FDA Approves New Omega-3 Supplement Reply

The FDA has approved a new omega-3 supplement for the treatment of adults with severe hypertriglyceridemia, defined as triglyceride levels 500 mg/dL or higher. The drug, which will be marketed under the brand name of Epanova, is manufactured by AstraZeneca, which acquired the drug when it purchased Omthera Pharmaceuticals in 2013.

Click here to read the full post on Forbes.

 

 

 

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FDA Comes Out Against Aspirin To Prevent First Heart Attacks 1

In the latest development in a long-simmering debate, the FDA has announced that aspirin should not be marketed for the prevention of a first heart attack or stroke in people with no history of cardiovascular disease. The announcement follows FDA’s rejection on Friday of Bayer Healthcare’s decade-old  petition requesting approval of a primary prevention indication. [PDF of FDA rejection letter]

Click here to read the full post on Forbes.

 

Another Failed HDL Therapy Trial Reply

Despite robust epidemiological evidence suggesting that HDL has a strong protective effect against cardiovascular disease, there has been no good evidence showing that HDL-based therapies are beneficial. Large trials of drugs that raise HDL levels, including niacin and CETP-inhibitors, have failed to demonstrate improvements in outcome. Some observers gleaned hope from several small studies of drugs that mimic HDL activity but these studies have been too small to offer convincing evidence. Now a new study– the largest to ever study an HDL mimetic– has failed to find even a glimmer of benefit.

Results of the CHI-SQUARE (Can HDL Infusions Significantly QUicken Atherosclerosis Regression) study were published online in the European Heart Journal.

Click here to read the full post on Forbes, with extensive comments from PK Shah and William Boden.

 

Stem Cell Therapy To Fix The Heart: A House Of Cards About To Fall? Reply

For more than a decade cardiac stem cell therapy has attracted an enormous amount of attention, promise, and research dollars. Now an original and important new study published in BMJ finds that many of the most promising results in the field are illusory and that the potential benefits of stem cells to treat heart disease are probably far more modest than we’ve been led to believe. The study also raises disturbing questions about ethics and research conduct (and misconduct) in a high-flying field.

Researchers in the UK, led by Darrel Francis, closely scrutinized 133 reports from 49 different clinical trials testing autologous bone marrow stem cells in patients with heart disease. They found an astonishingly large number  of discrepancies in the reports– altogether more than 600  discrepancies, ranging from minor oversights to serious unexplained errors and apparent deceptions. Many errors were mathematical or statistical errors while others were more general, such as conflicting descriptions of studies as either a prospective randomized trial or a retrospective observational study.

The key finding of the study is that there was a very strong correlation between the number of discrepancies in a study and the reported improvement in heart function as measured by left ventricular ejection fraction(LVEF)…

Click here to read the full post on Forbes.

 

What Role Should Coca-Cola Play In Obesity Research? 1

What role should Coca-Cola and other food and beverage companies play in funding and communicating research about nutrition and obesity?

The question is prompted by a recent article in the Journal of the American College of Cardiology. The “state-of-the-art” paper reviews the relationship of obesity and cardiovascular disease and presents the case that a decline in physical activity is the primary cause of the obesity epidemic.  The article downplays the role of calories and diet and does not include the words “sugar,” “soda,” or “beverage.” Three of the five authors of the paper report financial relationships with Coca Cola.

Click here to read the full post on Forbes.

 

Original illustration by Max Husten

Original illustration by Max Husten

 

New Study Lends Support For Alternative Heart Attack Treatment Strategy 2

It is generally agreed that the best treatment for heart attack patients is to immediately reperfuse the blocked artery with a stent. But many people live in areas where this strategy, known as primary PCI, is not available within the time frame when it produces the greatest benefit. Previous studies have found good short term outcomes in patients who receive a pharmaco-invasive strategy, in which patients first receive fibrinolytic therapy including a clot-busting drug and then later undergo angiography. Now long-term results from a large real-world study show that this strategy may be an acceptable alternative for some patients when immediate primary PCI is not available.

In a paper published in Circulation, French researchers report the 5 year mortality findings from nearly 1,500 STEMI patients enrolled in the 2005 cohort of FAST-MI (The French Registry on Acute ST-Elevation and Non–ST-Elevation Myocardial Infarction).

Click here to read the full post on Forbes.

 

Will Edwards Snatch Defeat From The Jaws Of Its Victory Over Medtronic? Reply

On the heels of a sweeping victory in the courts over its rival MedtronicEdwards Lifesciences is poised to dominate the TAVR (transcatheter aortic valve replacement) market– the revolutionary new catheter technology that offers some patients with life-threatening aortic valve disease an alternative to chest-splitting surgery. Although the legal wrangling is not quite over– Medtronic is appealing the decision and has requested that enforcement of the injunction be postponed– it appears likely that Edwards will ultimately achieve a broad legal and business victory.

