ࡱ> '` bjbjLULU 8.?.?^,,,,>-LAJ-:----.. .lnnnnnn$hi0..00--9393930--l930l93930|-- `Ψ^,0LD~:l0A~~v 1t.0/"93#/?/...#3...A0000 &d& 2011 Evidence Synthesis and Clinical Recommendations Angiotensin Converting Enzyme Inhibitors (ACEIs) Diabetics with microalbuminuria In type I diabetics with microalbuminuria, there is sufficient evidence to conclude that ACEIs reduce progression from microalbuminuria to macroalbuminuria. Clinical Evidence found one systematic review evaluating the effects of ACEIs vs. placebo on microalbuminuria in type 1 diabetics. Individual patient data from 12 trials (698 patients) were included. The review found that, compared with placebo or controls, angiotensin converting enzyme inhibitors (captopril, lisinopril, enalapril, perindopril, and ramipril) reduced progression to macroalbuminuria in type 1 diabetics with microalbuminuria. Methodology: Good Evidence Reference Clinical Evidence summary for Diabetic Nephropathy; search date November 2009 In normotensive type 1 diabetics with microalbuminuria, there is sufficient evidence to conclude that ACEIs can arrest or cause regression of albumin excretion. Clinical Evidence found one systematic review evaluating the effects of ACEIs on microalbuminuria in type I diabetics. Individual patient data from 12 trials (698 patients) were included. The review found that, compared with placebo or controls, angiotensin converting enzyme inhibitors (captopril, lisinopril, enalapril, perindopril, and ramipril) increased regression to normoalbuminuria in type 1 diabetics with microalbuminuria. Methodology: Good Evidence Reference: Clinical Evidence summary for Diabetic nephropathy; search date November 2009 In type 2 diabetics with microalbuminuria, there is sufficient evidence to conclude that ACEIs reduce progression from microalbuminuria to macroalbuminuria. Clinical Evidence found no systematic reviews evaluating the effects of ACEIs on progression of microalbuminuria to macroalbuminuria in type 2 diabetics. There were 3 relevant randomized controlled trials (4 publications). The first RCT (94 people with type 2 diabetes and with microalbuminuria; reported in 2 publications) found that enalapril 10mg significantly reduced the risk of progression to late nephropathy at 5 years compared with placebo (6/49 [12%] with enalapril v 19/45 [42%] with placebo; ARR 30%, 95% CI 15% to 45%). The second RCT (120 people with type 2 diabetes and microalbuminuria) found that enalapril 10mg daily significantly reduced the risk of progression to late nephropathy at 5 years compared with placebo (4/52 [8%] with enalapril v 12/51 [24%] with placebo; ARR 15.8%, CI not reported; P less than 0.001). The third RCT (4912 people with type 2 diabetes and early nephropathy) found no significant difference in mortality; end-stage renal disease; or incidence of stroke, heart failure, or MI between low-dose ramipril (1.25mg/day) and placebo at a median of 4 years (mortality: 334/2443 [14%] with ramipril v 324/2469 [13%] with placebo; RR 1.04, 95% CI 0.90 to 1.20; end-stage renal disease: 4/2443 [0.2%] with ramipril v 10/2469 [0.4%] with placebo; RR 0.40, 95% CI 0.13 to 1.30; stroke: 89/2443 [4%] with ramipril v 84/2469 [3%] with placebo; RR 1.07, 95% CI 0.80 to 1.44; heart failure: 76/2443 [3%] with ramipril v 91/2469 [4%] with placebo; RR 0.84, 95% CI 0.62 to 1.14; MI: 52/2443 [2.1%] with ramipril v 59/2469 [2.4%] with placebo; RR 0.89, 95% CI 0.61 to 1.29). The dose of ramipril used in this trial is below that typically used in current clinical practice Methodology: Good Evidence Reference: Clinical Evidence summary for Diabetic nephropathy; search date November 2009 Diabetics with macroalbuminuria In type 1 diabetics with macroalbuminuria, there is sufficient evidence to conclude that captopril reduce progression to end-stage renal disease, death, or renal transplantation over 3 years. No RCT has compared angiotensin II receptor blocker (ARB) against ACEI in type I diabetics with advanced nephropathy. Clinical Evidence found 1 RCT of 409 types I diabetics with macroalbuminuria (urine protein excretion e" 500 mg per day). Captopril reduced the risk of a doubling of the serum creatinine as well as the combined endpoint of death, dialysis, and renal transplantation (23/207 [11%] with captopril v 42/202 [21%] with placebo; RR 0/50, [CI 0.19-0.70]). Methodology: Good evidence Reference: Clinical Evidence summary for Diabetic nephropathy; search date November 2009 Clinical Evidence found no direct information from RCTs about the effects of ACE inhibitors versus placebo or angiotensin II receptor blockers in people with type 2 diabetes and late nephropathy. Non-diabetic patients There is fair evidence to conclude that ACEIs decrease progression of nephropathy in non-diabetic patients with chronic kidney disease. Clinical Evidence found one systematic review and two subsequent RCTs. The systematic