More Questions Raised About Boehringer Ingelheim’s Pradaxa Reply

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.

 

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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.

 

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.

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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.

 

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.

Blind_monks_examining_an_elephant

 

 

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)

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.

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.

 

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.

 

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.

 

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.