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.

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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.

 

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.

Click here to read the full post on Forbes.

 

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.

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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:

Click here to read the full post on Forbes.

 

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 Reply

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)

Running: Any Amount Is Good And More May Not Be Better Reply

Although there is broad agreement that exercise is beneficial there has been substantial uncertainty about how much exercise is good for you. Recently some studies have suggested that too much exercise may actually reduce the benefits of exercise. Now a new study published in the Journal of the American College of Cardiology finds that even a small amount of exercise, even running for as little as 5 minutes a day, may be just as healthful as more exercise.

Click here to read the full post on Forbes.

 

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.

 

Study Finds Flaws in New Treatment For Blood Clots Reply

In recent years, catheter-directed thrombolysis (CDT) has been added to the current standard of anticoagulation therapy in some patients with deep vein thrombosis (DVT). The hope was that CDT would help reduce the high rate of post-thrombotic syndrome (PTS), but now an observational study finds no benefits and some important disadvantages associated with CDT.

In a report published in JAMA Internal Medicine, Riyaz Bashir and colleagues analyzed data from more than 90,000 patients hospitalized for DVT, 3649 of whom received CDT plus anticoagulation.

Click here to read the full post on Forbes.

 

Probiotics May Help Reduce Blood Pressure Reply

As interest in probiotics has grown in recent years, some evidence has emerged that probiotics may favorably reduce blood pressure, but trials have been small and inconsistent. Now a meta-analysis published in Hypertension suggests that the blood-pressure lowering effects of probiotics may be genuine.

Click here to read the full post on Forbes.

 

New Evidence Fuels Concerns About The Safety Of Niacin Reply

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects.

Click here to read the full post on Forbes.

 

 

Cleveland Clinic Once Again Tops Heart Hospital Rankings Reply

For the twentieth year in a row the Cleveland Clinic made the #1 spot on the US News & World Report‘s annual ranking of heart hospitals. The Cleveland Clinic was 4th in the overall category. For the first time the Mayo Clinic was the top hospital overall, beating long-time rivals Massachusetts General and Johns Hopkins.

As I’ve stated before, I am not a big fan of these sort of ratings. But irrational as they may be they often have enormous practical significance.

Here’s the top 20:

Click here to read the full post on Forbes.

 

FDA Once Again Reaches Conclusions At Odds With Its Own Staff Reply

Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists.  Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the  FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug.

Back in 2010 the FDA said that it was initiating a safety review of olmesartan due to troubling findings from 2 clinical trials that raised the possibility that patients with type 2 diabetes taking olmesartan might have an increased risk of cardiovascular death. Four years later the FDA announced  that it had completed that review.

Click here to read the full post on Forbes, including comments from Sanjay Kaul and Franz Messerli and Sripal Bangalore.

FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant Reply

A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect.

REGULATE-PCI is a phase 3 trial comparing Revolixys to bivalirudin (Angiomax, The Medicines Company) in 13,000 patients undergoing PCI.

Click here to read the full post on Forbes.