The FDA appears to have incompletely scrubbed redacted text from the PDF documents posted on its web site. Two major issues:
Monthly Archives: January 2009
Prasugrel’s FDA outlook appears brighter 1
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 Reply
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 Reply
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 loss per year is only 2.5 kg. Making this drug available OTC will add false credibility to the notion that there is an easy pill-popping solution to obesity rather than long-term lifestyle changes.”
Urine test for CAD in the future? Reply
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 clinical test anytime soon, but this may be a hint of the future.
Generic metoprolol succinate shortage causing problems 1
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 brand name Toprol XL and some patients are being switched to metoprolol tartrate (Lopressor).
SPECT-MPI may be useful in new onset HF Reply
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 Reply
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) 1
CV Therapeutics, which markets Ranexa (ranolazine), has rejected a buyout bid from Astellas Pharma.
TIME-CHF: BNP-guided therapy misses the boat Reply
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 Reply
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 Reply
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 Reply
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 1
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 Reply
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 1
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 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.
Stun guns: study raises questions about safety Reply
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? Reply
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 Reply
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 Reply
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.
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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President Obama receives advice from Steve Nissen Reply
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 system.
Diastolic dysfunction associated with reduced exercise capacity Reply
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.
