Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients

  The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said  the trial had failed to meet its primary endpoint.   The RED-HF…

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Observation Units For Heart Failure Could Reduce Unnecessary Hospitalizations

Two new papers published in the Journal of the American College of Cardiology propose that most heart failure (HF) patients who present to the emergency department (ED) don’t need to be hospitalized and can be safely managed in an observation unit. Currently, the vast majority of HF patients  who show up in the ED are hospitalized…. Click…

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Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF

This week in CardioExchange Richard Lehman is not quite as funny as most weeks (perhaps he’s still recovering from New Years’ celebrations?), but he has some interesting and useful comments on a JAMA study comparing real world patients garcinia cambogia plant uses in registries to patients in clinical trials and an impressive Lancet study testing the role of…

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Should Body Weight Influence Choice of Antihypertensive Therapy?

The hypertension field has been troubled by repeated observations that normal weight patients have more cardiovascular (CV) events than obese patients. Now a new analysis of a large hypertension trial confirms this finding but also suggests that it may be explained by either an adverse effect of diuretics or a protective effect of calcium-channel blockers in non-obese…

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HeartWare LVAD Approved By FDA For Transplant Patients

The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year. HeartWare was approved based on data from the pivotal…

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Ultrafiltration Fails To Show Benefit In Acute Heart Failure

Although ultrafiltration (UF) in recent years has become increasingly popular as an alternative to intravenous diuretics for patients with acute decompensated heart failure with acute cardiorenal system (type 1), the first clinical trial to test its value shows that it is inferior to standard drug therapy. The results of CARRESS-HF (Cardiorenal Rescue Study in Acute Decompensated…

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RELAX-AHF Stirs Interest In Novel Drug For Acute Heart Failure

A new drug modelled on a hormone active in pregnancy may prove beneficial to patients with acute decompensated heart failure. Serelaxin is a recombinant form of human relaxin-2, which is known to mediate the hemodynamic changes that occur during pregnancy. The drug is under development by Novartis for use in acute heart failure. In the…

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BLOCK HF: A “Game Changer” For Cardiac Pacing

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Dr. Schloss was an investigator in the BLOCK HF trial. In what has been described as a “game changer” for the field of…

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ALTITUDE Autopsy Shows What Went Wrong With Aliskiren

In its short lifespan the direct renin inhibitor aliskiren (a.k.a., Rasilez or Tekturna) rapidly declined from being a highly promising, first-of-its kind drug to a major failure. The death blow was struck last December with the early termination of the ALTITUDE trial, after the data and safety monitoring committee found an increased risk in patients taking aliskiren. Now the final results…

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Novartis Announces Top Line Results For Phase 3 Trial Of New Acute Heart Failure Drug

Novartis announced preliminary results from the RELAX-AHF trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea. Novartis also reported a reduction in all cause mortality at 6 months. However, it should be…

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News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD

Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…

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ESC: Trial Finds No Benefit For Intraaortic Balloon Counterpulsation In Cardiogenic Shock

Despite a lack of evidence, circulatory support with intraaortic balloon counterpulsation (IABP) has a class 1 recommendation in the guidelines and is often used in patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. That situation may change soon, as no benefit was found for the use of IABP in the…

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First Detailed Look At Why Aliskiren Failed To Gain ALTITUDE

Last December the once-promising direct renin inhibitor aliskiren (Rasilez, Tekturna) suffered a fatal setback with the early termination of the ALTITUDE trial. The trial was stopped when the Data Monitoring Committee (DMC) found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months. At the ESC in Munich ALTITUDE investigator Hans-Henrik…

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Risks and Benefits Of Pediatric Ventricular Assist Device Explored

Few options besides extracorporeal membrane oxygenation (ECMO) have been available for children with systolic heart failure awaiting transplantation. Now a new report by Charles Fraser, Jr and colleagues published in the New England Journal of Medicine provides important new information about a ventricular assist device (VAD) designed for children. Trial investigators implanted 48 patients with the Excor…

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Stem Cell Therapy Company Hypes Preliminary Results

Update (July 6)–  I have heard from several investigators in the trial that the Osiris press release was issued without any input or consultation from the site investigators. In fact, the site investigators, including several who are  extremely experienced clinical trialists, have expressed frustration and disappointment because their input has not been sought at any point…

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Many CHF Patients Not Receiving– Or Getting Benefits From– High Dose ACE Inhibitors And ARBs

Although current guidelines recommend that ACE inhibitors and angiotensin-receptor blockers (ARBs) be used in high doses in patients with congestive heart failure, many CHF patients currently receive lower than recommended doses of these drugs. In a research letter published online in Archives of Internal Medicine, investigators in Montreal analyzed data from 43,405 patients with a first…

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Company Fails To Disclose Details About Heart Failure Risk of Drug

Boehringer Ingelheim failed to fully disclose data suggesting that one of its drugs, pramipexole,  a dopamine agonist sold under the brand name of Mirapex, is associated with a significantly increased risk of heart failure, according to a recent news report. The drug, which was originally developed for the treatment of Parkinson’s disease, is now also used to treat…

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WARCEF: No Advantage For Warfarin Over Aspirin In Heart Failure

A new study offers “no compelling reason” to use warfarin instead of aspirin in heart failure patients who don’t have atrial fibrillation. In a paper published in the New England Journal of Medicine, Shunichi Homma and members of the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) study group report the results of a trial…

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FDA Advisory Panel Gives Green Light To HeartWare Ventricular Assist System

The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted  8-3 that the device…

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Study Sheds Light on Cardiac Device Infective Endocarditis

A new study sheds light on a rare but highly dangerous complication associated with device implants: cardiac device infective endocarditis (CDIE). Approximately 10-23% of device infections result in CDIE, leading, in one estimate, to an overall rate of 1.14 cases per 1,000 device-years. In a paper published in JAMA, Eugene Athan and colleagues analyzed data from 3,284…

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Study Evaluates Losartan Efficacy in Heart Failure

The angiotensin II-receptor blocker (ARB) losartan has labored under the perception that it is not as potent as other ARBs, and some evidence has suggested that it may not confer the same clinical benefits as other ARBs in heart failure patients. In a paper from Denmark published in JAMA, Henrik Svanström and colleagues performed a country-wide registry study…

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