Editor’s note: 86-year-old Nina Mishkin was still healthy and active when she went to Dublin, Ireland last September. After she returned home she developed atrial fibrillation, and then much more. “I never felt particularly vulnerable and fragile before,” she writes. “Now I do… It’s a different universe I inhabit.” I am grateful to Nina for giving…
After Slow Start Entresto Is Poised For Takeoff
December 5, 2017 by 1 Comment
–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…
Some Doctors Reluctant To Deactivate LVADs
October 4, 2017 by 3 Comments
–LVAD deactivation is not euthanasia or physician-assisted suicide. Left ventricular assist devices (LVADs) are used increasingly as destination therapy instead of as a temporary bridge until a donor heart becomes available for transplantation. Now patients, their families, and their caregivers are forced to confront the extremely difficult question of when and how to turn off…
Big Mismatch In Risk Perception Between Heart Failure Patients and Their Physicians
August 17, 2017 by 4 Comments
There’s a big discrepancy between the way patients with “advanced” heart failure view themselves and the way their doctors view them, a new study published in JACC: Heart Failure shows. In a cohort of 161 ambulatory patients with advanced heart failure, physicians categorized 111 patients (69%) as being at high risk for urgent transplant, LVAD,…
Sudden Death Declining in Heart Failure
July 5, 2017 by Leave a Comment
–Does the trend mean that ICDs are indicated less often? The incidence of sudden death in heart failure patients with reduced ejection fraction, in clinical trials, has declined significantly in the last 20 years, according to a new study published in the New England Journal of Medicine that may impact inclination to recommend implantable cardioverter-defibrillators…
Last Beats of the Failing Heart — Two Views
May 30, 2017 by 1 Comment
–Milton Packer and Richard Lehman compare perspectives, Part 3 Editor’s note: This is the third installment of an ongoing discussion about heart failure (HF) between Milton PackerMD, who has been leading major heart failure clinical trials for decades, and Richard Lehman, MA, BM, BCh, MRCGP, a retired U.K. GP who writes a blog for the…
Should Everyone With Heart Failure Get Aggressive Treatment?
May 23, 2017 by 1 Comment
–A Conversation About Heart Failure With Milton Packer And Richard Lehman (Part 2) This is the second installment of an ongoing discussion about heart failure between Milton Packer, who has been leading major heart failure clinical trials for decades, and Richard Lehman, a retired UK GP who writes a blog for the BMJ website. (Click…
A Conversation About Heart Failure With Milton Packer And Richard Lehman
May 17, 2017 by 2 Comments
Milton Packer and Richard Lehman are both 66 years of age. Packer has been leading major heart failure clinical trials for decades. Lehman is a retired UK GP who writes a blog for the BMJ website. The two have agreed to answer questions and participate in a discussion about their different ideas and perspectives about…
Recent Blow Ups Spark Call For Overhaul Of Clinical Trials
May 11, 2017 by 2 Comments
[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…
Another Acute Heart Failure Drug Fails In Large Clinical Trial
May 5, 2017 by 2 Comments
–In RELAX-AHF-2 serelaxin didn’t improve clinical outcomes. Yet another promising drug for acute heart failure has failed to improve long-term outcomes. In the RELAX-AHF-2 trial 6,600 patients hospitalized for acute heart failure were randomized to a 48-hour infusion of serelaxin or placebo. There was no significant difference between the two groups in either of the…
As Another Trial Goes Bust Investigators Call For Major Changes In International Trials
April 29, 2017 by 2 Comments
–Why were so many ineligible patients in Eastern Europe enrolled in TRUE-AHF? A new analysis of the recent TRUE-AHF trial offers strong evidence that large numbers of patients from Eastern Europe were ineligible for the trial and should not have been enrolled. The analysis doesn’t change the main finding of the trial, but it does…
Serious Questions Raised About Integrity Of International Trials
April 26, 2017 by 4 Comments
–TOPCAT analysis is the ‘smoking gun’ for trouble from ‘offshoring’ trials. Large international randomized controlled trials, the cornerstone of modern medicine, are in big trouble. As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries…
Ularitide Still a Bust After TRUE-AHF Peer Review
April 12, 2017 by Leave a Comment
–As reported at AHA, novel vasodilator failed to improve outcomes in heart failure Short-term treatment with the novel vasodilator ularitide did not lead to improved clinical outcomes in the long term. Results of the TRUE-AHF trial, first presented in preliminary form last November at the American Heart Association annual meeting, have now been published in…
Long Unsuccessful Heart Failure Drug Once Again At Center Of Controversy
January 23, 2017 by 9 Comments
–The long, strange 30-year journey of BiDil. It’s been buried in the avalanche of related news but there’s an interesting and somewhat bizarre cardiology angle to the debate over Trump’s nomination of Tom Price to be the next HHS Secretary. ProPublica reported on Friday that last summer Price went to bat for the makers of…
Novartis Withdraws Support For Controversial Entresto Contest
December 19, 2016 by 3 Comments
(Updated) Novartis will no longer sponsor a contest designed to support the publication of peer review articles about Entresto, the company’s important new heart failure drug. The contest is taking place on Cureus, an open access journal, publishing platform, and vehicle for industry-sponsored content. The contest offered $10,000 in rewards for articles supporting a recent…
Novartis Contest Rewards Positive Peer Review Articles About Entresto
December 15, 2016 by 3 Comments
(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…
Long-Term Benefit in HF Patients Elusive for Novel Vasodilator
November 13, 2016 by Leave a Comment
–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…
Caffeine Study Gives Heart Failure Patients Green Light To Drink Coffee
October 17, 2016 by 1 Comment
–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…
Debate: Switching From Standard HF Therapy To Entresto
September 21, 2016 by 5 Comments
–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…
New Heart Failure Drug Struggles To Find Its Footing
August 29, 2016 by 1 Comment
–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…
Anticipated Heart Failure Trial Delayed Until November
August 23, 2016 by Leave a Comment
–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…
Flu Vaccine May Benefit Heart Failure Patients
May 24, 2016 by Leave a Comment
–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…
Entresto Gets Boost in Updated HF Guidelines
May 20, 2016 by 1 Comment
–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…
Novartis Announces Enormous Clinical Trial Program For Heart Failure Drug
May 19, 2016 by Leave a Comment
–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…
New Cardio Drugs Off To Very Slow Start
April 27, 2016 by Leave a Comment
–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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