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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Heartmate II LVAS gains destination therapy indication

Thoratec’s HeartMate II continuous flow left ventricular assist system (LVAS) has received FDA approval for use as destination therapy for patients who are not eligible for a heart transplant. The device had been previous approved as a bridge-to-transplant. “The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,”…

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Study suggests fixed doses of statins may be better than treating to target

In recent years the “treat to target” method for giving statins for prevention has gained widespread acceptance among healthcare professionals. Now a new study in the Annals of Internal Medicine finds evidence that an approach using fixed doses of statins based on the risk levels of individual patients might be better. Rodney Hayward and colleagues…

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Maryland hospital tells hundreds of heart patients their stents may have been unnecessary

St Joseph Medical Center in Towson, MD has informed hundreds of patients who received stents that they may have undergone an unnecessary procedure, according to a story by Robert Little in the Baltimore Sun. The action is the latest development in a federal investigation of health-care fraud into the hospital’s cardiology practice, according to the story….

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New research links radiation exposure to CV disease

Excess stroke and heart disease deaths may account for one-third as many radiation-associated excess deaths as cancer among survivors of Hiroshima and Nagasaki. That is the surprising and perhaps ominous finding of a prospective cohort study in BMJ of 86,611 atomic bomb survivors who received estimated radiation doses ranging from 0 to >3 Gy….

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Judge rejects ACC lawsuit against HHS Secretary Sebelius over Medicare cuts

A US District Court judge in Florida has blocked the ACC’s legal effort to overturn Medicare reimbursement cuts to cardiologists. The ACC published a statement on its website and the story was covered by Andis Robeznieks in Modern Healthcare….

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Lancet editorial on PLATO: ticagrelor the “new standard of care” in ACS

Results of the PLATO substudy of ACS patients undergoing an invasive strategy have been published in the Lancet, accompanied by a comment from Gregg Stone hailing  the introduction of ticagrelor as a landmark event that will redefine the care of ACS patients. The results of the substudy were originally presented by Chris Cannon at TCT and…

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SYNTAX: have drug-eluting stents removed the “death penalty” associated with diabetes and multivessel PCI?

A study of the 1-year results of diabetics enrolled in SYNTAX shows, as expected, that diabetic patients treated with a Taxus stent have a higher rate of revascularization than their counterparts randomized to surgery, but has somewhat unexpectedly found no significant differences in the composite safety end point of death, stroke, or MI. “Although further…

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Cocaine plays role in 3% of sudden deaths in Spain

Cocaine plays a role in 3% of sudden deaths in Spain, according to a new study appearing in the European Heart Journal. Most of the cocaine-related deaths were due to cardiac or cerebrovascular causes. Forensic pathologists in Spain carefully studied all the surrounding circumstances of a consecutive series of sudden deaths and found that 21…

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Increasing adherence to statins would save twice the number of lives as expanding eligibility

Although the beneficial effects of statins have been widely recognized, there is no agreement over the exact composition of the population who should receive statins. Now a new study from the UK makes the important point that extending the statin-eligible patient population would be far less effective than improving adherence in patients who are already…

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FDA’s Cardiorenal panel unanimously rejects nebivolol for HF

The FDA’s Cardiovascular and Renal Drugs advisory committee has unanimously voted to reject a heart failure indication for Forest Laboratories’ Bystolic (nebivolol). The vote follows an extremely negative FDA staff review posted last week, as reported by CardioBrief at the time. Click here to read a Dow Jones news report on the panel meeting. Click…

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