review identified 11 RCTs of 1860 people (mean serum creatinine 203 mcmol/L, SD 106 mcmol/L, mean proteinuria 1.8g/d SD 2.3 g/d). Fewer people reached ESRD with ACEI compared with the control group (ESRD 70/941 [7%] with ACEI v 106/919 [12%] with controls, RR 0.69, CI 0.51-0.94). There was no significant difference in mortality. Systolic blood pressure was 4.5 mm HG greater in ACEI compared with controls and decline in diastolic blood pressure was 2.3 mmHg greater with ACEI compared with controls. The first subsequent RCT (224 people with serum creatinine 274442 micromol/L and >0.3 g/day proteinuria for at least 3 months; mean GFR 26.3 mL/minute/1.73 m2, standard deviation 5.3 mL/minute/1.73 m2; mean serum creatinine 354 micromol/L, standard deviation 62 micromol/L; mean proteinuria 1.6 g/day, standard deviation 0.7 g/day) found that benazepril 20 mg daily significantly reduced the composite outcome of doubling of serum creatinine, ESRD, or death compared with placebo over 3.4 years (44/107 [41%] with benazepril v 65/108 [60%] with placebo; RR not reported; P = 0.004; analysis was not by intention to treat). This trial was not confounded by blood-pressure-lowering effects: open-label drugs other than ACE inhibitors and angiotensin II receptor antagonists were added as needed to maintain the same target blood pressure (systolic blood pressure <130 mmHg, diastolic blood pressure <80 mmHg) in both arms. The decline in blood pressure was similar in the two groups (absolute numbers presented graphically; P = 0.18). The second subsequent RCT (8280 people, all at least 50 years old with stable coronary artery disease and normal or mildly reduced left ventricular function [ejection fraction >40%] and serum creatinine <177 micromol/L) was a subgroup analysis of the Prevention of Events with ACE inhibition trial (PEACE). It compared trandolapril (target, 4 mg/day) versus placebo with a median follow-up of 4.8 years. [38] The RCT found that trandolapril significantly reduced all-cause mortality compared with placebo (adjusted HR: 0.73, 95% CI 0.54 to 1.00; P = 0.05) in people with a GFR of less than 60 mL/minute/1.73 m2. Similar trends were found for cardiovascular mortality, but not for the composite outcome of cardiovascular death or non-fatal MI, or for the primary composite outcome of cardiovascular death, non-fatal MI, or revascularization. No comparative data were reported for outcomes other than all-cause mortality. Methodology: Fair Evidence Reference: Clinical Evidence Summary on Chronic Renal Failure; search date March 2009. Harms/Risks Spironolactone is associated with an increased risk of hyperkalemia in patients with chronic kidney disease, especially in combination with an ACEI/ARB. One population-based study of 1.3 million patients published after the Randomized Aldactone Evaluation Study associated an abrupt increase in spironolactone prescription rate with rates of hyperkalemia-associated hospitalizations and deaths. Methodology: Insufficient evidence. Cause and effect can only be concluded from randomized controlled trials (RCTs). The above harms data is not from RCTs pre-specifying hyperkalemia as an outcome measure. Harms are rare events requiring many people to show statistically significant differences but when additional studies confirm harms, clinicians and patients should be made aware of the potential harms patients along with a thorough discussion of an agents benefits and potential harms. Reference: Juurlink ND et al. Rates of Hyperkalemia after Publication of the Randomized Aldactone Evaluation Study. NEJM. 351:543, 2004. Angiotensin II Receptor Blockers Diabetics with microalbuminuria Clinical Evidence found no systematic review or RCTs comparing the effects of ARBs with placebo in people with type 1 diabetes and early nephropathy for the outcomes of progression to late nephropathy, all-cause mortality, incidence of end-stage renal disease, or incidence of cardiovascular events (stroke, heart failure, and MI). No clinically important results from RCTs about angiotensin II receptor blockers in people with type 1 diabetes and late nephropathy were found. There is sufficient evidence to conclude that ARBs reduce the progression from microalbuminuria to macroalbuminuria in type 2 diabetics. Clinical Evidence found one RCT of 590 type 2 diabetics with microalbuminuria, given either irbesartan or placebo. Irbesartan 300 mg reduced progression from microalbuminuria to macroalbuminuria over 2 years vs. placebo. However, no significant decrease was observed with irbesartan 150 mg (10/194[5%] with irbesartan 300 mg v 30/201 [15%] with placebo; HR 0.30, 95 % CI 0.14-0.61; p< 0.001; 19/195 [10%] with irbesartan 150 mg vs. 30/201 [15%] with placebo; HR 0.61, 95% CI 0.34-1.08; p=0.08).. One RCT of 250 people with type 2 diabetes and microalbuminuria found to significant change in the glomerular filtration