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….
Do beta blockers inhibit the anti-inflammatory effect of statins?
February 6, 2009 by Leave a Comment
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:…
Alderman questions NYC efforts to cut salt in NY Times opinion piece
February 6, 2009 by 2 Comments
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,…
Early study finds anacetrapib safe and effective
February 5, 2009 by Leave a Comment
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…
Gordon Tomaselli named director of cardiology at Johns Hopkins
February 5, 2009 by Leave a Comment
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,…
Sir James Black, pioneer of propranolol, pans state of pharma
February 5, 2009 by Leave a Comment
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….
New DES studies add new understanding about clopidogrel duration, LAD usage, and ISR
February 5, 2009 by Leave a Comment
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…
Outspoken critic: prasugrel hearing was a “family picnic”
February 4, 2009 by 2 Comments
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…
FDA panel unanimously recommends approval of prasugrel
February 3, 2009 by 1 Comment
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…
Radiation in cardiology comes under increased scrutiny
February 3, 2009 by Leave a Comment
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….
Amid Washington uncertainty, Califf reportedly still in running to be FDA commissioner
February 3, 2009 by Leave a Comment
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…
T-wave alternans may help identify some patients who don’t need an ICD
February 3, 2009 by 1 Comment
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…
The Uninvited: Sanjay Kaul removed from prasugrel’s FDA advisory panel
February 2, 2009 by 5 Comments
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…
Get your original unscrubbed FDA prasugrel review document right here
February 2, 2009 by 4 Comments
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….
Atorvastatin gets its own planetoid
February 2, 2009 by Leave a Comment
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….
More on prasugrel: what the FDA doesn’t want you to know
January 30, 2009 by 1 Comment
The FDA appears to have incompletely scrubbed redacted text from the PDF documents posted on its web site. Two major issues:…
Prasugrel’s FDA outlook appears brighter
January 30, 2009 by 1 Comment
Next Tuesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee will help decide the fate of prasugrel (Effient), Lilly’s highly anticipated and somewhat controversial antiplatelet drug that many have predicted could be the next clopidogrel. The FDA has released its briefing documents for the meeting, and the bottom line is that prasugrel’s path to approval……
PPIs may interfere with clopidogrel, lead to repeat MI
January 29, 2009 by Leave a Comment
The following is taken from WikiDoc News: Clopidogrel, when taken with PPIs after MI, dramatically increases a patient’s chances of having a second MI, according to a study in the Canadian Medical Association Journal….
Lancet editorial: OTC orlistat not in the public interest
January 29, 2009 by Leave a Comment
Orlistat should not be available over-the-counter, according to a Lancet editorial. Orlistat recently received OTC approval in Europe and is already available OTC in the USA. According to the editorial, “better accessibility to orlistat may not necessarily be in the best interests of the public. Orlistat has limited effect in the management of obesity—the average weight…
Urine test for CAD in the future?
January 29, 2009 by Leave a Comment
A group of European and Australian researchers have taken the first step toward developing a urine test to detect coronary artery disease (CAD). In a new study in the Journal of Proteome Research, the team performed a urine proteomic analysis to identify a combination of 17 proteins associated with angiographically detected CAD. Don’t go looking for a…
Generic metoprolol succinate shortage causing problems
January 28, 2009 by 1 Comment
The Wall Street Journal Health Blog is reporting that a shortage of generic metoprolol succinate is causing trouble for some patients. Following an FDA warning last year, Sandoz recalled 6 millions bottles of the generic drug. Then, earlier, this month, KV Pharmaceutical stopped making its version of the drug. Some insurers won’t reimburse for AstraZeneca’s…
SPECT-MPI may be useful in new onset HF
January 28, 2009 by Leave a Comment
SPECT-MPI may be useful in ruling out coronary artery disease in patients with new onset heart failure, according to a non-randomized, observational, cohort study published in the Journal of Nuclear Cardiology. Click here to read the press release from Lantheus Medical, which makes Cardiolite. Here is the study abstract:…
FDA warning: dietary supplement contains sibutramine
January 28, 2009 by Leave a Comment
The FDA is warning consumers that Venom HYPERDRIVE 3.0, marketed by Applied Lifescience Research Industries Inc, contains significant amounts of sibutramine. Click here to read the FDA press release….
CV Therapeutics rejects buyout offer from Astellas Pharma (updated)
January 28, 2009 by 1 Comment
CV Therapeutics, which markets Ranexa (ranolazine), has rejected a buyout bid from Astellas Pharma. Click here to read the Astellas press release. Click here to read the response from CV Therapeutics….
TIME-CHF: BNP-guided therapy misses the boat
January 27, 2009 by Leave a Comment
BNP was no better than symptoms in guiding therapy for elderly CHF patients, according to a new study published in JAMA (2009;301(4):383-392). The study was originally presented last summer at the European Society of Cardiology meeting in Munich. In an accompanying editorial in JAMA, Ileana Pina and Christopher O’Connor conclude……
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