Roche announces more positive results for taspoglutide, but…

Roche announced more positive phase III results from its promising diabetes drug taspoglutide, but the announcement may not have amounted to the tsunami of new results that the press release seemed to promise. Today’s press release (reprinted below) said that “results from the first five Phase III clinical trials show that taspoglutide has met the…

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Boston Scientific and William Maisel clash over ICD flaws

In response to concerns raised about Boston Scientific Cognis and Teligen ICDs raised earlier this week in an article published online in Heart Rhythm, Boston Scientific has issued a rebuttal. Rebutting the rebuttal, William Maisel, the senior author of the paper, has sent a statement to CardioBrief….

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Rosuvastatin (Crestor) gains expanded primary prevention indication

The FDA today announced an expanded indication for rosuvastatin (Crestor) for the primary prevention of cardiovascular disease. The decision follows a positive vote last December by an FDA advisory panel. Notably, the new label does not endorse the use of rosuvastatin for everyone with elevated CRP levels and does not contain an indication for the…

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Study finds significant lesions in one-fifth of patients with zero calcium scores

A calcium score of zero does not completely rule out significant coronary disease, according to the surprising results of a substudy of the CORE64 multicenter trial, in which patients referred for angiography were also asked to undergo a calcium scan. Ilan Gottlieb and colleagues report in the Journal of the American College of Cardiology on…

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New concerns raised about Boston Scientific ICDs

Updated with remarks from William Maisel and a statement from Boston Scientific– A case of a weakened bond between the header and case of a subcutaneously implanted Cognis CRT-D is raising new concerns about the Boston Scientific Cognis and Teligen ICDs. Last December Boston Scientific issued a product advisory based on two cases of a…

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The two sides of aspirin: too much and not enough

On the one hand, a lot of people who should be taking aspirin aren’t doing so. On the other hand, a lot of people who are taking aspirin shouldn’t be doing so. Those are the dual conclusions of a new report and accompanying editorial from the REACH Registry appearing in the American Journal of Cardiology….

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More adverse events seen in patients on PPIs after DES

Following implantation of a drug-eluting stent (DES), patients who were taking a proton pump inhibitor (PPI) had more major adverse events (MACE) than patients not taking a PPI, according to a new report by Gaglia et al published online in the American Journal of Cardiology….

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Live AF ablation broadcast on Today Show: what’s wrong with this picture?

Mauricio Arruda performed a live AF ablation at University Hospitals in Cleveland on the Today Show yesterday morning. The 6-minute segment was relentlessly upbeat. The TV producers pulled every trick in the book to overcome the inherent difficulty of portraying a hard-to-explain disease like AF and an even harder-to-explain procedure like catheter ablation. Instead of…

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Alderman in JAMA: universal sodium reductions are a “rash route”

In the absence of “definitive evidence,” universal dietary sodium reductions are a “rash route,”  writes Michael Alderman in a JAMA commentary. Although measures to cut salt have been gaining widespread support– see the recent study and editorial in the NEJM, as well as a detailed discussion of US efforts to cut salt in heartwire— Alderman…

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Boston Scientific pays $1.725 to J&J to settle three patent disputes over stents

Boston Scientific said today that it had paid Johnson & Johnson $1.725 billion to settle 3 longstanding patent disputes. The Wall Street Journal Health Blog observed that J&J’s total sales of drug-eluting stents last year were only $919 million….

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Guest Post: Chantix and Cardiovascular Risk: Another Weak Safety Study

Editor’s Note: The following is a guest post by Joseph Ross, an assistant professor at the Mt Sinai School of Medicine. This post originally appeared on CardioExchange, an online cardiology community in the early stages of development by the New England Journal of Medicine. The editor-in-chief of CardioExchange is Harlan Krumholz, who frequently collaborates with Ross….

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Lilly reports modest sales figures for Effient (prasugrel)

In its first months on the market, sales of prasugrel (Effient, Lilly and Daiichi Sankyo) appear to have been modest, according to figures released by Eli Lilly today as part of their fourth-quarter and year-end report….

