NY Times: why is the ICD registry languishing?

 In 2004 Medicare mandated the creation of a national ICD registry, which has been run since then by the ACC and HRS. Now, New York Times reporter Barry Meier, who has been instrumental in bringing to light ICD problems in the past, notes in a February 26 story that the ICD registry is languishing for lack…

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Flap over prasugrel advisory committee leads to 2 congressional inquiries

The controversy surrounding the FDA’s cardiorenal advisory committee meeting, and in particular the “disinvitation” of Sanjay Kaul from the meeting, has prompted two separate congressional investigations. (Click here to see CardioBrief’s chronology of events.) As reported by Susan Heavey in Reuters, Rep. Bart Stupak, the chairman of the House Energy and Commerce Subcommittee on Oversight and…

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Astellas launches hostile takeover for CV Therapeutics

Astellas Pharma announced today that it was launching a hostile takeover for CV Therapeutics, the company that manufactures ranolazine (Ranexa) and regadenoson (Lexiscan).   As we reported back in January, CV Therapeutics previously rejected a friendly bid at the same price from Astellas. Astellas already markets regadenoson in the US. Astellas offered an explanation for…

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New predictive tool helps identify risk of AF

Using data from the Framingham Heart Study, researchers have developed a predictive tool that can help identify people who are at risk of atrial fibrillation, according to a new study in the Lancet. In addition to age, other factors associated with AF were sex, BMI, systolic BP, treatment for hypertension, PR interval, clinically significant heart…

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Speaking of prasugrel: TRITON-TIMI 38 STEMI substudy published in Lancet

Just in case you haven’t heard anything about prasugrel in the last 10 minutes, the STEMI substudy from TRITON-TIMI 38 has been published in the Lancet, along with an accompanying editorial by Gregg Stone. The results are consistent with the main study. The authors conclude that “prasugrel is an especially attractive alternative to clopidogrel to…

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Transcript of FDA February 23 News Conference on prasugrel advisory panel

The FDA provided CardioBrief with a transcript of a news conference that took place on February 23 with Janet Woodcock, director of the Center of Drug Evaluation and Research, and John Jenkins, Office of New Drugs. They spoke with reporters from Bloomberg, Reuters, and Dow Jones. Although the transcript does not contain any significant information…

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Meta-analysis: lowering BP in dialysis patients reduces CV events and deaths

Cardiovascular events account for nearly half of all deaths among dialysis patients. Although antihypertensive agents have been found to reduce CV events in the general population, their effect in dialysis patients has been uncertain. Now a new meta-analysis in The Lancet shows that treating dialysis patients with antihypertensive agents could reduce all cause mortality by…

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No difference in weight loss after 2 years on different diets

In a comparison of diets that were high or low in fat, carbohydrates, or protein, no significant differences were observed after two years, according to a new study in the New England Journal of Medicine. Weight loss in the 811 patients randomized in the study reached an average of 6 kg at 6 months. By 1 year…

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Califf now reportedly out of running for FDA commissioner

It’s starting to become clear that there won’t be a cardiologist in charge of the FDA. Duke’s Rob Califf, the last of two cardiologists rumored to be in the running for FDA commissioner, is no longer a contender for the influential position, according to The Washington Post and  The Scientist. (The Cleveland Clinic’s Steve Nissen had…

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ACC/AHA Guidelines: not enough evidence

Over the years there’s been an explosion in ACC/AHA guideline recommendations, but the evidence to support most recommendations has declined, according to a new report in JAMA. The authors, including major cardiology leaders Sidney Smith and Robert Califf, conclude: “Our finding that a large proportion of recommendations in ACC/AHA guidelines are based on lower levels…

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Sprint Fidelis leads: is the risk greater than feared?