But Edwards’ unprecedented victory also presents an unprecedented challenge to the company. While the court appears to have given Edwards everything it wished, the ultimate result could produce significant harm to Edwards’ relationship to the interventional cardiologists who are its core customers. More importantly, there is now a distinct possibility that at least for several years many people who could possibly benefit from the Medtronic technology will not be able to get it.

A Decisive Victory

In last week’s ruling a federal judge delivered a broad ruling in favor of Edwards:

Click here to read the full post on Forbes.

 

FDA Grants Fast Track Status To Amgen Heart Failure Drug Reply

Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an umet medical need, will aid the development and speed the review of the drug.

Click here to read the full post on Forbes.

 

New Medtronic Heart Valve Threatened By Court Decision Reply

A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery.

The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered the field of transcatheter aortic valve replacement with its Sapien devices, has sought to hinder Medtronic from competing in the US and international markets.

Click here to read the full post on Forbes.

 

The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure Reply

Following the spectacular crash and burn of the Symplicity HTN-3 trial at the American College of Cardiology two weeks ago, the future of renal denervation (RDN)– the once highly promising catheter technology that many thought would cure resistant hypertension– appears in doubt.

Although the device has not been approved in the US– and will not be approved without further clinical trials– in Europe and other places it remains on the market. So the questions about the technology’s future revolve around the future direction of research in the field and how the existing renal denervation market will be affected by the trial results.

Click here to read the full post on Forbes.

 

Lancet Editors Raise More Questions About Prominent Harvard Stem Cell Researcher Reply

There’s more trouble for Piero Anversa, the prominent and controversial stem cell researcher.

Today the Lancet issued an expression of concern about an influential, much-cited stem cell paper. As first reported by Retraction Watch, an investigation at Harvard Medical School and Brigham and Women’s Hospital has raised concerns about the integrity of data coming from Piero Anversa’s laboratory at the Brigham contained in the 2011 SCIPIO study published in the Lancet.

Here is the full Expression of Concern issued by the Lancet:

Click here to read the full post on Forbes.

 

Cardiology And The Medicare Data Avalanche Reply

The avalanche of data released by Medicare on Wednesday was followed shortly by an avalanche of news reports about the data. Here’s a review of some of the more significant cardiology-related details that came out in these stories.

Cardiology was the third in New York Times list of total Medicare payments received by the highest-paid 2% of doctors. This 2% accounted for nearly one-fourth of total Medicare payments. There were 2,176 cardiologists in the top 2% group and they received more than 1.6 billion dollars from Medicare. Ahead of cardiologists at the top of the list were ophthalmologists (2,995 providers who received more than $3.3 billion) and hematologists/oncologists (1,831 providers who received more than $2 billion).

The Washington Post‘s Wonkblog asked the top 10 Medicare billers to explain their charges…

Click here to read the full post on Forbes.

 

Troubled NHLBI TOPCAT Trial Disappoints Reply

Although a significant portion of people with heart failure have preserved ejection fraction, none of the proven heart failure therapies has been shown to be beneficial in this important and growing heart failure subpopulation. Now a new NHLBI-funded study has failed to find a benefit in this group for spironolactone, which is a cornerstone of therapy for heart failure patients with reduced ejection fraction. But trial investigators and heart failure experts believe it is too early to dismiss hope that spironolactone and other aldosterone antagonists– including Pfizer’s Inspra (eplerenone)– may eventually be found to work in this population.

TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), published in the New England Journal of Medicine, randomized 3,445 patients with heart failure with preserved ejection fraction (HFPEF) to either spironolactone or placebo.

Click here to read the full post on Forbes.

 

Circulation Retracts Paper By Stem Cell Pioneer And Its Own Editor Reply

Following an investigation by Harvard Medical School and Brigham and Women’s Hospital a 2012 paper published in Circulation has been retracted. The “institutional review… determined that the data are sufficiently compromised that a retraction is warranted.” The two senior authors of the paper are Piero Anversa, a pioneering researcher in cardiac stem cells, and Joseph Loscalzo, the editor-in-chief of Circulation and the chairman of the department of medicine at the Brigham.

Click here to read the full post on Forbes.

 

Study Suggests Link Between Viagra And Melanoma Reply

In recent years researchers have uncovered a potentially important pathway whereby PDE5A inhibitors (which include sildenafil– Viagra– and other drugs used to treat erectile dysfunction and pulmonary hypertension) could potentially increase the risk of developing melanoma. Now a new study provides early evidence showing an association between sildenafil and melanoma, though, like all observational studies, it is unable to demonstrate a cause-and-effect relationship.

Click here to read the full post on Forbes.

 

Title: Pathology: Patient: Melanoma Descriptio...

