RE-LY at ESC: dabigatran in, warfarin (finally) on the way out? 3

Is the long, unhappy reign of warfarin possibly drawing to a close? The RE-LY trial may have finally identified a candidate, dabigatran, an oral direct thrombin inhibitor that could one day replace warfarin. Unlike warfarin, dabigatran does not require dose adjustments or anticoagulation monitoring.

RE-LY randomized 18,113 AF patients to either one of two fixed doses of dabigatran (110mg or 150 mg twice daily) or warfarin. The results of RE-LY were presented this morning at the ESC and published simultaneously in the New England Journal of Medicine. The RE-LY investigators concluded that “compared with warfarin, the 110-mg dose of dabigatran was associated with similar rates of stroke and systemic embolism and lower rates of major hemorrhage; the 150-mg dose of dabigatran was associated with lower rates of stroke and systemic embolism but with a similar rate of major hemorrhage.”

Click to continue reading…

ARBITER-6 scheduled as AHA Late-Breaker, Kastelein to be discussant 1

ARBITER-6 is scheduled to be presented as a late-breaking clinical trial on Monday, November 16 at 11:07 AM. The discussant for the trial will be John Kastelein. Several knowledgeable observers have pointed out that, as the principal investigator of the highly controversial ENHANCE trial, and as a lecturer and consultant for numerous companies, including Merck and Schering Plough, which has a drug directly involved in the trial, Kastelein is an unusual and potentially controversial choice for the discussant.

Update: Readers may be interested to learn that Kastelein is the co-author of an article, “Surrogate markers in clinical trials– Challenges and opportunities,” in the September 2009 atherosclerosis.
Click to continue reading…

Topol and Teirstein argue about stents on NPR’s All Things Considered 3

To illuminate the topic of how difficult it is “to get doctors to quit ordering unnecessary procedures and tests,” NPR’s radio news show All Things Considered set up a discussion between Eric Topol and Paul Teirstein.

Reporter Chana Joffe-Walt used the two Scripps Health interventional cardiologists– “same specialty, same city, same hospital, very different points of view”– to demonstrate that “what seems unnecessary to some doctors is standard procedure for others.”
Click to continue reading…

Sensitive troponin assays enter the fray Reply

Two large new studies have demonstrated that newer, more sensitive troponin assays may improve the early diagnosis of acute MI. The major limitation of current troponin assays is that the tests are less sensitive in the early hours of ischemia. The two studies, along with an accomapnying editorial by David Morrow, are published in the New England Journal of Medicine.
Click to continue reading, including a detailed comment from Allan Jaffe…

Editorial: Prescription for medical education: sunshine 5

Note to readers: The following editorial by CardioBrief‘s Larry Husten appears simultaneously in a slightly different form on KevinMD.Com. CardioBrief thanks Dr. Kevin Pho for the opportunity to bring this piece before a much wider audience.

A recent hearing of the Senate Aging Committee on continuing medical education (CME) should scare anyone who might need to see a doctor in the next few years. But you don’t need to be a Washington policy wonk to discover that there’s a huge problem with CME.

Just walk into the lobby of any major downtown hotel when a large medical conference is in town and you will see big cardboard posters advertising “satellite” symposia (“satellite” because they orbit but are not an official part of the main conference). Unless you are a doctor the title of the sessions won’t mean anything to you, and the big, boldface names of doctors featured prominently on the posters will be unfamiliar.
Click to continue reading…

Cardiologist in McAllen, Texas sentenced to 4 years in prison Reply

Fabian Aurignac, a cardiologist in McAllen, Texas, was sentenced to 4 years and 9 months in prison for defrauding Medicare and Medicare, according to a report by Jeremy Roebuck in The Monitor.

According to court filings reported by Roebuck, in a 3-week period in 2003,while he was on vacation in Argentina, Aurignac fraudulently billed Medicare and Medicaid more than $900,000.
Click to continue reading…

Shanghai cardiology conference: putting the “con” back in the word “conference” Reply

An upcoming cardiology conference in Shanghai may be putting the “con” back in the word “conference,” according to a news item in TheScientist.Com by Alla Katsnelson. The article details the confusion and difficulties, including possible credit card fraud, that resulted when cardiologists and other scientists– including well-known University of Florida cardiologist C. Richard Conti– received invitations to attend the “1st International Cardiology Congress”  in Shanghai in December.
Click to continue reading…

BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance” 3

A large observational study has found a significantly higher risk of heart failure and death associated with rosiglitazone compared to pioglitazone. David Juurlink and colleagues in Toronto, Canada state in their conclusion:

Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone, questioning whether ongoing use of rosiglitazone is justified in any circumstance is reasonable.

