FDA announces ongoing safety review of clopidogrel 1

In an “early communication” posted on its website, the FDA announced today that it was examining the safety of clopidogrel.

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Innovative stent company seeks emergency intervention Reply

Xtent, a small company developing an innovative drug-eluting stent system featuring customized lengths and diameters, is being seriously threatened by the financial crisis. The company has announced that it will fire 112 of its 121 employees unless it can strike some sort of deal.

You can read the story in the Wall Street Journal.

Click to see the company’s press release.

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Abbott’s Xience V claims bragging rights as top-selling stent Reply

The economy may be in the dumps but today Abbott reported 10% growth in the last quarter. In addition to strong sales for its blockbuster Humira, company growth was fueled by rapidly growing sales of its Xience V drug-eluting stent. According to Abbott, the Xience V became the US market leader in the fourth quarter.

The Abbott upswing is partly a reflection of a general recovery in confidence with drug-eluting stents, which have now recaptured 70% of the stent market.

How does the media report on cardiovascular genetics? Reply

Last week Nature Genetics published– and we duly reported– an important study identifying a newly identified genetic mutation associated with cardiomyopathy that is widely prevalent in India.

If you’re interested in the way important studies like this get translated in the media, you should take a look at a recent entry in the Knight Science Journalism Tracker blog. The blog,

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Califf reportedly still in running for FDA commssioner Reply

Duke’s Robert Califf’s is being interviewed for the FDA commissioner job, but the leading candidate is still Baltimore Commissioner of Health Joshua Sharfstein, according to an item on the In Vivo Blog.

The blog doesn’t cite any sources, but says that Califf is the favorite of FDA insiders, while Sharfstein is the internal favorite in the Obama camp. No further word about Steve Nissen, the other cardiologist contender.

Gene variant found to increase risk of cardiomyopathy seven-fold in South Asians 1

A paper in Nature Genetics reports a seven-fold increase in cardiomyopathy in South Asians with a common 25 base pair deletion of the cardiac myosin binding protein C (MYBPC3). The variant occurs more frequently in southern and western India than in the north, and this distribution correlates with higher rates of heart failure in southern India, according to a press release from Nature.

ACC preannouncement season begins with small company’s press release Reply

I’d never heard of targeted pulsed electromagnetic field (tPEMF(tm)), or that it might be beneficial in ischemic heart disease, until I ran across the press release below. I’m always wary of press releases like these, especially when they come from tiny precarious companies. Nevertheless, there’s something intriguing about this, but I urge you to exhibit extreme caution. (Also, for the record, the Cleveland Clinic isn’t presenting anything here. Dr. Shen, who is affiliated with the Florida branch of the Cleveland Clinic, is the PI for the trial, but that hardly constitutes an endorsement.)

Update (January 16): A Cleveland Clinic spokesperson has told CardioBrief that the Cleveland Clinic did not approve or authorize the use of their name in this press release.

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FAME pubbed in NEJM: is FFR ready to step into the spotlight? 2

One of the most intriguing studies at last fall’s TCT was FAME, which tested the value of fractional flow reserve (FFR) versus conventional angiography for guiding PCI. Now the study has been published in the New England Journal of Medicine, accompanied by an editorial written by Stephen Ellis.

The use of FFR resulted in a significant reduction in MACE at one year in FAME. Ellis points out a number of important limitations of the study but holds out hope for the utility of FFR. He believes  FFR needs a validation study before it can be considered for routine clinical practice.

Ellis alludes to one potentially controversial aspect of FAME and FFR when he writes that “interventional cardiologists should recognize the limitations of coronary angiography and PCI.” Here’s the point: if FFR in fact can predict which lesions will benefit from PCI, it’s hard to avoid the conclusion that PCI for non-FFR indicated lesions may actually be harmful. I wonder if anyone will have the COURAGE to pursue this line of thought…

You can see the FAME slide set at ClinicalTrialResults.com, where it was originally posted following the initial TCT presentation.

You can also view a video interview with FAME investigator Nico Pijls by C. Michael Gibson on ClinicalTrialResults.com.

