Gilead’s Hepatitis Drugs Tripped By Old Heart Drug

Late last week Gilead Sciences issued a warning about a rare but potentially fatal interaction between its stellar new hepatitis C drug sofosbuvir and amiodarone, a potent but tricky antiarrhythmic agent. Sofosbuvir is marketed as Sovaldi and, in combination with another antiviral agent, as Harvoni. Amiodarone, which is used to treat dangerous heart rhythm problems, has a number of…

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A Requiem for Routine Clot Removal During Heart Attacks

Using a stent to open a blocked coronary artery is the treatment of choice in the early period of a heart attack (myocardial infarction). A limitation is the risk of dislodging part of the clot, leading to new downstream blockages of smaller vessels. One strategy that has been under development for a long time is thrombectomy, in…

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Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs?

The big news yesterday was important additional information about the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi/Regeneron. As I reported then, the studies were broadly consistent, showing the powerful cholesterol-lowering effects of the drugs and providing an early suggestion that the drugs may lead to significant reductions in heart attacks, stroke, and other cardiovascular events. But one finding, though not…

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Encouraging Long Term Results For Less Invasive Heart Valves

The publications five years ago of the two part PARTNER trial brought a major change in the treatment options available to some people with aortic valve disease, which is often an extremely serious condition with a poor prognosis. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who…

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New Cholesterol Drugs: Highly Effective But Important Questions Remain

New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors– evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron– were published in the New England Journal of Medicine. The effects of the two drugs appeared to be broadly consistent. Both lowered LDL cholesterol powerfully,…

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Has CT Angiography Lived Up to Its Early Promise?

When it first appeared more than a decade ago computed tomographic angiography (CTA) astounded cardiologists and other physicians. Until it came along the only way to check for blockages in the vital coronary arteries that supply the heart itself with blood was with cardiac catheterization, an expensive, highly invasive and unpleasant procedure. In the following years CTA (the…

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AstraZeneca Drug ‘Approaching The Point Of Diminishing Returns’

After a heart attack (myocardial infarction or MI) patients remain at high risk for recurrent events. The precise role of blood thinning with dual antiplatelet therapy to lower this risk has been the subject of considerable disagreement.  Now a new study offers fresh evidence that one important strategy, prolonged dual antiplatelet therapy, can lower risk…

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What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions. … Click here to…

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High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic

Transcatheter aortic valve replacement (TAVR) is one of the most important advances in cardiovascular medicine in recent years. TAVR devices, introduced recently in the US by Edwards Lifesciences and Medtronic, are associated with very high risks, but offer a less invasive alternative to traditional aortic valve replacement surgery. Because of early concerns about potential overuse and misuse of…

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Study Uncovers Confusion About When To Use An Important Heart Test

Appropriate use criteria (AUC) are designed to help make sure that medical procedures and interventions are performed in people most likely to benefit and, in turn, are not performed in people unlikely to gain benefit. Now a new study published in Annals of Internal Medicine suggests that the AUC for one very widely performed procedure, diagnostic cardiac catheterization, can provide…

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Orexigen ‘Crying All The Way To The Bank’ After ‘Egregiously Unethical’ Actions

On Tuesday morning the members of the Data Monitoring Committee of Orexigen’s Light study began a planned meeting in a hotel in Chicago. They had no way of knowing that in a few hours their routine duties would be completely interrupted by the news that data from the trial– which they thought was known only to…

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Takeda Disagrees With Orexigen Over Data Disclosure

(Updated) On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does not support the release of the interim data. Here is the Takeda statement: “Pursuant to the Collaboration Agreement between…

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Orexigen Released Interim Data Without Approval Of Trial Leaders

Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. (You can read a good summary of the findings by Adam Feuerstein on TheStreet.) The surprising thing about the Orexigen disclosure, which was contained in a Form…

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No, Drinking Coffee Won’t Save Your Life Or Prevent Heart Attacks

Once again the media has swallowed the bait hook, line, and sinker. Following the publication of a  a new study in the journal Heart last night, hundreds of news reports have now appeared extolling the miraculous benefits of coffee. Here’s just one typical headline from the Los Angeles Times: “Another reason to drink coffee: It’s good for your heart, study…

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Hospitals, Like Vampires, Want Your Blood

Original illustration by Max Husten

Anyone who has been in the hospital, either as a patient or a healthcare provider, is keenly aware that hospitals perform a lot of tests. It has even been suggested that some of those tests may not be necessary. Now a new study published in the Annals of Thoracic Surgery sheds light on just how excessive some of…

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New York City Ebola Doctor Slams Media And Governors Christie And Cuomo

The response in the US to the Ebola crisis last year brought out the worst in the media and our politicians. By comparison, our response to the recent measles crisis– by no means a model for public health communication– had the sophistication and intelligence of a debate at the Oxford Union. One of the chief victims of the hysteria was Craig…

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Common Pain Drugs Linked To More Problems After A Heart Attack

The cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and diclofenac has been the subject of considerable uncertainty and controversy. Now a new study published in JAMA raises specific concerns about the safety of these drugs in the highly vulnerable population of people who have had a recent heart attack. … Click here to read the full…

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Everybody Into The Sauna?

Spending more time in the sauna may lead to a longer and healthier life– at least if you live in Finland, according to a new study published in JAMA Internal Medicine. Finnish researchers analyzed data from the Kuopio Ischemic Heart Disease Risk Factor Study. The new analysis focused on 2,315 middle-aged men who had 1, 2-3, or 4-7 sauna bathing…

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Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year

Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their…

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No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year

In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case…. … Click here to read the full post on Forbes.  …

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More Guideline Controversy: The Tricky Business Of Calculating Cardiovascular Risk

Calculating cardiovascular risk has become a central and highly controversial component of cardiovascular guidelines. Now a study in the Annals of Internal Medicine finds that most of the commonly employed tools seriously overestimate the risk of people today. … Click here to read the full post on Forbes….

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Very Simple High-Fiber Diet Stands Up To American Heart Association Diet

Diets notoriously fail to help people lose a lot of weight. One problem is that most diets include a broad range of restrictions and guidelines that many people find difficult to follow. Another problem is that negative recommendations may have unintended consequences, such as low-fat recommendations leading to increased consumption of refined carbohydrates. Now a new…

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Three Trials Show Benefits Of Thrombectomy In Stroke Patients

Three new studies offer important additional evidence that early treatment with current thrombectomy devices that extract clots from blood vessels in the brain can lead to improved outcomes in carefully selected stroke patients. The trials were stopped early based on efficacy following positive findings last year from another trial, MR CLEAN. The three new trials were…

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New US Guidelines Will Lift Limits On Dietary Cholesterol

The influential  Dietary Guidelines Advisory Committee has recommended that limitations on dietary cholesterol be removed from the upcoming 2015 edition of Dietary Guidelines for Americans. Recommendations to reduce dietary cholesterol have been a mainstay of the USDA and other guidelines for many years, starting with guidelines from the American Heart Association in the 1960s. … Click here to read…

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Another Study Raises Questions About Blood Pressure Guidelines

Although the general benefits of lowering high blood pressure are widely accepted, there has been intense debate over specific goals for treatment and the threshold at which therapy should be initiated.  A large new meta-analsysis published in JAMA helps shed lights on this important controversy. UK and Australian researchers analyzed the effect of lowering blood pressure in people…

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