Long-Term Benefit in HF Patients Elusive for Novel Vasodilator

–Investigational drug ularitide had no effect on mortality or clinical outcomes NEW ORLEANS — Short term vasodilator treatment for acute heart failure in the hospital did not lead to long term clinical benefits in the largest and most rigorous trial in the field yet performed, researchers said. In the TRUE-AHF trial 2,157 patients with acute…

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Caffeine Study Gives Heart Failure Patients Green Light To Drink Coffee

–A small but rigorous study found no arrhythmias caused by caffeine consumption. Many people with heart failure are advised to avoid coffee because of fears that caffeine might provoke an arrhythmia. Now a rare example of a randomized controlled trial in the field offers some assuring evidence that these patients can safely drink coffee. The…

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Debate: Switching From Standard HF Therapy To Entresto

–A debate at the HFSA in Orlando over whether all patients tolerating standard therapy should be switched to Entresto. Editor’s Note: Heart failure specialist Eiran Z. Gorodeski (Cleveland Clinic) wrote this account of an important debate on Monday at the Heart Failure Society of America meeting in Orlando. (This account has been updated by Gorodeski with…

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New Heart Failure Drug Struggles To Find Its Footing

–Experts offer insight about Entresto at the ESC. Despite its success in a large and widely praised clinical trial the novel heart failure drug Entresto (sacubitril/valsartan, Novartis) has been struggling to gain a substantial foothold in the marketplace. Now new papers and presentations and commentary from experts at the European Society of Cardiology meeting are…

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Anticipated Heart Failure Trial Delayed Until November

–The results of TRUE-AHF won’t be presented at the ESC. The results of a highly anticipated and already-delayed clinical trial won’t be presented until November at the American Heart Association meeting in New Orleans. Presentation of the trial was originally scheduled earlier his year as a late-breaking presentation at the American College of Cardiology meeting…

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Flu Vaccine May Benefit Heart Failure Patients

–Studies find fewer hospitalizations and less dementia after vaccination Two new observational studies offer new evidence that heart failure patients may benefit from the flu vaccine. The studies were presented in Florence, Italy, at the Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure. In the first study Kazem Rahimi (University of…

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Entresto Gets Boost in Updated HF Guidelines

–Valsartan/sacubitril earns Class I recommendation Cardiology groups in the U.S. and Europe have updated their heart failure guidelines to include much-awaited recommendations for Entresto (the combination of valsartan and sacubitril manufactured by Novartis). The new guidelines offer broad support for the new drug. Since its approval last summer Entresto has struggled to gain a foothold…

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Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug

–The company plans to perform 40 clinical trials in 5 years with Entresto. Novartis announced today an enormous clinical trial program with its promising but slow starting heart failure drug Entresto (valsartan/sacubitril). The company said it would perform 40 clinical trials with the drug in the next five years. The Fortifying Heart Failure clinical evidence and…

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New Cardio Drugs Off To Very Slow Start

–Heart failure experts divided over how and when to use Entresto To many long-time observers, the approval last year of two new cholesterol drugs and a heart failure drug appeared to herald a rebirth of the cardiovascular marketplace after a long period of dormancy. But so far in 2016, those new drugs have hardly made…

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Companies Plan To Study Diabetes Drug In Heart Failure Population

–New attention paid to the intersection of heart failure and diabetes Boehringer Ingelheim and Eli Lilly announced on Wednesday that they were planning two separate outcomes trials to test the effect of the diabetes drug empagliflozin (Jardiance) in patients with chronic heart failure. The trials herald a remarkable shift in emphasis, since there have been…

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FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels

The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the  saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that…

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ATMOSPHERE: Heart Failure Trial Poisoned By Controversy

–Aliskiren raised regulatory pandemonium as it crashed in trials When it comes to interrupting the renin-angiotensin system, the third time was definitely not the charm. Following the enormous success of the ACE inhibitors and angiotensin-receptor blockers, there were early high expectations for a third class of drugs, the direct renin inhibitors. Those hopes were dashed…

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After a Decade, CABG Pulls Ahead of Meds for HF

–Life-saving benefit of CABG now clear in long-term trial follow-up Finally, after 10 years of follow-up, the life-saving benefits of coronary artery bypass graft (CABG) surgery in heart failure patients with coronary artery disease are clear. More than 15 years ago, the NIH funded the original STICH trial to answer a question that was already…

