The FDA appears to have incompletely scrubbed redacted text from the PDF documents posted on its web site. Two major issues:
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Prasugrel’s FDA outlook appears brighter
Posted on January 30, 2009 by Larry Husten
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…
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PPIs may interfere with clopidogrel, lead to repeat MI
Posted on January 29, 2009 by Larry Husten
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.
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Lancet editorial: OTC orlistat not in the public interest
Posted on January 29, 2009 by Larry Husten
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 [...]
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Urine test for CAD in the future?
Posted on January 29, 2009 by Larry Husten
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 [...]
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Generic metoprolol succinate shortage causing problems
Posted on January 28, 2009 by Larry Husten
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 [...]
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SPECT-MPI may be useful in new onset HF
Posted on January 28, 2009 by Larry Husten
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:
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FDA warning: dietary supplement contains sibutramine
Posted on January 28, 2009 by Larry Husten
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.
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CV Therapeutics rejects buyout offer from Astellas Pharma (updated)
Posted on January 28, 2009 by Larry Husten
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.
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TIME-CHF: BNP-guided therapy misses the boat
Posted on January 27, 2009 by Larry Husten
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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Thrombectomy found beneficial in primary PCI
Posted on January 27, 2009 by Larry Husten
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.
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Uric acid and insulin levels linked to risk of hypertension
Posted on January 27, 2009 by Larry Husten
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…
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Krumholz weighs in on NSAIDs in CHF
Posted on January 26, 2009 by Larry Husten
After the previous post on NSAIDs was published earlier today, I received a comment from Harlan Krumholz on the controversy. Here it is:
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Danish researchers recommend avoiding NSAIDs in HF
Posted on January 26, 2009 by Larry Husten
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).
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Combination of aerobic and strength exercise found best for elderly obese adults
Posted on January 26, 2009 by Larry Husten
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:
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FDA announces ongoing safety review of clopidogrel
Posted on January 26, 2009 by Larry Husten
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
Posted on January 26, 2009 by Larry Husten
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 [...]
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Stun guns: study raises questions about safety
Posted on January 23, 2009 by Larry Husten
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.
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Drug-eluting stents: are they cost effective?
Posted on January 23, 2009 by Larry Husten
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.
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Pooled analysis shows ezetimibe enhances CRP reduction
Posted on January 22, 2009 by Larry Husten
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”.
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Pascal Goldschmidt can’t stop running
Posted on January 22, 2009 by Larry Husten
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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Abbott’s Xience V claims bragging rights as top-selling stent
Posted on January 21, 2009 by Larry Husten
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 [...]
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How does the media report on cardiovascular genetics?
Posted on January 21, 2009 by Larry Husten
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 [...]
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President Obama receives advice from Steve Nissen
Posted on January 21, 2009 by Larry Husten
He may or may not still be a candidate for the top FDA job, but Steve Nissen gives Obama his advice about how to fix the FDA in a commentary in Nature. Nissen’s proposals include an end to FDA secrecy, a fixed 6-year term for the commissioner, and a complete revision of the agency’s funding [...]
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Diastolic dysfunction associated with reduced exercise capacity
Posted on January 20, 2009 by Larry Husten
I’m not sure what’s new or surprising here, but a new report in JAMA (2009;301[3]:286-294) from a team at the Mayo carefully documents the association between diastolic dysfunction and reduced exercise capacity.
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