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Total 621 results found since Jan 2013.

Functional Improvement After Ventricular Assist Device Implantation: Is Ventricular Recovery More Common Than We Thought?⁎
He who's down one day can be up the next, unless he really wants to stay in bed, that is … —Miguel de Cervantes Saavedra, Don Quixote () Of the roughly 5.8 million Americans with heart failure, approximately 10% will have Stage D heart failure, defined as symptoms at rest despite optimal medical therapy. American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend 3 options for these patients: 1) a ventricular assist device (VAD); 2) a heart transplant; or 3) hospice care (). Unfortunately, advanced therapies such as transplant and VAD are associated with significan...
Source: Journal of the American College of Cardiology - March 11, 2013 Category: Cardiology Authors: Eric Adler, Jorge Silva Enciso Tags: Heart Failure: Editorial Comment Source Type: research

Managing Blunt Trauma in Patients Receiving Dabigatran Etexilate: Case Study and Review of the Literature
The objectives of this article are to present a case of life-threatening bleeding in a patient receiving dabigatran etexilate, followed by a review of the current literature and a suggested reversal guideline.
Source: Journal of Emergency Nursing: JEN - April 1, 2013 Category: Nursing Authors: Peter Eamonn Croft, Katherine P. Cabral, Tania D. Strout, Michael R. Baumann, Michael A. Gibbs, Matthew C. DeLaney Tags: Trauma Notebook Source Type: research

Anticoagulation for non-valvular atrial fibrillation: new anticoagulant agents.
Abstract Atrial fibrillation (AF) is a common cardiac arrhythmia and it is associated with systemic thromboembolism. Until recently, vitamin K antagonists (VKA) such as warfarin were the only available oral anticoagulant therapy for prevention of stroke and systemic embolism in AF. Limitations of VKA therapy have prompted researchers to search for novel anticoagulant drugs, which do not necessitate coagulation monitoring due to their more predictable pharmacokinetic profile. Large-scale phase III trials have been completed for some of these drugs and 'U.S. Food and Drug Administration (FDA)' approved dabigatran an...
Source: The Anatolian Journal of Cardiology - April 11, 2013 Category: Cardiology Authors: Kepez A, Erdoğan O Tags: Anadolu Kardiyol Derg Source Type: research

Pharmacotherapy of obesity: clinical treatments and considerations.
Abstract Obesity is a world-wide epidemic associated with significant morbidity and mortality which costs billions of dollars per year. The associated related conditions are many and include heart disease, stroke, type II diabetes mellitus, sleep apnea and certain types of cancer. Given that it is a multifactorial problem, the treatments must also address the numerous causes associated with the development of obesity. The neurohormonal regulation of feeding and energy is a complex system often necessitating modification through more than 1 pathway to achieve weight loss. Therefore, in addition to lifestyle changes...
Source: The American Journal of the Medical Sciences - April 1, 2013 Category: Journals (General) Authors: Holes-Lewis KA, Malcolm R, O'Neil PM Tags: Am J Med Sci Source Type: research

FDA clears medical device for muscle and joint rehabilitation
(Oregon Health & Science University) The Food and Drug Administration today granted 510(k) clearance to a muscle and joint rehabilitation medical device developed by OHSU Scientist Dr. Paul Cordo, Ph.D., and AMES Technology, Inc. Patients who might use the device include stroke victims and patients with partial injuries to the spinal cord injury patients.
Source: EurekAlert! - Social and Behavioral Science - May 30, 2013 Category: Global & Universal Source Type: news

Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
Dateline City:  WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA). About Mer...
Source: Merck.com - Research and Development News - July 24, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Corporate News Latest News Source Type: news

The ATLAS ACS 2–TIMI 51 Trial and the Burden of Missing Data (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects With Acute Coronary Syndrome ACS 2–Thrombolysis In Myocardial Infarction 51)
Rivaroxaban is a factor Xa inhibitor that was recently reviewed by the Food and Drug Administration as a potential therapy to reduce the risk of recurrent atherothrombotic events in patients with acute coronary syndromes. Approval of this drug would represent a paradigm shift away from dual antiplatelet therapy toward long-term triple antithrombotic therapy. However, to date, no other experimental anticoagulant agent has demonstrated a favorable risk-benefit profile in this population, in part because of the expected increased risk in major bleeding by combining aspirin, a P2Y12 receptor inhibitor, and an anticoagulant. Ap...
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - August 19, 2013 Category: Cardiology Source Type: research

