US Proposal Would Greatly Expand Transparency Of Clinical Trials Reply

The US Department of Health and Human Services today proposed new rules that would greatly expand the number of clinical trials that companies and researchers are required to report.

Click here to read the full post on Forbes.

 

 

About these ads

Losartan No Better Than Atenolol in Marfan’s Syndrome Reply

Beta-blockers have been the standard treatment for people with Marfan’s syndrome, a rare inherited connective tissue disorder that affects about 1 in 5000 people. The goal of treatment is to prevent or slow down the dilation of the aorta and avoid aortic dissection, the main cause of death. In recent years, studies have raised the hope that losartan, an angiotensin receptor blocker, might be more effective than beta-blockers in slowing aortic enlargement.

The Pediatric Heart Network Investigators randomized 608 children and young adults with Marfan’s syndrome to the beta-blocker atenolol or losartan….

Click here to read the full post on Forbes.

 

 

HDL Raising Drugs Probably Won’t Work But This Might 1

A new study offers important new insights into the protective role of HDL cholesterol (the “good” cholesterol) against cardiovascular disease. Earlier studies with drugs that increase HDL levels, including niacin and CETP inhibitors, have not shown benefit. The new study suggests that simply increasing HDL levels isn’t the way to go. Instead, cholesterol efflux, the ability of HDL to remove cholesterol from cells, part of the process called reverse cholesterol transport, appears to be the key. The results were presented today by Anand Rohatgi at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

The investigators followed 2,416 people participating in the Dallas Heart Study who were free of cardiovascular disease at the start for 9.4 years….

Click here to read the full post on Forbes.

 

Large Japanese Trial Casts Further Doubt On Aspirin To Prevent A First Heart Attack Reply

Although once quite popular, the use of aspirin to prevent a first heart attack has grown less popular in recent years as evidence has accumulated that the small benefits are outweighed by the increased risk of bleeding. Now a large trial from Japan has once again failed to provide any evidence to support the use of routine aspirin in high risk elderly people to prevent a first cardiovascular event.

The Japanese Primary Prevention Project (JPPP),  presented at the American Heart Association meeting in Chicago and published simultaneously in JAMA, enrolled  patients between 60 and 85 years of age with  hypertension, dyslipidemia, or diabetes. The open label study randomized 14,464 patients to aspirin 100 mg once daily or no aspirin in addition to conventional therapy. Patients were followed for up to 6.5 years for the primary combined endpoint of cardiovascular death, nonfatal stroke, or nonfatal MI….

Click here to read the full post on Forbes.

 

IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe Reply

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo or that LDL might not be a reliable surrogate endpoint. The IMPROVE-IT results will also provide comfort to companies developing the next generation of cholesterol drugs, since their approval may have depended on validation of LDL as a surrogate endpoint.

The  Improved Reduction of Outcomes: Vytorin Efficacy International Trial, presented Monday morning at the American Heart Association meeting in Chicago, randomized 18,144 high-risk patients within 10 days of an acute coronary event to either ezetimibe or placebo on top of a statin….

Click here to read the full post on Forbes.

Cannon

Big Study Looks At Length of Drug Treatment After Stent Implantation Reply

The advent of drug-eluting stents dramatically reduced the restenosis (reclogging) rate associated with bare-metal stents but prompted new concerns about the rare but potentially lethal complication of stent thrombosis (ST). Cardiologists have relied upon dual antiplatelet therapy to prevent ST but there has been considerable uncertainty and controversy about the ideal duration of therapy.

The Dual Antiplatelet Therapy (DAPT) trial was coordinated by the Harvard Clinical Research Institute as part of a large-scale collaboration with the FDA, stent manufacturers, and pharmaceutical companies…. The main results of the trial were presented on Sunday at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs 1

There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the McCormick convention center.

Click here to read the full post on Forbes.

Amgen Door Hanger

 

IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine 1

The presentation of the eagerly awaited IMPROVE-IT trial, scheduled for Monday at the American Heart Association meeting, won’t be accompanied by a simultaneous publication in the New England Journal of Medicine. Although no one except for a small group of insiders knows for sure, this news may have important implications.

Click here to read the full post on Forbes.

 

Newly Identified Mutations Act Like a Lifetime of Treatment with Ezetimibe Reply

A very large genetic study published in the New England Journal of Medicine offers compelling evidence in support of a central role for LDL cholesterol in coronary heart disease.

