods, cereals, pastas — and in many other foods in small amounts. For people with celiac disease, even those small amounts ca...
Source: New Harvard Health Information - June 7, 2016 Category: Consumer Health News Authors: Claire McCarthy, MD Tags: Children's Health Healthy Eating Parenting Source Type: news

New reversal agent for factor Xa inhibitors shows promise
Commentary on: Siegal DM, Curnette JT, Connolly SJ, et al.. Andexanet alfa for the reversal of Factor Xa inhibitor activity. N Engl J Med 2015;373:2413–24. Context Direct oral anticoagulants (DOACs) have emerged as alternatives to vitamin K-antagonists (eg, warfarin) for the long-term management of stroke prevention for non-valvular atrial fibrillation or venous thromboembolic disease. Favourable side-effect profiles and absence of therapeutic monitoring are important benefits of these newer agents. Warfarin is readily reversed with fresh frozen plasma (FFP) or prothrombin complex concentrates.1 The first reversal ag...
Source: Evidence-Based Medicine - May 22, 2016 Category: Internal Medicine Authors: Ghadimi, K., Welsby, I. J. Tags: Clinical trials (epidemiology), Immunology (including allergy), Drugs: cardiovascular system, Stroke, Venous thromboembolism, Unwanted effects / adverse reactions Therapeutics/Prevention Source Type: research

Edoxaban for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Authors: Dzeshka MS, Lip GY Abstract INTRODUCTION: Oral anticoagulation is central to the management of patients with atrial fibrillation (AF) and at least one additional stroke risk factor. For decades, the vitamin K antagonists (e.g. warfarin) remained the only oral anticoagulant available for stroke prevention in AF. The non-vitamin K oral anticoagulants (NOACs) are now available, and these drugs include the direct thrombin inhibitors and factor Xa inhibitors. The latter class includes edoxaban, which has recently been approved for stroke prevention in AF by the United States Food and Drug Administration and the...
Source: Expert Opinion on Pharmacotherapy - February 14, 2016 Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother 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

Atrial Fibrillation and Renal Function How High Is the Price of Anticoagulation? ∗
For over a half century, vitamin K antagonists, chiefly warfarin, were the exclusive oral anticoagulants available for long-term anticoagulation. Being “the only game in town,” the emphasis of the accompanying clinical research was focused on determining the most appropriate method to measure anticoagulant effects, define the most efficacious and safe target range for anticoagulation, and identify strategies to maintain and reverse therapeutic anticoagulation. This emphasis came at the expense of turning a blind eye to rare concerns raised about the potential for warfarin to cause or worsen renal dysfunction (1,2). Th...
Source: Journal of the American College of Cardiology - June 8, 2015 Category: Cardiology 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

Why You Should Avoid Statins
At my anti-aging clinic, I continue to wage war against what I call the “medical-industrial complex.” And I do it for one reason only – I care more about my patients than I do about profits. Big Pharma clearly takes the opposite view. And now it seems these pharmaceutical behemoths won’t be happy until every man, woman and child is popping anti-cholesterol pills. Researchers at Duke University recently issued a report recommending that even children and people as young as 30 should be on statins, if they have just slightly elevated cholesterol levels.1 And why wouldn’t researchers at Duke recommen...
Source: Al Sears, MD Natural Remedies - February 3, 2015 Category: Complementary Medicine Authors: Dr. Al Sears Tags: Heart Health Source Type: news

Recent Advances in the Development of Specific Antidotes for Target‐Specific Oral Anticoagulants
Warfarin, a vitamin K antagonist, has been the only orally available anticoagulant for > 60 years. During the past decade, the U.S. Food and Drug Administration has approved several target‐specific oral anticoagulants (TSOACs) for the prophylaxis and treatment of arterial and venous thromboembolism and stroke prevention in patients with nonvalvular atrial fibrillation. These new agents have several advantages over warfarin including more predictable pharmacokinetics and pharmacodynamics, fewer food and drug interactions, and lack of need for routine coagulation monitoring. However, unlike warfarin, currently no ant...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - February 3, 2015 Category: Drugs & Pharmacology Authors: Yoonsun Mo, Felix K. Yam Tags: Review of Therapeutics Source Type: research

Oral anticoagulation in atrial fibrillation.
Authors: Ansari JG, Garcha GS, Lakkis N Abstract Atrial fibrillation affects approximately 5 million patients in the United States. The rate of stroke in adults with atrial fibrillation depending on their risk factors varies between 1-20% annually. Anticoagulation with vitamin K antagonists such as warfarin has been the mainstay therapy but it is cumbersome and requires close follow-up. Since 2010, three new oral anticoagulants have received Food and Drug Administration approval for stroke prevention in atrial fibrillation. This review summarizes data from three landmark trials: RE-LY, ROCKET-AF, and ARISTOTLE. In ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - December 5, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Oral Anticoagulation in Atrial Fibrillation.
Authors: Ansari JG, Garcha GS, Lakkis N Abstract Atrial fibrillation affects approximately 5 million patients in the United States. The rate of stroke in adults with atrial fibrillation depending on their risk factors varies between 1-20% annually. Anticoagulation with vitamin K antagonists such as warfarin has been the mainstay therapy but it is cumbersome and requires close follow-up. Since 2010, three new oral anticoagulants have received Food and Drug Administration approval for stroke prevention in atrial fibrillation. This review summarizes data from three landmark trials: RE-LY, ROCKET-AF, and ARISTOTLE. In ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

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