FDA Approves Amgen Heart Failure Drug Reply

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.

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Gilead’s Hepatitis Drugs Tripped By Old Heart Drug Reply

Late last week Gilead Sciences issued a warning about a rare but potentially fatal interaction between its stellar new hepatitis C drug sofosbuvir and amiodarone, a potent but tricky antiarrhythmic agent. Sofosbuvir is marketed as Sovaldi and, in combination with another antiviral agent, as Harvoni. Amiodarone, which is used to treat dangerous heart rhythm problems, has a number of different side effects and an extremely long half-life. Its use is generally reserved for difficult cases.

Gilead reported nine cases of symptomatic bradycardia (slow heart rate). One patient died of a cardiac arrest and 3 patients received a pacemaker.

Click here to read the full post on Forbes.

 

What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific Reply

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions.

Click here to read the full post on Forbes.

 

FDA Approves New Oral Anticoagulant From Daiichi Sankyo 1

And then there were four.

Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace…

Click here to read the full post on Forbes, including a comment from Sanjay Kaul.

 

Study Suggests Epinephrine for Cardiac Arrest May Be Harmful Reply

Epinephrine has been a cornerstone of therapy during cardiac resuscitation after cardiac arrest because of its well-established ability to stimulate the heart and increase the probability of a return of spontaneous circulation (ROSC). In recent years, however, concerns have been raised that people treated with epinephrine may have worse neurological outcomes following their resuscitation.

In a study published in the Journal of the American College of Cardiology, French researchers analyzed data from more than 1,500 patients who were successfully resuscitated after an out-of-hospital cardiac arrest and were subsequently treated at a large hospital in Paris….

Click here to read the full post on Forbes.

 

FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug Reply

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed.

Click here to read the full post on Forbes.

Grad Student Invents Flying Ambulance Drone To Deliver Emergency Shocks Reply

Drones have been used to kill people in war zones and to spy on people. Now a sharp young  graduate student in the Netherlands has come up with an innovative new use for drones that could one day help save thousands of lives.

Click here to read the full post on Forbes.

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FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device Reply

The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use.

Click here to read the full post on Forbes.

 

Novel Boston Scientific Device Headed For Another Rough FDA Panel Reply

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak through.

Click here to read the full post on Forbes.

 

Counterintuitive Advice About Staying Alive After A Heart Attack 1

An interventional cardiologist– the cardiologists who put in stents and usually treat heart attack patients in the first few hours– asked an electrophysiologist– the cardiologists who treat arrhythmias– whether wearable defibrillators should be used post-MI. Here’s what that electrophysiologist, Edward J. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, replied. It is a good example of how sometimes a procedure or a therapy that seems, intuitively, to be worthwhile and beneficial, may actually not be beneficial at all. Here’s his response, which he originally posted on Twitter:

Click here to read the full post on Forbes.

 

SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug Reply

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 failure indication.

Now a very large new study presented at the European Society of Cardiology meeting in Barcelona and published simultaneously in the New England Journal of Medicine has found no evidence of benefit in a stable angina population and found more adverse events associated with the drug and even suggested the likelihood of harm in a very large and important trial subgroup. The findings have resulted in an investigation by the European Medicines Agency, placing a cloud over the future status of the drug.

Click here to read the full post on Forbes.

 

Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference Reply

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.

According to the ESC, the SIGNIFY investigators, who include Kim Fox, Ian Ford, Philippe Gabriel Steg, Jean-Claude Tardif, Michal Tendera, and Roberto Ferrari, told the ESC leadership that regulators at the European Medicines Authority (EMA) had told the investigators that because they (the investigators) were scheduled to appear before the EMA they should not discuss or comment on their trial outside the official presentation at the ESC conference.

Click here to read the full post on Forbes.

 

 

 

Increased Heart Risk Linked To Popular Antibiotic Reply

Acute use of the popular macrolide antibiotic clarithromycin has been linked to a small but significant increase in cardiac death. In a report in the BMJ, researchers in Denmark analyzed the effects over a 14-year period of the acute use of penicillin V, roxithromycin, and clarithromycin.

Earlier research raised concerns that marcrolide antibiotics in general, and erythromycin and azithromycin in particular, might prolong the QT interval and increase the risk for fatal arrhythmias.

In the new study, clarithromycin was associated with a significant increase in the rate of sudden cardiac death compared with the other two antibiotics…

Click here to read the full post on Forbes.

 

Study Offers Little Support for an Old Drug Reply

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 arrived. There have been no good trials in AF.

A new observational study published in the Journal of the American College of Cardiology now provides the most detailed perspective on digoxin use in AF. …

Click here to read the full post on Forbes.

