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Condition: Heart Failure
Management: Food and Drug Administration (FDA)

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6 Simple Health Tips for Buying Chocolate
Shopping for "good" chocolate is kind of like searching for a viable online date. Approach the market without a plan and it's easy to get duped by glossy packaging and false claims. Know what you're looking for, though, and you can find yourself a sweetie with substance -- guaranteed to reduce your stress levels, ignite your sex life, and make your heart sing from the first blissful encounter. In fact, findings from a new long-term study in Heart journal involving 25,000 volunteers suggest that eating up to 3.5 ounces of high-quality chocolate per day can significantly reduce risks of heart disease and stroke. Sort through...
Source: Healthy Living - The Huffington Post - February 14, 2016 Category: Consumer Health News Source Type: news

Integration of recent evidence into management of patients with atherosclerotic cardiovascular disease and type 2 diabetes
Publication date: Available online 26 January 2017 Source:The Lancet Diabetes & Endocrinology Author(s): Eberhard Standl, Oliver Schnell, Darren K McGuire, Antonio Ceriello, Lars Rydén Cardiovascular outcome trials of antihyperglycaemic drugs and non-statin LDL-cholesterol-lowering drugs in patients with type 2 diabetes who have, or who are at high risk of, atherosclerotic cardiovascular disease have provided new evidence that has substantially affected the management of cardiovascular risk in these patients. On the basis of proven cardiovascular and renal benefit, the antihyperglycaemic drugs empagliflozin, lira...
Source: The Lancet Diabetes and Endocrinology - January 25, 2017 Category: Endocrinology Source Type: research

SAVOR-TIMI to SUSTAIN-6: A critical comparison of cardiovascular outcome trials of anti-diabetic drugs.
Abstract INTRODUCTION: Since the inception of mandatory cardiovascular (CV) safety outcome trial (CVOT) promulgated by US Food and Drug Administration in 2008, seven trials have so far been published with three different classes of anti-diabetic drugs in type 2 diabetes mellitus (T2DM). This mini-review aims to critically analyse these CVOTs in terms of different outcomes achieved. Areas covered: An electronic search pertaining to the subject was conducted till September 2016. The three CVOT conducted with saxagliptin, alogliptin and sitagliptin respectively, found them to be CV-neutral. However, both saxagliptin ...
Source: Pharmacological Reviews - January 24, 2017 Category: Drugs & Pharmacology Authors: Singh AK, Singh R Tags: Expert Rev Clin Pharmacol Source Type: research

Bromocriptine-QR therapy for the management of type 2 diabetes mellitus: developmental basis and therapeutic profile summary.
Authors: Raskin P, Cincotta AH Abstract An extended series of studies indicate that endogenous phase shifts in circadian neuronal input signaling to the biological clock system centered within the hypothalamic suprachiasmatic nucleus (SCN) facilitates shifts in metabolic status. In particular, a diminution of the circadian peak in dopaminergic input to the peri-SCN facilitates the onset of fattening, insulin resistance and glucose intolerance while reversal of low circadian peak dopaminergic activity to the peri-SCN via direct timed dopamine administration to this area normalizes the obese, insulin resistant, gluco...
Source: Expert Review of Endocrinology and Metabolism - August 2, 2018 Category: Endocrinology Tags: Expert Rev Endocrinol Metab 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

Sodium –Glucose Cotransporter-2 Inhibitors and Heart Failure Prevention in Type 2 Diabetes
In 2008, the European Medicines Agency and US Food and Drug Administration (FDA) issued industry guidance stating that all future novel glucose-lowering agent trials must undergo routine cardiovascular risk evaluation either before approval or as a post-marketing commitment.1 This mandated that all cardiovascular endpoint committees prospectively adjudicate all major adverse cardiovascular events, including cardiovascular death, non-fatal MI and stroke, occurring across Phase II and III diabetes trials.
Source: Radcliffe Cardiology - November 4, 2019 Category: Cardiology Authors: mehul Source Type: research

