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Specialty: General Medicine
Management: Food and Drug Administration (FDA)

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Total 27 results found since Jan 2013.

Remote Ischemic Conditioning —Feasible and Potentially Beneficial for Ischemic Stroke
Stroke is the second leading cause of death and disability in the world. In 1996, tissue plasminogen activator (tPA) was approved by the US Food and Drug Administration and remains the only approved pharmacologic agent for treatment of ischemic stroke in the US. In 2015, mechanical thrombectomy was shown to be beneficial for large vessel occlusion ischemic stroke, although 50% of patients treated with mechanical thrombectomy remain disabled at 3 months. Due to short time windows for thrombolytic therapy administration and the stroke system infrastructure needed for mechanical thrombectomy, these reperfusion therapies are a...
Source: JAMA - August 16, 2022 Category: General Medicine Source Type: research

Stroke After Transcatheter Aortic Valve Replacement
This study reported about a 7% risk of stroke, which was not surprising given the patient population and the likelihood of particulate embolization when expanding a new valve within the annulus of the stenosed and calcified native valve. Nevertheless, even with this stroke risk, there was a clear mortality benefit and quality of life was improved as well. After the PARTNER 1A high-risk cohort demonstrated similar or improved outcomes relative to open surgical aortic valve replacement (SAVR) in patients at high (but not inoperable) surgical risk, the US Food and Drug Administration (FDA) approved TAVR in 2011 and the proced...
Source: JAMA - June 18, 2019 Category: General Medicine Source Type: research

FDA Approves First Nerve-Stimulation Device to Aid Stroke Recovery
FRIDAY, Aug. 27, 2021 -- A first-of-a-kind nerve stimulation treatment for people who have problems moving their arms after a stroke has been approved by the U.S. Food and Drug Administration. " People who have lost mobility in their hands and arms...
Source: Drugs.com - Daily MedNews - August 27, 2021 Category: General Medicine Source Type: news

Error in USPSTF Report on Statin Use
The 2016 review for the US Preventive Services Task Force on statins for prevention of cardiovascular disease in adults had errors in the analysis of statins vs placebo and cardiovascular mortality. For the JUPITER trial, we interpreted “MI, stroke or cardiovascular death” as reported in the main trial publication as “myocardial death, stroke death, or cardiovascular death,” when it meant “nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.” Therefore, the analysis erroneously included nonfatal myo cardial infarction and stroke events (83/8901 vs 157/8901 in the rosuvastatin vs placebo gro...
Source: JAMA - February 18, 2020 Category: General Medicine Source Type: research

Dabigatran, a Cause of Hematologic Emergency.
Abstract ABSTRACT:: Dabigatran etexilate, a direct thrombin inhibitor, has become an alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. There remains a concern about its overdose and life-threatening hemorrhage because of unavailability of appropriate coagulation tests to monitor and antidotes to reverse its effects. There are no clinical data about its safety in patients with fluctuating renal function. Multiple bleeding events reported with dabigatran have prompted the U.S. Food and Drug Administration to further investigate these reports. Four clinical cases with lif...
Source: The American Journal of the Medical Sciences - December 5, 2012 Category: Journals (General) Authors: Lal Y, Van Heukelom J Tags: Am J Med Sci 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

Parent artery reconstruction for large or giant cerebral aneurysms using a Tubridge flow diverter (PARAT): study protocol for a multicenter, randomized, controlled clinical trial
This study is a multicenter, randomized, controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation. A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1. The treatment group will receive Tubridge implantation alone or combined with bared coils, and the control group will be treated with stent-assisted coiling (bare coils). The primary endpoint will be the complete occlusion...
Source: BioMed Central - May 4, 2014 Category: Journals (General) Authors: Yu ZhouPeng-Fei YangYi-Bin FangYi XuBo HongWen-Yuan ZhaoQiang LiRui ZhaoQing-Hai HuangJian-Min Liu Source Type: research

Cardiovascular Effects of Incretin-Based Therapies.
This article reviews the most recent CV outcome trials of the DPP-4 inhibitors (SAVOR-TIMI 53, EXAMINE, and TECOS) as evidence that the incretin-based therapies have acceptable CV safety profiles for patients with T2DM. The studies differ with regard to patient population, trial duration, and heart failure outcomes but show similar findings for CV death, nonfatal myocardial infarction, and stroke, as well as hospitalization for unstable angina. PMID: 26768240 [PubMed - in process]
Source: Annual Review of Medicine - January 14, 2016 Category: Journals (General) Authors: White WB, Baker WL Tags: Annu Rev Med Source Type: research