 

J Am Coll Cardiol. 2014; 64(7): 660-668.

 

 

Death By Running: It’s The Heat And Not The Heart Reply

The growing popularity of marathons and other extreme sports has sparked worries about the potential dangers of these activities. The popular press and medical research have both focused on the risk of cardiac arrest and other heart rhythm problems. But  that concern may be misdirected. A new study from Israel published in the Journal of the American College of Cardiology finds that a much more serious danger may be heat stroke, which is defined as a core body temperature above 104 or 105 degrees associated with multiorgan dysfunction.

Click here to read the full post on Forbes.

 

English: Marthon Tel Aviv - A view on the beac...

English: Marthon Tel Aviv – A view on the beach עברית: מרתון תל אביב – מראה על הים (Photo credit: Wikipedia)

More Questions Raised About Boehringer Ingelheim’s Pradaxa 1

Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the  investigations editor for The BMJ, casts doubt on the reliability of the data supporting the drug as well as the behavior and decisions of regulatory authorities, trial investigators, and employees  of Boehringer Ingelheim, the drug’s manufacturer.

Click here to read the full post on Forbes.

 

ESC Hot Lines: First Real Data On Promising Novartis Heart Failure Drug Reply

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 in cardiovascular mortality in patients taking LCZ696 (a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor) instead of the current gold standard of treatment, an ACE inhibitor….

Here is the complete list of Hot Line trials:

Click here to read the full post on Forbes.

 

Yet Another Delay For Boston Scientific’s Watchman Device Reply

Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said that it had been informed by the FDA that it will need to undergo yet another advisory panel before gaining approval.

Click here to read the full post on Forbes.

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Prophylactic ICDs Appear Effective In Less Severe HF Patients Reply

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 clinical trials.

Now a new study published in JAMA suggests that the benefits in this group are similar to the benefits in heart failure patients with more severely depressed EFs.

Click here to read the full post on Forbes.

 

Hospitalizations For Atrial Fibrillation Are On The Rise Reply

In recent years there has been an explosion of interest in atrial fibrillation (AF), the most common heart rhythm disorder. Although it is sometimes thought to be relatively benign, AF increases the risk of stroke if untreated. Even if treated, it can be the source of significant discomfort and can contribute to additional complications, especially when accompanied by other cardiovascular conditions. Now a new study published in Circulation finds that hospitalizations for AF are on the increase, and this may have important implications for the delivery and economics of health care in the coming years.

Researchers analyzed data  from nearly 4,000,000 hospitalizations in which AF was the primary discharge diagnosis from the years 2000 through 2010. Here are some of their key findings:

Click here to read the full post on Forbes.

 

Exercise: Can There Be Too Much Of A Good Thing? Reply

In recent years researchers have developed a more complicated view of the relationship of health and exercise. Although observational studies have consistently shown that some physical activity is better than none, studies that have drilled deeper into the data suggest that these health benefits may be curtailed in people who exercise very frequently or very intensely. Now two new studies from Europe, published in the journal Heart, offer new support for these observations.

Click here to read the full post on Forbes.

 

FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa Reply

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared to warfarin. But the study also found that, dabigatran was associated with an increased risk for major gastrointestinal bleeding. There was no difference between the drugs in the risk of MI.

Click here to read the full post on Forbes.

 

Routine Shock Testing Not Required During ICD Implantation Reply

When cardiologists implant defibrillators in patients at high risk of dying from a heart rhythm disorder they nearly always perform a defibrillation test in which they induce a lethal arrhythmia, ventricular fibrillation, to make sure the device accurately detects the arrhythmia and terminates it with an appropriate shock. But routine defibrillation testing has never been shown to be safe or necessary. In recent years some experts have maintained that routine defibrillation testing may not be necessary.

Now a new study, presented yesterday at the Heart Rhythm Society meeting in San Francisco, offers evidence that although routine testing is generally safe it may increase complications without producing any improvement in outcomes.

Click here to read the full post on Forbes.

 

 

MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D Reply

MADIT-CRT was an influential trial that showed a reduction in heart failure complications — but not mortality — when cardiac resynchronization therapy (CRT) was added to an implantable defibrillator in patients with mild heart failure who also had left bundle-branch block (LBBB). Patients in the trial were followed for 2.4 years, raising questions about the long-term effects of CRT. Now, a second look at 854 patients who participated in a follow-up study, presented at the American College of Cardiology and published in the New England Journal of Medicine, suggests that over the long term, CRT may save lives in this population. MADIT-CRT was sponsored by Boston Scientific.

Click here to read the full post on Forbes.

 

 

 

MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D