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Section I

What do the guidelines say and how will they affect day-to-day management of CKD in people with diabetes?. Section I. Objectives and background for this learning resource. Introduction:

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Section I

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  1. What do the guidelines say and how will they affect day-to-day management of CKD in people with diabetes? Section I

  2. Objectives and background for this learning resource Introduction: This learning resource has been developed as part of a medical education initiative supported by Janssen. The content of this slide kit has been developed by an advisory board of renal physicians, GPs and specialist nurses. The panel of experts includes members of the British Renal Society Chronic Kidney Disease (CKD) Strategy Group. Bedrock Healthcare, a medical communications agency, has provided editorial support in developing the content; Janssen has reviewed the content for technical accuracy. Educational objectives: • To provide clear and applicable clinical guidance on chronic kidney disease (CKD) in people with type 2 diabetes to primary care healthcare professionals • To advise primary healthcare professionals on what people with diabetes need to know about their own condition with relation to CKD Usability objectives: • To provide essential, relevant and up to date information in concise presentations • To enable primary healthcare professionals to locate, select and use the content of the learning resource, as appropriate to their needs • To enable secondary care experts in CKD to refer their primary care colleagues to the resource

  3. Contents overview This learning resource comprises the following 10 sections (A-E):

  4. Contents overview (cont.) This learning resource comprises the following 10 sections (F-J):

  5. Section I – 3 key learning objectives • Treatment of people with diabetes and CKD should be informed by the guidelines, but individualised accordingly • An understanding of which guidelines are most appropriate for treating people with diabetes and CKD • Awareness of the Quality and outcomes Framework (QoF)

  6. Relevant Guidelines The guidelines that are most relevant to the treatment of people with diabetes and CKD are listed below

  7. Key aspects covered by the guidelines The key points from each guideline are listed on slides 7-20;they cover the following aspects of diabetes and CKD: • Testing for kidney disease • When to suspect non-diabetic renal disease • Acute kidney injury • Therapeutic interventions • Therapeutic targets • Referral advice • Reviews and monitoring • Auditing

  8. NICE CG87 type 2 diabetes guidelines issued 2009, modified December 2014 (slide 1 of 3) Testing for kidney disease: • First-pass morning urine specimen to be tested once a year for ACR testing1 • Measure serum creatinine and eGFR annually at the time of ACR testing1 • Discuss the significance of finding an abnormal ACR, and its trend over time, with the individual concerned1 eGFR = estimated glomerular filtration rate ACR = albumin creatinine ratio NB: ACR is an important indicator of cardiovascular risk and progression. Reference: 1. NICE clinical guideline 87. The management of type 2 diabetes. Issued: May 2009 last modified: December 2014.

  9. NICE CG87 type 2 diabetes guidelines issued 2009, modified December 2014 (slide 2 of 3) Therapeutic interventions: • Start ACE inhibitors with the usual precautions and titrate to full dose in all individuals with confirmed raised ACR1 • Have an informed discussion before starting an ACE inhibitor in a woman for whom there is a possibility of pregnancy, assessing the relative risks and benefits of the use of the ACE inhibitor1 • Use an ARB instead of an ACE inhibitor for a person with an abnormal ACR if an ACE inhibitor is poorly tolerated1 Therapeutic targets: • For a person with an abnormal ACR, maintain blood pressure below 130/80 mmHg1 Referral advice: • Agree referral criteria for specialist renal care between local diabetes specialists and nephrologists1 Reference: 1. NICE clinical guideline 87. The management of type 2 diabetes. Issued: May 2009 last modified: July 2014.

  10. NICE CG87 type 2 diabetes guidelines issued 2009, modified December 2014 (slide 3 of 3) When to suspect non-diabetic kidney disease: • Suspect renal disease other than diabetic nephropathy and consider further investigation or referral when the ACR is raised and ANY of the following apply:1 • There is no significant or progressive retinopathy1 • Blood pressure is particularly high or resistant to treatment1 • The person previously had a documented normal ACR and develops heavy proteinuria (ACR > 100 mg/mmol)1 • Significant haematuria is present1 • The glomerular filtration rate has worsened rapidly1 • The person is systemically ill1 Reference: 1. NICE clinical guideline 87. The management of type 2 diabetes. Issued: May 2009 last modified: July 2014.

  11. NICE CG182 CKD guidelines issued July 2014 (slide 1 of 4) Testing for kidney disease:1 • Offer testing for CKD to people with any of the following risk factors: • Diabetes • Hypertension • Acute kidney injury • Cardiovascular disease (ischaemic heart disease, chronic heart failure, peripheral vascular disease or cerebral vascular disease) • Structural renal tract disease, recurrent renal calculi or prostatic hypertrophy • Multisystem diseases with potential kidney involvement – e.g. systemic lupus erythematosus • Family history of end-stage kidney disease or hereditary kidney disease • Opportunistic detection of haematuria Reference: 1. NICE clinical guideline 182. Chronic kidney disease early identification and management of chronic kidney disease in adults in primary and secondary care. July 2014.