The ATLAS ACS 2–TIMI 51 Trial and the Burden of Missing Data: (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects With Acute Coronary Syndrome ACS 2–Thrombolysis In Myocardial Infarction 51)
Rivaroxaban is a factor Xa inhibitor that was recently reviewed by the Food and Drug Administration as a potential therapy to reduce the risk of recurrent atherothrombotic events in patients with acute coronary syndromes. Approval of this drug would represent a paradigm shift away from dual antiplatelet therapy toward long-term triple antithrombotic therapy. However, to date, no other experimental anticoagulant agent has demonstrated a favorable risk-benefit profile in this population, in part because of the expected increased risk in major bleeding by combining aspirin, a P2Y12 receptor inhibitor, and an anticoagulant. Ap...
Source: Journal of the American College of Cardiology - June 10, 2013 Category: Cardiology Authors: Mori J. Krantz, Sanjay Kaul Tags: VIEWPOINT Source Type: research

Baxter Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps
Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
Source: Food and Drug Administration - September 19, 2013 Category: Food Science Source Type: news

Balancing Burdens and Benefits: Ethical Issues of Off-Label Prescription Pharmaceutical Use
I remember when Botox (Allergen, Irvine, CA) was becoming all the rage in rehabilitation in the mid 1990s. As I recall, the only U.S. Food and Drug Administration (FDA) approved uses at the time were for spasmodic torticollis and blepharospasm. In a short period of time, however, Botox was the new treatment du jour for adults and children alike with spasticity from CP, traumatic brain injury (TBI), and stroke. I also remember feeling a bit queasy about it. Perhaps having recently completed a fellowship in clinical medical ethics colored my view. Images of thousands of people with limb deficiencies, the tragic consequence ...
Source: PM and R - October 1, 2013 Category: Rehabilitation Authors: Ford Vox, Alexander M. Capron, Marilyn F. Kraus, G. Caleb Alexander, Kristi L. Kirschner Tags: Ethical Legal Source Type: research

FDA says new cholesterol drugs may not need outcome studies
(Reuters) - Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower "bad" cholesterol, and may not need to show that they reduce the risk of heart attack and stroke, the Food and Drug Administration said on Thursday.
Source: Reuters: Health - November 15, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

Trans Fats On the Way Out? The FDA Moves to Ban Partially Hydrogenated Oils
(HealthCastle.com) You probably know that trans fats are bad for you: They raise your LDL (bad) cholesterol and can increase your risk of heart disease or stroke. Some countries have already banned them. In the United States, trans fats were not even required to be listed on product labels until 2006. Now, just seven years later, the U.S. Food and Drug Administration (FDA) is moving to phase artificial trans fats out from packaged foods sold in the United States. read more
Source: HealthCastle.com Nutrition Tips - written by Registered Dietitians - November 23, 2013 Category: Nutrition Source Type: news

Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today said it was pleased with the U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack. ...
Source: Merck.com - Research and Development News - January 15, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

The New Era of Anticoagulation
This article reviews the literature on these novel anticoagulants, including their pharmacokinetics and treatment indications.
Source: Annals of Vascular Surgery - January 10, 2014 Category: Surgery Authors: Nedaa Skeik, Kyle K. Rumery, Gabriel T. Rodriguez Tags: General Review Source Type: research

FDA lifts clinical ban on Morrisville pharma's lead candidate
Morrisville drug developer Oxygen Biotherapeutics received good news from federal regulators when it heard that the FDA lifted a clinical ban on Oxygen’s leading product candidate. The U.S. Food and Drug Administration had put a clinical hold on Oxycyte, the leading product developed by Oxygen Biotherapeutics (Nasdaq: OBXT) that would carry oxygen throughout the body, potentially reducing negative effects from a stroke or traumatic brain injury. The clinical hold essentially stopped further development…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 5, 2014 Category: Pharmaceuticals Authors: Jason deBruyn Source Type: research