Prasugrel: now the real work starts

The spotlights have been turned elsewhere, but it’s only now that thereal work on prasugrel will take place. As a brief item in Inside Indiana Business notes, Lilly officials will now begin “a period of intense discussions” with the FDA over labeling of the drug. In an accompanying video interview, Lilly VP Tony Ware said…

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SPIRIT III trial published

The two-year followup of the SPIRIT III trial comparing an everolimus- and a paclitaxel-eluting stent has been published in Circulation. The slide set is available from ClinicalTrialResults.Com….

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List of ACC 2009 Late-Breakers published

The ACC has posted the schedule of Late-Breakers for the 2009 Scientific Sessions and i2 Summit. There are 6 ACC and 3 i2 Late-Breaker sessions, and on Monday morning you’ll have to choose between two simultaneous sessions. You can search or browse using the online planner by starting at this link. Or you can download…

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David Sabiston Jr, pioneering surgeon, dead at 84

David Sabiston Jr, who performed an early version of coronary bypass surgery in 1962 while at Johns Hopkins, died last month. Sabiston’s early work helped pave the way for the ascension of CABG as a mainstay of modern medicine. Sabiston went on to become the head of Duke’s department of surgery. Sabiston’s textbook is a…

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PCI for MI: Experienced hospitals and physicians are best

Practice makes perfect. A new study in JACC shows that high volume hospitals and high volume physicians do far better for their patients than their low-volume counterparts. The data is taken from the New YorkState PCI registry. “When rare but severe complications arise, a team experienced in its recognition and treatment may be the difference…

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Expensive urine: multivitamins have no effect on major endpoints

Women who take multivitamins have the same risk for cancer, cardiovascular disease, and death as women who don’t take vitamins, according to a new study in the Archives of Internal Medicine. “These results suggest that multivitamin use does not confer meaningful benefit or harm in relation to cancer or cardiovascular disease risk in postmenopausal women,”…

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Study finds lower risk of death for primary prevention use of statins

Patients who take statins for primary prevention have a lower risk of death, according to a large new observational study published in Archives of Internal Medicine. “The observed benefits from statins were greater than expected from randomized clinical trials, emphasizing the importance of promoting statin therapy and increasing its continuation over time for both primary…

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Mass General under scrutiny for high mortality rate in cath lab

The Boston Globe is reporting that Massachusetts General Hopsital and St Vincent Hospital in Worcester are being monitored by state officials for high death rates in 2007 in cardiac catheterization patients. At MGH, 43 or 1,543 patients died. In response, the hospitals claim the high rates are due to agressive treatment of exceptionally sick patients….

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Editorial: The Incompetence Of The FDA

As a journalist and editor who’s covered the cardiovascular arena for more than 25 years I’ve tried as much as possible to avoid taking positions on the major controvesies that have appeared over the years. I’m proud that during the “TPA wars” I remained on good terms with not only Eric Topol, Rob Califf and…

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5 new studies shed new light on the genetics of MI

Nature Genetics has published 5 new genome wide association studies that may help unravel the genetic tangle behind heart attacks….

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FDA approves 2 ablation catheters for AF

The FDA today approved the first ablation catheters for the treatment of atrial fibrillation. The devices approved today are the NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav….

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Do beta blockers inhibit the anti-inflammatory effect of statins?

A new study in the American Journal of Cardiology raises the possibility that beta blockers might blunt the CRP-reducing effects of statins. Franz Messerli provided a comment on this provocative study to CardioBrief:…

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Alderman questions NYC efforts to cut salt in NY Times opinion piece

In an opinion piece in today’s New York Times, hypertension expert and salt skeptic Michael Alderman questions the wisdom of a New York City public health campaign  to reduce salt content in processed food by 40% over the next 10 years. Given the lack of randomized clinical trials, and the ambiguity of the observational evidence,…

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Early study finds anacetrapib safe and effective

 Anacetrapib, Merck’s CETP inhibitor, was safe and effective in a study of 589 patients. The results are in sharp contrast to those for torcetrapib, the Pfizer CETP inhibitor that was pulled from development after it was found to raise blood pressure. In the new study, anacetrapib had no discernible effect on blood pressure.  The full text…

