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.

 

About these ads

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…

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.”

Click here to read the full post on Forbes.

 

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.

 

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.

Click here to read the full post on Forbes.

 

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)

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.

 

 

 

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)

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.

 

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.

 

 

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.

Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy Reply

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck. The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.

MSD Italy, the Italian arm of the company, sent two “cease and desist” letters to Alberto Donzelli, who is “the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare),” according to The  BMJwhich published a news report of the affair.

Click here to read the full post on Forbes.

 

Januvia Linked To Increase in Heart Failure Hospitalizations Reply

The cardiovascular effects of drugs used for glucose control in patients with diabetes have been a subject of controversy for many years now. More recently, attention has started to focus specifically on the risk for heart failure. Now, an observational study will likely raise new questions about the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck).

In a paper published in JACC Heart Failure, Daniala Weir and colleagues analyzed insurance claims from a database of more than 7600 patients with diabetes and heart failure.

Click here to read the full post on Forbes.

 

 

FDA Ends Olmesartan Safety Review, But… Reply

The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk of cardiovascular death.

Now the FDA says that it “has found no clear evidence of increased cardiovascular risks associated” with olmesartan in diabetic patients.

Click here to read the full post on Forbes.

 

 

In Emerging China Heart Attacks Skyrocket But Treatment Lags Reply

Accompanying all the other changes in China over the past decade, admission to the hospital for heart attacks ST-elevation myocardial infarction, or STEMI) has soared, according to a paper published in the LancetAlthough the study finds that there have been some genuine improvements in treatment, the Chinese healthcare system still has a long way to go in order to improve the outcome of these patients.

Click here to read the full post on Forbes.

 

If You Snus, You Lose: Study Shows Benefits of Quitting Smokeless Tobacco Reply

The adverse effects of smoking are well known and documented. The effect of smokeless tobacco is less clear. Now a study from Sweden, published in Circulationoffers evidence that quitting smokeless tobacco after a heart attack is about as beneficial as quitting smoking. The results do not support the common view that smokeless tobacco is a safe alternative to smoking.

Click here to read the full post on Forbes.

 

English: Skruf løs snus

English: Skruf løs snus (Photo credit: Wikipedia)

Large Genetic Studies May Help Unravel The Triglyceride Problem 1

The precise role of triglycerides in heart disease has been very difficult to determine. To help untangle the knotty problem two research groups studied large populations and identified rare variations in a gene (APOC3) that encodes for apolipoprotein C3, which is known to increase triglyceride levels.

The two studies have received a lot of attention in the media, including, most notably, great stories with lots of details and perspective by Gina Kolata on the front page of the New York Times and Matt Herper in Forbes. Both stories provide lots of background on these studies and present a wide variety of opinions about their significance. In general, though, they suggest that triglycerides and HDL are ready to trade roles: triglycerides are now ready for prime time as HDL fades into the background.

Click here to read the full story on Forbes.