Management of Blood Pressure

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  KDOQI Commentary KDOQI US Commentary on the 2012 KDIGO Clinical PracticeGuideline for Management of Blood Pressure in CKD Sandra J. Taler, MD, 1 Rajiv Agarwal, MD, 2  George L. Bakris, MD, 3  Joseph T. Flynn, MD, 4,5  Peter M. Nilsson, MD, 6  Mahboob Rahman, MD, 7  Paul W. Sanders, MD, 8,9  Stephen C. Textor, MD, 1 Matthew R. Weir, MD, 10  and Raymond R. Townsend, MD  11 In response to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guideline for blood pressuremanagementinpatientswithchronickidneydiseasenotondialysis,theNationalKidneyFoundationorganizedagroupofUSexpertsinhypertensionandtransplantnephrologytoreviewtherecommendationsandcommenton their relevancy in the context of current US clinical practice and concerns. The overriding message was thedearthofclinicaltrialevidencetoprovidestrongevidence-basedrecommendations.ForpatientswithCKDwithnormal to mildly increased albuminuria, goal blood pressure has been relaxed to   140/90 mm Hg for bothdiabetic and nondiabetic patients. In contrast, KDIGO continues to recommend goal blood pressure  130/80mm Hg for patients with chronic kidney disease with moderately or severely increased albuminuria and for allrenal transplant recipients regardless of the presence of proteinuria, without supporting data. The expert panelthoughttheKDIGOrecommendationsweregenerallyreasonablebutlackinginsufficientevidencesupportandthat additional studies are greatly needed. Am J Kidney Dis.  62(2):201-213.  ©  2013 by the National Kidney Foundation, Inc. INDEXWORDS:  Kidney Disease: Improving Global Outcomes (KDIGO); guideline; blood pressure. INTRODUCTION KDIGO (Kidney Disease: Improving Global Out-comes) is an international initiative formed to developand implement clinical practice guidelines for theoptimal care of patients with chronic kidney disease(CKD). KDIGO recently published an updated evi-dence-based practice guideline for the management of blood pressure in individuals with non–dialysis-dependent CKD (CKD ND) of any stage. 1 This reportbuildsuponthepreviousguidelinepublishedbyNKF-KDOQI (National Kidney Foundation–Kidney Dis-ease Outcomes Quality Initiative) in 2004. 2 In re-sponse, the NKF organized a group of US experts inhypertension,nephrology,andtransplantationnephrol-ogy to review the recommendations and comment ontheir relevancy and the potential for their implementa-tion in the context of current US clinical practice.Thiscommentary presents the KDIGO guideline recom-mendations and statements, followed in each topicarea by a succinct discussion and commentary of thesupporting rationale and potential applicability issuesraised by the expert panel.Thegenesisandimplementationoftreatmentguide-lines are by themselves often a study of bias andbelief, but development of guidelines may also laybare the significant lack of gold-standard studies, inother words, randomized controlled trials (RCTs), thatpractitioners can use to guide clinical care. Treatmentof hypertension, particularly in the setting of CKDND, is no exception. KDIGO commissioned an evi-dence review of the recent literature and assembled awriting group to create the current recommendations.While data from RCTs were preferred, the evidencebase included published systematic reviews and meta-analyses and selected RCTs that included CKD sub-groupsorindividualsatincreasedcardiovascular(CV)risk without specific diagnosis of CKD. Outcomeswere related to kidney disease progression and CV From the  1  Division of Nephrology and Hypertension, College of  Medicine,MayoClinic,Rochester,MN; 2  IndianaUniversitySchoolof Medicine and Richard L. Roudebush Veterans Administration Medical Center, Indianapolis, IN;  3  Department of Medicine, ASH Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL;  4  Division of Nephrology, Seattle Chil-dren’s Hospital;  5  Department of Pediatrics, University of Wash-ington, Seattle, WA;  6   Department of Clinical Sciences, Lund University, Skåne University Hospital, Malmö, Sweden;  7   Divi-sion of Nephrology & Hypertension, Case Western ReserveUniversity, Cleveland, OH;  8  Department of Veterans Affairs Medical Center;  9  Division of Nephrology, Department of Medi-cine, Nephrology Research and Training Center, Center for Free Radical Biology, Center for Aging, and Department of Cell, Developmental and Integrative Biology, University of Alabama at  Birmingham, Birmingham, AL;  10  Division of Nephrology, Univer-sityofMarylandSchoolofMedicine,Baltimore,MD;and  11  Depart-ment of Medicine, Renal Division, University of Pennsylvania,Philadelphia, PA.Originally published online May 17, 2013. AddresscorrespondencetoRaymondR.Townsend,MD,Depart-ment of Medicine, Renal Division, University of Pennsylvania,3400 S  pruce St, 122 Founders Bldg, Philadelphia, PA 19104. E-mail: townsend@exchange.upenn.edu ©  2013 by the National Kidney Foundation, Inc.0272-6386/$36.00http://dx.doi.org/10.1053/j.ajkd.2013.03.018 Am J Kidney Dis. 2013;62(2):201-213 201  events. Overall, the KDIGO committee did an excel-lent job of carefully reviewing the evidence andprovided an accurate grading of the available data tosupport their recommendations for the managementof blood pressure in patients with CKD ND. However,the final product is disappointing, offering few recom-mendations that are supported by even moderate-quality evidence. Because many trials routinely ex-cluded patients when their serum creatinineconcentrationwas  1.5-2.0mg/dL,thereisanimpres-sive lack of information in this area in general. This isclearly evident in the current report. This limitation isdistinctlyhighlightedbytheuseoftheGRADE(Grad-ing of Recommendations Assessment, Developmentand Evaluation) evidence grading scale. 