–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…
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…
Companies Plan To Study Diabetes Drug In Heart Failure Population
April 21, 2016 by 1 Comment
–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…
But Cardiomyopathy Isn’t Supposed To Be Funny
October 14, 2015 by Leave a Comment
Cardiomyopathy isn’t funny. In fact, sad to say, most of medicine isn’t exactly a laugh riot. But Jorge Muniz, a physician assistant and comic artist, wants to bring humor to medical education. Here’s a link to his kickstarter campaign. …
Heart Failure Experts SPRINT To An Early Finish
October 7, 2015 by Leave a Comment
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…
Cost Effectiveness Of Entresto And CardioMEMS Evaluated
September 14, 2015 by 1 Comment
The new Novartis heart failure drug Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) is cost effective but the CardioMEMS monitoring system (St. Jude Medical) is not, according to draft reports issued last week by the Institute for Clinical and Economic Review (ICER). The same organization released a widely discussed report about the cost…
Novartis Heart Failure Drug Gains Speedy FDA Approval
July 7, 2015 by Leave a Comment
Entresto, Novartis’s novel heart failure (HF) drug, gained FDA approval earlier today. The approval arrived 6 weeks ahead of the drug’s action date. Formerly known as LCZ 696, the drug had already received a fast track designation and an expedited review under the FDA’s priority review program.Novartis said the wholesale acquisition cost of Entresto will be $12.50 per day, less discounts….
Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel
May 22, 2015 by Leave a Comment
Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain. FDA approval of Entresto is expected…
200-Year-Old Heart Drug Linked To Increased Risk Of Death
May 5, 2015 by Leave a Comment
For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin. Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there…
FDA Approves Amgen Heart Failure Drug
April 15, 2015 by Leave a Comment
The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. … Click here to read the full post on Forbes. …
New Heart Drug From Novartis: Will It Raise The Risk of Alzheimer’s Disease?
February 9, 2015 by Leave a Comment
LCZ696 is a heart failure drug from Novartis that many observers think will gain FDA approval later this year and go on to become a blockbuster. Perhaps the biggest obstacle to the drug’s success is the fear that it might raise the risk of Alzheimer’s disease. Now a new article in a top cardiology journal lays out the detailed basis for…
FDA Approves New Heart Pump From Abiomed
January 28, 2015 by Leave a Comment
Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single arm Recover Right study, in which 30 patients were enrolled. The overall survival…
An Emerging Consensus About Novartis’s New Potential Blockbuster
January 7, 2015 by Leave a Comment
Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in…
SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug
August 31, 2014 by Leave a Comment
The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart…
Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference
August 30, 2014 by Leave a Comment
Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon….
PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment
August 30, 2014 by Leave a Comment
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…
Predicting PARADIGM-HF, Or What To Expect When You’re Expecting
August 27, 2014 by Leave a Comment
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…
Study Offers Little Support for an Old Drug
August 11, 2014 by Leave a Comment
Digoxin is one of the oldest drugs in the cardiovascular arsenal, derived from the foxglove plant and first described in the 18th century by William Withering. It is frequently used in patients with heart failure (HF) and with atrial fibrillation (AF). The few trials supporting its use were performed in HF patients before newer treatments…
Januvia Linked To Increase in Heart Failure Hospitalizations
July 2, 2014 by Leave a Comment
The cardiovascular effects of drugs used for glucose control in patients with diabetes have been a subject of controversy for many years now. More recently, attention has started to focus specifically on the risk for heart failure. Now, an observational study will likely raise new questions about the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck). In a…
ESC Hot Lines: First Real Data On Promising Novartis Heart Failure Drug
July 1, 2014 by Leave a Comment
The first real details about the much-anticipated novel new heart failure drug from Novartis will kick off this year’s Hot Line sessions at the annual meeting of the European Society of Cardiology in Barcelona, Spain. The meeting runs from August 30 until September 3. As I have previously reported, the PARADIGM-HF trial was stopped because of a highly statistically significant reduction…
Prophylactic ICDs Appear Effective In Less Severe HF Patients
June 3, 2014 by Leave a Comment
ICDs are routinely implanted in heart failure patients with ejection fractions (EFs) of 35% and lower to prevent sudden cardiac death. However, the benefits in patients at the higher end of the spectrum– between 30% and 35%– have not been well demonstrated in clinical trials, since few patients in this range have been enrolled in…
FDA Approves Novel Implanted Sensor To Monitor Heart Failure
May 28, 2014 by Leave a Comment
The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted…
FDA Rejects Novel Novartis Drug For Acute Heart Failure
May 16, 2014 by Leave a Comment
Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. … Click here to read the full post…
Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality
March 31, 2014 by 1 Comment
The largest-ever trial in heart failure was stopped early because of a highly statistically significant reduction in cardiovascular mortality, according to one of the trial’s two primary investigators. Earlier today I reported that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early because the trial had demonstrated…
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