KDOQI-糖尿病及慢性肾脏病

Upd Guid Dise Running date of deline ease g head: Diab P f the K for D betes Guide UBLIC KDOQ Diabete eline Update C REVI QI™ Cli es and e IEW D inical d Chro RAFT Pract onic K 2012 tice Kidneyy ii DISCLAIMER SECTION I: USE OF THE CLINICAL PRACTICE GUIDELINE This Clinical Practice Guideline document is based upon the best information available as of December 2011. It is designed to provide information and assist decisionmaking. It is not intended to define a standard of care, and should not be construed as one, nor should it be interpreted as prescribing an exclusive course of management. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every health-care professional making use of these recommendations is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation. The recommendations for research contained within this document are general and do not imply a specific protocol. SECTION II: DISCLOSURE Kidney Disease Outcomes Quality Initiative™ (KDOQI) makes every effort to avoid any actual or reasonably perceived conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the Work Group. All members of the Work Group are required to complete, sign, and submit a disclosure and attestation form showing all such relationships that might be perceived or actual conflicts of interest. This document is updated annually and information is adjusted accordingly. All reported information will be printed in the final publication and are on file at the National Kidney Foundation (NKF). NOTE: Please do not quote or reproduce any part of this document. iii TABLE OF CONTENTS Disclaimer…………………………………………………………………………………………………………. ii Work Group Membership…………………………………………………………………………………………. iv Reference Keys……………………………………………………………………………………………………. vii Nomenclature and Description for Rating Guideline Recommendations………………………………………… viii Abbreviations and Acronyms……………………………………………………………………………………... ix Executive Summary ………………………………………………………………………………....................... xi Guideline Statements ……...................................................................................................................................... xv Guideline 2: Management of Hypergylcemia and General Diabetes Care in CKD………………………………. 1 Guideline 4: Management of Dyslipidemia in Diabetes and CKD……………………………………………….. 8 Guideline 6: Management of Albuminuria in Normotensive Patients with Diabetes.……………………………. 13 Research Recommendations………………………………………………………………………………………. 17 Work Group Biographic and Disclosure Information…………………………………………………………….. 21 References…………………………………………………………………………………………………………. 26 iv WORK GROUP MEMBERSHIP Work Group Co-Chairs Robert G. Nelson, MD, PhD National Institutes of Health Phoenix, AZ Katherine R. Tuttle, MD, FASN, FACP Providence Medical Research Center University of Washington School of Medicine Spokane, WA Work Group Rudy Bilous, MD The James Cook University Hospital Martin Road Middlesbrough, UK J. Michael Gonzalez-Campoy, MD, PhD, FACE Minnesota Center for Obesity, Metabolism and Endocrinology, PA (MNCOME) Eagan, MN Michael Mauer, MD University of Minnesota Medical School Minneapolis, MN Mark Molitch, MD Northwestern University Chicago, IL Kumar Sharma , MD David Geffen School of Medicine at UCLA La Jolla, CA Liasion Members Judy Fradkin, MD National Institutes of Health Bethesda, MD Andrew Narva, MD National Institutes of Health Bethesda, MD v KDOQI Evidence Review Team University of Minnesota Department of Medicine Minneapolis VA Center for Chronic Disease Outcomes Research. Minneapolis, MA, USA: Timothy Wilt, MD, MPH, Professor of Medicine and Project Director Areef Ishani, MD MS, Chief, Section of Nephrology, Associate Professor of Medicine Yelena Slinin, MD, MS, Assistant Professor of Medicine Patrick M. Fitzgerald, Project Coordinator Maureen Carlyle, MPH, PIVOT Coordinator NKF-KDOQI™ Guideline Development Staff Kerry Willis, PhD, Senior Vice-President for Scientific Activities Emily Howell, MA, Commununications Director Michael Cheung, MA, Guideline Development Director Sean Slifer, BA, Guideline Development Manager vi KDOQI™ LEADERSHIP Michael Rocco, MD KDOQI™ Chair Jeffrey Berns, MD Vice Chair, Guidelines and Commentary Joseph Nally, MD Vice Chair, Public Policy Holly Kramer, MD Vice Chair, Research Michael J. Choi, MD Vice Chair, Education vii REFERENCE KEYS CURRENT CKD NOMENCLATURE USED BY KDOQI CKD Categories Definition CKD CKD of any stage (1–5), with or without a kidney transplant, including both non–dialysis