Non-Invasive Cardiac Output Monitoring in Cardiogenic Shock: The NICOM Study
The bioreactance technique is a relatively new, totally noninvasive technique that is used to measure cardiac output (CO) and is easy to use. The Non-Invasive Cardiac Output Monitor (NICOM) is 1 such system. Although approved by the Food and Drug Administration for measurement of stroke volume, there is a paucity of literature validating this technology in decompensated heart failure and cardiogenic shock.
Source: Journal of Cardiac Failure - November 17, 2019 Category: Cardiology Authors: Aniket S. Rali, Tyler Buechler, Bridget Van Gotten, Andrew Waters, Zubair Shah, Nicholas Haglund, Andrew Sauer Tags: Brief Report Source Type: research

Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.
This report summarizes these discussions and the key takeaway messages from this meeting. PMID: 31841369 [PubMed - in process]
Source: Circulation - December 16, 2019 Category: Cardiology Authors: Butler J, Packer M, Greene SJ, Fiuzat M, Anker SD, Anstrom KJ, Carson PE, Cooper LB, Fonarow GC, Hernandez AF, Januzzi JL, Jessup M, Kalyani RR, Kaul S, Kosiborod M, Lindenfeld J, McGuire DK, Sabatine MS, Solomon SD, Teerlink JR, Vaduganathan M, Yancy CW, Tags: Circulation Source Type: research

A Call for a New Paradigm for Diabetes Care in the Era of Sodium –Glucose Cotransporter 2 Inhibitors (SGLT2i)
This article is based on previously conducted studies and the authors disclose  their roles in relevant trials in the Acknowledgements.
Source: Cardiology and Therapy - July 12, 2020 Category: Cardiology Source Type: research

FDA clears use of MRI for Impulse Dynamics' Optimizer
The U.S. Food and Drug Administration (FDA) has cleared for conditional use...Read more on AuntMinnie.comRelated Reading: Socioeconomic status predicts heart failure mortality AI predicts heart attack, stroke on cardiac MRI MRI discovers heart damage among male triathletes
Source: AuntMinnie.com Headlines - January 20, 2021 Category: Radiology Source Type: news

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA ™(6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.1 The FDA approval of INVEGA ...
Source: Johnson and Johnson - September 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

The Current Role of Clevidipine in the Management of Hypertension
AbstractAcute hypertension, which may damage blood vessels, causes irreversible organ damage to the vasculature, central nervous system, kidney, and heart. Clevidipine, the first third-generation calcium channel antagonist approved by the Food and Drug Administration (FDA) in the past 20 years, is an ultra-short-acting calcium channel blocker that inhibits L-type calcium channels with high clearance and low distribution, can be rapidly metabolized into the corresponding inactive acid, and is rapidly hydrolyzed into inactive metabolites by esterase in arterial blood. Clevidipine is the same as nicardipine in that the main p...
Source: American Journal of Cardiovascular Drugs - September 2, 2021 Category: Cardiology Source Type: research

Janssen Demonstrates Commitment to Advancing Science and Innovation in the Treatment of Solid Tumors at ESMO Annual Congress
September 8, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than ten data presentations from its lung cancer, bladder cancer and prostate cancer portfolio and pipeline will be featured during the European Society for Medical Oncology (ESMO) Annual Congress 2021 virtual meeting, September 16–21. Further details about these data and the science Janssen is advancing will be made available throughout ESMO via the Janssen Oncology Virtual Newsroom.“With a diverse oncology portfolio and pipeline spanning bladder cancer, lung cancer and prostate cancer, Janssen...
Source: Johnson and Johnson - September 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

ERLEADA ® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates
September 11, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. The strong PSA response was also seen in a separate post-hoc analysis that showed a correlation between rapid and deep PSA response and prolonged survival in both metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. The post-hoc analysis also suppor...
Source: Johnson and Johnson - September 12, 2021 Category: Pharmaceuticals Source Type: news