  12. NICE CG182 CKD guidelines issued July 2014 (slide 2 of 4) Testing for kidney disease: • Initial testing to identify CKD should include eGFR and ACR1 Therapeutic targets: • Blood pressure should be maintained to target • CKD with ACR <70 mg/mmol and no diabetes – target of 120-139/90 mmHg1 • CKD with ACR >70 mg/mmol, or diabetes – target of 120-129/80 mmHg1 Reference: 1. NICE clinical guideline 182. Chronic kidney disease early identification and management of chronic kidney disease in adults in primary and secondary care. July 2014.

  13. NICE CG182 CKD guidelines issued July 2014(slide 3 of 4) Reviews and monitoring: • Agree the frequency of monitoring (eGFRcreatinine and ACR) with the person with, or at risk of, CKD; bear in mind that CKD is not progressive in many people1 • Use the table shown to guide the frequency of GFR monitoring for people with, or at risk of CKD1 • The frequency of monitoring should be tailored to the individual, according to: • The underlying cause of CKD1 • Past patterns of eGFR and ACR1 • Comorbidities1 • Changes to their treatment1 • Intercurrent illness1 • Whether they have chosen conservative management of CKD1 • Increasing risk • Increasing risk Adapted from: NICE clinical guideline 182. Chronic kidney disease early identification and management of chronic kidney disease in adults in primary and secondary care. July 2014. Reference: 1. NICE clinical guideline 182. Chronic kidney disease early identification and management of chronic kidney disease in adults in primary and secondary care. July 2014.

  14. NICE CG182 CKD guidelines issued July 2014(slide 4 of 4) Testing and monitoring for kidney disease: • Creatinine-based eGFR can give a misleading result1 • In certain circumstances a cystatin C test may help to confirm or refute a CKD diagnosis made with a creatinine-based eGFR1 • Consider using cystatin C-based eGFR at initial diagnosis to confirm or rule out CKD in people with: • An eGFR of 45–59 mL/min/1.73m2, sustained for at least 90 days and1 • No proteinuria (ACR less than 3 mg/mmol) or other marker of kidney disease1 • Slide 14 provides a summary of the key differences between creatinine-based eGFR and cystatin C-based eGFR • Do not diagnose CKD in people with: • An eGFR (estimated using serum creatinine) of 45–59 mL/min/1.73m2and1 • An eGFR (estimated using cystatin C) of more than 60 mL/min/1.73m2and1 • No other marker of kidney disease1 Reference: 1. NICE clinical guideline 182. Chronic kidney disease early identification and management of chronic kidney disease in adults in primary and secondary care. July 2014.

  15. A comparison of estimating GFR using cystatin C versus creatinine based tests *Prices are quoted according to 2015 figures Reference: 1. Lewis R. Updated NICE guidelines for the diagnosis and management of chronic kidney disease: what they mean for your practice. Article to be submitted to Primary Care Cardiovascular Journal. 2. Singh D et al. Nephrology Dialysis Transplantation 2007;22:1087–1092.

  16. Acute kidney injury: NICE CG182 CKD guidelines issued July 2014 Acute kidney injury: Guideline 182 recommends: • Monitor people for the development or progression of CKD for at least 2-3 years after acute kidney injury, even if serum creatinine has returned to baseline1 • Advise people who have had acute kidney injury that they are at increased risk of CKD developing or progressing1 • In people with a new finding of reduced GFR, repeat the GFR within 2 weeks to exclude causes of acute deterioration of GFR – for example, acute kidney injury1 Reference: 1. NICE clinical guideline 182. Chronic kidney disease early identification and management of chronic kidney disease in adults in primary and secondary care. July 2014.

  17. NICE CG169 acute kidney injury guidelines issued August 2013 Acute kidney injury: • Investigate for acute kidney injury, by measuring serum creatinine and comparing with baseline, in adults with acute illness if diabetes is likelyor present1 • Before offering iodinated contrast agents to adults for emergency ornon-emergency imaging, assess their risk of acute kidney injury1 • Be aware that increased risk of acute kidney injury is associated with diabetes, but only with chronic kidney disease1 • Adults with an eGFR less than 40 mL/min/1.73m2 are at particular risk1 • Assess the risk of acute kidney injury in adults before surgery1 • Be aware that increased risk is associated with diabetes1 Reference: 1. NICE clinical guideline 169. Prevention, detection and management of acute kidney injury up to the point of renal replacement therapy. August 2013.