dependent CKD (CKD 1–5ND) and dialysis-dependent CKD (CKD 5D) CKD ND Non–dialysis-dependent CKD of any stage (1–5), with or without a kidney transplant (i.e., CKD excluding CKD 5D) CKD T Non–dialysis-dependent CKD of any stage (1–5) with a kidney transplant Specific CKD Stages CKD 1, 2, 3, 4 Specific stages of CKD, CKD ND, or CKD T CKD 3-4, etc. Range of specific stages (e.g., both CKD 3 and CKD 4) CKD 5D Dialysis-dependent CKD 5 CKD 5HD Hemodialysis-dependent CKD 5 CKD 5PD Peritoneal dialysis–dependent CKD 5 viii NOMENCLATURE AND DESCRIPTION FOR RATING GUIDELINE RECOMMENDATIONS Within each recommendation, the strength of recommendation is indicated as Level 1, Level 2, or Not Graded, and the quality of the supporting evidence is shown as A, B, C, or D. Grade Implications Patients Clinicians Policy Level 1 “We recommend” Most people in your situation would want the recommended course of action and only a small proportion would not. Most patients should receive the recommended course of action. The recommendation can be evaluated as a candidate for developing a policy or a performance measure. Level 2 “We suggest” The majority of people in your situation would want the recommended course of action, but many would not. Different choices will be appropriate for different patients. Each patient needs help to arrive at a management decision consistent with her or his values and preferences. The recommendation is likely to require a substantial debate and involvement of stakeholders before policy can be determined. * The additional category “Not Graded” was used, typically, to provide guidance based on common sense or where the topic does not allow 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 declarative statements, but are not meant to be interpreted as being stronger recommendations than Level 1 or 2 recommendations. Grade Quality of evidence 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 substantially different. 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. ix ABBREVIATIONS AND ACRONYMS 4D Deutsche Diabetes Dialyse Studie 4S Scandinavian Simvastatin Survival Study ACCORD Action to Control Cardiovascular Risk in Diabetes ACE Angiotensin-converting enzyme ADA American Diabetes Association AdDIT Adolescent type 1 diabetes mellitus cardio-renal Intervention Trial ADVANCE Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation ALERT Assessment of Lescol in Renal Transplant trial ALTITUDE Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints ARB Angiotensin receptor blocker AURORA A study to evaluate the use of Rosuvastatin in subjects on regular hemodialysis: an assessment of survival and cardiovascular events AVOID Aliskiren in the Evaluation of Proteinuria in Diabetes BP Blood pressure CARDS Collaborative Atorvastatin Diabetes Study CARE Cholesterol and Recurrent Events CI Confidence interval CKD Chronic kidney disease CVD Cardiovascular disease DAIS Diabetes Atherosclerosis Intervention Study DCCT The Diabetes Control and Complications Trial DKD Diabetic kidney disease DM Diabetes mellitus DPP-4 Dipeptidyl peptidase-4 EDIC Epidemiology of Diabetes Interventions and Complications eGFR Estimated glomerular filtration rate ESKD End-stage kidney disease FDA Food and Drug Administration FIELD Fenofibrate Intervention and Event Lowering in Diabetes GBM Glomerular basement membrane GFR Glomerular filtration rate GLP-1 Glucagon-like-peptide-1 GlycoHb Glycohemoglobin HbA1c Hemoglobin A1c HDL-C High-density lipoprotein cholesterol HOPE Heart Outcomes Prevention Evaluation HPS Heart Protection Study HR Hazard ratio JNC Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure KDIGO Kidney Disease: Improving Global Outcomes KDOQI™ Kidney Disease Outcomes Quality Initiative™ KQ Key question LDL-C Low-density lipoprotein cholesterol LIPID Long-term Intervention with Pravastatin in Ischemic Disease LPD Lower-protein diet LVH Left ventricular hypertrophy MICROHOPE Microalbuminuria, Cardiovascular, and Renal Outcomes in Heart Outcomes Prevention Evaluation NHANES III Third National Health and Nutrition Examination Survey NIH National Institutes of Health NKF National Kidney Foundation NPH Neutral Protamine Hagedorn RAS Renin-angiotensin system RR Relative risk SCr Serum creatinine x SHARP Study of Heart and Renal Protection TBM Tubular basement membrane TNT Treating to New Targets UKPDS UK Prospective Diabetes Study USRDS United States Renal Data System VADT Veternans Affairs Diabetes Trial VA-HIT Veterans’ Affairs High-Density