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ACC.10 & i2 Summit in Atlanta: Late-Breaking Clinical Trials

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Study identifies shortcut to diagnosing long QT syndrome

Observing the QT interval when a patient stands up quickly can provide a simple and quick method to identify patients who may have Long QT syndrome (LQTS), according to Sami Viskin and colleagues in an expedited study in JACC. The researchers studied 68 patients with LQTS and 82 controls. Each subject had a baseline ECG…

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Lancet: researchers find Goldilocks effect in glucose control for diabetes

It turns out that blood glucose may be a lot like porridge, and that physicians, like Goldilocks, need to get it just right. In a new study appearing online first in the Lancet, researchers from Cardiff, UK and Eli Lilly examined data from 48,000 patients in the UK General Practice Research Database. All cause mortality was…

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Cath lab coming attractions: 3D images of the coronary arteries

eHeart_Model

It may not be as sexy as Avatar in 3D at the local Imax, but recent advances in technology may one day allow cardiologists to see 3D images of the coronary arteries in the catheterization lab, according to a new feasibility study published in Circulation: Cardiovascular Interventions. The new system uses existing X-ray systems in the…

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JAMA: RF ablation superior to drugs in multicenter AF trial

Catheter ablation of AF was superior to antiarrhythmic drugs in the ThermoCool AF Trial, according to a new report in JAMA. Led by David Wilber, the trial investigators randomized 167 patients at 19 hospitals to the multicenter, randomized trial. The primary endpoint was the time to protocol-defined treatment failure within the 9 month evaluation period. At 9 months, 66%…

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FDA approves liraglutide (Victoza) for type 2 diabetes

The FDA announced today that it had approved liraglutide (Victoza, Novo Nordisk) for the treatment of type 2 diabetes. It is not recommended as initial therapy, and the label includes a black box warning about thyroid tumor risk….

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FDA approves first percutaneous heart valve, Medtronic’s Melody Pulmonary Valve

The FDA today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System. It is the first percutaneous valve to receive FDA approval. The Melody valve is intended to help patients with poorly functioning pulmonary valve conduits delay the need for open-heart surgery. The device was approved for use under the FDA’s Humanitarian Device Exemption…

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Sandoz starts to prepare for generic enoxaparin in the US

A generic form of enoxaparin (Lovenox) may be available in the US sooner than expected, according to Sanford Bernstein analyst Timothy Anderson. In partnership with the biotech company Momenta, Sandoz, the generic arm of Novartis, has been setting prices and soliciting pre-orders for generic enoxaparin, writes Anderson in a research report. “This covert action suggests…

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Abbott suspends marketing of sibutramine in Europe following EMEA warning (updated)

Updated–Following a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) that sibutramine be withdrawn from European markets, Abbott announced today that it had suspended marketing of the drug in Europe.  The events in Europe  closely follow an announcement earlier in the day from the US FDA that sibutramine will now be contraindicated in…

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FDA: sibutramine now contraindicated in people with cardiovascular disease

The FDA now says that sibutramine is contraindicated in people with a history of cardiovascular disease. The change comes as a result of a safety review of sibutramine announced by the FDA in November. (On the same day the EMEA issued a similar warning about sibutramine.)…

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Generic clopidogrel besilate makes inroads into European Plavix market

Generic versions of clopidogrel with the alternate besilate salt form have started to capture substantial portions of the Plavix/Iscover (clopidogrel bisulfate) market, according to a research report from Sanford Bernstein analyst Timothy Anderson. Many European countries– but not the US–  consider alternative salt forms of drugs to be acceptable generic equivalents….

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NEJM study and editorial advocate widespread salt reductions

Reducing dietary salt in the US could save thousands of lives each year and prevent even more MIs and strokes, according to a new study in the New England Journal of Medicine. But at least one critic, hypertension expert Michael Alderman, maintains the data are not sufficient to justify a large-scale change in public policy….

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NIH puts Baylor on a tight leash after failure to disclose Merck payments to Ballantyne

After failing to disclose substantial payments from Merck to Christie Ballantyne, Baylor College of Medicine (BCM) has been put on a very tight leash by the NIH,  according to an article in Nature News by Brendan Borrell. Baylor headed to the NIH’s doghouse last fall, when a Senate investigation uncovered significant expenditures from Merck to Ballantyne…

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