Newly Elected European Society Of Cardiology President Co-Authored Hundreds Of Papers With Don Poldermans Reply

The ESC today announced that Jeroen Bax, a Dutch cardiologist, will serve as the group’s President Elect for the next two years before becoming President starting in 2016. Bax is a professor of cardiology at Leiden University Medical Center.

Bax is also known for his very close collaboration with Don Poldermans, the disgraced Dutch researcher who has been accused of significant and multiple examples of scientific misconduct.

Click here to read the full post on Forbes.

 

 

 

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Early Hint At Cardiovascular Outcomes With Sanofi’s and Regeneron’s Rapidly Advancing Cholesterol Drug Reply

Amid a slew of new data demonstrating yet again that PCSK9 inhibitors lower LDL cholesterol– drastically and in a wide variety of different patient populations– data from one trial offers the first suggestion that the drugs may in fact improve cardiovascular outcomes. But the analysis, the authors cautioned, is a post-hoc analysis of a trial neither designed nor powered to study outcomes, so should be considered preliminary and speculative at best.

Four phase 3 trials with the Sanofi and Regeneron PCSK9 inhibitor alirocumab (pronounced “allee rock you mab” by Chris Cannon at a news conference) were presented today at the European Society of Cardiology meeting in Barcelona.

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.

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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.

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PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment Reply

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 everything its sponsor (Novartis) and its investigators (led by Milton Packer and John McMurray) hoped. It met all its major endpoints in all the subgroups without raising any sort of a safety signal. If the findings are confirmed after a rigorous FDA review, then Novartis will likely have a blockbuster on its hand.

All the excitement is over a new drug still known only by its number, LCZ696.

Click here to read the full post on Forbes, including a detailed interview with Milton Packer.

 

Predicting PARADIGM-HF, Or What To Expect When You’re Expecting Reply

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 and give Novartis that rarest of gems, a new and genuine blockbuster cardiovascular drug.

The main results of the trial will first be presented at a press conference in Barcelona, Spain this Saturday in connection with the annual meeting of the European College of Cardiology.

Click here to read the full post on Forbes.

 

Rise In Popularity Of E-Cigarettes Sparks Concerns And Recommendations Reply

The recent dramatic rise in popularity of e-cigarettes threatens to reverse hard-fought progress in the war against smoking, according to a new policy statement from the American Heart Association. “E-cigarettes have caused a major shift in the tobacco-control landscape,” said the lead author of the statement, Aruni Bhatnagar, chair of cardiovascular medicine at the University of Louisville.

But the AHA did not completely reject the use of e-cigarettes as an aid to stop smoking.

Click here to read the full post on Forbes.

 

Why Guidelines Should Be Waged Like War 1

Here’s a modest proposal: we need fewer and shorter guidelines. In fact, I’d like to propose that guidelines, like war, should be waged only when there is absolute consensus and overwhelming evidence.

Anyone interested in the subject is aware that guidelines are in a complete mess.

Click here to read the full post on Forbes.

United Nations Security Council Resolution 707

United Nations Security Council Resolution 707 (Photo credit: Wikipedia)

 

FDA Grants New Indication For Apixaban Reply

The FDA today approved an expanded indication for  the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy.

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…

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US Department Of Justice Ends Investigation Of AstraZenca Trial Reply

AstraZeneca announced today that the US Department of Justice has ended its investigation into alleged misconduct associated with the pivotal PLATO trial. The company said it had fully cooperated with the investigation, which began in October of 2013.

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An Old Study Fuels Debate Over Blood Pressure Guidelines Reply

In the last year new guidelines relating to cardiovascular disease have been the subject of intense criticism and debate. The status of the blood pressure guidelines has been particularly contentious, since several different groups have published contradictory guidelines, while several authors of the most prominent group, the Eighth Joint National Committee, published an impassioned dissent from their own published guideline. Many hypertension experts have taken aim at the change in therapeutic target for systolic blood pressure in patients age 60 or older, from 140 mm Hg to 150 mm Hg.

In an attempt to determine the optimal blood pressure for patients age 60 or older, Sripal Bangalore and colleagues performed a post-hoc analysis of 8,354 patients who participated in the INVEST trial, who were age 60 or older, and who had a baseline systolic blood pressure greater than 150 mm Hg…

Click here to read the full post on Forbes, including comments from Sripal Bangalore and Harlan Krumholz.

 

An Expert’s Perspective: Why Salt Is Not Like Tobacco And Why Guidelines Are Tricky Reply

At the center of this week’s renewed debate on salt was Salim Yusuf, the long influential and often controversial cardiology researcher and clinical trialist based at McMaster University in Hamilton, Ontario. I spoke with Yusuf before the publication of the New England Journal of Medicine papers, which include his own two papers from the PURE study.

Yusuf was troubled by the tone of the salt debate. He’s no stranger to scientific controversies and intense disagreement, but “scientific criticism is one thing, personal attack is another,” he said. Because he has presented data that suggests that moderately high levels of sodium may not be as bad as some had thought, and that very low levels of sodium may actually be harmful, “we’ve come under huge attack.”

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New Studies Fuel The Debate Over Sodium Reply

Three papers and an editorial in the New England Journal of Medicine are sure to throw fresh fuel on the ongoing fiery debate over sodium recommendations. Current guidelines recommend that people should limit their intake of sodium to 1.5  to 2.4 grams per day, but these recommendations are based on projections and have never been tested in clinical trials or other large studies.