 

Boehringer Ingelheim’s Pradaxa Gains New Indication 1

The new oral anticoagulants continue to gain additional indications from the FDA. Earlier today Boehringer Ingelheim announced that the FDA had approved Pradaxa (dabigatran) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).

 Click here to read the full post on Forbes.

 

 

Cardiovascular Disease Declines in Rich Countries but Grows Elsewhere Reply

A new Global Cardiovascular Disease (CVD) Atlas portrays a divided world where rich countries are gradually freeing themselves from the yoke of CVD but where many poor and middle-income countries are still struggling.

Ischemic heart disease and stroke were the two biggest contributors to the global burden of disease in 2010, accounting for 5.2% and 4.1%, respectively, of all disability adjusted life years (DALYs)….

Click here to read the full post on Forbes.

 

A New Novartis Heart Failure Drug Might Be A Blockbuster Reply

I try to avoid using words like “blockbuster” and “breakthrough” when writing about new drugs and treatments. I’ve been disappointed too many times. But, though they’ve been in short supply lately in cardiovascular medicine, sometimes there really are breakthroughs and blockbusters. In my career writing about cardiovascular medicine I’ve seen the introduction of the ACE inhibitors, statins, stents, ICDs, and clopidogrel, among others. All of these became multibillion-dollar products. Now there’s a new candidate that just might join this group. I’ll tell you why, but I can’t emphasize strongly enough that right now we only have extremely preliminary information. So be warned. And don’t be completely surprised if it does bomb out. We’ve been down this road before.

As I reported previously (here and here), early on Monday Novartis disclosed that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early. As I later found out, the news was even better than Novartis had said in its press release. I spoke with the co-principal investigator of the trial, Milton Packer, who told me that the trial had been stopped because of a highly statistically significant reduction in cardiovascular mortality in patients taking LCZ696 instead of the current gold standard of treatment, an ACE inhibitor. Marc Pfeffer, a cardiologist at the Brigham and Women’s Hospital with long experience in heart failure, told me that he interprets “the stopping of a major clinical outcome trial for effectiveness by an experienced DSMB [Data and Safety Monitoring Board] as indicating that the final results will be both definitive and important.”

The first thing to know is that a reduction in cardiovascular mortality is a really big deal….

Click here to read the full post on Forbes.

 

 

Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality 1

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 a significant reduction in the combined primary endpoint of cardiovascular death and heart failure hospitalization. This information was taken from a Novartis press release.

But it turns out that the press release wasn’t entirely accurate. For once, a company appears to have actually downplayed a positive finding in its trial….

Click here to read the full post on Forbes.

English: Mohawk Stop Sign

English: Mohawk Stop Sign (Photo credit: Wikipedia)

Aspirin and Clonidine Fail to Help Surgery Patients Reply

Heart attacks (myocardial infarctions) are among the most common and serious side effects of noncardiac surgery. An effective regimen to minimize this risk has been the subject of considerable debate in recent years. The controversy was recently exacerbated because the recommendation to use beta-blockers in this setting was based on research which has now been discredited. Substantial evidence against the use of perioperative beta blockers came from the original POISE trial.

Now a second POISE trial, the Perioperative Ischemic Evaluation 2 (POISE-2) trial, casts doubt on the value of two other proposed strategies to reduce death and MI in patients undergoing noncardiac surgery. Results of POISE-2 were presented at the American College of Cardiology meeting in Washington, DC and published simultaneously in two papers in the New England Journal of Medicine.

Click here to read the entire post on Forbes.

 

Early Success For Novel Novartis Heart Failure Drug Reply

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 heart failure hospitalization.

PARADIGM-HF randomized patients with heart failure and reduced left ventricular ejection fraction to either the ACE inhibitor enalapril or LCZ696, an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that is the first in its class.

Click here to read the full post on Forbes.

 

 

High-Sensitivity Troponin Test Could Identify Low Risk Chest Pain Patients In The ED Reply

Approximately 15-20 million people in Europe and the United States go to the emergency department every year with chest pain. Many can be discharged early if they are not having an acute coronary syndrome. A large new single-center observational study, presented at the American College of Cardiology meeting in Washington, DC and published simultaneously in the Journal of the American College of Cardiology, provides fresh evidence that high-sensitivity cardiac troponin T (hs-cTnT) may be useful in helping identify chest pain patients in the emergency department who do not need to be admitted to the hospital.

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

First TAVR Comparison Trial Favors Sapien XT Over CoreValve Reply

With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards Sapien device, but all the experts have warned against cross-trial comparisons. Now an actual randomized trial has emerged comparing the two platforms. The results favor the Sapien XT, but the size and scope of the trial mean that the discussion and debate will certainly continue.

Click here to read the entire post on Forbes.

 

 

Survival Advantage for TAVR Over Surgery in High-Risk Patients Reply

Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery.

Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.