Prasugrel critics once again raise cancer concerns Reply

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 is impossible to demonstrate with certainty an increased risk of cancer, but say that “a safety concern has been raised” and that “physicians should consider the potential cancer risks before prescribing prasugrel, especially with prolonged use and in patients with known cancer.”
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Authors of JUPITER attack are members of obscure anti-cholesterol group 5

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 statins and to highlight what they perceive as serious and widely pervasive side effects (including cancer) of the drugs. The first author of the Archives paper, Michel de Lorgeril, and one of the co-authors, Harumi Okuyama, are listed as THINCS members on the organization’s website.
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Meta-analysis questions value of statins for primary prevention; JUPITER comes under attack 2

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 among those taking a statin. The risk ratio of 0.91  did not achieve statistical significance (95% CI=0.83-1.101). They also observed that baseline LDL levels did not appear to have an impact on mortality.
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ACC and AHA respond to boxed warning on Plavix (clopidogrel) label Reply

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 clopidogrel, but for the small number of patients who have problems, these are big problems.”
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Tightening the noose yet again on Avandia 2

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 second paper, Steve Nissen and Kathy Wolski update their original meta-analysis that ignited the entire Avandia controversy.
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Once-weekly exenatide performs well in DURATION-2 Reply

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 exenatide-treated group. The main drawback to the drug was nausea and diarrhea. The authors concluded:
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CHMP recommends European approval for vernakalant for recent onset AF Reply

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 seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.”

Click here to download a PDF of the CHMP opinion.
Click here to read the press release from Merck and Cardiome…

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

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 week, several of which will be of considerable interest to CardioBrief readers.
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Milwaukee hospital misreads 30% of echocardiograms Reply

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 was discovered before surgery was done.” In addition, 18 patients unnecessarily underwent transesophageal echocardiography and 19 patients unnecessarily underwent cardiac catheterization. The hospital is hiring 4 “internationally known experts” to bolster its echo lab and has asked 2 cardiologists to stop reading echoes, Fauber reports. The review was presented at the recent American Society of Echocardiography meeting.
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ACCME reverses rule that would have prevented industry employees from speaking at scientific sessions Reply

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 scientific meeting.” The statement does not mention that the ACCME was roundly criticized by top medical leaders at a recent NIH meeting, including NIH director Francis Collins.
Click here to read the AHA statement…

CardioBriefs: EAS to recommend niacin and Lp(a) screening; lowering homocysteine fails again 1

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 Reed Miller. The statement will also recommend the use of niacin to bring Lp(a) levels below 50 mg/dl. Although the consensus panel “acknowledges that there have not been randomized, controlled trials selectively targeting plasma levels of Lp(a),” consensus panel cochair Dr John Chapman said: “we consider the level of evidence to be sufficient to warrant the identification of Lp(a) as a causal, independent cardiovascular risk.”
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CardioBriefs: Aggrenox study fails, Livalo launched, NY Times spotlights ICDs with benefits 1

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 Aggrenox failed to cause a significant reduction in recurrent stroke, and in fact there was a trend toward more strokes in the Aggrenox group than in the aspirin group (45 versus 32, p=0.097).
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Cardiologist accused of prescribing unnecessary ICDs because his son was a St Jude salesman 1

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 St Jude employee testified that Burnam’s son was given the job– and a guaranteed $200,000 minimum salary– in exchange for Burnam prescribing St Jude products. Burnam also wanted St Jude to pay for a nurse to serve as a research coordinator.
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What do cardiologists think about the unread echocardiograms at Harlem Hospital? Reply

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 misdiagnosed because their tests had not been handled properly,” according to the hospital spokeswoman quoted in the story. Of the 12 patients who have been contacted, none “were found to have suffered adverse effects from the failure to properly read their tests.”

I’ve received two thoughtful and provocative responses from cardiologists about the latest development in this fascinating and disturbing story. Here they are:
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German committee recommends against reimbursement for Avandia and Actos Reply

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. We believe that patients should be protected against useless and, more importantly, harmful therapies.”


New delays for taspoglutide; renewed cancer concerns for insulin glargine Reply

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 in phase 3 studies and that it would implement a risk mitigation plan.

A study published online in Diabetes Care found an increase in the risk of cancer associated with higher doses of insulin glargine (Lantus, Sanofi). A Sanofi representative told Bloomberg News that the study was too small to be reliable. The study appears almost exactly one year after studies in Europe  first raised cancer concerns over the drug.
Click here to read the Roche press release…

Trial of PFO closure fails to meet primary endpoint Reply

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 patients with documented stroke or TIA who had a PFO, was the two year rate of stroke or TIA, as well as all cause mortality for the first 30 days of follow-up or hospital discharge, whichever is longer, and neurological mortality from > 31 days of follow-up.

In its press release, the company said that PFO closure “provided a small, but not statistically significant, benefit over current best medical therapy.” The company said it expected the full results of the trial to be presented in November at the American Heart Association.
Click here to read the press release from NMT Medical

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

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 the Resolute zotarolimus-eluting stent or the Xience V everolimus-eluting stent. At 12 months, the rate of target lesion failure was 8.2% in the Resolute arm and 8.3% in the Xience V arm, thereby demonstrating noninferiority of the new Resolute stent (p<0.001 for noninferiority). There were no significant differences in death from cardiac causes, MI, or revascularization between the two groups. Stent thrombosis occurred in 2.3% of the Resolute group compared to 1.5% in the Xience V group (p=0.17).
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Industry employees no longer allowed to speak at AHA scientific sessions Reply

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 sessions. The news was first discussed publicly at a meeting of the Advisory Committee to the Director of NIH on June 10 (see the video starting at the 108 minute mark) and was first reported by John Fauber in the Journal-Sentinel.

At the NIH meeting Keith Yamamoto initially described the new policy, which he termed “blood curdling,” as an example of “conflict of interest considerations run amuck.” NIH director Francis Collins agreed, saying it would “squash something that is really important to us, the science going on in the private sector.”
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HDL and Cancer: Study Finds Strong Inverse Relationship Reply

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. More…

Meta-analysis finds increased risk of cancer associated with ARBs Reply

(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 Lancet Oncology found a modest but statistically significant increase in the risk of cancer associated with the use of angiotensin-receptor blockers (ARBs). Researchers from Case Western Reserve University School of Medicine found that patients who received ARBs in clinical trials had a higher rate of new cancers than patients in control groups (7.2% versus 6%, p=0.016). Lung cancer by itself occurred more often in the ARB group than in the control group (0.9% versus 0.7%, p=0.01). No difference in cancer deaths was observed.

Telmisartan was the ARB most often used as the study drug in studies in which new cancer data was available. With the limited data available the researchers were unable to reach firm conclusions about individual ARBs.
Click here for commentary from Steve Nissen, Clyde Yancy, and Franz Messerli…

FDA reviewing safety of olmesartan (Benicar) 4

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 of death.” Patients taking the drug for hypertension should not stop taking it unless told to do so by a healthcare professional.

In both ROADMAP and ORIENT patients with type 2 diabetes were randomized to olmesartan or placebo. The primary endpoint was the progression of kidney disease. In the larger ROADMAP trial, which included 4,447 patients, there were 15 cardiovascular deaths in the olmesartan group versus 3 in the placebo group. In ORIENT, which included 566 patients, there were 10 CV deaths in the olmesartan group versus 3 in the placebo group.
Click here to read the FDA communication…