In a series of studies analyzing blood samples from nearly 100,000 people, Sekar Kathiresan and colleagues identified 15 rare mutations that block the activity of a single gene — called Niemann-Pick C1-Like 1 (NPC1L1). The mean LDL level was 12 mg/dL lower in mutation carriers than noncarriers. There were just 11 carriers of the mutations among 29,954 people with CHD versus 71 carriers among 83,140 people without known CHD (carrier frequency: 0.04% vs. 0.09%).  This worked out to a 53% reduction in CHD risk for mutation carriers.

Click here to read the full post on Forbes, including comments from James Stein, Sekar Kathiresan, and Harlan Krumholz.

Popular Diets Achieve Only Modest Long-Term Weight Loss Reply

Four of the most popular current weight loss diets produce at best only modest long-term benefits, a new study published in Circulation: Cardiovascular Quality and Outcomes shows. The study also found few significant differences across the four diets, offering little hope that any one diet can produce a serious dent in the obesity epidemic.

Mark Eisenberg and colleagues systematically searched the literature for studies evaluating the effects of the Atkins, South Beach, Zone, and Weight Watchers diets. They identified 12 randomized, controlled studies with follow-up of at least 1 year. Ten studies compared one of the diets with usual care. In these trials, Weight Watchers was the only diet to consistently outperform usual care in achieving weight loss, but this difference was modest at best, yielding a 1-year weight loss range of 3.5 to 6 kg with Weight Watchers compared with 0.8 to 5.4 kg with usual care. In the two head-to-head trials, Atkins and Zone resulted in a similar but modest weight loss. Longer-term data out to 2 years — available only for the Weight Watchers and Atkins diets– showed that some of the original weight loss was regained over time. Only one small trial studied the South Beach diet.

Click here to read the full post on Forbes.

 

What You Need To Know About IMPROVE-IT Reply

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing the end of its patent life the commercial significance is somewhat limited. However, IMPROVE-IT will also have very important implications beyond its specific effect on one drug franchise and could influence the fate of several new drugs now being investigated and may even alter the entire drug development and evaluation process.

Here’s some background information and links to useful resources.

Click here to read the full post on Forbes.

 

Nonobstructive Coronary Artery Disease Linked to Elevated Risk Reply

A large number of people who undergo elective coronary angiography are found to have nonobstructive coronary artery disease, and these patients have significantly increased risk for myocardial infarction and death, according to a retrospective study published in JAMA.

Click here to read the full post on Forbes.

 

 

AF Patients at Increased Risk for Silent Strokes Reply

The increased risk of stroke in people with atrial fibrillation (AF) is well known, and this stroke risk is, of course, linked to an increased risk of cognitive impairment and dementia. Less well known is that people with AF have an increased risk for cognitive impairment independent of their stroke risk. Now a new study published in Annals of Internal Medicine offers evidence that this increased risk may be linked to a higher rate of silent strokes in AF patients.

Click here to read the full post on Forbes.

 

Economic Study Finds VTE Prophylaxis with Low-Molecular-Weight Heparin Cost Effective Reply

Critically ill patients in the hospital are at high risk for developing venous thromboembolism (VTE). The 2011 PROTECT trial compared the two most common drug strategies used to prevent VTE — unfractionated heparin (UFH) and dalteparin, a low-molecular-weight heparin (LMWH) —  and found no difference between the two groups in the primary endpoint of the trial, leg deep-vein thrombosis.

But PROTECT did turn up a significant reduction in the dalteparin group in the important secondary endpoints of pulmonary embolism (PE) and heparin-induced thrombocytopenia (HIT). Now a prespecified economic analysis of PROTECT, published in JAMA, indicates that use of LMWH, though it is more expensive than UFH, may lead to lower hospital costs due to the reduction in PE and HIT.

Click here to read the full post on Forbes.

 

FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug Reply

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed.

Click here to read the full post on Forbes.

Aortic Valve Surgery for Nonagenarians Reply

As people continue to live longer physicians are increasingly confronted with very elderly patients who have serious conditions that might benefit from surgery but who are at high risk for surgical complications. In a paper published in the Annals of Thoracic Surgerydoctors at the Mayo Clinic reviewed their experience with 59 patients age 90 or older who had severe aortic stenosis and underwent surgical (SAVR) or transcatheter aortic valve replacement (TAVR).

Click here to read the full post on Forbes.

 

Grad Student Invents Flying Ambulance Drone To Deliver Emergency Shocks Reply

Drones have been used to kill people in war zones and to spy on people. Now a sharp young  graduate student in the Netherlands has come up with an innovative new use for drones that could one day help save thousands of lives.

Click here to read the full post on Forbes.

