More Controversy Over Major Cardiology Clinical Trial

Think about this: A new article reports that a major NIH-funded trial runs into trouble. The article raises all sorts of fundamental questions about our ability to perform meaningful clinical research. But instead of expressing concern about these legitimate problems, medical leaders ignore these questions and instead focus their ire and criticism on the article authors,…

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Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial

As a major clinical trial in cardiology nears completion it has provoked a storm of criticism and controversy. The brouhaha erupted in response to a late change to one of the most important— and already controversial— trials in cardiovascular medicine. The NIH-funded ISCHEMIA trial was designed back in 2011 to provide a definitive answer to…

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The ODYSSEY Trial Ends Well— But Will It Be Enough?

Sanofi and Regeneron achieved a modest victory with the much anticipated ODYSSEY Outcomes trial of its cholesterol lowering drug Praluent (alirocumab). The trial met its primary endpoint and even reported a significant improvement in all-cause mortality. But the mortality finding has an asterisk attached to it and it is far from clear whether the overall…

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Esperion Releases Top Line Results For First Pivotal Phase 3 Study

Esperion announced positive results today for the first in a series of pivotal phase 3 studies of its cholesterol lowering drug. The trial (Study 4, or 1002-048) compared bempedoic acid to placebo in 269 patients with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD who have high LDL cholesterol levels (100 mg/dl or greater)…

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Device Companies Fund Courses For Doctors In Training

At a crucial early stage of their careers young interventional cardiologists attend brief training courses that are considered essential for their careers. It is not generally appreciated that large device and drug companies provide the money that enable these young doctors to attend these meetings. The money from industry covers the cost of travel, hotel, meals,…

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Low-Carb And Low-Fat Diets Battle To A Draw

A new study comparing a low-carbohydrate diet with a low-fat diet found no important differences in weight loss or other important outcomes between the two diets. Some experts believe the result shows that the  debate over the relative worth of these different diets has been overblown and confirms the view that calories count. Others say…

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Moment Of Truth For Struggling And Expensive Cholesterol Drugs

It will be the moment of truth for the expensive new cholesterol drugs known as PCSK9 inhibitors. Next month we will learn much more about the PCSK9 inhibitor class of cholesterol drugs. A lot of the remaining uncertainty about the efficacy— or lack of efficacy— of these drugs will be resolved when a large cardiovascular…

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The Hypertension Guideline War Is Not A Fake War

The war over the new blood pressure guideline is not a fake war or a childish dispute. It is a real war over genuine differences in how we should think about health and disease and prevention. The publication last November of the new US blood pressure guideline sparked a vigorous and important debate. A central part…

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Statin Critic Accused Of Image Manipulation In Earlier Research

A journalist who has been a frequent critic of statins has been publicly accused of scientific misconduct involving image manipulation in an earlier research paper. Maryanne Demasi is an Australian journalist who has a PhD in Rheumatology from the Royal Adelaide Hospital in South Australia. She has been a frequent critic of statins, a proponent of…

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More Mini-Trials And Fewer Mega-Trials?

Just as dinosaurs ruled the earth for millions of years, for more than 30 years now cardiology has been ruled by mega-trials. Over the years the cardiology landscape would shake and tremble as ever more gigantic mega-trials emerged to  dominate the field. Just as the giant dinosaurs paid no attention to the seemingly inconsequential little…

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Nuance And The Healthcare Apocalypse

(Updated) If you actually have a life you may not be aware that there’s been a fierce debate on Twitter and the blogosphere over Lisa Rosenbaum’s NEJM article decrying the oversimplification and self-righteousness of the “less is more crusade.”  In response to fierce criticism, from myself, the Lown Institute, and others, Saurabh Jha praised and defended Rosenbaum for embracing nuance…

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Ms. Inappropriate Defends The Status Quo

I think I would have liked the younger Lisa Rosenbaum, the cardiologist who last week in the New England Journal of Medicine launched a missile at the “less is more” movement. Here’s how her piece begins: They called me Ms. Appropriate. When I was a cardiology fellow, health care costs were skyrocketing, and I considered devoting…

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Guest Post: Get Ready For A Tsunami Of ECGs

Editor’s note: Ethan Weiss, a cardiologist at UCSF, reflects on a recent patient who may well be a forerunner of many more patients in the near future. I saw a man in his early 40’s. He’s super healthy. He had a Ziopatch as part of a general medical workup (not really important why). He was…