  18. UK Renal Association CKD guidelines 5th Edition, 2009-2011 (slide 1 of 2) Therapeutic targets: • For people with CKD and diabetes, the systolic blood pressure should be lowered to <130 mmHg (target range 120-129 mmHg) and diastolic blood pressure should be <80 mmHg, unless the risks are considered to outweigh the potential benefits1 Therapeutic intervention: • Antihypertensive therapy should be individualised and lowering the systolic blood pressure to <120 mmHg should be avoided1 • Patients with diabetes and albuminuria should be treated with an ACE inhibitor (ACEI) or ARB, titrated to maximum licensed antihypertensive dose if tolerated, regardless of the initial blood pressure, unless these drugs are specifically contraindicated1 • People with diabetes and CKD should achieve ‘good glycaemic control’1 Reference: 1. UK Renal Association. Clinical Practice Guidelines. Detection, Monitoring and Care of Patients with CKD. 5th Edition, 2009-2011. Final Version (28.02.2011).

  19. UK Renal Association CKD guidelines 5th Edition, 2009-2011 (slide 2 of 2) Auditing: • Possible audit measures for detection, monitoring and care of CKD include: • Proportion of patients with diabetes and albuminuria (without specific contraindications) who had an ACEI or ARB on their last recorded list of chronic medications1 • Proportion of patients receiving an ACEI or ARB for diabetes and albuminuria who received the maximum licensed antihypertensive dose (or maximum dose tolerated without hypotension) on their most recent prescription1 • Proportion of patients with diabetic kidney disease and follow-up for at least six months, whose last recorded HbA1c was below their agreed target1 • Average HbA1c of all patients with diabetes and CKD1 Screening: There is high quality evidence on the economic case for screening for CKD in patients with diabetes1 Early intervention: As loss of renal function in CKD is generally irreversible, it is assumed that early intervention is of more benefit. The precise stage at which intervention becomes worthwhile is not well-defined except for diabetes1 Reference: 1. UK Renal Association. Clinical Practice Guidelines. Detection, Monitoring and Care of Patients with CKD. 5th Edition, 2009-2011. Final Version (28.02.2011).

  20. ADA/EASD position statement issued 2012, updated 2015 (slide 1 of 2) • In 2012, the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) published a position statement on the management of hyperglycaemia in non-pregnant adult patients with type 2 diabetes1,2 • This was needed because of an increasing array of antihyperglycemic drugs and growing uncertainty regarding their proper selection and sequence3 • The key points from the initial recommendations were as follows: • Glycaemic targets and glucose-lowering therapies must be individualised1 • Diet, exercise and education remain the foundation of any treatment programme1 • Unless there are prevalent contraindications, metformin is the optimal first-line drug1 • After metformin, combination therapy with an additional 1-2 oral or injectable agents is reasonable1 • Many patients will require insulin therapy alone or in combination with other agents1 • All treatment decisions, where possible, should be made in conjunction with the patient1 • Comprehensive cardiovascular risk reduction must be a major focus of therapy1 References: 1. InzucchiSE, et al. Diabetes Care 2012;35:1364–1379. 2. InzucchiSE et al. Diabetologia 2012;55:1577–1596. 3. InzucchiSE et al. Diabetes Care 2015;38:140–149.

  21. ADA/EASD position statement issued 2012, updated 2015 (slide 2 of 2) • In 2015, the position statement was updated and the following information on glucose lowering agents was included: The 2015 update“…there are now more head-to-head trials that show slight variance between agents with regard to glucose-lowering effects.”1 • Key points from the 2015 update: • The major change in treatment options has been the availability of a new class of glucose-lowering drugs, the sodium–glucose co-transporter 2 (SGLT2) inhibitors, which reduce HbA1c by 0.5-1.0% (5.5-11 mmol/mol) vs. placebo1 • While the SGLT2 inhibitors are approved as monotherapy, they are mainly used in combination with metformin and/or other agents; given their demonstrated efficacy and clinical experience to date, they are reasonable options as second-line or third-line agents1 • Earlier concerns that the thiazolidinediones are associated with bladder cancer have largely been allayed by subsequent evidence1 • In patients where glucose control remains poor despite the use of three antihyperglycemic drugs in combination, the effectiveness of combining GLP-1 receptor agonists with basal insulin has been demonstrated1 References: 1. InzucchiSE et al. Diabetes Care 2015;38:140–149.

  22. NICE Quality Standard for Diabetes QS6 (slide 1 of 2) Reference: 1. NICE quality standard 6. Diabetes in adults quality standard. Issued: March 2011.

  23. NICE Quality Standard for Diabetes QS6 (slide 1 of 2) Reference: 1. NICE quality standard 6. Diabetes in adults quality standard. Issued: March 2011.

