Search Results for: paradigm hf

PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment

So far as I can tell the only problem with PARADIGM-HF is that the results are so good that it’s boring. Anyone interested can reasonably assume that what they hear or read about PARADIGM-HF — and cardiologists will be seeing and hearing an awful lot about it —  will be overwhelmingly positive. Briefly, the trial did…

Click here to continue reading…

Predicting PARADIGM-HF, Or What To Expect When You’re Expecting

The wait is almost over. For the last 5 months the most eagerly awaited trial in the cardiovascular universe has been PARADIGM-HF, the large (8,500 patient) trial of a new and novel heart failure drug from Novartis. If reality lives up to the early hope and hype, the drug, LCZ696, could completely reshape the heart failure landscape…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

Novartis Contest Rewards Positive Peer Review Articles About Entresto

(See the bottom of the story for updates. Since the original publication of the story the cardiologists on the “peer review panel” have resigned and Novartis has withdrawn its support for the contest.) Despite the fact that it had one of the biggest clinical trial successes in recent years, the Novartis heart failure drug Entresto has…

Click here to continue reading…

Hot Lines, Simultaneous Publications, And The Decline Of Medical Meetings

Back in the Dark Ages when I covered big medical conferences (like the European Society of Cardiology meeting now getting underway in London) it was necessary to attend the sessions, roam the halls, and talk to doctors. There were no late-breaking or hot line sessions and there were certainly no simultaneous publications in journals. (If memory…

Click here to continue reading…

Clinical Trials: You Can’t Always Get What You Want

–Trial investigators have lost control of their trials’ messages. Editor’s Note: The following is a lightly edited version of a talk I presented (without slides!) at the CVCT workshop in Washington, DC earlier this week. The topic was the changing role of media in communicating the results of clinical trials. When it comes to the…

Click here to continue reading…

After Slow Start Entresto Is Poised For Takeoff

–Novartis sees open road to blockbuster status for heart failure drug After a slow start, the novel heart failure drug Entresto (valsartan/sacubitril) is now poised to become a blockbuster, if drugmaker Novartis’s projections are on target. The combination pill will record sales of about $500 million in 2017 and may eventually achieve $5 billion in…

Click here to continue reading…

Cardiac Stem Cell Therapies May Get Boost From New FDA

–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain FDA approval far earlier than most people expect, despite the fact that these therapies have consistently failed to produce any convincing evidence of safety and efficacy. Under the old FDA…

Click here to continue reading…

Recent Blow Ups Spark Call For Overhaul Of Clinical Trials

[Updated] –Trial leaders say they need to get down into the weeds of trial details. Large international trials are under fire. In recent weeks, as I’ve reported, serious questions have been raised about three major heart failure trials. There is no reason to believe these are the only trials about which questions will be raised…

Click here to continue reading…

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…

Click here to continue reading…

Time For Cardiologists To Start Prescribing Diabetes Drugs?

There’s an emerging consensus that now may be the time for cardiologists to start thinking seriously about prescribing diabetes drugs. Until now most cardiologists have not considered this to be part of their job description. But now new data from large cardiovascular outcome trials (CVOTs) shows that these drugs may one day become, like statins and…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

2015: The Year We Finally Cured Heart Disease!

Editor’s note: Larry was too depressed to write the 2015 yearly review. Veteran healthcare journalist and eternal optimist Candide Corn volunteered to take over the task this year. Candide’s motto is “all is for the best in the best of all possible worlds.” What a great year for cardiology! The year brought us an unending…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…