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Top HF Expert Decries ‘Unbelievable Folly’ of Clinical Trials and Guidelines

–Milton Packer, MD, calls the system to test and evaluate heart failure drugs dysfunctional The system is completely broken, writes heart failure specialist Milton Packer, MD, in an editorial in Circulation: Heart Failure. The results of important clinical trials are not being incorporated into guidelines quickly, intelligently, or consistently, Packer argued. The most important reason…

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LVADs Prolong Life But Sow Confusion

–Patients with LVADs and their caregivers suffer from confusion and uncertainty at the end of life.  More and more people with advanced heart failure are receiving left ventricular assist devices (LVADs) as destination therapy. Now clinicians who treat these patients are reporting that the patients and their caregivers are suffering from an extraordinary amount of…

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Deals Seek To Link Entresto Cost To Effectiveness

For two large insurance companies payment for the new heart failure drug Entresto will be linked to its health benefits. Both Cigna and Aetna have confirmed that they have reached a pay-for-performance deal with the drug’s manufacturer, Novartis. According to  a press release issued by Cigna, “the pay-for-performance agreement ties the financial terms to how…

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Entresto Maker In Deep Water Over Terrifying TV Advertisement

Updated with comments from Novartis and Mary Knudson– A Novartis television commercial and advertising campaign is terrifying millions of people and provoking sharp criticism from doctors. The critics include Milton Packer, a top expert who ran the main trial testing the company’s big new heart failure drug, Entresto. The ad depicts a middle-aged man in…

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Slow Start For ‘Blockbuster’ Heart Failure Drug Entresto

Entresto, the new heart failure drug from Novartis that is widely expected to be a blockbuster, is off to an exceptionally slow start. Approved last July, the drug, formerly known as LCZ 696, had sales of only $21 million in 2015, only $5 million of which came in the fourth quarter. Despite low expectations in the early…

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Paper Raises More Questions About Salt Restriction In Heart Failure

Sodium restriction is a cornerstone of heart failure management, but many people would be surprised to learn that there is no good supporting evidence for the practice. In the 2009 heart failure guidelines sodium restriction in heart failure received a Class I recommendation (recommended), but this was based only on expert consensus (a C level of evidence of…

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More Concerns Raised About Possible Risks Of New Heart Failure Drug

(Updated with an additional comment from Milton Packer) More safety concerns are being voiced about Entresto, the new, ballyhooed heart failure drug from Novartis.  Fueling these concerns is a mix of speculation, worry about the FDA’s rapid approval of the drug, and a long-running feud between two leading heart failure researchers. The concerns, raised in a JAMA Viewpoint by heart failure…

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PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years

Treatment with Entresto (the combination of sacubitril and valsartan, formerly known as LCZ 696) instead of an ACE inhibitor will add approximately one to two years of life for most people taking the drug, according to new estimates published in the New England Journal of Medicine. Because of the time and population limitations of clinical trials it…

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Novartis Heart Failure Drug Gains Approval In Europe

Entresto, the novel heart failure drug from Novartis, has now been approved in Europe. The company said the drug, a twice-a-day combination of sacubitril and valsartan (formerly known as LCZ 696), had been approved by the European Commission for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). The news follows previous approval of the drug by…

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Slow Start For New Novartis Heart Failure Drug Entresto

Initial sales of Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) have been slow. In the first few months after its approval in July the drug only had $16 million in sales, the drug’s manufacturer, Novartis, reported last week during its quarterly earnings report. The novel heart failure drug is widely expected to be…

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Heart Failure Experts SPRINT To An Early Finish

According to a recent news report a group of prominent heart failure doctors  have eagerly embraced a lower blood pressure target of 120 mm Hg for heart failure patients based on the preliminary results of the SPRINT trial announced last month. But another equally prominent heart failure doctor says that it is far too early to…

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Sanjay Kaul On The Empa-Reg Outcome Study

The really big medical news today is the publication of the highly anticipated Empa-Reg Outcome study in the New England Journal of Medicine. It is the first large clinical trial with a diabetes drug (empagliflozin, Jardiance) to demonstrate a significant reduction in cardiovascular outcomes. The trial even resulted in a surprising, statistically significant reduction in mortality. I asked Sanjay Kaul for…

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