Major Medical Organizations Establish Ambitious Diabetes Registry Reply

Our knowledge of diabetes today is a bit like the way blind men understand an elephant. With a myriad of isolated perspectives it’s nearly impossible to gain a broad overview. Now, a new initiative from a group of major medical organization will seek to provide the tools to better see a full picture of the elephantine problem of diabetes.

The American College of Cardiology, the American Diabetes Association, the American College of Physicians, and the Joslin Diabetes Center announced today that they will launch the Diabetes Collaborative Registry, which they say is “aimed at tracking and improving the quality of diabetes and cardiometabolic care across the primary and specialty care continuum.”

Click here to read the full post on Forbes.

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Wide Range In Cancer Risk From Radiation In Children Undergoing Heart Surgery Reply

Children with heart disease are at increased risk for developing cancer later in life due to their exposure to radiation during imaging procedures. Since an ever-growing number of children with heart disease now reach adulthood, this may become an increasingly important public health issue.

A new study published in Circulation offers some reassurance in finding that for most children the increased risk is low or negligible. But for some children who undergo more complex procedures, the increased risk is significant.

Click here to read the entire story on Forbes.

 

 

 

Air Pollution and Cardiovascular Disease: It’s Complicated Reply

Epidemiology studies have provided powerful evidence linking air pollution to cardiovascular disease, especially heart attacks (MI) and stroke. By some estimates, air pollution may be responsible for 3.2 million deaths each year, most from cardiovascular causes.

At first glance, a new study published in Heart appears to cast doubt on this association.

Click here to read the full post on Forbes.

 

English: Air pollution

English: Air pollution (Photo credit: Wikipedia)

Prophylactic ICDs Appear Effective In Less Severe HF Patients Reply

ICDs are routinely implanted in heart failure patients with ejection fractions (EFs) of 35% and lower to prevent sudden cardiac death. However, the benefits in patients at the higher end of the spectrum– between 30% and 35%– have not been well demonstrated in clinical trials, since few patients in this range have been enrolled in clinical trials.

Now a new study published in JAMA suggests that the benefits in this group are similar to the benefits in heart failure patients with more severely depressed EFs.

Click here to read the full post on Forbes.

 

Large Study Uncovers New Details About the Role of Hypertension in CVD Reply

Although high blood pressure has long been recognized and studied as a cardiovascular risk factor, a large new study published in the Lancet provides a more detailed, granular view of the specific role of different forms of hypertension.

Eleni Rapsomaniki and colleagues in the U.K. analyzed data from 1.25 million people without existing cardiovascular disease age 30 and older. An important, and perhaps surprising, new finding is that high blood pressure was not a simple monolithic cardiovascular risk factor. Instead, the researchers found that different types of hypertension at different stages of life had different cardiovascular effects.

Click here to read the full post on Forbes.

 

Portrait of the Global Obesity Pandemic Reply

A new, comprehensive analysis, published in the Lancet, paints a frightening portrait of the global obesity pandemic.  Analyzing data from a wide variety of international sources, the Global Burden of Disease Study 2013 finds that from 1980 through 2013, the worldwide prevalence of overweight and obesity rose by 27.5% for adults and by 47.1% for children. The result was an absolute increase from 857 million overweight and obese people in 1980 to 2.1 billion in 2013.

For men, the proportion with a BMI of 25 or greater increased from 28.8% to 36.9%. For women, the proportion increased from 29.8% to 38.0%. Although the increase was observed in every country, the patterns were different between developed and developing countries. In developed countries, there were more men than women who were overweight or obese; in developing countries, the pattern was reversed. In 2013, nearly a quarter of children and adolescents in developed countries were overweight or obese.

The multinational team of researchers reported that the biggest gains in overweight and obesity took place between 1992 and 2002. One hint of good news: the increase in adult obesity appeared to slow starting in 2006.

Prescription Delay Following Stent Implantation Is a Common and Deadly Problem Reply

After receiving a stent, many patients delay or fail to fill their prescription for clopidogrel or another antiplatelet agent. Now, a study published in the Journal of the American Heart Association offers evidence that this problem is widespread and often leads to serious consequences.