Lipoprotein Intervention Trial vs Versus WOSCOPS West of Scotland Coronary Prevention Study xi EXECUTIVE SUMMARY INTRODUCTION Chronic kidney disease (CKD) is a worldwide public health problem that affects millions of people from all racial and ethnic groups. Diabetes is the leading cause of CKD, and the rapidly increasing prevalence of diabetes worldwide virtually assures that the proportion of CKD attributable to diabetes will continue to rise. Indeed, a recent report from the National Health and Nutrition Education Survey (NHANES) found that prevalence of diabetic kidney disease (DKD) increased steadily from 1988 through 2008, and the latest United States Renal Data System (USRDS) report indicates a ~30% increase in incidence of end stage kidney disease (ESKD) in persons with diabetes in the USA between 1992 and 2008 (1, 2). In 1997, as part of an effort to address the growing problem of CKD, the National Kidney Foundation (NKF) established the Kidney Disease Outcomes Quality Initiative (KDOQI™) to develop clinical practice guidelines for the management of all stages of CKD (3). By 2007, with the publication of the KDOQI™ Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease (4), the KDOQI™ reached its primary goal of producing evidence-based guidelines on the aspects of CKD most likely to improve care for patients (5). To ensure that practitioners and patients benefit from the latest knowledge, an essential part of KDOQI™ activities is to provide regular updates of these guidelines. Since publication of the diabetes guidelines in 2007, several large well-designed clinical trials have addressed management issues relevant to patients with diabetes and CKD. Findings from these trials suggest that the existing guideline recommendations for the management of hyperglycemia, hypertension, hyperlipidemia, and albuminuria may no longer accurately reflect current medical knowledge. To properly incorporate the new findings from these clinical trials and other recent studies into a guideline update, a systematic review of the new evidence was warranted to formally determine their applicability and methodologic quality. This report describes updates of guidelines for the management of hyperglycemia, hyperlipidemia and albuminuria in patients with diabetes and kidney disease as a result of this systematic review. An update of the guideline for management of blood pressure is presently underway by Kidney Disease: Improving Global Outcomes (KDIGO), a sister organization managed by the NKF, but organized as an independent not-for-profit foundation governed by its own international board of directors. KDIGO was established to improve international cooperation in the development, dissemination, and implementation of clinical practice guidelines (6). KDOQI™ and KDIGO work in concert to expand the scope of guidelines relevant to the care of patients with CKD and improve the care of these patients worldwide (5). METHODS The guideline update effort was a voluntary and multidisciplinary undertaking that included input from NKF scientific staff, an evidence review team from the Minneapolis Veterans Administration Center for Chronic Disease Outcomes Research, and a Work Group of experts in relevant disciplines. The approach to the systematic literature review and the comprehensive findings prepared for this update was reported in detail elsewhere (7). Briefly, MEDLINE was searched to identify randomized controlled trials published between January 2003 and October 2010 that related to xii albuminuria, glycemic and lipid management in patients with diabetes. All titles and abstracts were assessed for their appropriateness to address key questions that were developed by the multidisciplinary team and outlined in Figure 1. Study reference lists, reviews, and meta-analyses were evaluated and references to other clinical trials were elicited from members of the Work Group. Data from each study that pertained to study quality, trial characteristics, population characteristics, efficacy outcomes, withdrawals, and adverse events were extracted. Evidence tables were created to address the key questions. Study quality was rated as good, fair or poor according to criteria suggested by the Cochrane Collaboration, and included adequate allocation concealment, method of blinding, use of the intention- to-treat principle for data analysis, reporting of dropouts, and reasons for attrition. KQ 1: In patients with diabetes (type 1 or 2), with or without CKD, does