JNC 8, ATP 4 Guidelines (Still) Soon to Be Released

January 11, 2013

BETHESDA, Maryland — There's a page on the National Heart, Lung, and Blood Institute (NHLBI) website with a table that tracks the progress of three "expert panels" and two "working groups" charged with devising an overarching, interdependent set of guidelines for reducing cardiovascular risk in clinical practice [1].

There are few specifics, but the table suggests that the long-awaited documents, particularly the expert-panel recommendations on blood pressure, cholesterol management, and obesity, are at different review stages but are nearing completion.

And that's how it's been for several years.

"They've been keeping us waiting for a long time. Whatever has slowed the process down, it's much too slow," according to Dr Roger S Blumenthal (Johns Hopkins University, Baltimore, MD). The process should also be more transparent.

Maybe for Valentine's Day the NHLBI can give the clinical community the gift of seeing what the expert panels have come up with.

"When no new guidelines come out on blood pressure and cholesterol risk assessment for so many years, people start to wonder whether there are controversies or anything new and that maybe we shouldn't bother as much with risk-factor management. Nothing could be further from the truth," Blumenthal told heartwire . "It's time to move forward. It's not fair to all the people on the committees who did the hard work to have it drag on."

The most recent third Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults: Report from the Adult Treatment Panel (ATP 3) document came out in 2001, with an update in 2004. The seventh version of Managing Blood Pressure in Adults: Report from the Joint National Committee (JNC 7) was released in 2003. And the first Managing Overweight and Obesity in Adults: Report from the Obesity Expert Panel (Obesity 1) is even grayer, dating from 1998.

Blumenthal was senior author on a paper last year lamenting the delay in unveiling ATP 4 that proposed specific practice changes that could be implemented in the meantime [2]. To the entire affair, the paper applies a reputed French proverb: "People count up the faults of those who keep them waiting."

Only the writing panels know why the documents have taken so long, he notes. But "my feeling is five years is long enough to be working on it. Maybe for Valentine's Day the NHLBI can give the clinical community the gift of seeing what the expert panels have come up with."

One Step Away . . . 

The table on the NHLBI site suggests that ATP 4 is one step away from release as a draft for public comment. So is the new Clinical Guidelines on Cardiovascular Risk Reduction in Adults, Lifestyle Intervention Working Group document.

It says drafts of JNC 8 and Obesity 2 have yet to be reviewed by at least three separate bodies before they're ready for public comment. A fifth guideline, Lifestyle Recommendations to Reduce Cardiovascular Risk: Report from the Lifestyle Work Group, has only one such review to complete.

A big part of the frustration relates to the many "false starts" by the societies in promising to unveil the new documents, observed Dr Suzanne Oparil (University of Alabama at Birmingham), cochair of the JNC 8 expert panel, for heartwire . Expectations are raised, only to be dashed.

She attributes the delays partly to a new set of procedures followed in developing the guidelines and to at least one novel aspect of them: they are going to be almost entirely evidence-based.

If you spend a couple days together you sometimes get more done than if you spend, say, 90 minutes every week.

For JNC 8, she said, "We're trying to use strictly what's in the literature based on randomized controlled trials of blood-pressure treatment and not rely too heavily on the opinions of the panel members." Mostly left out, she said, are meta-analyses and observational studies.

"This is a government document," she cautions. There is a limited budget, and summaries of the evidence that the panel reviews depend on the schedules of private contractors. "We didn't have resources for a lot of face-to-face meetings, so everything was done by teleconference and sometimes videoconferencing," Oparil said. "That's somewhat more cumbersome--if you spend a couple days together you sometimes get more done than if you spend, say, 90 minutes every week."

On the other hand, she said, the delays occurred "not because there's a lot of conflict." In general, the panel has agreed on most of the recommendations, once they were presented with the evidence.

"Probably in the Spring . . . "

JNC 8 "is in the home stretch," according to Oparil. A date for releasing the final document hasn't been made known, but it will be "probably in the spring. We're essentially finished with the first-draft document." Now it will need to be "integrated, to some extent, with the work of the other panels" and then reviewed by other government-sponsored panels before it's posted for a public-comment period.

A fuller integration of the five documents, which a committee will work on sometime after the five documents are complete, is a final step that isn't obvious from the NHLBI page with the tracking chart. But it's an important aspect of the new methodology involved in the guidelines' development process, according to Dr Nathan D Wong (University of California, Irvine), who is a past president of the American Society for Preventive Cardiology and not on any of the writing groups.

Whether [<70 mg/dL] is adopted as the official primary target in ATP 4, I think we'll have to see. But it has already been recommended.

The guidelines on blood pressure, cholesterol, obesity, risk assessment, and lifestyle, he said, "are all connected in many ways. For example, we can't talk about cholesterol management unless we talk about lifestyle and how we should best assess cardiovascular risk to determine appropriate treatment goals. We really need to look at them all together."

The hope is that clinicians will be able "to see these as one package of prevention guidelines, working together in a coherent fashion to maximize the effectiveness of their delivery."

Wong acknowledged that the guidelines, especially JNC 8 and ATP 4, have been a long time coming but noted that clinicians haven't been practicing in a vacuum for the past decade and are probably treating beyond ATP 3 criteria. There have been several updates from 2004 to 2011 in which, for example, <70 mg/dL--based on randomized trials--has evolved into an optional target for reducing LDL cholesterol in patients with CHD.

"Whether that is adopted as the official primary target in ATP 4, I think we'll have to see. But it has already been recommended," Wong said.

Publicity around important studies can also influence practice without help from guidelines, he noted. "An example might be the ACCORD BP trial, which did not show an added benefit for aggressive BP management in those with diabetes or the recent failure of AIM-HIGH due to lack of efficacy of niacin in reducing CVD events beyond a statin in persons with coronary disease."

That the forthcoming guidelines are coming from the NHLBI should add to their credibility, he said. They "are raising the bar very high" in basing their recommendations almost entirely on randomized controlled trials.

And that bodes well for how the new documents are ultimately received. As more than a few signs suggest the first of the guidelines will see light in the next few months, clinicians are more likely to find them well worth the wait.

Blumenthal has no disclosures. Oparil has no known disclosures. Wong says he has received research support from Merck and Bristol-Myers Squibb and is a consultant for AVIIR.