Researchers analyzed data from all stent implantations performed in British Columbia from 2004 through 2006. In all, 15,629 stents were implanted: 3,599 patients received at least one drug-eluting stent (DES), and 12,030 received bare metal stents (BMS) alone. Nearly a third of the patients in each stent group did not fill their prescription within 3 days after leaving the hospital.

A delay of 3 or more days in filling a first prescription for clopidogrel after hospital discharge was associated with significant increases in the risk for death and readmission with MI at 2 years:

Click here to read the full post on Forbes.

 

FDA Approves Novel Implanted Sensor To Monitor Heart Failure Reply

The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of  NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted in the pulmonary artery, a catheter-based delivery system, and a system that acquires and processes PA pressure measurements from the implanted monitor and transfers the data to a secure database.

Click here to read the entire post on Forbes.

 

Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million Reply

Boehringer Ingelheim said today that it will pay $650 million in a “comprehensive settlement” of lawsuits over Pradaxa (dabigatran), the company’s novel anticoagulant. The company said that it expects the settlement will resolve about 4,000 current cases against the company in the US.

Click here to read the full post on Forbes.

 

The Walking Dead: Renal Denervation In Europe Just Can’t Be Stopped Reply

Earlier this year the only large, well-designed trial of renal denervation– the once highly-promising catheter-based technology that was widely expected to “cure” difficult cases of resistant hypertension– failed spectacularly. Many hypertension experts believe that ultimately the technique will prove to be beneficial, but after the failure of Simplicity HTN-3 it is clear that there’s a great deal of research that needs to be performed to find out just how– or if– this novel technology should be used.

In the US this does not present a problem. The FDA has not approved renal denervation so it can only be used in a research setting. But that is not the case in Europe, where the device is available due to lower standards for device approval.

Right now Europe’s largest interventional cardiology meeting, Euro PCR, is underway in Paris. Surprisingly– or perhaps not– renal denervation is still being heavily promoted in Europe. Here is the evidence: a series of tweets by @Jeddacath, an interventional cardiologist who trained at the Brigham & Women’s Hospital in Boston and who is attending the meeting.

Click here to read the full post on Forbes.

 

Walking Dead

Medtronic To Pay Over $1Billion To Settle Patent Litigation With Edwards Lifesciences Reply

After years of protracted and often bitter litigation in the US and abroad, Edwards Lifesciences and Medtronic today announced a broad resolution to all their patent disputes over transcatheter heart valves.

Medtronic will pay more than a billion dollars over the course of the agreement, which lasts until April 2022.

Click here to read the full post on Forbes.

 

Hospitalizations For Atrial Fibrillation Are On The Rise Reply

In recent years there has been an explosion of interest in atrial fibrillation (AF), the most common heart rhythm disorder. Although it is sometimes thought to be relatively benign, AF increases the risk of stroke if untreated. Even if treated, it can be the source of significant discomfort and can contribute to additional complications, especially when accompanied by other cardiovascular conditions. Now a new study published in Circulation finds that hospitalizations for AF are on the increase, and this may have important implications for the delivery and economics of health care in the coming years.

Researchers analyzed data  from nearly 4,000,000 hospitalizations in which AF was the primary discharge diagnosis from the years 2000 through 2010. Here are some of their key findings:

Click here to read the full post on Forbes.

 

BMJ Names Panel Members To Review Disputed Statin Articles Reply

The BMJ has released the names of an outside expert panel who will decide the fate of two articles that are the subject of a heated dispute.

As previously reported, last week the BMJ published a correction to two papers published last year, explaining that both papers had  inaccurately overstated the incidence of the adverse effects of statins. However, a fierce critic of the papers, the head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, Rory Collins, still insisted upon a full retraction. In an editorial published in BMJ, the journal’s editor-in-chief, Fiona Godlee, wrote that she was  uncertain “whether the error is sufficient for retraction, given that the incorrect statements were in each case secondary to the article’s primary focus.” As a result the BMJ has convened an outside panel of experts “with no dog in this fight.”

Iona Heath, former chair of the Royal College of General Practitioners and of The BMJ’s ethics committee, will be the chair of the panel. There are six additional members…

Click here to read the full post on Forbes.

