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.

 

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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.

 

 

 

Study Explores Expanded Use For Edwards’ And Medtronic’s New Heart Valves Reply

In the last few years transcatheter aortic valve replacements from Edwards Lifesciences and Medtronic have entered the marketplace and now offer an alternative to surgery for some patients. Now these valves are being considered for use in patients who have already undergone surgery but whose bioprosthetic valves have failed.

Although surgeons and patients increasingly prefer bioprosthetic valves to mechanical valves, the chief drawback to the bioprosthetic valves is that they may eventually deteriorate, which means that more and more physicians and patients will inevitably be faced with the dilemma of how best to treat degenerated valves. Although surgical reoperation is considered the best solution, many patients are too old and frail for surgery. Transcatheter aortic valve implantation (TAVI) has been proposed for use in this situation, though the risks and benefits have not as yet been well defined.

Now, a new study in JAMA provides information on 459 patients with failed bioprosthetic valves who underwent TAVI with either the Edwards Sapien device or the Medtronic Corevalve device.

Click here to read the full post on Forbes.

 

Controversial Trial Finds No Benefit For Expensive Medicines Company Drug Reply

Although there is broad consensus in the medical community that primary PCI is the best treatment for heart attack patients when it can be delivered promptly, there is no agreement about the best accompanying drug regimen, which usually entails a combination of antiplatelet and antithrombotic drugs. The role of one antithrombotic, bivalirudin (Angiomax, The Medicines Company) has been particularly uncertain because it is far more expensive than its alternative, unfractionated heparin.

HEAT-PPCI was designed to help settle this problem.

Click here to read the full post on Forbes.

 

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.

 

More Sunshine: CMS Wants Companies To Report Payments To Physicians For Medical Education Reply

In a major reversal of policy, CMS wants industry to report payments to physicians for continuing medical education. The move would eliminate from the Physician Payment Sunshine Act the current exemption for CME.

Initially CMS’s  proposal for implementation of the Sunshine Act required industry to report payments to physicians for CME programs. But after considerable debate and lobbying from industry, the final rule included an exemption. As a result, companies are not now required to report payments to speakers at accredited CME events as long as the companies don’t select the speakers or directly pay them.

CMS now appears to have changed its mind. Near the end of its list of proposed changes for next year, CMS is proposing to eliminate the exemption:

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.

 

 

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.

 

Study Offers Reassurance About Newer Drug-Eluting Stents Reply

Drug-eluting stents (DES) have been viewed as a great advance over earlier stents and balloon angioplasty because they result in many fewer cases of restenosis. But enthusiasm for the first generation of DES was somewhat curbed due to reports of late stent thrombosis (ST), a rare but very dangerous complication. Now findings from a large ongoing registry study provide some reassurance about the long-term safety of the new generation of drug-eluting stents in patients with heart attacks (STEMI). The results are published  in the Journal of the American College of Cardiology.

SCAAR (Swedish Coronary Angiography and Angioplasty Registry) investigators analyzed data from 34,000 primary PCI patients who received a bare-metal stent, an old-generation DES, or a new-generation DES.

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.

 

FDA Recalls Another Batch Of Generic Metoprolol Reply

The FDA has recalled more than 13,000 bottles of metoprolol succinate extended release tablets manufactured by Dr. Reddy’s Laboratories. Two months ago the agency recalled another lot of generic metoprolol from a different company, Wockhardt. Both recalls were for medicines manufactured at facilities in India. There have been multiple reports in recent years of problems with generic drugs made in India.

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)

Mobile Cardiovascular Screening Programs Come Under Fire Reply

It seems like a no brainer. Cardiovascular disease is the #1 killer in the world so broad screening of the general population must be a good idea, right? Wrong, says the consumer group Public Citizen, at least when such screening is performed indiscriminately. Somewhat surprisingly, Public Citizen, which is often held at arm’s length by mainstream medicine, gained some support for its position from a major cardiology organization.

In its statement Public Citizen urged 20 hospitals to sever their involvement in a mobile cardiovascular screening program. The HealthFair Cardiovascular Screening Packages are unethical, mislead consumers, and do more harm than good, said Public Citizen.

In a blog post, the president of the American College of Cardiology. Patrick O’Gara, said that “the questions raised about screening have some merit…. we do not recommend broad and untargeted screening.”

Click here to read the full post on Forbes, including a detailed comment from cardiologist Ethan Weiss.

 

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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.

 

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.

Watchman_2

 

Mixed Results for Thrombolysis in Pulmonary Embolism Reply

The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation.

A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients. Overall, there was a significant, 47% reduction in mortality with thrombolysis relative to standard anticoagulation, but this was accompanied by significant increases in major bleeding, including intracranial hemorrhage.

Click here to read the full post on Forbes.

 

FDA Approves Second Generation Heart Valve From Edwards Lifesciences Reply

The next phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had approved its second generation Sapien XT TAVR device  for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).

Click here to read the full post on Forbes.

 

European Regulators Investigate Cardiovascular Safety Of Ibuprofen Reply

The European Medicines Agency announced on Friday that it had initiated a review of the cardiovascular safety of ibuprofen when taken in high doses over  an extended period of time. The review will be performed by the Pharmacovigilance Risk Assessment Committee (PRAC).

Click here to read the full post on Forbes.