Παρασκευή 17 Ιανουαρίου 2014

CONTROVERSIES OVER HYPERTENSION GUIDELINES

Five members of the Eighth Joint National Committee (JNC 8) are adding their voices to the cacophony of debate over how best to treat hypertension with a paper spelling out their concerns over the final panel recommendations that were published in the Journal of the American Medical Associationlast month.
Drs Jackson Wright (University Hospitals Case Medical Center, Cleveland, OH), Lawrence Fine (National Heart, Lung, and Blood Institute (Bethesda, MD), Daniel Lackland (Medical University of South Carolina, Charleston), Gbenga Ogedegbe(New York University School of Medicine, New York), andCheryl Dennison Himmelfarb (Johns Hopkins University School of Nursing, Baltimore, MD) all signed on to the paper published but, as they write this week in the Annals of Internal Medicine, they felt that the JAMA paper only "briefly summarized" their concerns[1].
Specifically, the five take exception to the recommendation to increase the target systolic blood pressure (SBP) from 140 mm Hg to 150 mm Hg in patients over age 60—one of the key departures from JNC 7.
Speaking with heartwire , Wright was frank: "This article is not intended as an attack on the 2014 hypertension guidelines. . . . The purpose of this Annals commentary was to clarify the rationale behind the defense of keeping the 140-mm-Hg target, rather than raising it to 150 mm Hg."
The Annals publication is the latest in a series of papers and announcements hinting at the discord that appears to have delayed and complicated the guideline process, as reported by heartwire .
Key Concerns
With the exception of this issue in elderly patients, the JNC 8 panel reached "almost unanimous agreement on nearly all recommendations," the paper notes. Their key concerns, however, were the following:
  • Increasing the systolic BP target in those 60 years or older will have the effect of reducing the intensity of antihypertensive treatment among patients already being treated, among them a large population with established CVD or at high risk for CVD (including African Americans and patients with multiple CVD risk factors other than chronic kidney disease).
  • The evidence supporting upping the target from 140 mm Hg to 150 mm Hg in people 60 or older was insufficient and inconsistent with the evidence supporting the decision considered by the panel to use the target of 140 in younger patients.
  • Raising the target may have the unintended effect of reversing decades of declining CVD rates, especially stroke mortality.
  • Evidence from trials and observational studies that the panel did not use as part of its review supports the lower goal, especially in high-risk patients.
To heartwire , Wright stressed that the gains made over the past decade in treating hypertension have been particularly marked in people over age 60, who make up a full 50% of the 72 million people with hypertension in the US. Increasing age is also a key risk factor for cardiovascular complications.
"If you look at the cardiovascular-disease mortality rate, it's about 35 times higher in those over age 60 compared with those under age 60," he noted. "So essentially we'd be backing off on therapy in those who are the highest risk."
Evidence Reviewed
A key concern of the five dissenters was how and what randomized clinical-trial evidence was used to reach the JNC 8 recommendations; their data review was conducted according to Institute of Medicinecriteria for guideline development.
Authors of the Annals paper note that the panel was content with a lack of evidence of risk or benefit in treating people younger than 60 to a target of 140 mm Hg—the target that JNC 8 ultimately chose in this group—yet the committee did not take into account data from SHEP and HYVET , which found a benefit of a target lower than 150 in people age 60 and older and 80 and older, respectively. Three other trials cited by the JNC 8 panel as supporting a higher target ( JATOS and VALISH ) were not adequately powered, while the larger FEVER trial, in Chinese subjects, found a significant reduction in its primary composite end point among patients treated to below 140 mm Hg yet was not considered in the data review. Other nonrandomized studies also supported the use of a lower target in subjects 60 or older, although the five Annals authors said they agree with recent American Society of Hypertension(ASH)/International Society of Hypertension(ISH) guidance that used the 150-mm-Hg target in patients over age 80.
Ultimately, they summarize, "The majority [of the JNC 8 panel] embraced the view that in the absence of definitive evidence, increasing the SBP goal was the optimum approach [in patients 60 or older]. We, the panel minority, believed that evidence was insufficient to increase the SBP goal from its current level of less than 140 mm Hg because of concern that increasing the goal may cause harm by increasing the risk for CVD and partially undoing the remarkable progress in reducing cardiovascular mortality in Americans older than 60 years."
That lower target, they note, is in line with recent European, Canadian, UK, ACC/AHA , and ASH/ISH guidance.
What Next?
Some experts have suggested that all the different opinions that have swamped the hypertension field over the past month are confusing physicians and patients alike. Wright, however, said there is "always room" for dissension and debate, adding that he'd enjoyed working with "the entire JNC 8 panel."
Asked what it would take to reach consensus, Wright said "it can be resolved with data."
"What we've demonstrated is that there is a gap in the data such that . . . no one can specifically say what the ideal BP target should be. But we do know that since the US target has been at less than 140 mm Hg, or at least as we've been trying to approach that target, the rates of CVD have come down at least in part due to the reduction in BP."
Some answer, he noted, will come from SPRINT , the National Heart, Lung, and Blood Institute–sponsored trial randomizing patients over age 50 to an SBP target of <120 hg.="" hg="" mm="" p="" vs="">
Wright has received personal fees from Sankyo and Pfizer; is chair of the data safety and monitoring board for the Rheos Pivotal Trial ; is a member of the observational safety and monitoring board for theJackson Heart Study ; has received grants from the National Institutes of Health and Medtronic. Disclosures for the coauthors are listed on the journal website.

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