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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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.

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.

 

 

 

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.

 

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.

 

 

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)

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.

 

Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug Reply

There may be trouble on the horizon for ivabradine, a heart drug marketed by Servier under the brand names of Corlentor and Procoralan. The drug is widely available in Europe and elsewhere, though it is not available in the US, where it is under development by Amgen. Although it hasn’t been widely noticed– I can find no other press reports– the European Medicines Agency said that it has started a review of the drug based on troubling findings from the SIGNIFY study. (Ivabradine is used to treat patients with long-term stable angina and long-term heart failure.)

The main results of SIGNIFY are scheduled to be presented on August 31 at the European Society of Cardiology meeting in Barcelona. But on May 8 the European Medicines Agency announced that it had initiated a review of ivabradine based on  preliminary results…

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

 

 

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.

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.