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Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives

Editor’s note: In this guest post Sanjay Kaul (Cedars-Sinai) explains why it is unlikely that the ORBITA trial will have a big impact on clinical practice. Guest Post: Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives.   by Sanjay Kaul, MD (Cedars-Sinai Medical Center) Shortly after celebrating the 40th anniversary of PCI, first…

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In Defense Of ORBITA

–The trial investigators respond to their numerous critics. If you’ve been reading about ORBITA then you probably know that the first ever placebo-controlled trial of PCI was interesting and provocative. But you’ve also probably heard that the trial was too small, too short and performed in patients who should not have been studied. Simultaneously, you…

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Clinical Trials: You Can’t Always Get What You Want

–Trial investigators have lost control of their trials’ messages. Editor’s Note: The following is a lightly edited version of a talk I presented (without slides!) at the CVCT workshop in Washington, DC earlier this week. The topic was the changing role of media in communicating the results of clinical trials. When it comes to the…

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After Slow Start Entresto Is Poised For Takeoff

–Novartis sees open road to blockbuster status for heart failure drug After a slow start, the novel heart failure drug Entresto (valsartan/sacubitril) is now poised to become a blockbuster, if drugmaker Novartis’s projections are on target. The combination pill will record sales of about $500 million in 2017 and may eventually achieve $5 billion in…

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FDA Approves ECG Band For Apple Watch

(Updated) —Kardia Band is the first FDA approved medical accessory for the Apple Watch. The FDA has cleared a band for the Apple Watch that records an ECG. According to AliveCor, the Kardia Band is the first medical device accessory cleared by the FDA for the Apple Watch. The Kardia Band is activated with a…

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No Benefit Found For PFO Closure In Migraine

–A sham-controlled trial defies previous expectations. A rigorous sham-controlled trial has failed to demonstrate a significant benefit for patent foramen ovale (PFO) closure in addressing frequent migraine headaches. There has long been a strong suspicion that some migraine headaches may be caused by PFO, but this relationship has never been conclusively demonstrated, and it has…

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Why was ORBITA MIA at the AHA?

By offering a last minute 2-for-1 deal shortly before its annual meeting in Anaheim the American Heart Association signalled its desperation. During the meeting, as the tumbleweed rolled down the lonely halls of the Anaheim Convention Center, the reason for the deal was apparent to everyone. The lack of crowds, the low energy, the paucity…

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The Once— And Future?— Catastrophic Cost of MI & Stroke

–Obamacare has protected many people with heart disease. Cardiovascular disease can often have a catastrophic economic effect on people who don’t have insurance. Two studies presented at the American Heart Association in Anaheim illustrate how the Affordable Care Act, aka Obamacare, likely has helped hundreds of thousands of people avoid financial apocalypse. The first study,…

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The Survey Says: BP Measurement In SPRINT Was All Over The Place

–BP measurement question limits the trial’s ability to inform clinical practice. A long-promised report from the SPRINT investigators offers important new information about how blood pressure was monitored in the trial. The report is unlikely to satisfy critics or resolve the larger controversy of how the trial should be interpreted. At the American Heart Association…

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AHA President Suffers A Heart Attack Monday Morning

–The AHA reports that he received a stent and is doing well. The president of the American Heart Association, John Warner, had a “mild heart attack” on Monday morning, according to the AHA. Warner received a stent at an undisclosed hospital. The AHA said he is “doing well.” Warner is 52. The attack occurred while…

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New Blood Pressure Guideline Sets Lower 130/80 Threshold

Expanded guideline means more than 100 million people have high blood pressure. The new US blood pressure guideline lowers the definition of high blood pressure to 130/80 mm Hg. This means that more than 100 million adults will now have high blood pressure, though many will be unaware of the diagnosis. The 192 page guideline…

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CANTOS Substudy Shows Major Role For Inflammation

–Large reductions in hsCRP appeared to foretell improved outcomes. ANAHEIM — An important CANTOS trial substudy bolsters evidence that inflammation plays an independent role in cardiovascular disease (CVD) and may point toward a new targeted approach to treatment of CVD and perhaps even more profoundly impact cancer treatment. The report, presented by Paul Ridker (Brigham…

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