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Condition: Heart Failure
Management: Food and Drug Administration (FDA)
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Total 40 results found since Jan 2013.
Can I use DOAC in a patient with renal disease?
Case
A 76-year-old man is diagnosed with non-valvular atrial fibrillation. His comorbid conditions are hypertension, diabetes complicated by neuropathy, and chronic kidney disease stage 3. His current medications include metformin, lisinopril, gabapentin, and aspirin. His most recent laboratories showed a creatinine 1.8, creatinine clearance (CrCl) 35 mL/min, hemoglobin 11g/dL, and international normalized ratio 1.0. His congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, and sex (CHADSVASc) score is 4. Which medication should we use to prevent stroke in this patient?
Brief overview of the is...
Source: The Hospitalist - February 3, 2022 Category: Hospital Management Authors: Ronda Whitaker Tags: Renal & Genitourinary Source Type: research
EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus.
Abstract
During the last decade, the armamentarium for glucose-lowering drugs has increased enormously by the development of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors, allowing individualization of antidiabetic therapy for patients with type 2 diabetes (T2DM). Some combinations can now be used without an increased risk for severe hypoglycemia and weight gain. Following a request of the US Food and Drug Administration, many large cardiovascular (CV) outcome studies have been performed in patients with longstanding disease and established CV disease. In the majority of CV outcome studies, CV ris...
Source: Clinical Therapeutics - May 18, 2016 Category: Drugs & Pharmacology Authors: Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH Tags: Clin Ther Source Type: research
Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by ove...
Source: Johnson and Johnson - March 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Diabetes drug pioglitazone could get personal: Neither panacea, nor peril
When I was in training, one of my beloved mentors declared, “I never use a drug until it’s been on the market for 20 years.” I was young enough then that I couldn’t fathom being a doctor for 20 years, let alone waiting two decades to use a new drug. As my career has progressed, I’ve seen many new drugs released to the market. Some of them are truly miraculous, bringing people longer, healthier, and more productive lives. Many of them have not withstood the test of time. More than a few have even been taken off the market. Even though the Food and Drug Administration diligently reviews each new medicine before it...
Source: New Harvard Health Information - May 5, 2016 Category: Consumer Health News Authors: Lori Wiviott Tishler, MD, MPH Tags: Diabetes Drugs and Supplements pioglitazone thiazolidinediones Source Type: news
Ritalin Could Trigger Heart Problems In Children
Ritalin and similar forms of ADHD medication may trigger abnormal heart rhythms and increase heart attack risk in some children soon after they start taking the drug, according to a new study.
This connection was especially true for children who were born with heart disease.
According to the study, published in the British medical journal BMJ, kids had an increased risk of heart attack between eight and 56 days after starting methylphenidate, a stimulant most commonly sold as Ritalin, although this heightened risk didn’t reach statistical significance. The researchers could find no evidence of a heightened...
Source: Science - The Huffington Post - June 8, 2016 Category: Science Source Type: news
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
Biosense Webster Unveils Late-Breaking Results from PRECEPT Study in Patients with Persistent Atrial Fibrillation
IRVINE, CA – May 8, 2020 – Johnson & Johnson Medical Devices Companies* today announced that Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation Catheter, evaluated in the PRECEPT study for the treatment of persistent atrial fibrillation (AF), resulted in freedom from any documented, symptomatic atrial arrhythmias at 15 months post-procedure for eight out of ten study participants (80.4 percent).1 Use of the THERMOCOOL SMARTTOUCH SF CATHETER for persistent atrial fibrillation is investigational only. This PRECEPT study data support a Premarket Approval supplement application to the U.S. Food and Drug Adm...
Source: Johnson and Johnson - May 12, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
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
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
Study: Fish Oil Doesn ’ t Seem To Prevent Heart Problems
This study is consistent with earlier trials.
The US Food and Drug Administration approved the fish oil-based drug Vascepa for heart attack and stroke prevention in 2019.
Nissen hopes the FDA will take a look at these studies and reconsider that decision.
“But it’s hard to get something undone once the genie gets out of the bottle,” he said.
An editorial in the journal that accompanies the study written by Dr. Gregory Curfman, assistant professor of medicine at Harvard Medical School, also suggested the FDA should require a postmarketing clinical trial of a high-dose of fish oil, such as Vascepa, vs. corn...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 16, 2020 Category: Consumer Health News Authors: CBS Boston Tags: Boston News Health Syndicated CBSN Boston CNN fish oil Source Type: news
Families face battle with GSK over dangerous diabetes drug
Exclusive: Pharmaceutical giant resists claims despite settlement with victims in USThousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.A scientist with the Food and Drug Administration estimated that Avandia co...
Source: Guardian Unlimited Science - January 29, 2013 Category: Science Authors: Sarah Boseley Tags: The Guardian United States World news Pharmaceuticals industry Medical research Legal aid Law UK news Diabetes GlaxoSmithKline Business Source Type: news
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
Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis
Publication date: Available online 11 August 2015 Source:The Lancet Diabetes & Endocrinology Author(s): Miles Fisher, Mark C Petrie, Philip D Ambery, Jill Donaldson, John J V McMurray, June Ye Background Albiglutide is a glucagon-like peptide-1 receptor agonist, a new class of drugs used to treat type 2 diabetes. We did a prospective meta-analysis of the cardiovascular safety of albiglutide as stipulated by the US Food and Drug Administration recommendations for the assessment of new treatments for diabetes. Methods We did a meta-analysis of eight phase 3 trials and one phase 2b trial in which patients wer...
Source: The Lancet Diabetes and Endocrinology - August 12, 2015 Category: Endocrinology 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
Testosterone and Cardiovascular Disease
Testosterone (T) is the principal male sex hormone. As men age, T levels typically fall. Symptoms of low T include decreased libido, vasomotor instability, and decreased bone mineral density. Other symptoms may include depression, fatigue, erectile dysfunction, and reduced muscle strength/mass. Epidemiology studies show that low levels of T are associated with more atherosclerosis, coronary artery disease, and cardiovascular events. However, treating hypogonadism in the aging male has resulted in discrepant results in regard to its effect on cardiovascular events. Emerging studies suggest that T may have a future role in t...
Source: Journal of the American College of Cardiology - February 2, 2016 Category: Cardiology Source Type: research
