KDIGO Clinical Practice Guideline for ... - KIDNEY DISEASE

1 Official Journal of the International Society of Nephrology KDIGO Clinical Practice Guideline for Lipid Management in chronic KIDNEY DISEASE volume 3 | issue 3 | november 2013. KDIGO Clinical Practice Guideline for Lipid Management in chronic KIDNEY DISEASE KDIGO gratefully acknowledges the founding sponsor, National KIDNEY Foundation, and the following consortium of sponsors that make our initiatives possible: Abbott, Amgen, Bayer Schering Pharma, Belo Foundation, Bristol-Myers Squibb, Chugai Pharmaceutical, Coca-Cola Company, Dole Food Company, Fresenius Medical Care, Genzyme, Hoffmann-LaRoche, International Society of Nephrology, JC Penney, Kyowa Hakko Kirin, NATCO The Organization for Transplant Professionals, National KIDNEY Foundation (NKF)-Board of Directors, Novartis, Pharmacosmos, PUMC Pharmaceutical, Robert and Jane Cizik Foundation, Shire, Takeda Pharmaceutical, Transwestern Commercial Services, Vifor Pharma, and Wyeth.

2 Sponsorship Statement: KDIGO is supported by a consortium of sponsors and no funding is accepted for the development of specific guidelines . contents & 2013 KDIGO . VOL 3 | ISSUE 3 | NOVEMBER 2013. KDIGO Clinical Practice Guideline for Lipid Management in chronic KIDNEY DISEASE v Tables and Figures vi KDIGO Board Members vii Reference Keys viiii CKD Nomenclature ix Conversion Factors x Abbreviations and Acronyms 259 Notice 260 Foreword 261 Work Group Membership 262 Abstract 263 Summary of Recommendation Statements 266 Introduction: The case for updating and context 268 Chapter 1: Assessment of lipid status in adults with CKD. 271 Chapter 2: Pharmacological cholesterol-lowering treatment in adults 280 Chapter 3: Assessment of lipid status in children with CKD. 282 Chapter 4: Pharmacological cholesterol-lowering treatment in children 284 Chapter 5: Triglyceride-lowering treatment in adults 286 Chapter 6: Triglyceride-lowering treatment in children 287 Methods for Guideline Development 297 Biographic and Disclosure Information 302 Acknowledgments 303 References This journal is a member of, and subscribes to the principles of, the Committee on Publication Ethics (COPE) contents & 2013 KDIGO .

3 TABLES. 269 Table 1. Secondary causes of dyslipidemias 270 Table 2. Examples of situations in which measuring cholesterol level might or might not change the management implied by Recommendation 272 Table 3. Rate of coronary death or non-fatal MI (by age and eGFR). 274 Table 4. Recommended doses of statins in adults with CKD. 281 Table 5. Plasma lipid concentrations for children and adolescents 288 Table 6. Systematic review topics and screening criteria 289 Table 7. Hierarchy of outcomes 289 Table 8. Literature yield for RCTs 290 Table 9. Work products for the Guideline 290 Table 10. Classification of study quality 291 Table 11. GRADE system for grading quality of evidence 293 Table 12. Final grade for overall quality of evidence 293 Table 13. Balance of benefits and harms 293 Table 14. KDIGO nomenclature and description for grading recommendations 293 Table 15.

4 Determinants of strength of recommendation 294 Table 16. The Conference on Guideline Standardization (COGS) checklist for reporting Clinical Practice guidelines FIGURES. 272 Figure 1. Adjusted relation between LDL-C and HR of myocardial infarction by eGFR as a continuous variable 273 Figure 2. Future 10-year coronary risk based on various patient characteristics 292 Figure 3. Grading the quality of CKD subgroups of non-CKD trials Additional information in the form of supplementary materials can be found online at KIDNEY International Supplements (2013) 3, v v & 2013 KDIGO . KDIGO Board Members Garabed Eknoyan, MD. Norbert Lameire, MD, PhD. Founding KDIGO Co-Chairs Kai-Uwe Eckardt, MD. Immediate Past Co-Chair Bertram L Kasiske, MD David C Wheeler, MD, FRCP. KDIGO Co-Chair KDIGO Co-Chair Omar I Abboud, MD, FRCP Michel Jadoul, MD.