What FDA ’s new sodium guidelines could look like in practice
With nine out of 10 U.S. adults and children consuming too much sodium, the U.S. Food and Drug Administration (FDA) has released draft proposed voluntary guidelines to encourage companies to significantly reduce sodium in processed and restaurant foods by 2020. Some of the recommended changes may be eye-opening for patients who don ’t closely monitor their sodium intake. The need to decrease sodium consumption High sodium intake has a direct correlation to high blood pressure, which leads to heart disease and stroke —the most common causes of death in the U.S., contributing to more than 1,000 deaths per day. “...
Source: AMA Wire - June 8, 2016 Category: Journals (General) Authors: Troy Parks Source Type: news

Clot Retrieval Device Approval Expanded
TUESDAY, Sept. 6, 2016 -- Two similar devices that help doctors retrieve blood clots and avoid potential disability among stroke victims have been approved for new uses by the U.S. Food and Drug Administration. The Trevo devices were first cleared...
Source: Drugs.com - Daily MedNews - September 6, 2016 Category: Journals (General) Source Type: news

Edoxaban: How Does the Newest Agent Fit into the DOAC Landscape?
Edoxaban is the most recently approved factor Xa inhibitor within the class of direct oral anticoagulants (DOACs). Like other DOACs, edoxaban was approved by the US Food and Drug Administration for treatment of venous thromboembolism and prevention of stroke in patients with nonvalvular atrial fibrillation. Similar to other DOACs, edoxaban has fewer drug –drug interactions than warfarin and does not require routine laboratory monitoring. Unlike other DOACs, edoxaban has yet to be approved for secondary or postoperative venous thromboembolism thromboprophylaxis.
Source: The American Journal of Medicine - April 5, 2017 Category: General Medicine Authors: Caitlin M. Gibson, Shannon W. Finks Tags: Review Source Type: research

Antithrombotic Therapy in Nonvalvular Atrial Fibrillation: Consensus and Challenges.
This article discusses the advantages and disadvantages of currently approved oral antithrombotics in nonvalvular AF, with a special emphasis on the DOACs and their individual characteristics. PMID: 29753377 [PubMed - in process]
Source: The American Journal of the Medical Sciences - May 1, 2018 Category: General Medicine Authors: Khattak F, Alam MB, Paul TK, Rijal S, Wazir S, Lavie CJ, Saba S Tags: Am J Med Sci Source Type: research

The Reply
We recently reported an updated meta-analysis of 5 randomized clinical trials demonstrating that transcatheter closure of patent foramen ovale reduces the risk of recurrent neurologic events compared with medical therapy after cryptogenic stroke.1 Key trials have collectively studied more than 10 different patent foramen ovale closure devices, including the US Food and Drug Administration –approved AMPLATZER PFO Occluder (Abbott Vascular, Santa Clara, Calif). These devices vary considerably in material, size, and profile and differ with respect to procedural deployment.
Source: The American Journal of Medicine - May 19, 2018 Category: General Medicine Authors: Muthiah Vaduganathan, Arman Qamar, Ankur Gupta, Navkaranbir Bajaj, Harsh B. Golwala, Ambarish Pandey, Deepak L. Bhatt Tags: Letter Source Type: research

Spotlight on Antidiabetic Agents with Cardiovascular or Renoprotective Benefits.
Authors: Madievsky R Abstract Type 2 diabetes mellitus often goes hand in hand with cardiovascular and renal comorbidities. Stroke, myocardial infarction, heart failure, and chronic kidney disease are high-risk complications of type 2 diabetes that contribute to morbidity and mortality. Recent clinical trials have uncovered evidence that certain antidiabetic agents may confer cardiovascular and/or renal benefits such as reduced cardiovascular and all-cause mortality and reduced need for renal replacement therapy. Two landmark trials in particular, EMPA-REG OUTCOME (Empagliflozin, Cardiovascular Outcomes, and Mortal...
Source: The Permanente journal - September 21, 2018 Category: General Medicine Tags: Perm J 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