 

Disappointing Results For Statins In Two NIH Trials Reply

Two NHLBI studies have failed to find any benefit for statin therapy in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). Previous observational studies had raised the possibility that statins, perhaps due to their anti-inflammatory effects, might improve outcomes in people with these serious diseases. But both trials were stopped early by their data and safety monitoring boards for futility. The results of the trials were presented at the annual meeting of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.

Click here to read the entire post on Forbes.

 

FDA Rejects Novel Novartis Drug For Acute Heart Failure Reply

Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy.

Click here to read the full post on Forbes.

 

 

Exercise: Can There Be Too Much Of A Good Thing? Reply

In recent years researchers have developed a more complicated view of the relationship of health and exercise. Although observational studies have consistently shown that some physical activity is better than none, studies that have drilled deeper into the data suggest that these health benefits may be curtailed in people who exercise very frequently or very intensely. Now two new studies from Europe, published in the journal Heart, offer new support for these observations.

Click here to read the full post on Forbes.

 

BMJ Articles Critical Of Statins Provoke Kerfuffle Reply

The authors of two BMJ articles have withdrawn statements about the adverse effects of statins. The two papers inaccurately cite an earlier publication and therefore overstate the incidence of adverse effects of statins. As a result, the two papers have drawn much criticism and set off a kerfuffle involving the editor of BMJ and a prominent British trialist who is demanding a full retraction of the articles. But the controversy probably won’t be resolved any time soon, since an independent panel, which will be asked to decide the issue, is still in the process of being assembled.

Click here to read the entire post on Forbes.

 

FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa Reply

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared to warfarin. But the study also found that, dabigatran was associated with an increased risk for major gastrointestinal bleeding. There was no difference between the drugs in the risk of MI.

Click here to read the full post on Forbes.

 

Strike 2 For Once Promising GSK ‘Stinkbomb’ Heart Drug Reply

GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company  announced that another phase 3 trial with the same drug had  failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it would not seek regulatory approval for the drug.

The SOLID-TIMI 52 (Stabilisation Of pLaques usIng Darapladib – Thrombolysis In Myocardial Infarction 52) trial randomized more than 13,000 patients within 30 days of an acute coronary syndrome to receive either placebo or darapladib, an anti-inflammatory drug designed to stabilize atherosclerotic plaques. GSK reported today that the drug did not significantly reduce major coronary events.  The full results of the trial will be presented at a future scientific meeting.

Click here to read the full post on Forbes.

 

Intensive Insulin Therapy Saves Lives– But Is The Finding Still Relevant? 1

A trial that started back in 1990 continues to demonstrate a significant mortality advantage for intensive insulin therapy in heart attack (MI) patients. But experts say the trial design is so outdated that the findings should have no influence on clinical practice today.

During the years 1990 through 1993 the Swedish DIGAMI I (Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infaction 1) trial randomized 620 MI patients with elevated glucose levels to either intensive insulin treatment or conventional therapy. Earlier results from the trial showed beneficial effects, including improved survival, for patients in the intensive treatment arm.

Now, a paper published in The Lancet Diabetes & Endocrinology, presents 20-year followup results showing an average 2.3 year increase in survival for patients in the treatment arm (median survival 7.0 years versus 4.7 years, HR 0.83, CI 0.70-0.98, p=0.27).

Click here to read the entire post on Forbes, including an extensive comment from Darren McGuire.

 

Routine Shock Testing Not Required During ICD Implantation Reply

When cardiologists implant defibrillators in patients at high risk of dying from a heart rhythm disorder they nearly always perform a defibrillation test in which they induce a lethal arrhythmia, ventricular fibrillation, to make sure the device accurately detects the arrhythmia and terminates it with an appropriate shock. But routine defibrillation testing has never been shown to be safe or necessary. In recent years some experts have maintained that routine defibrillation testing may not be necessary.

Now a new study, presented yesterday at the Heart Rhythm Society meeting in San Francisco, offers evidence that although routine testing is generally safe it may increase complications without producing any improvement in outcomes.

Click here to read the full post on Forbes.

 

 

FDA Approves Novel Merck Drug To Prevent Heart Attacks And Strokes Reply

The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (heart attack), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that had experienced nearly as many ups and downs as an amusement park roller coaster.

Click here to read the full post on Forbes.

 

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.

 

 

 

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.