A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and…
FDA Advisory Panel Recommends Against Approval Of Novartis Heart Failure Drug
March 27, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last…
FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug
March 25, 2014 by 1 Comment
Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year. On Thursday the FDA’s Cardiovascular and Renal Drugs…
Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials
March 12, 2014 by Leave a Comment
Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of prominent cardiovascular and diabetes researchers. It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. Now, however, that belief is no longer widely held and the FDA now…
European Setback For Novartis Heart Failure Drug
January 24, 2014 by Leave a Comment
European regulators have dealt a setback to a novel heart failure drug under development by Novartis. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which…
FDA Advisory Panel To Review New Heart Failure Drug From Novartis
January 7, 2014 by Leave a Comment
A novel acute heart failure drug from Novartis will be evaluated next month by an FDA advisory committee, perhaps countering a long string of crash-and-burn cardiology drugs. On February 13 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection from Novartis. The indication is for the improvement of the…
Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck Drug?
December 4, 2013 by Leave a Comment
Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the…
CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel
October 9, 2013 by Leave a Comment
The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System. The small implantable device provides provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that…
Study Raises Questions About Digoxin Use Today
September 24, 2013 by Leave a Comment
Digitalis is one of the oldest medicines in the cardiovascular arsenal. When William Withering identified digitalis as the active ingredient in the foxglove plant more than 200 years ago he was only codifying a longstanding folk remedy for heart failure, or “dropsy” as it was known then. Digitalis fully entered the modern era with the…
Study Fails To Support Broader Patient Population For Cardiac-Resynchronization Therapy
September 3, 2013 by Leave a Comment
Cardiac-resynchronization therapy (CRT) has been shown to be beneficial in heart failure (HF) patients with a wide QRS interval. These benefits have not been reproduced so far in patients with narrow QRS intervals, though many such patients have ventricular dyssynchrony. Now a new study, presented at the European Society of Cardiology in Amsterdam and published…
Automatic Wireless Monitoring Shows Benefits in Chronic Heart Failure
September 2, 2013 by Leave a Comment
Following in the wake of studies that failed to find benefits associated with remote wireless monitoring of heart failure (HF) patients, the In-Time trial, presented at the European Society of Cardiology meeting in Amsterdam, is the first trial to show that home monitoring of HF patients may be beneficial. Gerhard Hindricks, the coordinating investigator of…
Faint PRAISE: 13 Year Delay In Publication Of A Major Clinical Trial Sparks Criticism
August 5, 2013 by Leave a Comment
13 years after first being presented the results of the PRAISE-2 trial finally have been published in JACC: Heart Failure. The trial itself is now largely irrelevant to current clinical practice, as the hypothesis it tested has long been abandoned, but the long delay in publication may serve to bring even more awareness to the…
Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA
June 27, 2013 by 1 Comment
Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the…
Interpretations Differ Over Study Of Coenzyme Q10 In Heart Failure
May 28, 2013 by Leave a Comment
Coenzyme Q10 (CoQ10) may be beneficial in heart failure, according to the results of the Q-SYMBIO study presented this past weekend at the Heart Failure 2013 meeting in Lisbon, Portugal. But the results should be viewed with a critical eye, say experts. … Click here to read the full post on Forbes, including a comment from Milton…
European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System
May 20, 2013 by 1 Comment
The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure. The EMA said that the review was being performed to…
Study Questions Role Of Dual-Chamber ICDs For Primary Prevention
May 14, 2013 by Leave a Comment
Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC…
FDA Warns That Tolvaptan Can Lead To Serious Liver Injury
May 1, 2013 by 1 Comment
The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because…
BLOCK HF: CRT Superior To Conventional Pacing In Heart Failure Patients With AV Block
April 24, 2013 by Leave a Comment
Patients with atrioventricular (AV) block generally receive right ventricular pacing; cardiac resynchronization therapy (CRT) has been restricted to patients with a low ejection fraction and a wide QRS duration. However, RV pacing may worsen LV dysfunction in AV block patients with low ejection fractions. Previous studies have raised the possibility that these patients may…
Another Negative Trial With Darbepoetin Alfa
March 10, 2013 by 1 Comment
Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine. A total of 2278 patients with systolic heart failure…
Eplerenone May Help Prevent Heart Failure In Acute STEMI Patients
March 10, 2013 by Leave a Comment
A new trial presented at the ACC in San Francisco suggests that the mineralocorticoid receptor antagonist eplerenone Pfizer, Inspra) may help prevent the development of heart failure when given acutely in STEMI patients without preexisting heart failure. In the REMINDER trial 1,012 STEMI patients were randomized to eplerenone or placebo. After 10.5 months of followup, the primary endpoint–…
Study Warns Against Dual Blockade of Renin-Angiotensin System In Heart Failure And Hypertension
January 28, 2013 by 1 Comment
The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the US currently receive this therapy. Now a large…
Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients
January 16, 2013 by Leave a Comment
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…
Observation Units For Heart Failure Could Reduce Unnecessary Hospitalizations
January 9, 2013 by 1 Comment
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…
Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF
January 7, 2013 by Leave a Comment
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…
WARCEF: No Advantage For Warfarin Over Aspirin In Heart Failure
May 3, 2012 by 1 Comment
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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