30日間連続 1ch 心電図ホルター又は二週間連続モニター用設定可 FDA認可済 本邦研究用

30日間連続 1ch 心電図ホルター又は二週間連続モニター用設定可 FDA認可済 本邦研究用

体温センサー 0.1°精度 72時間 ディスポ スマホ・タブレット連携 FDA認可 本邦研究用

体温センサー 0.1°精度 72時間 ディスポ スマホ・タブレット連携 FDA認可 本邦研究用

2014年5月28日水曜日

the threshold to a systolic pressure of 150 mm Hg or higher

BP Guidelines: No Simple Answers Published: May 19, 2014 | Updated: May 20, 2014 By Todd Neale, Senior Staff Writer, MedPage Today Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner Action Points • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. • Note that there is considerable controversy about the recommendation in JNC 8 to reduce the level at which treatment is initiated in patients 60 and older without diabetes or chronic kidney disease as compared with JNC 7. NEW YORK CITY -- Confusion about conflicting guidance on the management of high blood pressure continues, with some clinicians calling for a "guide to the guidelines" at the American Society of Hypertension meeting here. Although there is much agreement among the several guideline documents from the U.S. and abroad, one conflict stands above the rest: the recommendation to loosen the threshold at which treatment is initiated in patients 60 and older without diabetes or chronic kidney disease -- to a systolic pressure of 150 mm Hg or higher or a diastolic pressure of 90 mm Hg or higher -- and to make the target blood pressure below that level. That recommendation was published in the Journal of the American Medical Association at the end of last year by "the panel members appointed to the Eighth Joint National Committee (JNC 8)," a panel with no backing at the time of publication by the National Heart, Lung and Blood Institute (NHLBI) or any other group. In a joint session between ASH and the American Society of Nephrology, one of the panel members -- Raymond Townsend, MD, of the University of Pennsylvania in Philadelphia -- defended the recommendation, saying that there was insufficient evidence to support the lower threshold of 140/90 mm Hg recommended in JNC 7 and other guidelines. In those other guidelines, the threshold is relaxed at age 80, not age 60. But the controversial aspect of the recommendation was underscored by the fact that five of the 17 panel members voted against making the change, including Jackson Wright Jr., MD, PhD, of Case Western Reserve University in Cleveland. He and his fellow dissenters went so far as to publish the reasons for their disapproval in a commentary in Annals of Internal Medicine in January. The thrust of their argument, Wright explained at the ASH/ASN session, was that evidence was insufficient to make a change, that loosening the threshold would lower the intensity of antihypertensive treatment in higher-risk groups, including older individuals and blacks, and that less intensive control of blood pressure might counteract improvements that have been made in death rates from coronary heart disease and stroke. He noted that just a single additional No vote would have defeated the recommendation Although that recommendation is the biggest source of contention, there also is confusion bred by the presence of multiple different guidelines for the management of hypertension. At the ASH/ASN session, Sandra Taler, MD, of the Mayo Clinic in Rochester, Minn., detailed one of the documents, the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guideline for the management of blood pressure in patients with chronic kidney disease (CKD) not on dialysis. In a commentary published last year giving the U.S. perspective on the guideline from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI), Taler and colleagues pointed out that "the overriding message was the dearth of clinical trial evidence to provide strong evidence-based recommendations." "For patients with CKD with normal to mildly increased albuminuria, goal blood pressure has been relaxed to ≤140/90 mm Hg for both diabetic and nondiabetic patients," they wrote. "In contrast, KDIGO continues to recommend goal blood pressure ≤130/80 mm Hg for patients with chronic kidney disease with moderately or severely increased albuminuria and for all renal transplant recipients regardless of the presence of proteinuria, without supporting data." "The expert panel thought the KDIGO recommendations were generally reasonable but lacking in sufficient evidence support and that additional studies are greatly needed," they wrote. However, that same caution could be applied to other hypertension documents, as well. Townsend noted that in the past few years guidelines for managing high blood pressure have been released by ASH/ISH (International Society of Hypertension), the European Society of Hypertension/European Society of Cardiology (ESH/ESC), and the National Institute for Health and Care Excellence (NICE) from the U.K. There are some similarities between the documents, but also some differences, with large variation in length of the guidelines, number and content of the recommendations, and target audiences. "It would not be a very simple thing to try and get these various committees in a room ... and have us all hash out our differences and come to unanimity about every aspect of blood pressure," Townsend said. "We probably wouldn't even agree on what the core clinical questions would be in the first place." Moving