3 Using GRADE, the strength of each recommenda-tion is indicated as either Level 1, a strong recommen-dation, indicating that most patients should receivethis course of action, or Level 2, a weak or discretion-ary recommendation, indicating that different choicesof therapy would be appropriate for different patients.Strength of recommendation is reflected in the se-lected wording, with the use of terms such as “recom-mend” or “should” to imply that most patients shouldreceive this course of action (Level 1) or the use of terms such as “suggest” or “might” to indicate thatdifferent choices may be appropriate for differentpatients depending on their circumstances (Level 2).Moreover, each statement is given a grade reflectingthe quality of the supporting evidence: A (high), B(moderate), C (low), or D (very low). The readershould note that none of the graded recommendationsreceived anAgrade. Four (23.5%) received a B grade;3 (17.7%), a C grade; and 10 (58.8%), a D grade. Forstatements that could not be subjected to systematicevidence review, a “Not Graded” category was as-signed (4, or 19.1%, of  all recommendations). Thissystem, summarized in Box 1, was used throughout the report.The guideline was developed to assist health careprofessionals (nephrologists, other physicians, nurses,and pharmacists) in providing care to patients withCKD. While the ideal is to base all recommendationson RCT-derived data, reality must be taken into con-sideration and when the data were lacking, the expertsthought their clinical acumen and experience wouldbe preferable to leaving gaps with no recommenda-tions. The resulting expert opinion statements arerated with a low strength of recommendation and lowstrength of evidence. In addition, there are a number Box1. Nomenclature and Description for Rating Recommendation Strength and Quality of Evidence Rating Strength of Recommendation Grade a Implications for Patients Implications for Clinicians Implications for Policy Level 1“We recommend”Most people in your situationwould want therecommended course ofaction and only a smallproportion would not.Most patients should receive therecommended course of action.The recommendation can beevaluated as a candidate fordeveloping a policy or aperformance measure.Level 2“We suggest”The majority of people in yoursituation would want therecommended course ofaction, but many would not.Different choices will be appropriate fordifferent patients. Each patientneeds help to arrive at amanagement decision consistentwith her or his values andpreferences.The recommendation is likely torequire substantial debateand involvement ofstakeholders before policycan be determined. Rating Quality of Evidence GradeQuality ofEvidence Meaning A High We are confident that the true effect lies close to that of the estimate of the effect.B Moderate The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantiallydifferent.C Low The true effect may be substantially different from the estimate of the effect.D Very low The estimate of effect is very uncertain, and often will be far from the truth. Note:   Within each recommendation, the strength of recommendation is indicated as Level 1, Level 2, or Not Graded, and the qualityof the supporting evidence is shown as A, B, C, or D. a The additional category Not Graded was used typically to provide guidance based on common sense or when the topic does notallow adequate application of evidence. The most common examples include recommendations regarding monitoring intervals,counseling, and referral to other clinical specialists. The ungraded recommendations are generally written as simple declarativestatements, but are not meant to be interpreted as being stronger recommendations than Level 1 or 2 recommendations.Am J Kidney Dis. 2013;62(2):201-213202 Taler et al   of Not Graded recommendations that provide guid-ance based on sound clinical judgment in areas lack-ing in evidence. As stated in the report, the processwas not designed or intended to guide regulators or setperformance measures. In an area with so little deci-sion making based on optimal data, it is important toaccentuate this distinction.A minor but important point is the discrepancy of the KDIGO guideline with other guidelines in using“less than or equal to” as the goal rather than thegenerally adopted convention of using “less than”targets. For example, other guidelines use the bloodpressure goal   140/90 instead of    140/90 mm Hg.As hypertension