Prasugrel critics once again raise cancer concerns

Two critics of prasugrel have again sought to link the drug to an increased risk of cancer. The paper by  James Floyd and Victor Serebruany appears in Archives of Internal Medicine. The cancer data is taken from the detailed FDA analysis of the TRITON-TIMI 38 trial. The authors acknowledge that with the current data it…

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ACCORD analyses find a few faint glimmers of hope

New analyses of the ACCORD trial, presented at the ADA meeting and published online in the Lancet and the New England Journal of Medicine, find a few, very faint glimmers of hope amid the generally dismal results of the trial….

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Authors of JUPITER attack are members of obscure anti-cholesterol group

Two of the authors of the recent vicious attack on JUPITER published in Archives of Internal Medicine are members of an obscure, cult-like group of cholesterol skeptics. The organization,  The International Network of Cholesterol Skeptics (THINCS), is resolutely opposed to the cholesterol hypothesis. Members of the group consistently seeks to denigrate the beneficial effects of…

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Meta-analysis questions value of statins for primary prevention; JUPITER comes under attack

A new meta-analysis raises questions about the benefits of statins when given to people without a clinical history of heart disease. Kausik Ray and colleagues, in a paper in Archives of Internal Medicine, analyzed data from 65,229 subjects in 11 studies. There were 2793 deaths in the studies, 1447 among those taking placebo and 1346…

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ACC and AHA respond to boxed warning on Plavix (clopidogrel) label

Responding to the FDA’s addition of a boxed warning on the Plavix (clopidogrel) label, the ACC and the AHA have released a clinical alert intended to provide guidance to clinicians. David Holmes, Jr, the chair of the writing group, said in a press release (below) that “the majority of patients do very well with standard guideline-based…

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Tightening the noose yet again on Avandia

rope-noose

With the publication of two new papers Avandia appears to be caught again between a Nissen and a hard place.  In the first paper,  FDA official David Graham and colleagues analyze Medicare data and find an increased risk of heart failure, stroke, and death in elderly people taking rosiglitazone compared to those taking pioglitazone. In the…

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Once-weekly exenatide performs well in DURATION-2

In DURATION-2, presented this week at the  annual meeting of the American Diabetes Association and published in the Lancet, 491 type 2 diabetics were randomized for 26 weeks to once-weekly exenatide, sitagliptin, or piolgitazone. Exenatide treatment resulted in a significantly greater reduction in HbA1c than either sitagliptin or pioglitazone. Weight loss was also significantly greater in the…

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CHMP recommends European approval for vernakalant for recent onset AF

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for vernakalant (Brinavess, Merck, Cardiome), a novel IV antiarrhythmic agent. The approved indication is for “the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of…

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ADA kicks off with Lancet papers on CV deaths in diabetes, once-weekly exenatide, and dapagliflozin

Expect to see lots of big diabetes-related news starting this Friday as the annual meeting of the American Diabetes Association gets underway. To start things off, here are a few highlights of 3 papers appearing in a special diabetes issue of the Lancet. There will be many more papers over the weekend and early next…

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Milwaukee hospital misreads 30% of echocardiograms

CardioBrief: A Milwaukee hospital found that nearly 30% of diagnostic echocardiograms were misread, according to an article by John Fauber in the Journal-Sentinel. An internal review of 235 echocardiograms performed at Aurora St Luke’s Medical Center turned up 5 cases in which patients “actually went into the operating room with a faulty diagnosis, although the problem…

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ACCME reverses rule that would have prevented industry employees from speaking at scientific sessions

The ACCME has reversed its earlier controversial ruling and will now permit the AHA to allow industry employees to speak at the AHA’s annual scientific sessions. According to a statement issued by the AHA (see below) the ACCME has “agreed that AHA’s extensive internal controls assure independence, and are appropriate for CME accreditation for a…

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CardioBriefs: EAS to recommend niacin and Lp(a) screening; lowering homocysteine fails again

European Atherosclerosis Society Will Recommend Lp(a) Screening and Niacin: In a consensus statement not yet published, the EAS will recommend that patients at high to moderate risk of cardiovascular disease should be screened for elevated Lp(a) levels. Details of the statement were presented at the EAS Congress in Hamburg, Germany, and reported on TheHeart.Org by…

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CardioBriefs: Aggrenox study fails, Livalo launched, NY Times spotlights ICDs with benefits

