Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race Reply

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.

Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics License Application (BLA) for alirocumab, their PCSK9 inhibitor…

Click here to read the full post on Forbes.

 

Salt, Science, And The American Heart Association’s Double Standard Reply

Once again the American Heart Association is sticking by its recommendation that pretty much everyone should consume no more than 1,500 milligrams of sodium each day. This is dramatically lower than the 3,500 mg/d the average American now consumes. In a blog post reprinted on MedPage Today the president of the American Heart Association,  Elliott Antman, assails a study published earlier this week which found no benefits– and even a hint of harm–  for elderly people with low sodium consumption.

But Antman only tells one side of the story.

Click here to read the full post on Forbes.

 

New Device to Lower Resistant High Blood Pressure Shows Early Promise 1

A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from privatelyheld ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates a connection between the vein and the artery, which lowers blood pressure in the arteries by letting some of the blood drain off into the veins.

In a paper published in the Lancet, European investigators report the results of an open-label trial in in which 83 patients with persistent high blood pressure despite taking multiple antihypertensive drugs were randomized to implantation of the Coupler device or current treatment…

Click here to read the full post on Forbes, including comments from Franz Messerli, Sripal Bangalore, and Deepak Bhatt.

 

Intense Exercise Doesn’t Eliminate the Hazard of Intense Sitting Reply

James Brown had it right. There may be no better medical advice these days than to “Get Up Offa That Thing.

A large new analysis published in Annals of Internal Medicine supports earlier observations that the health hazards of sedentary behavior aren’t completely neutralized by exercise.

Researchers in Toronto scoured the literature to find studies that assessed the health effects of sedentary behavior adjusted for physical activity. They found 47 studies, including 13 that assessed all-cause mortality, 14 that assessed cardiovascular disease and diabetes, and 14 that assessed cancer. Sedentary behavior was defined as “waking behaviors characterized by little physical movement and low-energy expenditure,” including sitting and television watching.

Click here to read the full post on Forbes.

 

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How Much Salt Should Old People Consume? Reply

A new study offers fresh evidence that current salt recommendations should be taken with, well, a grain of salt. Current guidelines now recommend that everyone should have sodium intake levels below 2300 mg per day. For many people at higher risk, including everyone over 50 years of age, sodium intake should be below 1500 mg/d. (The American Heart Association promotes the more rigorous goal of 1500 mg/d for everyone.) But a 2013 report from the Institute of Medicine, along with findings from the PURE study published last year, have raised concerns that the lower target level in particular is neither practical nor beneficial.

The new study, published in JAMA Internal Medicine, looks at the growing and important elderly patient population…

Click here to read the full post on Forbes.

 

 

Success For 40-Year Effort In One Rural County To Curb Cardiovascular Disease Reply

A 40-year program in one poor rural county to combat cardiovascular disease appears to have been successful, resulting in reduced rates of hospitalization and death compared with other counties in the same state over the same time period. The new findings from the study are described in a paper published in the Journal of the American Medical Association.

Click here to read the full post on Forbes.

 

Millions Of Americans Taking Aspirin When They Shouldn’t Reply

More than a third of US adults– more than 50 million people– now take aspirin for the primary and secondary prevention of cardiovascular disease. (Primary prevention is the prevention of a first event; secondary prevention is the prevention of a recurrent event.) Although it was once broadly recommended, because of the increased risk of bleeding complications the use of aspirin for primary prevention of cardiovascular disease is now only indicated in people who have a moderate to high 10-year risk. (Aspirin is still broadly recommended for secondary prevention.) Now a new report  published in the Journal of the American College of Cardiology finds that there are still a significant number of people who are receiving aspirin inappropriately.

Click here to read the full post on Forbes.

 

Healthy Habits Of Young Women Lead To Long-Term Health Benefits 1

It may seem obvious but a new study shows that young women with healthy habits are less likely as they age to get coronary heart disease or go on to develop cardiovascular risk factors like high blood pressure, high cholesterol, or diabetes.

Andrea Chomistek and colleagues analyzed data from more than 88,000 women participating in the Nurses Health Study II and who were between 27 and 44 years of age at the start of the study.

Click here to read the full post on Forbes.

 

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No Advantage For Low Glycemic Index Diet Reply

In recent years the glycemic index (GI), a measure of a carbohydrate’s impact on blood sugar, has assumed a major role in discussions about diets and nutrition. Now a new study suggests that by itself, within the context of an otherwise healthy diet, GI may not be an important factor in improving cardiovascular risk.

In a paper published in JAMA, Frank Sacks and colleagues report the results of a randomized, crossover-controlled 5-week feeding trial comparing 4 different diets in 163 overweight or obese adults. The diets were either low- or high-carb and either low- or high-GI. Importantly, all the diets were based on previously established healthy dietary patterns based on the DASH diet, which is low in saturated and total fat and includes substantial amounts of fruits, vegetables, and low-fat dairy foods.

Click here to read the full post on Forbes.

 

Get Rid of Sugar, Not Salt, Say Authors Reply

Too much negative attention has been focused on salt and not enough on sugar, write two authors in Open Heart. Reviewing the extensive literature on salt and sugar, they write that the adverse effects of salt are less than the adverse effects of sugar. The evidence supporting efforts to reduce salt in the diet is not convincing and we would be far better off reducing sugar instead of salt in the modern diet.

Click here to read the full post on Forbes.

 

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Women: Don’t Use Aspirin For Routine Prevention Of Heart Attacks, Stroke, And Cancer Reply

Although once widely recommended, aspirin for the prevention of a first heart attack or stroke (primary prevention) has lost favor in recent years, as the large number of bleeding complications appeared to offset the reduction in cardiovascular events. But at the same time evidence has emerged demonstrating the long-term effect of aspirin in preventing colorectal cancer, leading some to think that the risk-to-benefit equation for aspirin should be reconsidered.

Investigators in the Women’s Health Study therefore analyzed long-term followup data from 27,939 women who were randomized to placebo or 100 mg aspirin every other day.

Click here to read the full post on Forbes.

 

No, The Mediterranean Diet Won’t Help You Live Forever Reply

A new study published today provides fresh evidence for the healthful effects of the Mediterranean Diet. It even suggests that people who follow the Mediterranean Diet may live longer than people on most other diets. And this is just the latest piece of good news about this diet to appear in the last few years. But I want to warn my readers not to go overboard with this study. It appears to be an excellent, well-performed study, but it has many inherent limitations and is by no means definitive. In the long run it may raise as many questions as it answers.

The new study, published in The BMJfinds that women who more closely followed a Mediterranean diet had longer telomeres on the end of their chromosomes…

Click here to read the full post on Forbes.

 

Study Suggests Epinephrine for Cardiac Arrest May Be Harmful Reply

Epinephrine has been a cornerstone of therapy during cardiac resuscitation after cardiac arrest because of its well-established ability to stimulate the heart and increase the probability of a return of spontaneous circulation (ROSC). In recent years, however, concerns have been raised that people treated with epinephrine may have worse neurological outcomes following their resuscitation.

In a study published in the Journal of the American College of Cardiology, French researchers analyzed data from more than 1,500 patients who were successfully resuscitated after an out-of-hospital cardiac arrest and were subsequently treated at a large hospital in Paris….

Click here to read the full post on Forbes.

 

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.

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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.

 

 

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.

 

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.