Two papers from the  ongoing Prospective Urban Rural Epidemiology (PURE) study offer fresh evidence against the low sodium recommendations.

Click here to read the full post on Forbes.

 

The Complicated Story Behind Yet Another Disappeared Article At A Top Heart Journal Reply

Once again the European Heart Journal has “unpublished” an article without any notice of retraction or explanation. Strangely, the article– Russian science through the prism of intelligence: is fraud still possible?– can still be viewed (at least for now) with a vestigial URL , but it can not be found through the usual channels on the journal site. The pages for the story on PubMed and the EHJ site now state: “This article has been temporarily removed.”

…a more careful examination of the original article leads to the suspicion that this story is a bit more complicated and raises questions both about the internal peer review process at the EHJ and about the original paper.

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IMPROVE-IT Trial Scheduled For Presentation In November Reply

Results of the eagerly-awaited and highly controversial IMPROVE-IT trial are finally going to be revealed. The American Heart Association has announced that the  trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions . IMPROVE-IT compared the effect on cardiovascular outcomes of the statin simvastatin with Vytorin (the combination of simvastatin and ezetimibe, manufactured by Merck) in more than 18,000 patients with acute coronary syndromes.

Both Vytorin and IMPROVE-IT have been the subject of considerable controversy.

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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.

 

 

Warning: Neck Adjustments Might Lead To Stroke 2

After a neck adjustment — also known as cervical manipulative therapy and typically employed by chiropractors and other healthcare providers — people are at increased risk for cervical dissections (tears), which can lead to stroke, according to a scientific statement released by the American Heart Association/American Stroke Association. Although a cause-and-effect relationship is far from being proved, the groups say that healthcare providers should tell their patients about the association before starting the procedure.

Click here to read the full post on Forbes.

 

Superficial dissection of the right side of th...

Superficial dissection of the right side of the neck, showing the carotid and subclavian arteries. (Photo credit: Wikipedia)

Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful Reply

Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the   principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still viable.

Click here to read the full post on Forbes.

 

Clot Busters For Stroke Gain More Support Reply

Although thrombolysis for ischemic stroke has been widely recognized as beneficial, its use has been limited because of concerns about its effects on patients treated after 3 hours, on older patients, and on patients with mild and with severe strokes. Now a new metaanalysis published in the Lancet offers evidence that the use of thrombolysis should be more aggressively pursued.

Click here to read the full post on Forbes.

 

 

No Retraction For You! Review Panel Exonerates Medical Journal In Statin Kerfuffle Reply

An independent review panel has rejected a demand by a prominent researcher that TheBMJ retract two controversial articles. The report largely exonerates the journal’s editors from any wrongdoing.

As previously reported, Rory Collins, a prominent researcher and head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, had demanded that TheBMJ retract two articles that were highly critical of statins. Although TheBMJ issued a correction for both papers for inaccurately citing an earlier publication and therefore overstating the incidence of adverse effects of statins, this response did not satisfy Collins. He repeatedly demanded that the journal issue a full retraction of the articles, prompting TheBMJ’s editor-in-chief, Fiona Godlee, to convene an outside panel of experts to review the problem.

The report of the independent statins review panel exonerates TheBMJ from wrongdoing and said the controversial articles should not be retracted:

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Guideline Critics Shift Attacks From Beta Blockers To Statins Reply

With the release today of updated European and US guidelines the ongoing controversy regarding beta-blockers appears to be resolved. But that doesn’t necessarily mean there will be an outbreak of guideline peace and harmony. The critics who helped ignite the controversy over beta blockers now say new statin recommendations contained in the guidelines are based on deeply flawed evidence.

Both the new European and US guidelines say that preoperative initiation of statin therapy may be considered in patients undergoing vascular surgery and that people already taking statins should continue taking them. Now some of the same critics who attacked the reliability of the beta blocker guideline say that this recommendation is not supported by the evidence.

Click here to read the full post on Forbes.

 

 

 

Dutch Investigation Finds Serious Flaws In Influential New England Journal Of Medicine Study Reply

Erasmus Medical Center says it has wrapped up its investigation of Don Poldermans, the disgraced cardiology researcher who was fired for research misconduct. The full extent of the misconduct has never been known, and from an examination of the Erasmus report it appears likely that it never will be known.

One major finding– though downplayed in the medical center’s press release– is that the most prestigious and influential publication from the Poldermans’ group, the 1999 publication of the DECREASE 1 study in the New England Journal of Medicine– appears to be riddled with serious problems.

Click here to read the full post on Forbes.

 

 

Medicine faculty of the Erasmus MC, taken in t...

Medicine faculty of the Erasmus MC, taken in the afternoon (Photo credit: Wikipedia)

 

Hormone Therapy At Menopause Fails To Halt Heart Disease Progression 1

More than a decade ago the Women’s Health Study produced surprising and important results when it showed that broad use of hormone replacement therapy did not reduce cardiovascular risk in post-menopausal women. But the study also led to speculation  that hormone therapy  might be beneficial when delivered closer to the time of menopause. Now a study published in Annals of Internal Medicine shows that menopausal hormone therapy (MHT) may have some favorable effects on some cardiovascular risk factors but it does not reduce the progression of atherosclerosis.

Click here to read the full post on Forbes.

 

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)