Aggrenox Fails to Beat Aspirin in Japanese Study: Aggrenox, the combination of extended-release dipyridamole and aspirin, is indicated for the reduction of subsequent stroke in patients who have had a TIA or ischemic stroke. But results from JASAP (Japanese Aggrenox Stroke Prevention vs. Aspirin Programme), which compared Aggrenox to aspirin in 1294 patients, found that…

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Cardiologist accused of prescribing unnecessary ICDs because his son was a St Jude salesman

A Tarzana California cardiologist, Michael Burnam, has been accused of prescribing  medically unnecessary ICDs made by St Jude because his son was a salesman for the company. The arrangement came to light after one patient nearly died during the implant procedure. The story was originally reported by Lance Williams on the California Watch Blog. A former…

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What do cardiologists think about the unread echocardiograms at Harlem Hospital?

A few days ago the New York Times reported that Harlem Hospital Center had finally completed its investigation into thousands of echocardiograms that after receiving an initial reading by a technician had never been read by a physician. It turns out that out of 7,000 tests that went unread, only 14 patients “might have been…

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German committee recommends against reimbursement for Avandia and Actos

An influential Germany group has recommended that health insurers stop paying for Avandia (rosiglitazone, GlaxoSmithKline) and Actos (pioglitazone, Takeda). The recommendation was made by Germany’s Federal Joint Committee of doctors and health insurers. A Reuters news story quoted the committee chairman, Rainer Hess:  there are other pharmaceuticals that have no such side effects and long-term risks….

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INTERSTROKE: accounting for Stroke

10 risk factors appear to account for 90% of the risk of stroke, according to INTERSTROKE, a large study presented at the World Congress of Cardiology in Beijing and published online in the Lancet. …

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New delays for taspoglutide; renewed cancer concerns for insulin glargine

Two diabetes drugs are under new fire today. The development of taspoglutide, which had been the subject of a series of promising press releases from its manufacturer, Roche, will now be delayed for at least 12-18 months. In a press release (see below), Roche said it had found a higher than expected rate of hypersensitivity…

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Trial of PFO closure fails to meet primary endpoint

NMT Medical today announced that the CLOSURE 1 trial had failed to meet its primary endpoint. The trial was designed to test the efficacy of PFO closure with the STARFlex device in preventing recurrent strokes and TIAs. The primary endpoint of the trial, which was designed to compare PFO closure to medical therapy in 900…

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ESC Posts Hot Line Trials for 2010 Congress in Stockholm

The ESC has posted the Hot Line presentations for the ESC Congress 2010 in Stockholm. Click here if you want to search the program….

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CardioBriefs: New Generation Stent Tested; BMS Versus DES for STEMI

The following news briefs are republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site. New Generation Stent Tested: In the Resolute All Comers Trial, Patrick Serruys and colleagues randomized 2292 PCI patients to either…

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Industry employees no longer allowed to speak at AHA scientific sessions

Update: The AHA issued a statement in response to news reports about the new guidelines. The statement is reprinted at the bottom of this story. The ACCME has ruled that the AHA and other scientific societies can no longer allow industry employees to speak at CME-accredited events, including large meetings like the AHA’s annual scientific…

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HDL and Cancer: Study Finds Strong Inverse Relationship

Jaffri and colleagues found a significant inverse association between HDL and the risk of cancer in a meta-analysis of 24 trials that included more than 600,000 person-years of follow-up and 8,125 cancer cases. In their paper in the Journal of the American College of Cardiology, they report a dose response relationship in which each 10 mg/dl increase in HDL was associated with a 36% lower rate of cancer. The association remained significant after adjustment for other baseline factors, including LDL, age, BMI, diabetes, sex, and smoking status….

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Meta-analysis finds increased risk of cancer associated with ARBs

(Editor’s note: The Lancet Oncology paper and accompanying comment discussed in this post were were embargoed until 6:30 PM ET on Sunday, June 13. However, the embargo appears to have been broken early in a press release from Boehringer Ingelheim and a news article by Reuters. –Sunday, June 13, 3:15 PM) A meta-analysis appearing in…

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FDA reviewing safety of olmesartan (Benicar)

The FDA announced today that it was conducting an ongoing safety review of olmesartan after data from the ROADMAP and ORIENT clinical trials turned up the unexpected finding of a higher rate of cardiovascular deaths in patients taking olmesartan compared to placebo. The FDA said that it has “not concluded that Benicar increases the risk…

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