Newer antipsychotic agents also cause SCD Reply

Newer antipsychotic agents like olanzapine, risperidone, and quetiapine are just as likely to cause sudden cardiac death as older agents such as haloperidol and thioridazine, according to a new study published in the New England Journal of Medicine.

In an accompanying editorial, Sebastian Scheeweiss and Jerry Avorn argue that in “the absence of clearly established benefits” the use of these drugs should be restricted, especially “in vulnerable populations and outside the labeled indications.” When the drugs are deemed necessary, ECGs should be obtained before and after initiation of drug therapy.

More headaches for PFO closure devices 1

PFO closure devices have been having a tough time. First the trials for treatment of migraine ran into all sorts of trouble. (See below.) Now the first trial for prevention of stroke may be in similar hot water.

Yesterday, NMT medical issued a press release with a very complicated update on the company’s CLOSURE I clinical trial of its STARFlex PFO closure device to prevent stroke and TIA. Enrollment in the trial began 5 years ago and has been problematic.

Today a story in the  New York Times reports some more details. The trial was originally supposed to enroll 1,600 patients but after five years has only enrolled 900 patients, although the company believes this number may be sufficient given the number of events that have accrued over 5 years.  The story quotes William Maisel, who notes that until recently neither physicians nor industry were motivated to do the necessary clinical trials, since thousands of devices were being implanted under humanitarian exemptions. Now that the FDA has cracked down on this loophole it is time to complete the trials, says Maisel.

 related New York Times story treats the saga of Peter Wilmshurst, the British cardiologist who had been a co-PI of the NMT migraine trial. He is now being sued for slander by NMT Medical. His story has been extensively covered by Shelley Wood on theheart.org (and I should state here that I was Shelley’s editor at the time, though I can’t take credit for her excellent reporting). The Times provides some new details about the case, including more detailed comments from the company’s perspective.

Senate investigation revealing new details in Avandia case, WSJ reports 2

Senator Grassley’s investigation into the Avandia case is turning up new, potentially embarrassing details about GSK’s internal responses to the controversy, according to a story in the Wall Street Journal.  In response to the forthcoming Nissen meta-analysis, a GSK consultant wrote: “The numbers are the numbers, the analysis is very similar to our own.”

The WSJ article quotes an email from Moncef Slaoui, GSK’s director of research: “FDA, Nissen and GSK all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30% to 43%!” In response, a GSK spokeman said that Slaoui “used imprecise language” and that he “was more precise in written testimony to Congress when he said that the company didn’t agree with Dr. Nissen’s conclusions and thought that his methodology had significant limitations.”

 

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Despite negative endpoints, researchers remain committed to lifestyle modifications Reply

Despite two negative NHLBI-sponsored trials presented at the AHA last November, researchers remain convinced that lifestyle modification is worthwhile, according to  a feature news story in JAMA by Mike Mitka. Both FIT Heart and HF-ACTION failed to reach their primary endpoint, but the researchers, Lori Mosca of Columbia and Chris O’Connor of Duke, make a strong case for the continued utility of the interventions tested in their trials.

After a year-long review FDA finds nothing new about vytorin Reply

The FDA has finally completed its review of ENHANCE that it started in January 2008. It’s finding: there was no difference in clinical outcome between the vytorin-treated and the simvastatin-treated patients in clinical outcomes, though vytorin, as expected, had greater efficacy in lowering cholesterol. The FDA advises patients that, pending the results of IMPROVE-IT, “patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about these medications.”

None of this should come as a surprise to anyone reading this blog, I suppose.

Click here to read the FDA statement.

45 years in the business (Bill Roberts part 2) Reply

In addition to dissecting, like the good pathologist he is, the status of cardiovascular journals (see previous post in this blog),  Bill Roberts, AJC editor, looks back on 45 years in the cardiovascular arena. In 1963  he was a cardiology fellow under Braunwald at the NIH. Roberts writes:

That was the year President John F. Kennedy was killed in Dallas, Texas. When he arrived at Parkland Hospital, there was no electrocardiograph in the emergency room. What has occurred in cardiovascular medicine since that fatal November day in 1963 is astounding! No specialty in medicine has had such a transformation.

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