5 Sharon Adler, MD, FASN Simon Jenkins, MBE, FRCGP. Rajiv Agarwal, MD Suhnggwon Kim, MD, PhD. Sharon P Andreoli, MD Martin K Kuhlmann, MD. Gavin J Becker, MD, FRACP Nathan W Levin, MD, FACP. Fred Brown, MBA, FACHE Philip K-T Li, MD, FRCP, FACP. Daniel C Cattran, MD, FRCPC Zhi-Hong Liu, MD. Allan J Collins, MD, FACP Pablo Massari, MD. Rosanna Coppo, MD Peter A McCullough, MD, MPH, FACC, FACP. Josef Coresh, MD, PhD Rafique Moosa, MD. Ricardo Correa-Rotter, MD Miguel C Riella, MD. Adrian Covic, MD, PhD Adibul Hasan Rizvi, MBBS, FRCP. Jonathan C Craig, MBChB, MM (Clin Epi), DCH, FRACP, PhD Bernardo Rodriquez-Iturbe, MD. Angel LM de Francisco, MD Robert Schrier, MD. Paul E de Jong, MD, PhD Justin Silver, MD, PhD. Ana Figueiredo, RN, MSc, PhD Marcello Tonelli, MD, SM, FRCPC. Mohammed Benghanem Gharbi, MD Yusuke Tsukamoto, MD.

6 Gordon Guyatt, MD, MSc, BSc, FRCPC Theodor Vogels, MSW. David Harris, MD Angela Yee-Moon Wang, MD, PhD, FRCP. Lai Seong Hooi, MD Christoph Wanner, MD. Enyu Imai, MD, PhD Elena Zakharova, MD, PhD. Lesley A Inker, MD, MS, FRCP. NKF- KDIGO Guideline DEVELOPMENT STAFF. Kerry Willis, PhD, Senior Vice-President for Scientific Activities Michael Cheung, MA, Guideline Development Director Sean Slifer, BA, Guideline Development Manager vi KIDNEY International Supplements (2013) 3, vi & 2013 KDIGO . Reference Keys 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. Implications Grade* Patients Clinicians Policy-makers Level 1 Most people in your situation would want Most patients should receive the The recommendation can be evaluated as a We recommend' the recommended course of action and only recommended course of action.

7 Candidate for developing a policy or a a small proportion would not. performance measure. Level 2 The majority of people in your situation Different choices will be appropriate for The recommendation is likely to require We suggest' would want the recommended course of different patients. Each patient needs help to substantial debate and involvement of action, but many would not. arrive at a management decision consistent stakeholders before policy can be with her or his values and preferences. 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.

8 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. KIDNEY International Supplements (2013) 3, vii vii & 2013 KDIGO . CURRENT chronic KIDNEY DISEASE (CKD) NOMENCLATURE. USED BY KDIGO . CKD is defined as abnormalities of KIDNEY structure or function, present for 43 months, with implications for health.

9 CKD is classified based on Cause, GFR category (G1-G5), and Albuminuria category (A1-A3), abbreviated as CGA. Prognosis of CKD by GFR and albuminuria category Persistent albuminuria categories Description and range A1 A2 A3. Prognosis of CKD by GFR. and Albuminuria Categories: Normal to Moderately Severely mildly KDIGO 2012 increased increased increased <30 mg/g 30-300 mg/g >300 mg/g <3 mg/mmol 3-30 mg/mmol >30 mg/mmol GFR categories (ml/min/ m2). G1 Normal or high 90. Description and range G2 Mildly decreased 60-89. Mildly to moderately G3a 45-59. decreased Moderately to G3b 30-44. severely decreased G4 Severely decreased 15-29. G5 KIDNEY failure <15. Green: low risk (if no other markers of KIDNEY DISEASE , no CKD); Yellow: moderately increased risk;. Orange: high risk; Red, very high risk. viii KIDNEY International Supplements (2013) 3, viii & 2013 KDIGO .

10 CONVERSION FACTORS OF CONVENTIONAL UNITS TO SI UNITS. Parameter Conventional unit Conversion factor SI units Cholesterol (total, HDL-C, LDL-C) mg/dl mmol/l Creatinine (serum, plasma) mg/dl mmol/l Triglycerides (serum) mg/dl mmol/l Abbreviations: HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol. Note: Conventional unit conversion factor SI unit. KIDNEY International Supplements (2013) 3, ix ix & 2013 KDIGO . Abbreviations and Acronyms 4D Die Deutsche Diabetes Dialyse Studie HDL-C High-density lipoprotein cholesterol ACCORD Action to Control Cardiovascular Risk in Diabetes HR Hazard ratio trial IDEAL Incremental Decrease in Endpoints Through AGREE Appraisal of guidelines for Research and Evaluation Aggressive Lipid Lowering trial ALERT Assessment of Lescol in Renal Transplantation trial KDIGO KIDNEY DISEASE : Improving Global Outcomes ALLHAT Antihypertensive and Lipid Lowering Treatment to KDOQI KIDNEY DISEASE Outcomes Quality Initiative Prevent Heart Attack Trial LDL-C Low-density lipoprotein cholesterol ALLIANCE Aggressive Lipid Lowering Initiation Abates New Lp(a) Lipoprotein(a).