FDA Warns That Tolvaptan Can Lead To Serious Liver Injury

The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because…

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Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised

Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation.  … Pradaxa label gains boxed warning. …   Click here to read the full story on Forbes.    …

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Edwards CEO Sold Stock 2 Weeks Before It Tanked

(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed…

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Another Cleveland Clinic Study Links TMAO To Atherosclerosis

A new study from the Cleveland Clinic research group headed by Stanley Hazen offers more evidence in support of the hypothesis that TMAO (trimethylamine-N-oxide) may play a role in the development of heart disease. The new research, published in the New England Journal of Medicine, follows closely on a related study published recently in Nature…

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Actelion Executive To Head American College of Cardiology

Shalom “Shal” Jacobovitz will be the new chief executive officer of the American College of Cardiology, the ACC announced today. Jacobovitz is currently the president of the US division of Actelion Pharmaceuticals, best known for its pulmonary hypertension drugs. Click here to read the complete story on Forbes.  …

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The FDA, Surrogate Endpoints, And Blood Pressure Drugs

In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions…

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Advice For Physicians: How To Behave Online

Although the internet represents “a new frontier in medicine” for physicians and patients it also presents numerous and novel challenges to professionalism, according to a position paper from the American College of Physicians and the Federation of State Medical Boards published in Annals of Internal Medicine. The paper offers physicians a new conceptual “framework for analyzing medical ethics…

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More Reasons Why Health Hype Stories Are Bad

In response to my post yesterday about why health stories should nearly always be received with caution, I received the following comment from a distinguished cardiovascular researcher: One lost point is the role of the investigators and media in hyping their research. Hazen (principal investigator of the first study) is a bright and thoughtful guy, but through…

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FDA Schedules Another 2 Day Avandia Advisory Panel

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  “discuss the results…

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Is Red Meat A Fish Story? Why You Should Never Believe Health Headlines

Don’t believe the the hype! That’s the cardinal rule to obey when reading health news. “Breakthroughs” and “cures” are rare, and should always be viewed with caution and skepticism. This week was a great example. Last Sunday, the New York Times, the major networks, and a host of other media outlets (including this one) reported on a paper…

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Scientific Misconduct: From Darwin And Mendel To Poldermans And Matsubara

Responding to recent episodes of scientific misconduct in cardiovascular research involving once prominent cardiovascular researchers, the editor of the European Heart Journal, Thomas Lüscher, has written an editorial discussing the significance of the new cases and placing them in a historical context that includes allegations of scientific misconduct by Mendel and Darwin, among many others. … Poldermans was the…

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FDA Approves First SGLT2 Inhibitor For Diabetes

The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The drug has been studied as monotherapy and in combination with…

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79-Year-Old Cardiologist Sentenced To 6 Years In Prison For Fen-Phen Fraud

A 79-year-old Florida cardiologist has been sentenced to 7 years in prison for his participation in the Fen-Phen fraud, according to a report by John Martin on Philly.Com. The article notes that other cardiologists have been convicted for similar reasons in the Fen-Phen case, but Tai’s case is unusual because of the length of the…

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Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension

For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that…

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Embers Of Poldermans Case Still Smoldering

A prominent US cardiologist has rebuked Don Poldermans, the cardiovascular researcher at the center of a research scandal in the Netherlands. As reported here previously, Poldermans was fired for scientific misconduct by the Erasmus Medical Center in Rotterdam, where he had been a professor of medicine and the head of perioperative cardiac care. He was widely published and…

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CHMP And FDA Diverge On Mipomersen And Rivaroxaban

The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected— for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the…

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The PREVAIL Fail Revisited: Spinning The Truth

The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing…

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HPS2-THRIVE: A ‘Disappointing But Clear’ Result

The results of HPS2-THRIVE were “disappointing but clear,”  said Jane Armitage, who presented the results this morning at the ACC in San Francisco. HPS2-THRIVE randomized 25,673 high-risk patients who could tolerate niacin to either placebo or extended-release niacin plus laropiprant (Tredaptive, Merck), an anti-flushing agent, in addition to background therapy. The primary endpoint was the time to…

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Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC

UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that…

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ACC Prevails Upon Boston Scientific To Present More Data At Late Breaker

In an unusual reversal of a statement it made two days ago, Boston Scientific announced this afternoon that it would present all three co-primary endpoints of the PREVAIL clinical trial this Saturday at the American College of Cardiology scientific sessions in San Francisco. The PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage…

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FDA Issues Warning Letter To CoreValve Investigator

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA…

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HPS2-THRIVE Coming Attraction: First Look At What Went Wrong With Niacin

In a few weeks, on March 9, the main results of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study will be presented in San Francisco at the annual meeting of the American College of Cardiology. These results have been eagerly awaited since Merck’s brief announcement in December that the trial had not met its primary endpoint…

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‘Bias in choosing the question is a much bigger issue than lying about the data’

Robert Califf takes questions about conflict of interest from Harlan Krumholz. Here are a few choice quotes. Read the entire Q&A on CardioExchange. …focusing exclusively on the medical products industry and failing to consider other sources of conflict of interest is a huge mistake and leads to sensationalism that then engenders reactive rules that add to bureaucracy…

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‘Somebody has finally twigged that the heart and the lungs are joined up to each other and live in this space called the chest…’

Here are a few gems from Richard Lehman’s weekly cardiovascular literature review. Read the whole thing on CardioExchange. On a JAMA study showing that ramipril increases walking time in patients with intermittent claudication: This is the kind of trial that makes nobody millions of dollars, but which we should all be doing in our fields…

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Seeking Cardiovascular Safety Data, FDA Blocks Approval Of Novo Nordisk’s Long-Acting Insulin

The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But…

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