NY Times: most nitroglycerin in the US is in regulatory limbo

Most of the nitroglycerin tablets taken in the US has never received FDA approval and exists in a kind of regulatory limbo, according to an article in Saturday’s New York Times by Natasha Singer….

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More Multaq: Prystowsky whack-a-mole, ACC responds, Sanofi overtures to EPs

In response to yesterday’s posting about several problems involving a supposedly independent ACC/HRS website (AFibProfessional.org) supported by Sanofi-Aventis, the manufacturer of Multaq (dronedarone), several new events have transpired: Prystowsky Whack-a-Mole– The Eric Prystowsky lecture has been removed from AFibProfessional.org. An ACC spokesperson told CardioBrief that the ACC, in conjunction with its partner, HRS,  was “taking some immediate…

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WTF? Now you can diagnose your own heart attack right at home

Great news for hypochondriacs: you no longer have to go to the ER or see a doctor to find out if you are having a heart attack– at least if you live in Europe. Now you can do it from the comfort of your own home. A Chinese company announced that its consumer test for…

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Pieces of a puzzle: Multaq, Sanofi, ACC, HRS, Prystowsky, AF Guidelines

CardioBrief today dispenses with its usual format. Our post today is a puzzle. Here are the various pieces of the puzzle: Puzzle Piece 1: The commercial prospects of Multaq (dronedarone) appear increasingly cloudy, according to a news report by Jim Edwards on bnet.com. Wall Street estimates for the drug, which some had thought might reach € 3…

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Avandia again: Nissen and JAMA editors spin RECORD round and round

Avandia is back in the news. After a month of relative silence, following the New York Times disclosure of FDA and Senate reports critical of rosiglitazone, the subsequent release of the Senate report, and the revelation that Steve Nissen had secretly recorded a meeting with GSK executives (though the significance of this last event is unclear), a…

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Why is there a red dress on diet Coke cans?

Diet Coke icon

I have a question for the NHLBI: why is there a red dress on diet Coke cans? But before raising the question, let’s step back for a moment. Last Tuesday at the ACC Bob Harrington and Steve Nissen debated each other (and, occasionally, the audience) over the subject of conflicts of interest in medicine. The…

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Sir James Black, Nobel laureate who invented beta blockers, dead at 85

James Black, the Nobel Laureate who followed up his invention of propranolol, the first beta blocker, with key contributions to the discovery of cimetidine, the first effective anti-ulcer drug, has died at the age of 85….

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FDA panel recommends approval of Medtronic’s MRI-safe pacemaker

The FDA Circulatory System Devices Panel unanimously voted to recommend approval of Medtronic’s  REVO MRI SureScan Pacing System, the first MRI-safe pacing system. The panel said the company should be required to perform a post-approval study. In addition, they requested that the label prominently note that the device should only be used with leads that have been tested…

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FDA warns about increased risk of myopathy with 80 mg simvastatin

The FDA said today that it was informing the public about an increased risk for myopathy and rhabdomyolysis in patients taking simvastatin 80 mg. The warning is based on an ongoing review of the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial and other data….

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FDA panel supports expanded indication for CRT-Ds

The FDA Circulatory System Devices Panel voted unanimously in favor of an expanded indication for Boston Scientific’s CRT-D devices based on the MADIT-CRT study. The panel stipulated that the expanded indication should be limited to NYHA Class I and II patients with LBBB, LVEF ≤ 30% and QRS duration ≥ 130ms. The panel also stipulated that the…

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FDA: Watchman device will need to wait a bit longer

The FDA is requiring Atritech to perform another study to confirm the safety and efficacy of the Watchman left atrial appendage closure device before it can receive full approval. Atritech said it will work closely with the FDA on the study design and that it hopes to start the study later this year….

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More details emerge about Boston Scientific’s suspension of ICD sales

Details about Boston Scientific’s suspension of ICD sales are now beginning to emerge. Wells Fargo analyst Larry Biegelsen wrote the following summary of events….