Click to continue reading…

Wall Street guesses ARBITER-6 will be AHA late-breaker 1

Updated (story originally published on August 17)– Wall Street analysts are speculating that ARBITER 6 will be presented as a late-breaker at this year’s AHA meeting in Orlando in November.

Wells Fargo analyst Larry Biegelsen last week wrote that “we expect the ARBITER 6 HALTS study to be presented as a late-breaker at the AHA in November 2009,” though he acknowledged that this information was “not confirmed. On Monday morning CNBC pharmaceuticals reporter Mike Huckman, who is on vacation, twittered that the Leerink Swann pharmaceutical analyst said that ARBITER 6 will be presented at the AHA.
Click to continue reading…

WATCHMAN: will it replace warfarin in some patients? (updated) 2

Updated with commentary from David Kandzari– The WATCHMAN percutaneous left atrial apendage closure device is as effective as warfarin in reducing the risk of stroke in patients with non-valvular AF, but use of warfarin is not likely to go away anytime soon, according to the publication of the PROTECT AF trial in the Lancet and an accompanying comment.
Click to continue reading…

Cardio-Sis in the Lancet: is 130 the new 140? Reply

Cardio-Sis, a large trial from Italy, provides the first good evidence that systolic blood pressure goals in non-diabetic patients should be lowered to 130 mm Hg. Most guidelines now recommend that systolic blood pressure be reduced to below 140 mm Hg, though in diabetics it is now generally accepted that the target should be 130 mm Hg. The findings are published today in the Lancet.
Click to continue reading, including commentary from prominent J-curve proponent Franz Messerli…

NEJM: Califf et al shed light on the SEAS controversy Reply

Are there important lessons to be learned from the ezetimibe cancer controversy? Almost exactly a year after an increased cancer risk with ezetimibe was found in the SEAS trial, the Duke investigators who were at the eye of the ensuing storm have made several recommendations for changing the way information is handled in major clinical trials. The paper by Robert Califf, Robert Harrington, and Michael Blazing appears in a special article in the New England Journal of Medicine.
Click to continue reading…

“This has not been a well managed review process” –FDA official on prasugrel approval 1

A month after approving prasugrel the FDA has released some, but not all, of the documents it is required to post on its website. According to knowledgeable observers, the full action document has not yet been released.

CardioBrief has not reviewed these documents in detail, but noticed a few items that might be of interest to readers:

Norman Stockbridge, director of the division of cardiovascular and renal products, states what has long been obvious to almost anyone observing the approval process:

This has not been a well managed review process. The issues were pretty clear early enough to have allowed us to meet the original PDUFA goal. What has been missing is a clear means or will to declare an end to discussions and to allow the regulatory process to complete. No one associated with this review should feel good about this.[p 5, Division Director Memo]

Click to continue reading and for links to the FDA documents…

Large study increases concerns over TZD fracture risk Reply

Both men and women who take thiazolidinediones (TZDs) may be at increased risk for fractures, according to a large new prospective cohort study published in the Archives of Internal Medicine.

Colin Dormuth and colleagues studied nearly 85,000 patients in British Columbia who began treatment with a thiazolidinedione or a sulfonylurea. They found a 28% increased risk of peripheral fractures in both men and women among patients who took TZDs compared to those who took sulfonylureas.
Click to continue reading…

Antioxidant supplements (round 3): Harrington remains “naturally skeptical” 3

Bob Harrington has told CardioBrief that he remains skeptical of claims that antioxidant supplements can prevent damage from radiation exposure.

In response to our initial story last week reporting that UCLA’s Matthew Budoff had endorsed a patented nutritional supplement “designed to neutralize the damaging free radicals produced by medical x-rays,” we quoted an alternate, highly skeptical perspective from Duke’s Bob Harrington. In a subsequent post, and in lengthy comments attached to the post, James Ehrlich, a board member of the company behind the pill, defended the pill and implied that in private correspondence Harrington had modified his position.

In his new statement to CardioBrief, Harrington has reaffirmed his original position. Here is his statement:
Click to continue reading…