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.
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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…

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…

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:
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Matthew Budoff, a well-respected UCLA cardiologist best known for his strong advocacy of coronary calcium screening, has endorsed a patented nutritional supplement, BioShield-Radiation R1, “designed to neutralize the damaging free radicals produced by medical x-rays,” according to a press release from the supplement’s manufacturer, Premier Micronutrient Corporation. The press release states that Budoff “has become the first cardiologist in California to offer patients” the new pill.

But Duke’s Bob Harrington tells CardioBrief that the claims of the company for the supplement are unsubstantiated: “The whole thing is smoke and mirrors. Show us some data!”
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Prasugrel is now available in pharmacies in the US, according to a press release issued by Lilly and Daiichi Sankyo.

Click here to read the press release.

Click here for a complete chronology of the prasugrel controversy.

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The FDA today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.
Click here to read press releases from the FDA and from Livalo…