Guest Post: Chantix and Cardiovascular Risk: Another Weak Safety Study 3

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. CardioBrief’s Larry Husten is the news editor of CardioExchange.

Chantix and Cardiovascular Risk: Another Weak Safety Study

by Joseph S. Ross, MD, MHS

In 2008, Dr. John Spangler of the Wake Forest University School of Medicine wrote a letter to the editor of Current Medical Research and Opinion expressing concern about a Pfizer-funded, randomized, placebo-controlled trial of the smoking-cessation drug varenicline (Chantix). By 1 year, the varenicline group had experienced a higher rate of serious adverse events than the placebo group; many were cardiovascular (CV) events. The difference was not statistically significant, but Spangler considered it clinically significant and deserving of further study.
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Study identifies shortcut to diagnosing long QT syndrome Reply

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 while lying down and was then asked to stand up quickly. Both groups had a similar heart rate acceleration in response to standing, but significant differences were found in the response of the QT interval.
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Lancet: researchers find Goldilocks effect in glucose control for diabetes Reply

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 lowest in those who achieved an HbA1c level of 7.5%. Mortality increased as HbA1c levels increased or decreased from this level, which the investigators described as a U-shaped association. The analysis was adjusted for age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity.

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Cath lab coming attractions: 3D images of the coronary arteries 1

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 cath lab and may decrease patient exposure to radiation and contrast dye, say the study’s authors, led by John Carroll at the University of Colorado, and including researchers from Philips. The study compared standard 2-D images to automatically generated, computer-reconstructed 3-D images in 23 patients. The images were obtained using rotational angiography and ECG gated iterative reconstruction.
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JAMA: RF ablation superior to drugs in multicenter AF trial Reply

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% of the catheter ablation group were failure free, compared with only 16% of patients receiving drug therapy. At 30 days, major treatment-related adverse events had occurred in 8.8% of the drug therapy group versus 4.9% of the ablation group. In addition, quality of life was significantly better improved in the ablation group.
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FDA approves first percutaneous heart valve, Medtronic’s Melody Pulmonary Valve 2

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 (HDE) program. Use of the valve will therefore only be used at hospitals that have an Institutional Review Board. In October 2006, the valve received the CE mark in Europe, becoming the the first transcatheter valve to receive regulatory approval anywhere in the world.
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Sandoz starts to prepare for generic enoxaparin in the US 1

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 Novartis believes approval of its generic might finally be nearing.”
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Abbott suspends marketing of sibutramine in Europe following EMEA warning (updated) Reply

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 people with cardiovascular disease. Abbott said sibutramine would remain available outside the EU.

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Generic clopidogrel besilate makes inroads into European Plavix market Reply

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

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 and many other researchers. Senator Grassley then sent a query to NIH about Ballantyne and other recipients of the Merck money who were also NIH grantees.

In a letter dated January 14, NIH director Francis Collins informed Grassley that the investigation “raised serious concerns regarding BCM’s compliance” with federal COI regulations. “As a result, the NIH has imposed special award conditions on all BCM grant awards until BCM can assure the NIH that the detected deficiencies noted in their response have been appropriately addressed and BCM can demonstrate compliance…”
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Heartmate II LVAS gains destination therapy indication Reply

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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”
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Study suggests fixed doses of statins may be better than treating to target Reply

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 estimated the treatment effect of a tailored treatment based on 5 year CAD risk, in which patients with a 5% to 15% risk received simvastatin 40 mg and patients with a CAD risk over 15% received atorvastatin. Compared to treat-to-target approaches from the National Cholesterol Education Program (NCEP) III guidelines, the tailored strategy treated saved 500,000 more quality-adjusted life-years and treated fewer people with high-dose statins.
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Maryland hospital tells hundreds of heart patients their stents may have been unnecessary 3

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. The patients had all received stents from the hospital’s star interventionalist, Mark G. Midei, who last summer lost his hospital privileges and stopped practicing.
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Lancet editorial on PLATO: ticagrelor the “new standard of care” in ACS 1

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 reported by CardioBrief at the time. The main results of PLATO in 18,624 ACS patients were presented last summer at the ESC.
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SYNTAX: have drug-eluting stents removed the “death penalty” associated with diabetes and multivessel PCI? Reply

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 study is needed,” write the SYNTAX investigators, “these exploratory results may extend the evidence base for DES use (particularly PES) in selected diabetic and nondiabetic patients with left main and/or 3-vessel disease.” The new SYNTAX diabetes paper appears in JACC.
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Cocaine plays role in 3% of sudden deaths in Spain Reply

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 out of 668 cases were related to cocaine use.
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Increasing adherence to statins would save twice the number of lives as expanding eligibility Reply

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 prescribed the drugs.
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FDA’s Cardiorenal panel unanimously rejects nebivolol for HF Reply

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 here to read a Heartwire story by Steve Stiles.