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Guest Post: Freezing in AF ablation: not so fast you all…

(Editor’s note: The following post is written by Dr. John Mandrola, an electrophysiologist in Louisville, KY. Mandrola is also the author of his own blog, Dr John M, where this post originally appeared, and which we recommended highly to our readers.) Freezing the heart is in the news.  The STOP-AF trial was presented at ACC, and…

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FDA panel set to review expanded indication for CRT-D and first MRI-safe pacing system

The FDA Circulatory System Devices Panel meets on Thursday and Friday. On Thursday the panel will consider an expanded indication for Boston Scientific’s CRT-D devices to include ischemic NYHA Class 1 and all NYHA Class II patients with LVEF ≤ 30% and QRS duration ≥ 130ms. On Friday the panel will review Medtronic’s  REVO MRI SureScan…

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AHA/ACC release thoracic aortic disease guidelines

The ACC and AHA have released new practice guidelines for the management and treatment of thoracic aortic disease….

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CABG in PLATO’s cave: is the reduction in mortality real or an illusion

Previous treatment with ticagrelor resulted in a significant reduction in death among patients who underwent CABG within 7 days of stopping drug treatment, according to the results of a PLATO substudy presented in Atlanta at the ACC on Tuesday by Claes Held. The findings are the latest in a series of promising results for the drug, beginning…

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US Attorney’s office investigating Medtronic over ties to Lahey Clinic cardiologists

Medtronic has disclosed that it is being investigated by the US Attorney’s Office in Massachusetts about its relationship with cardiologists at the Lahey Clinic. The statement appears in the company’s most recent quarterly report….

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FDA says it will review the ACCORD data

The FDA announced today that it will conduct a review of the ACCORD data. As reported here yesterday, ACCORD found that fenofibrate, when added to statins, failed to improve outcome in patients with type 2 diabetes. The FDA said it “has made no new conclusions or recommendations regarding the combination use of simvastatin or other…

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Optimal duration of dual antiplatelet therapy still unresolved

The optimal duration of dual antiplatelet therapy following DES implantation is unknown and the subject of intense interest among cardiologists. “Sadly,” writes Peter Berger in an editorial in the New England Journal of Medicine, a study from Korea that attempts to shed light on this issue will “fail to inform physicians’ practice with any degree…

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SORT OUT III chucks out zotarolimus-eluting stents

Discussion of drug-eluting stent trials in the interventional cardiology community today is a bit reminiscent of medieval scholars debating the number of angels that can dance on the head of a pin. The debates can be very spirited and each side can find more than enough evidence to support its position. The latest contribution to…

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Boston Scientific suspends ICD sales due to administrative errors

Boston Scientific has suspended sales of its ICDs. The suspension occurred after the company discovered that some of its manufacturing practices had not been submitted for FDA approval. The nature of the error and the duration of the suspension have not been revealed. News of the suspension was originally reported by a Sanford Bernstein analyst. Boston…

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RACE II: don’t rush to slow down

Lenient rate control is just as effective as strict rate control in AF, and has the added advantage of being more convenient for patients and physicians as well, according to results of the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation) trial presented here in Atlanta at the ACC and published simultaneously in the…

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NAVIGATOR provides little guidance in diabetes

Attempts to navigate the tempestuous waters of diabetes have once again been dashed against the rocks of clinical reality. The trial failed to find any evidence of clinical benefit for either valsartan of nateglinide in patients with impaired glucose tolerance. Results of NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) were presented today…

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EVEREST II: Catheter-based mitral repair system reaches new peak

The MitraClip catheter-based mitral valve repair system appears to be safer than mitral valve repair surgery at 30 days and as effective at one year. Ted Feldman reported the results of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study ) this morning at the ACC. Feldman concluded his presentation by saying that “the MitraClip procedure is an…

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ACCORD fails to find benefits for fenofibrate or lower blood pressure target

When added to statins, fenofibrate failed to improve outcome in patients with type 2 diabetes. In addition, lowering systolic blood pressure to 120 mm Hg or lower was no better than the traditional target of 140 mm Hg. These are the main results of the two arms of ACCORD (Action to Control Cardiovascular Risk in…

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