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Gordon Tomaselli named director of cardiology at Johns Hopkins

from WikiDoc News:  Dr. Gordon Tomaselli is taking the helm of the cardiology division at Johns Hopkins University School of Medicine. A cardiac electrophysiologist, Tomaselli’s been at Johns Hopkins since 1986, concentrating primarily on arrhythmias. He will continue on as co-director of the school’s Heart and Vascular Institute. Tomaselli is taking over for Eduardo Marbán,…

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Sir James Black, pioneer of propranolol, pans state of pharma

Sir James Black, the Scottish scientist who developed two blockbusters that transformed the pharmaceutical industry and modern medicine, propranolol and cimetidine, laments the state of research at big pharma. Of the Pfizer-Wyeth merger he says: “Will they never learn? They will completely exhaust each others’ energies for two years.” Read  the  interview in the Financial Times….

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New DES studies add new understanding about clopidogrel duration, LAD usage, and ISR

Clopidogrel duration:  In a study of nearly 3,000 DES patients, stopping clopidogrel at 30 days or 6 months, but not 12 months,  was associated with stent thrombosis, “thus suggesting,” according to Waksman’s group at the Washington Hospital Center in an article in press in the American Journal of Cardiology, “the optimal duration of therapy for the…

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Outspoken critic: prasugrel hearing was a “family picnic”

Victor Serebruany, a well-known platelet researcher who has consulted for many companies, including Sanofi-Aventis (makers of clopidogrel), and a patent application holder on prasugrel with Lilly, spoke to CardioBrief and expressed strong feelings about the advisory committee meeting. He was critical of the meeting, calling it a “family picnic,” because in his view the outcome…

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FDA panel unanimously recommends approval of prasugrel

The FDA’s cardiorenal advisory committee has unanimously recommended approval of prasugrel. According to the Dow Jones news story, the panel said prasugrel should not be used in patients with a history of stroke or in patients undergoing cardiac surgery. The panel recommended that a bleeding warning be included for older patients and underweight patients. Updated (8:40 PM): CardioBrief…

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Radiation in cardiology comes under increased scrutiny

Radiation exposure in clinical practice in cardiology is coming under increased scrutiny. The AHA has just released a science advisory urging that CT scans “should be used judiciously to minimize exposure to ionizing radiation. In addition, a new study in JAMA has found a wide variation in radiation dose between different institutions and different devices….

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Amid Washington uncertainty, Califf reportedly still in running to be FDA commissioner

Robert Califf is still in the running to be the next FDA commissioner, according to the InVivo blog. Califf’s bid is apparently backed by Senator Ted Kennedy, while Sharfstein, the other often-named contender for the job, is backed by Henry Waxman, a powerful figure in the House. One important word of caution: the blog post…

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T-wave alternans may help identify some patients who don’t need an ICD

T-wave alternans (TWA) is still on the long and winding road to widespread clinical acceptance, and there’s no end to its journey in sight right now. The ABCD (Alternans Before Cardioverter Defibrillator) Trial has been published in JACC. The study investigators, and the editorialists, agree that TWA has promise, but that it can not yet…

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The Uninvited: Sanjay Kaul removed from prasugrel’s FDA advisory panel

CardioBrief has learned from multiple sources that Sanjay Kaul will not be a member of the FDA advisory panel on Tuesday’s hearing to evaluate prasugrel. Kaul has been a sharp critic of recent drug trials, and has raised public concerns about prasugrel and other cardiovascular agents in recent years. Kaul’s name appeared on the FDA…

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Get your original unscrubbed FDA prasugrel review document right here

The FDA has rescrubbed the prasugrel review document on its site. You can see the original document, as it was posted last Friday, right here. You can find the hidden text by using the text tool in Adobe Reader and selecting the blank sections on pages 77 and 80 of the PDF document….

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Atorvastatin gets its own planetoid

It’s certainly not a gas giant on the scale of JUPITER, but a new study published in Clinical Therapeutics has found that high dose atorvastatin is more effective at reducing CRP than low dose atorvastatin. With only 340 patients, the trial was not large enough to detect any differences in clinical outcomes, of course….

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