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Specialty: Cardiology
Management: Food and Drug Administration (FDA)

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Total 188 results found since Jan 2013.

Evaluating Cardiovascular Safety of Novel Therapeutic Agents for the Treatment of Type 2 Diabetes Mellitus
Abstract Type 2 diabetes increases the risk of developing cardiovascular (CV) complications such as myocardial infarction, heart failure, stroke, peripheral vascular disease, and CV-associated mortality. Strict glycemic control in diabetics has shown improvement in microvascular complications related to diabetes but has been unable to demonstrate major effects on macrovascular complications including myocardial infarction and stroke. Conventional therapies for diabetes that include insulin, metformin, sulfonylureas (SU), and alpha-glucosidase inhibitors have limited and/or controversial data on CV safety based on...
Source: Current Cardiology Reports - October 10, 2014 Category: Cardiology Source Type: research

Keeping the Genie in the Bottle Growth Hormone and Cardiovascular Disease ∗
Anabolic hormone use is increasingly common and includes replacement in patients with hormone deficiencies, questionable uses in those with borderline-low levels, and clear abuses among athletes aiming to gain a competitive advantage. Recently, direct-to-consumer marketing touting the benefits of “low T” treatment has led to increased testosterone use among middle-aged and older men, despite inadequate cardiovascular safety data. Although the Testosterone in Older Men Trial showed improvements in strength among treated patients, it was prematurely halted due to increased cardiovascular events in the treatment arm (1). ...
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - September 29, 2014 Category: Cardiology Source Type: research

Reply Regarding the Effect of Dabigatran Plasma Concentrations
We would like to respond to Dr. Rao's questions concerning our paper (1). First, it is incorrect to state that any data on dabigatran and plasma levels were suppressed. This information has been submitted to all regulatory authorities as part of the original registration process of dabigatran etexilate for reduction of stroke in patients with atrial fibrillation. These data have also been in the public domain since the U.S. Food and Drug Administration (FDA) Advisory Committee meeting in September 2010, before marketing approval (2).
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - June 23, 2014 Category: Cardiology Source Type: research

Phases in development of an interactive mobile phone-based system to support self-management of hypertension
Inger Hallberg,1,11 Charles Taft,1,11 Agneta Ranerup,2,11 Ulrika Bengtsson,1,11 Mikael Hoffmann,3,10 Stefan Höfer,4 Dick Kasperowski,5 Åsa Mäkitalo,6 Mona Lundin,6 Lena Ring,7,8 Ulf Rosenqvist,9 Karin Kjellgren1,10,11 1Institute of Health and Care Sciences, 2Department of Applied Information Technology, University of Gothenburg, Gothenburg, 3The NEPI Foundation, Linköping, Sweden; 4Department of Medical Psychology, Innsbruck Medical University, Innsbruck, Austria; 5Department of Philosophy, Linguistics and Theory of Science, 6Department of Education, Communication and Learning, University of Gothenburg...
Source: Integrated Blood Pressure Control - May 6, 2014 Category: Cardiology Tags: Integrated Blood Pressure Control 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: 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

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

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