FDA: sibutramine now contraindicated in people with cardiovascular disease Reply

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 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.

Reevaluating ESAs: too little, too late? Reply

The NEJM Perspective by 4 top FDA officials raises several questions: what was the FDA’s role in creating the current situation? And is the “reevaluation” mentioned by the FDA officials a good example of “too little, too late”?

Anyone reading the article would be hard-pressed to know that the FDA played a key role in allowing the current situation to develop. Clearly, the FDA could have played a much more pro-active role in the past and have helped prevent the current crisis. Further, the “reevaluation” mentioned by the FDA authors may not address the root cause of the problem, says at least one well-placed expert.

TREAT lead investigator Marc Pfeffer spoke with CardioBrief about the NEJM Perspective. Although Pfeffer expressed broad agreement with the need for a reevaluation, he is also troubled that not enough will be done to address the problem.
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COMPARE investigators in the Lancet: “paclitaxel-eluting stents should no longer be used in everyday clinical practice” Reply

Everolimus-eluting stents are superior to paclitaxel-eluting stents, and the latter should no longer be used in everyday clinical practice. That’s the conclusion of the COMPARE investigators in a report published online in the Lancet. But at least one expert in the field, David Kandzari, thinks the conclusion, though justified by the data, goes beyond the simple binary choice of choosing one stent over another. (See below for his perspective.)
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FDA staff recommends against heart failure indication for Bystolic (nebivolol) 2

FDA staff reviewers have strongly recommended that Bystolic (nebivolol) not receive a new indication for heart failure. The scathing review was published on the FDA’s website in advance of next Monday’s meeting of the Cardiovascular and Renal Advisory Drugs committee.

The recommendation of the clinical reviewer was about as clear and concise as you will ever find in an FDA document:

“Approval is not recommended for nebivolol for the treatment of heart failure.”

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NEJM: FDA to reevaluate ESAs in treatment of anemia 1

The FDA plans to convene an advisory panel in 2010 “to reevaluate the use of ESAs in the treatment of anemia due to chronic kidney disease,” according to a “Perspective” written by four FDA officials in the New England Journal of Medicine.

In response to the failure of 3 large clinical trials to establish any clinical benefits for the drugs, Ellis Unger, Aliza Thompson, Melanie Blank, and Robert Temple write that although ESAs “have been widely accepted” to maintain or increase RBC levels and to avoid transfusions, “optimal hemoglobin targets have never been established.” Several trials “endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes. Unfortunately, and unexpectedly, all results have suggested the opposite.”
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Braunwald: “In all fairness, what was OK three years ago is not OK now.” Reply

A new policy from Partners Healthcare that limits compensation to doctors from industry is provoking lots of discussion (see below), at least in part because of a story in the New York Times by Duff Wilson. (Click here to read the press release Partners issued last April. Click here to read the full report.) One reason, of course, is that Partners is a major teaching affiliate of Harvard Medical School and includes top-rated Brigham and Women’s Hospital and Massachusetts General Hospital. Another reason is that the chairman of the policy-writing group was Eugene Braunwald.
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Leading Israeli cardiologists blocking their country’s participation in planned NIH-funded ISCHEMIA trial Reply

A group of prominent Israeli cardiologists is blocking their country’s participation in the ISCHEMIA trial, the planned NIH-funded follow-up to COURAGE. At a recent meeting of Israeli hospital cardiology department directors, according to an article in the Israeli newspaper Haaretz by Dan Even, the directors recommended that Israel not take part in the trial.
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ICTUS at 5 years still fails to find benefit for early invasive strategy in ACS Reply

The 5-year clinical results of ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) confirm and extend the one-year results of the trial, which found no evidence of an advantage for an early invasive strategy in the treatment of ACS. The 5-year paper is published online in the Journal of the American College of Cardiology.

ICTUS randomized 1,200 patients with ACS to an early invasive or selective invasive strategy. Here are the major results at 5 years:
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Second study on approval of CV devices largely confirms FDA deficiencies Reply

On the heels of a JAMA study (which we reported earlier today), researchers from the FDA and Beth Israel Deaconess hospital released a similar paper appearing in the American Journal of Therapeutics. The report reaches many of the same conclusions as the JAMA paper, though, naturally, with a somewhat more sympathetic understanding of the FDA’s constraints.

A team led by William Maisel evaluated all 88 CV PMAs undertaken by the FDA between January 1, 2000 and December 31, 2007, including 132 clinical studies involving more than 37,000 study subjects. They found that safety and efficacy end points were “often not defined with precision” and concluded that their “study findings demonstrate that submitted studies frequently lack important details, including information about study subjects and study end point definitions.”
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