is defined as blood pressure  140/90mm Hg, in order to achieve a normal blood pressure,the guideline should have recommended a goal of   140/90 mm Hg. This approach runs through theentire document and is relevant to guideline sections 3through 7.Asecond difference pertains to the additionof the term “consistently” to all recommendationscontaining blood pressure goals. Using the argumentthat blood pressure variability will result in a subset of readings above goal, the KDIGO panel specified theneed for more intensive treatment whereby a portionof readings will be below the blood pressure goal inorder to meet the consistency requirement. This is achange from other guidelines that may be lost as asubtlety hinging on a single word.The guideline is consistent with the KDIGO 2012guideline for the evaluation and management of CKD,which uses a revised terminology for albuminuriabased on quantitative measurements. 4 Recommenda-tionsarestratifiedaccordingtourinaryalbuminexcre-tion  30, 30-300, or  300 mg/24 h, which fits wellwith the updated classification of normal to mildlyincreased,moderately,andseverelyincreasedalbumin-uria, respectively, used in the KDIGO CKD guideline.This applies to guideline sections 3 and 4, whererecommendations differ by extent of albuminuria.The guideline recommendations are divided into 5sections that address specific populations within thetotal population with CKD according to the presenceor absence of diabetes mellitus, with separate guide-lines for kidney transplant recipients, children, andthe elderly. This division further highlights differ-ences in the strength of evidence and thus the greatneed for additional trials to address these deficiencies.Each section concludes with a set of recommenda-tions for research. The exercise of defining and grad-ing current evidence flows nicely into a roadmap forareas in need of further study. Clearly the needs arelegion and new initiatives will need to prioritize basedon the utility and applicability of the knowledge to begained. REVIEWOFKDIGOBLOODPRESSUREMANAGEMENTRECOMMENDATIONS CKDNDPatients CommentaryonRecommendationStatements KDIGO recommendations on lowering blood pres-sure in patients with CKD ND are provided in Box 2. General strategies.  Recommendation 2.1 is notgraded due to the general lack of RCT data to guidedecision making in this area. The recommendation toindividualize care and inquire about tolerance of thetreatment is considered to be good clinical practice.The authors raise important general concepts: thedifficulty reaching blood pressure goals in patientswith CKD, concerns regarding the widened pulsepressure associated with arterial stiffness, and thepotential to lower diastolic pressures excessively withgreaterriskformorbidityormortality.NationalHealthand Nutrition Examination Study (NHANES) dataindicate that CKD ND is often associated with resis-tant hypertension, 5 defined as blood pressure thatremains above goal despite the concurrent use of 3antihypertensive agents of different classes. 6 Thechoice of agents must be made after consideration of  Box2. KDIGO Recommendations for Lifestyle and Pharmaco-logic Treatments for Lowering Blood Pressure in CKDND Patients GENERALSTRATEGIES 2.1: Individualize BP targets and agents according to age,co-existent cardiovascular disease and other co-morbidi-ties, risk of progression of CKD, presence or absence ofretinopathy (in CKD patients with diabetes) and toler-ance of treatment. (Not Graded)2.2: Inquire about postural dizziness and check for posturalhypotension regularly when treating CKD patients withBP-lowering drugs. (Not Graded) LIFESTYLEMODIFICATION 2.3: Encourage lifestyle modification in patients with CKD tolower BP and improve long-term cardiovascular andother outcomes:2.3.1: We recommend achieving or maintaining a healthyweight (BMI 20 to 25). (1D)2.3.2: We recommend lowering salt intake to   90 mmol(  2 g) per day of sodium (corresponding to 5 g ofsodium chloride), unless contraindicated. (1C)2.3.3: We recommend undertaking an exercise programcompatible with cardiovascular health and toler-ance, aiming for at least 30 minutes 5 times perweek. (1D)2.3.4: We suggest limiting alcohol intake to no more thantwo standard drinks per day for men and no morethan one standard drink per day for women. (2D)Abbreviations: BMI, body mass index; BP, blood pressure;CKD, chronic kidney disease; ND, non–dialysis-dependent.Reproduced with permission of KDIGO from the  KDIGO Clinical Practice Guideline for the Management of Blood Pres- sure in Chronic Kidney Disease  . 1 Am J Kidney Dis. 2013;62(2):201-213 203 KDOQI Commentary on KDIGO Guideline for Blood Pressure in CKD   comorbidities, including renovascular disease or vol-ume depletion, along with potential drug interactions.Patients with CKD ND are often treated with multipleantihypertensive medications that can each have un-toward side effects. Good clinical practice dictatesthat periodic assessment of medication side effects isan essential feature of management of CKD ND.Although not mentioned, discerning a patient’s toler-ance to treatment may also improve patient adherenceto the prescription, since adverse side effects imposeadditional burdens.Recommendation 2.2, which is also not graded, is areasonable approach, particularly for the elderly ordiabetic patient with the potential for autonomic neu-ropathy, who is prone to develop symptomatic pos-tural hypotension while taking antihypertensive medi-cations. Checking for postural hypotension regularlyshould be considered good clinical practice. Lifestyle modifications.  