intensive glycemic control (as defined by lower target glycosylated hemoglobin) improve health outcomes compared to controls? KQ 2: What harms result from more intense glycemic control in individuals with diabetes (type 1 or 2)? KQ 3: In patients with diabetes (type 1 or 2) and chronic kidney disease, what evidence is there for specific lipid management targets (defined as goals for total cholesterol, LDL, HDL, triglycerides) that improve health outcomes? KQ 4: Is there evidence for specific lipid altering agent use for patients with diabetes (type 1 or 2) and chronic kidney disease? KQ 5: What harms result from more intense lipid management or use of specific lipid altering agents in individuals with diabetes (type 1 or 2) and CKD? KQ 6: What interventions prevent incident albuminuria and/or progression of albuminuria in patients with diabetes mellitus in whom further reduction in blood pressure is not the specific treatment objective? KQ 7: Is albuminuria a valid surrogate for health outcomes in diabetes? Figure 1. Key questions (KQ) to be addressed by the evidence review. In formulating the guideline statements, separate Recommendation level (1 or 2) grades were assigned for each specific recommendation based on the overall quality of the evidence for a particular intervention and outcome (Tables 1 and 2) (8). The overall quality and strength of evidence was assessed using methodology developed by the Agency for Healthcare Research and Quality and the Effective Health Care Program. Quality of evidence ratings included four categories: 1) high confidence, which indicated that further research was unlikely to change the confidence in the estimate of effect; 2) moderate confidence, which indicated that further research may change the confidence in the estimate of effect; 3) low confidence, which indicated that further research would likely have an important impact on the confidence in the estimate of effect; and 4) insufficient, which indicated that the evidence was unavailable or did not permit a conclusion. The strength of guideline recommendations was determined by a four-tiered letter grade: A) high-quality evidence that the practice improves health outcomes; B) moderate-quality evidence; C) low-quality evidence; and D) very low quality evidence (8). T Outcomes T outcomes significan severity to in the leve and progr these heal Nomencla G moral imp recommen Table 1. Gra Table 2. G s The primary he included ESK nt retinopathy o require the a el of albumin ression to ≥sta lth and interm ature Guideline state perative that c nd” if the stre ade for the st Grade for qu ealth outcome KD and cardi including vis assistance of uria and glom age 4 CKD (7 mediate outcom ements have e clinicians “sh ength of the re trength of re Diseas uality of evide G e examined in iovascular dea sion loss, amp another perso merular filtrati 7). The impac mes was asse evolved since ould” implem ecommendati xiii commendati se Guideline ence in the D Guideline n this review ath, non-fatal putations, and on. Intermedia ion rate, doub ct of treatment ssed in formu e the publicati ment a particu on was strong ion in the Dia Diabetes and was all-cause l cardiovascul d symptomati ate outcomes bling of serum ts described i ulating the gu ion of the orig ular treatment g or moderate abetes and C Chronic Kid e mortality. S lar events, cli ic hypoglycem s examined in m creatinine c in the recent c uideline statem ginal diabetes t was replaced ely strong and Chronic Kidn dney Disease econdary hea inically mia of sufficie ncluded chang concentration clinical trials ments. s guideline. T d by “We d “We sugges ney alth ent ges , on The st” xiv if the strength of the recommendation was weak (8). This change was made to reflect the uncertainties inherent to all research findings and the need to adjust any recommendations to the needs of the individual patient. GUIDELINE STATEMENTS The customary practice of the NKF when the original diabetes guideline was published was to divide the statements into clinical practice guidelines and clinical practice recommendations. The guideline statements were based on a consensus with the Work Group that the strength of the evidence was sufficient to make definitive statements about appropriate clinical practice. When the strength of the evidence was not sufficient to make such statements, the Work Group offered recommendations based on the best available evidence and expert opinion. The original document contained five clinical practice