[youtubevid id="y-rEI4bezWc"]

 

 

 

Ebola, Natural Cures, And Panic: A Rant Reply

I try to stick to writing about cardiovascular topics but it’s been hard to avoid thinking about ebola in recent weeks. Trying to take a break from the ebola insanity yesterday I turned to Facebook to find some cute cat videos. Instead, I found this, posted by an old friend, from the Organic Consumers Association:

There are natural methods proven to be effective for prevention and treatment of Ebola. But doctors refuse to explore them.

My friend simply asked her FB friends: “What do you think? Please share.”

I’m afraid I didn’t respond well:

Click here to read the full post on Forbes.

Organic Ebola FB

`

Genetic Study Suggests Possible Causal Role for LDL in Aortic Valve Disease Reply

Although LDL is an important risk factor for aortic valve disease, the precise role it plays has been uncertain. Lipid-lowering therapy in people with established aortic valve disease has not been shown to be beneficial. Now, however, a new genetic study published in JAMA suggests that LDL cholesterol may in fact cause an increase in aortic valve calcium and aortic valve stenosis. This may mean that LDL-lowering therapy could prove beneficial when given earlier in the disease process.

Click here to read the full post on Forbes.

 

Paper Behind The Green Coffee Bean Diet Craze Retracted Reply

The “scientific” paper that helped ignite the green coffee bean diet craze has been retracted. The details of the retraction and the full background of the story were fully reported by Ivan Oransky on Retraction Watch.

The paper, published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, purported to report the substantial weight loss findings of a randomized, double-blind, placebo-controlled crossover study of green coffee bean extract. The article has been viewed or downloaded by more than three-quarters of a million people since its publication in January 2012.

Click here to read the full post on Forbes.

 

English: Photo of Dr.Oz at the Time 100 Gala.

English: Photo of Dr.Oz at the Time 100 Gala. (Photo credit: Wikipedia)

 

Cigna Sues Embattled HDL Laboratory For $84 Million Reply

The Cigna Health and Life Insurance company is suing Health Diagnostic Laboratory Inc. for $84 million.  As reported previously, the embattled lab company is the subject of an ongoing Federal investigation concerning kickbacks and fraudulent billing.

The charges against HDL in the suit filed last week in federal court closely echo the earlier allegations against the company.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack! Reply

Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals, including a patient and a health care provider, whose stories appear to confirm and provide additional perspective about the allegations in the earlier articles.

“Your test results are giving me a heart attack!”

Click here to read the full post on Forbes.

 

Another Diet Myth Exploded: Gradual Weight Loss No Better Than Rapid Weight Loss Reply

Once again, a popular weight loss myth has been exploded. It has been widely believed that weight loss, which is nearly always difficult to maintain, is even less likely to stay lost if it is the product of a rapid weight loss. The belief is even enshrined in current guidelines. Now a study published in The Lancet Diabetes & Endocrinology provides no support for this view. Instead, the study suggests that although long-term weight loss remains elusive regardless of the diet, short-term weight loss is actually more likely with rapid weight loss.

Click here to read the full post on Forbes.

 

Inappropriate Heart Stress Tests May Waste Half A Billion Dollars A Year Reply

Inappropriate cardiac stress tests may cost the US healthcare system as much as half a billion dollars each year, according to a new study published in Annals of Internal Medcine.

Click here to read the full post on Forbes.

 

Nuclear medicine myocardial perfusion scan wit...

Nuclear medicine myocardial perfusion scan with Thallium-201 for the rest images (bottom rows) and Tc-Sestamibi for the stress images (top rows). The nuclear medicine myocardial perfusion scan plays a pivotal role in the noninvasive evaluation of coronary artery disease. The study not only identifies patients with coronary artery disease, it also provides overall prognostic information or overall risk of adverse cardiac events for the patient. (Photo credit: Wikipedia)

 

Medicare Reimbursement for Lung Cancer Screening Provokes Debate 1

Although 160,000 people in the U.S. die each year from lung cancer, accounting for more than a quarter of all cancer deaths, screening for lung cancer remains controversial. Based on results from the National Lung Screening Trial (NLST) in 2011, the U.S. Preventive Services Task Force (USPSTF) issued a B recommendation in favor of low-dose CT screening for high-risk current and former smokers. Due to a provision in the Affordable Care Act, private insurance is now mandated. More recently, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) concluded that there is only low to intermediate confidence that “there is adequate evidence to determine if the benefits outweigh the harms.” The Centers for Medicare and Medicaid Services (CMS) is expected to issue a final decision on national coverage in 2015.

Click here to read the full post on Forbes.