Minority Report: Five Guideline Authors Reject Change In Blood Pressure Goal Reply

It didn’t seem possible but the guideline situation just got even more confusing. Last December, after  years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, the target remained the same for adults under 60 years of age but for people over the age of 60 the new guideline set a more conservative, easier-to-achieve target of 150 mm Hg or lower.

Now, however,  five of the 17 JNC 8 authors have written a commentary, published in Annals of Internal Medicine, disagreeing with this change. They say they are in agreement with the other major recommendations of JNC 8 but that they reject the new target, arguing that the evidence does not support the change, and predict that the change may well lead to harmful consequences.

Click here to read the full post on Forbes.

Confusion

 

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L.A. Confidential: Preview Of AHA Scientific Sessions 2012 Reply

The American Heart Association scientific sessions, which start next weekend in Los Angeles, will be bigger than ever, with 853 separate sessions– 111 more than last year– and 27 late-breaking clinical trials– 6 more than last year. Elliott Antman, chair of the scientific sessions program committee, provided a preview of some of the highlights of this year’s late-breakers.

Two of the most interesting trials will be presented at the first late-breaking session on Sunday afternoon. Perhaps the most eagerly anticipated trial of the entire meeting is the NIH’s FREEDOM (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) trial, which will be presented by Valentin Fuster. The trial will evaluate the relative worth of CABG and PCI in patients with diabetes.

Immediately preceding FREEDOM on the program is another NIH-sponsored trial, TACT (The Trial to Assess Chelation Therapy), testing the potential value of chelation therapy, a controversial alternative therapy. “We ought to take our hat off to the NIH for doing this trial, since industry was never going to fund this trial,” said Antman. Although most physicians have a skeptical view of chelation therapy, patients often express interest in it. TACT will finally provide real data about this approach.

Directly following the first session, the second late-breaking session will focus on economic and quality-of-life studies, including a quality of life TACT substudy and a cost-effectiveness FREEDOM substudy.

On Monday, two Italian trials will look at the role of omega-3 fatty acids for recurrent atrial fibrillation (FORWARD) and for the prevention of post-operative AF (OPERA). The Physicians Health Study II will examine the effect of multivitamins for cardiovascular endpoints. The UMPIRE study will test the feasibility of giving the polypill in 2,000 patients for a period of 15 months.

The second late-breaker session on Monday will present the results of three phase 2 trials of PCSK9 inhibitors. The session will include a panel discussion and an overview of this fast-moving and much-anticipated new therapeutic area. Also at this session will be the results of the  dal-OUTCOMES phase 3 trial of the CETP inhibitor dalceptrapib. Although the drug is no longer in clinical development, many observers are eager to see if the results will have implications for other CETP inhibitors.

A Tuesday morning session will be entirely devoted to stem cell regeneration trials. Antman said this was a “promising avenue of investigation” but acknowledged that we still don’t know if this whole approach might fail.

Later on Tuesday, Arthur Moss will present the results of the MADIT Randomized Trial to Reduce Inappropriate Therapy, comparing customized programming to standard programming for the reduction of ICD-induced inappropriate shocks. At the same session the results of RELAX-AHF will be presented, testing the novel agent relaxin in acute heart failure. Finally, the CARRESS-HF  study will offer insight into the role of ultrafiltration in patients with acute decompensated heart failure and worsening renal function.

Walking With the American Heart Association: Valerie Bertinelli and Chester Cheetah 1

A few weeks ago Chester Cheetah, the official mascot for Frito Lay’s Cheetos, played an official part in  the American Heart Association’s Dallas Heart Walk. Yoni Freedhoff, on his Weighty Matters blogpretty much says what needs to be said about this disgraceful association between Frito Lay and the AHA.

This weekend I received a press kit from Jenny Craig. The diet company was publicizing the participation of  tabloid celebrity Valerie Bertinelli, a Jenny Craig “brand ambassador,”  in the AHA’s Los Angeles Heart Walk on Saturday. At first glance, Jenny Craig’s relationship with the AHA does not appear to be as awful as Frito Lay’s. After all, whatever else you may think about the company and its methods, obesity is a major problem, and if some people can defy the odds and lose weight with Jenny Craig then all the better for them.

But the Jenny Craig relationship brings up another, more subtle harm caused by these sort of increasingly popular arrangements in which nonprofit organizations accept money from for-profit corporations. I was astonished to read the second paragraph of the Jenny Craig press release:

Bertinelli, who has lost weight on the Jenny Craig program, recognizes the importance of being in good heart health, and owes her mother’s life to Jenny Craig.  Bertinelli’s mother, Nancy, lost 54 pounds* on Jenny Craig after witnessing her daughter’s success on the program. In October of 2008, Bertinelli’s mother required emergency heart valve replacement surgery.  After the successful surgery, the cardiologist pulled Bertinelli and her brother aside and told them that if their mother hadn’t previously lost weight, she would not have survived the surgery.

Scientifically and medically, this is an entirely irresponsible statement, if in fact a cardiologist did make this statement. My source for this assertion? The AHA itself. Here’s what an AHA science advisory had to say about this exact topic:

Severe obesity has not been associated with increased mortality in patients undergoing cardiac surgery but has been associated with an increased length of hospital stay and with a greater likelihood of renal failure and prolonged assisted ventilation.

One of the most important roles of the AHA is to encourage, develop, and support the use of evidence-based medicine. Why then does the AHA agree to partner with companies that flagrantly (Frito Lay) or more subtly (Jenny Craig) undermine that effort?

Fun facts: Jenny Craig is a wholly owned subsidiary of Nestlé. Frito Lay is owned by Pepsi.

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Click here to read the Jenny Craig press release…

News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD Reply

Cholesterol Trends

The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings:

…cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported being told they had high cholesterol increased from 33.2% to 35.0%. Previously identified demographic disparities persist.

AHA Previews LBCTs

The American Heart Association has published a preview of the late-breaking clinical trials scheduled for presentation in November at the scientific sessions in Los Angeles. 28 LBCTs have been selected, including the NIH’s FREEDOM (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) trial and the controversial Trial to Assess Chelation Therapy (TACT).

J&J Provides More Information To FDA About Rivaroxaban

Johnson & Johnson said today that it had fully responded to the FDA’s request for more information about the use of rivaroxaban (Xarelto) in patients with acute coronary syndromes. The company also said it had resubmitted its supplemental New Drug Application (sNDA) for the drug to reduce the risk of stent thrombosis in ACS patients.

Heartware HVAD Close To FDA Approval

The Heartware HVAD ventricular assist system may be approved soon by the FDA, according to Wells Fargo analyst Larry Biegelsen. Robert Kormos, a cardiothoracic surgeon at the University of Pittsburgh, who also consults for Heartware,  said during a session at a Society of Thoracic Surgeons symposium that the device would be approved in the next few weeks.

Republished with permission from CardioExchange, a NEJM group publication.