Much of this section relieson observational and epidemiologic studies in thegeneral population, including short-term interventiontrials. An excellent review and rationale are providedfor Recommendation 2.3.1. Application to a CKDpopulation is by extrapolation, with few randomizedtrials in CKD. While obesity may associate with CKDprogression, there remains a lack of high-quality dataon interventions in CKD ND. It is worth emphasizinga cautionary note that some popular weight-loss dietsemphasize foods high in potassium and protein andmay produce hyperkalemia or accelerate kidney dis-ease progression in this patient population.Regarding Recommendation 2.3.2, abundant pre-clinical evidence supports a role for restricting dietarysalt intake in the control of hypertension and arterialfunction. Dietary salt restriction is a potentially inex-pensive means by which to reduce blood pressure andCV event rates, particularly in high-risk populations. 7 Although some patients with CKD ND may sufferfrom salt-wasting forms of kidney disease, most pa-tients with CKD ND exhibit salt retention. It is worthnoting that the Institute of Medicine recommendslimiting sodium intake to 1,500 mg/d, 8 which repre-sents an adequate intake for adults and is lower thanthe  2-g sodium (  5-g sodium chloride) goal recom-mended by KDIGO. Debate about the lower limit of salt restriction and individualizing the level of intakecontinues, 9 but excess salt intake remains an impor-tant and economical modifiable risk factor for CVevents. While there was an overall lack of high-quality studies to support this practice in the treatmentof CKD ND, the committee considered dietary saltrestriction in the management of CKD ND to be aLevel 1C recommendation.For Recommendation 2.3.3, high-quality random-ized trials involving exercise in CKD ND were lack-ing. However, randomized controlled trials in thegeneralpopulationsupportabeneficialeffectofphysi-cal exercise on blood pressure control. The committeeindicated there were no data to suggest that patientswith CKD ND might respond differently from thegeneral population and concluded that while the evi-dence was uncertain, undertaking an exercise pro-gram should be a Level 1D recommendation.For Recommendation 2.3.4, ethanol ingestion canproduce acute and chronic increases in blood pressurein the general population and should be restricted toreduce blood pressure. However, there may be anindependent effect of red wine polyphenols on bloodpressure since dealcoholized red wine promoted sig-nificant decreases in both systolic and diastolic bloodpressure in men. 10 Because the effects in patients withCKD ND have not been specifically examined, theconclusion that the evidence was 2D was appropriate. Other interventions: cigarette smoking.  The impact of tobacco use on blood pressure in CKD ND has notbeen examined, but as a known CV risk factor even inthe absence of a randomized trial, it is prudent torecommend tobacco cessation in CKD ND. Other interventions: dietary supplementation.  Severalstudies have examined the effect of potassium supple-mentation on blood pressure in the general popula-tion, with some reporting a salient effect while otherssuggested no effect. Given the reduced capacity totolerate dietary potassium intake in CKD ND and inthe absence of definitive studies in this population, weagree it is most appropriate not to recommend potas-sium supplementation in CKD ND to reduce bloodpressure. Similarly, without evidence to support otherelectrolyte or dietary supplements, it is prudent not torecommend them. Blood pressure–lowering agents.  Beyond the use of angiotensin-converting enzyme inhibitors (ACEis) orangiotensin-receptor blockers (ARBs) in the setting of albuminuria or proteinuria, RCT-based evidence doesnot support specific recommendations for antihyper-tensive drug therapy choices for CKD ND. Nor arethere data to support selection of second or thirdagents in a multiagent regimen. The report provides aclinically useful summary of the pharmacology andpractical aspects of medication use in patients withCKD, primarily as an update to the KDOQI 2004guidelineonhypertensionandantihypertensiveagentsin CKD. 2 The report provides a good summary of clinical useof renin-angiotensin-aldosterone system (RAAS)blockers in practice. ForACEis, this includes metabo-lism, pharmacokinetics, and side effects (cough andangioedema). Common concerns, such as an increasein serum creatinine level after initiating ACEi/ARBtherapy and hyperkalemia, are addressed. Greater Am J Kidney Dis. 2013;62(2):201-213204 Taler et al 
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