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.

 

 

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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.

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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.

 

Positive Results For New Oral Drug From Actelion Reply

Actelion has announced positive top-line results for a phase III trial of a new oral drug for the treatment of pulmonary arterial hypertension (PAH). The drug, selexipag, is a first-in-class orally available selective prostacyclin IP receptor agonist.

The pivotal, double-blind GRIPHON study was the largest outcome trial ever performed in PAH. 1,156 PAH patients were randomized to selexipag or placebo. The company said that trial had “met its primary efficacy endpoint with high statistical significance.”

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.

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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.