The failure rate of Medtronic’s Sprint Fidelis leads may be much higher than previous estimates, according to a new report by Robert Hauser and David Hayes in HeartRhythm. The two investigators (Hauser was the first to spot the problems with the Medtronic leads) looked at the rate of lead failure among patients who received the…

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Cardiology $$$: Mt Sinai’s Samin Sharma tops Columbia’s Moses

In response to our post yesterday, in which we reported that Columbia University’s Jeffrey Moses $2.5 million compensation package in 2006-2007 vaulted him to 8th place in the Chronicle of Higher Education’s list of highest total compensation at private colleges for 2006-2007, CardioBrief received a message from Mt. Sinai’s Samin Sharma. According to WikiPedia, Sharma performs 1,500…

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Anger increases risk for sudden death

Anger can increase the risk of sudden death, at least in patients who already have ICDs, according to a new study published in the Journal of the American College of Cardiology. Yale investigators gave T-wave alternans tests to ICD patients during a mental stress protocol. Patients with positive TWA tests were much more likely to…

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Chronology of Prasugrel Controversy

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Medtronic gobbles up 2 aortic valve companies

Medtronic announced today that it has entered into an agreement to acquire CoreValve, and that it had acquired Ventor Technologies. Both companies develop transcatheter aortic valves. Medtronic said the Ventor acquisiton “adds two technologies to Medtronic’s transcatheter valve portfolio: a minimally invasive, surgical transapical technology and a next generation percutaneous, transfemoral technology.” CoreValve is a…

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Prasugrel gains European approval

Prasugrel has gained European approval for the prevention of atherothrombotic events in patients with ACS undergoing PCI, according to the drug’s sponsors, Daiichi Sankyo and Lilly. The drug will be marketed under the brand name Efient. Earlier this month prasugrel received a positive recommendation for approval from the FDA’s Cardiorenal advisory committee, although the hearing…

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Jeffrey Moses ranks #8 on Chronicle’s salary list

A football coach tops the list at $4.4 million, and a Columbia dermatologist followed closely at $4.4 million, but Jeffrey Moses $2.5 million salary was enough to put him in 8th place in the Chronicle of Higher Education‘s list of highest total compensation at private colleges for 2006-2007.  The article notes that college president’s salaries…

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JUPITER substudy: stroke cut in half by rosuvastatin

Rosuvastatin can cut the risk of stroke by nearly half, according to the results of a substudy from JUPITER presented at the International Stroke Conference in San Diego. “Today’s analysis of the JUPITER data clearly indicated that people who were smokers, over 70 years of age, had high blood pressure, or were at greater overall…

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Promising phase 2 results for anti-atherosclosis drug

Initial phase 2 results for an anti-atherosclerotic agent that inhibits sPLA2 are encouraging, according to a new report and commentary published in the Lancet. In a dose-ranging study of 393 patients with stable coronary disease, the experimental drug A-002 (Anthera Pharmaceuticals) reduced sPLA2 by 87% and also caused reductions in LDL cholesterol and CRP levels….

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US Justice Dep’t joins lawsuit against Scios/J&J

The US Department of Justice has joined two whistleblower lawsuits against Johnson & Johnson, “alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs,” according to a Justice Dep’t…

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The Uninvited (part 2): FDA offers more detailed explanation for Kaul’s absence on prasugrel committee

In response to queries from CardioBrief, an FDA spokesperson, Sandy Walsh, has provided the most detailed explanation yet of the sequence of events leading to the withdrawal of Sanjay Kaul from the Cardiorenal advisory committee meeting for prasugrel. Previously the FDA told CardioBrief that “the FDA did not receive sufficient information until much later than…

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Questions raised over globalization of clinical research

The globalization of clinical research is raising a number of troubling ethical and scientific concerns, according to a new article by Duke researchers in the New England Journal of Medicine. The problems discussed in the article include patient selection, transparency of results, regulatory oversight, experience of clinical investigators, and IRB quality. Coauthors of the paper…

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SYNTAX published in NEJM

The SYNTAX trial, which compared CABG to PCI in patients with 3-vessel or left main coronary disease, has been published in the NewEngland Journal of Medicine. The trial found that CABG was superior to PCI at one year, but the results have generated considerable controversy. As always, the devil is in the details. An editorial by…

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OAT: No improved quality of life found for late opening of occluded arteries

Despite a marginal advantage at 4 months, after two years PCI does not improve the quality of life when compared to medical therapy after late opening after MI, according to a new report from the Occluded Artery Trial Investigators published in the New England Journal of Medicine. In addition, PCI, as expected, is more expensive…

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Pharmacogenetics: a better path to warfarin dosing?

Using a pharmacogenetic algorithm to estimate the initial warfarin dose is better than using the usual clinical or fixed-dose approaches, according to a new study from the Imternational Warfarin Pharmacogenetics Consortium published in the New England Journal of Medicine. The benefits of the pharmacogenetic algorithm were especially noticeable in those……

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