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…
T-wave alternans may help identify some patients who don’t need an ICD
February 3, 2009 by 1 Comment
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……
Thrombectomy found beneficial in primary PCI
January 27, 2009 by Leave a Comment
Thrombectomy helps prevent thrombus embolization and may be beneficial in primary PCI, according to a new study from Italy published in JACC. You can also see the slide set on our sister site, ClinicalTrialResults.Com….
Uric acid and insulin levels linked to risk of hypertension
January 27, 2009 by Leave a Comment
Small increases in uric acid and insulin levels, even at levels usually considered “normal,” are linked to an increased risk of hypertension, according to a new study in the Archives of Internal Medicine. Commenting on the report for CardioBrief, Franz Messerli……
Krumholz weighs in on NSAIDs in CHF
January 26, 2009 by Leave a Comment
After the previous post on NSAIDs was published earlier today, I received a comment from Harlan Krumholz on the controversy. Here it is:…
Danish researchers recommend avoiding NSAIDs in HF
January 26, 2009 by 1 Comment
NSAIDs are associated with significant increases in death and cardiovascular morbidity, according to a large, new registry study from Denmark in the Archives of Internal Medicine (2009;169(2):141-149)….
Combination of aerobic and strength exercise found best for elderly obese adults
January 26, 2009 by Leave a Comment
The combination of aerobic and strength exercise reduces insulin resistance and improves functional abilities, according to a new study published in the Archives of Internal Medicine. Click to read the Archives press release:…
FDA announces ongoing safety review of clopidogrel
January 26, 2009 by 1 Comment
In an “early communication” posted on its website, the FDA announced today that it was examining the safety of clopidogrel….
Innovative stent company seeks emergency intervention
January 26, 2009 by Leave a Comment
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…
Stun guns: study raises questions about safety
January 23, 2009 by Leave a Comment
Although promoted as a safe alternative to traditional firearms, a new study published online in the American Journal of Cardiology finds that the incidence of shooting-related deaths increased rather than decreased with the introduction of stun guns. You can also read a press release issued by the University of California, San Francisco….
Drug-eluting stents: are they cost effective?
January 23, 2009 by Leave a Comment
If you take into account the extra expenses associated with late stent thrombosis, drug-eluting stents are not very cost effective, according to a new analysis by a McGill University team in the American Journal of Cardiology….
Pooled analysis shows ezetimibe enhances CRP reduction
January 22, 2009 by Leave a Comment
We still don’t know for sure what the clinical effects of ezetimibe are, but a new pooled analysis in AJC by Pearson et al shows that adding ezetimibe to statins “ignificantly enhanced CRP reductions”….
Pascal Goldschmidt can’t stop running
January 22, 2009 by Leave a Comment
As if his marathon 16 hour workdays aren’t enough, Pascal Goldschmidt, dean of the University of Miami’s hypercompetitive medical school, runs real marathons, according to a feature story in the Miami Herald. Each week Goldschmidt runs with a group of medical students and this Sunday they will run together in the Miami Marathon….
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