Forward One of the audience members after the ASH/ASN session suggested that ASH should take the lead on reaching out into the clinical community to help clear up any confusion that surrounds the presence of multiple guidelines, possibly through creating a "guide to the guidelines." When asked about that, Sica said, "I think what you're going to see coming forward, probably within the next year, is how to distill out the essence of the guidelines and apply them at the bedside. The consensus document [in JAMA] never was able to distill out the essence and give you how do you apply it at the bedside." He said that ASH likely would be involved in such a document. "I think ASH's stance is to try and establish a set of complementary I wouldn't say guidelines, but support statements that take a field which is very bereft of adequate information right now [forward] because the guidelines have a number of gaps which most everyone would agree to," Sica said. He suggested that clinicians managing hypertension need to find out what works best for their practice in the presence of multiple guidelines, and that being at the meeting and hearing directly from the creators of the documents is important in helping them do that. "I think what the people at this meeting will do is they will come up with their own treatment algorithm from hearing four, six, or eight different experts in guidelines," Sica said, adding that "when it comes down to it, you cannot make a decision for a clinician." Henry Black, MD, of NYU Langone Medical Center, who criticized the JAMA guideline based on the fact that more than half of the recommendations (six of the 11) were based on expert opinion and did not touch on several important issues that were included in JNC 7, gave some advice on how to make sense of the plethora of hypertension guidance. When asked whether clinicians should continue to follow JNC 7, he said, "I think at this point if clinicians feel that they really know what to do about blood pressure, they don't have to do anything more. If not, it's very important -- and this applies to anything -- to identify someone that you communicate with whose opinion you trust, and stick with that person's opinion." "Guidelines can be a problem when they are conflicting, as we see, and I don't know what I would do if I were 35 years old, starting practice now, thought I knew about blood pressure, and I get hit on all ends by what are conflicting recommendations," Black told MedPage Today. "I would throw my hands up and say, 'They don't know what they're talking about. I don't know who to listen to.'" Although clinicians should be encouraged to read the JAMA guideline, he said, they should also read the others and then consult with a local expert in managing hypertension. Help on the Way? The American Heart Association and American College of Cardiology -- who, along with the CDC, issued a call last year to broaden the attack on hypertension -- have both said that they will not endorse the JAMA guideline. The panel members were invited to join the AHA/ACC process that resulted in publication of the set of four cardiovascular disease prevention guidelines dealing with the assessment of cardiovascular risk and management of cholesterol, lifestyle, and weight last year, but they declined, opting instead to publish on their own without endorsement from any federal agency or professional organization. To complete the suite of prevention guidelines, the AHA/ACC task force will spend the year crafting its own hypertension guidance, with the intention of having them ready by early 2015. Black disclosed relevant relationships with Elsevier, Servier, Novartis, Takeda, Merck Sharp & Dohme, NFL, Zumbro, Hope, JDS, WebMD, Bayer, Pfizer, AstraZeneca, Argo, the Agency for Healthcare Research & Quality, and PCA. Sica disclosed no relevant relationships with industry. JAMA guideline: James disclosed no relevant relationships with industry. Oparil disclosed relevant relationships with Bayer, Daiichi Sankyo, Novartis, Medtronic, Takeda, Backbeat, Boehringer Ingelheim, Bristol Myers-Squibb, Eli Lilly, Merck, Pfizer, AstraZeneca, Eisai, Gilead, Amarin Pharma, and LipoScience. Townsend disclosed relevant relationships with Medtronic, Janssen, GlaxoSmithKline, Merck, UpToDate, and Medscape. Wright disclosed relevant relationships with Medtronic, CVRx, Takeda, Daiichi Sankyo, Pfizer, Novartis, and Take Care Health. One of the other panel members disclosed relevant relationships with Merck, Lilly, Novartis, Sciele Pharmaceuticals, Takeda, sanofi-aventis, Gilead, Calpis, Pharmacopoeia, Theravance, Daiichi Sankyo, Noven, AstraZeneca Spain, Omron, and Janssen. CKD guideline: Taler disclosed support from the NIH. Her co-authors disclosed support from the NIH and the Department of Veterans Affairs. Take Posttest Primary source: Journal of the American Medical Association Source reference: James P, et al "2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8)" JAMA 2013; DOI: 10.1001/jama.2013.284427. Additional source: American Journal of Kidney Diseases Source reference:Taler S, et al "KDOQI U.S. commentary on the 2012 KDIGO clinical practice guideline for management of blood pressure in CKD" Am J Kidney Dis 2013; 62: 201-213.

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