  24. NICE Quality Standard for CKD QS5 Reference: 1. NICE quality standard 5. Chronic kidney disease. Issued: March 2011 last modified: November 2014.

  25. QOF: CKD indicator for 2015-16 As of April 2015 the QOF in England will include the following indicator: Note: CKD is no longer included in the QOF for Wales Reference: 1. NHS employers. Summary of changes to QOF 2015/16 – England. Available at: http://www.nhsemployers.org/~/media/Employers/Documents/Primary%20care%20contracts/ QOF/QOF% 20Home%20Page/ 2015-16%20Summary%20of%20changes%20to%20QOF.pdf. Website last accessed 15.01.15.

  26. QOF: Diabetes indicators for 2015-16 (slide 1 of 2) Reference: 1. NHS employers. Summary of changes to QOF 2015/16 – England. Available at: http://www.nhsemployers.org/~/media/Employers/Documents/Primary%20care%20contracts/ QOF/QOF% 20Home%20Page/ 2015-16%20Summary%20of%20changes%20to%20QOF.pdf. Website last accessed 15.01.15.

  27. QOF: Diabetes indicators for 2015-16 (slide 2 of 2) Reference: 1. NHS employers. Summary of changes to QOF 2015/16 – England. Available at: http://www.nhsemployers.org/~/media/Employers/Documents/Primary%20care%20contracts/ QOF/QOF% 20Home%20Page/ 2015-16%20Summary%20of%20changes%20to%20QOF.pdf. Website last accessed 15.01.15.

  28. National CKD Audit • The National Chronic Kidney Disease Audit will audit the care of all eligible people over 18 years with CKD1 • This important 3-year project focuses on the diagnosis and management of people with CKD in primary care to: • Improve the identification of CKD patients in primary care1 • Improve the management and outcomes of CKD patients1 • Tailor the care of people with CKD to local care pathways1 • Regular audit reports and Quality Improvement Tools will support in running the audit1 • It was commissioned by the Healthcare Quality Improvement Partnership (HQIP), and funded by NHS England1 • A pilot stage, involving 440 GPpractices. The full auditwill then commence in early 20151 Reference: 1. National Kidney Chronic Kidney Disease Audit. Available at: http://www.ckdaudit.org.uk. Website last accessed 15.01.15

  29. National Diabetes Audit • The following data show the percentages of patients with type 2 diabetes recorded against criteria in the 2012-13 National Diabetes Audit • NICE-recommended care processes • Completion of eight care processes (all care processes except eye screening) = 61.9%1 • Completion was less likely to be achieved by those aged under 40 vs. older people1 • NICE-recommended treatment targets • Glucose control (HbA1c <58mmol/mol) = 64.8%1 • Blood pressure (<140/80) = 68.7%1 • Serum cholesterol <4 mmol/L = 40.5%1 • NICE-recommended structured education* • Offered structured education = 16.7% of newly diagnosed; 6% of all people with type 2 diabetes1 • Attended structured education = 3.6% of newly diagnosed; 1.6% of all people with type 2 diabetes1 NICE-recommended care processes (annual checks)1 • HbA1c • Blood pressure • Cholesterol • Serum creatinine • Urine albumin • Foot surveillance • BMI • Smoking • Eye screening *NICE guidance recommends that people with diabetes be offered patient education programmes, officially known as 'structured education‘1 Reference: 1. Health and Social Care Information Centre, National Diabetes Audit 2012-2013 Report 1: Care Processes and Treatment Targets. Available at: http://www.hqip.org.uk/assets/NCAPOP-Library/NCAPOP-2014-15/NDA-Care-Processes-report-1-Final.pdf Website last accessed on 09.01.15

  30. Summary of guidance, standards and indicators to consider in patients with diabetes and CKD Diabetes CKD NICE CG87 NICE CG182 UK Renal Association Guidelines NICE QS6 NICE CG169 QOF CKD Indicator ADA/EASD Position Statement NICE QS5 National CKD Audit QOF Diabetes Indicators National Diabetes Audit

  31. Section I – summary • ACR and eGFR should be measured annually in people with diabetes • Diabetic kidney disease should be monitored with increasing frequency as disease progresses, in line with NICE guidelines • Early intervention is key to improving prognosis • Blood pressure should be managed with ACE inhibitors or ARBs first line (unless contraindicated) • In people with diabetes and proteinuria, ACE inhibitors and ARBs should be used even if patients are normotensive (unless contraindicated) • Treatment of people with diabetes and CKD should be informed by the guidelines, but individualised accordingly • Agree a referral procedure within your own network/locality • It is important to audit best practice in addition to QOF measures

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