rate, mortality, stroke, heart failure, or MI between an ARB (telmisartan) and ACEI enalapril over 5 years. Methodology: Good Evidence Reference: Clinical Evidence summary for Diabetic nephropathy; search date November 2009. Diabetics with macroalbuminuria There is sufficient evidence to conclude that ARBs reduce progression to end stage renal disease in type 2 diabetics with macroalbuminuria. Clinical evidence found one systematic review comparing angiotensin II receptor antagonists with placebo for end stage renal disease and all cause mortality. Most patients had late nephropathy although it combined RCTs of early and late nephropathy. Angiotensin II receptor antagonists significantly reduced end stage renal disease compared with placebo ( 3 RCTs, 3251 patients; 229/1719 [13%] with angiotensin II receptor antagonists v 195/1532 [12.7%] with placebo; RR 0/78, 95% CI 0.67-0.91) Most people from the review were from two RCTs comparing the effects of ARBs versus placebo in type 2 diabetics with macroalbuminuria, on the outcomes of progression to end stage renal disease, cardiovascular events, and all cause mortality. The first RCT of 1513 people with moderate renal insufficiency (creat 1.3 to 3 mg/dl) and urine albumin/creatinine ratio e" 300 mg/g, showed that losartan reduced progression to end-stage renal disease over 3.4 years versus placebo (147/751 [20%] with losartan v 194/762 [26%] with placebo RR 0.72, 95% CI 0.58-0.89; ARR 2.3/100 person years). The second RCT of 1715 patients with type 2 diabetes, mild-moderate renal insufficiency (creatinine 1to 3 mg/dl), and proteinuria > 900 mg compared irbesartan and placebo. Irbesartan was associated with a significant reduction in the doubling of the serum creatinine. There was no significant difference, however, between the groups in progression to end-stage renal disease or death from any cause over 2.6 years (82/579 [14%] with irbesartan v 113/569 [20%] with placebo; RR 0.77, 95% CI 0.57-1.03; p = 0.07; death from any cause RR 0.92 95% CI 0.69-1.23). Methodology: Fair Evidence Reference: Clinical Evidence summary for Diabetic nephropathy; search date November 2009 Nondiabetics There is insufficient evidence that ACEI and ARBs are comparable in rates of doubling of the serum creatinine, ESRD, or mortality Clinical Evidence found no systematic reviews and 2 RCTs of very low methodologic quality. References: Clinical Evidence summary for Chronic Renal Failure; search date March 2009. Shoda et al. A five-year comparison of the renal protective effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with non-diabetic nephropathy. Internal Med 2006;45:193198. Hou F, Xie D, Zhang X, et al. Renoprotection of Optimal Antiproteinuric Doses (ROAD) Study: A Randomized Controlled Study of Benazepril and Losartan in Chronic Renal Insufficiency. J Am Soc Nephrol 2007;18:18891898. Combination ACEI and ARBs Diabetics There is insufficient evidence to conclude that combination ACEI and ARB in reduce renal outcomes in type I or type II diabetes. Methodology: Insufficient Evidence Reference: Clinical Evidence Summary for Diabetic Nephropathy; search date November 2009, Cochrane Systematic Review Angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists for preventing the progression of diabetic kidney disease 2006 (search date December 2005); CKD 2011 update search Nondiabetics There is insufficient evidence to conclude that compared with ACEIs or with ARBs alone, ACEIs plus ARBs is more effective at reducing disease progression or end-stage renal disease in people with chronic renal failure. The COOPERATE study has been discredited so it is withdrawn from consideration. Nakao et al. Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease (COOPERATE): a randomized controlled trial. Lancet 2003; 361:117-124. A RCT (25620 high vascular risk people mean age 66 yrs old with BMI 28, mean bp 141.8/82.1 compared telmisartan 80 mg + ramipril 10 mg with ramipril 10 mg alone. No specific criteria used for starting HD. 56 month median follow-up. The primary composite endpoint (all dialysis, doubling of the serum creatinine) was higher with telmisartan+ramipril group than with either telmisartan or ramipril alone (telmisartan 1147 [13.4%], ramipril 1150 [13.5%]. Combination 1233 [14.5%] HR 1.09, CI 1.01-1.18, p=0.037). Much of the change was due to acute dialysis in the combination group vs. ramipril alone (combination 28 [33%] combination vs. 13 [15%] ramipril alone, HR 2.19. CI 1.13-4.22, p=0.020). Risk for renal outcomes was higher in low renal risk groups (no microalbuminuria/macroalbuminuria, no diabetes, and no hypertension). Methodology: Insufficient Evidence for therapy, Fair Evidence for harms References: Mann et al. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multi-centre, randomized, double-blind, controlled trial. Lancet 2008; 372: 547-53. Targeted Proteinuria Nondiabetics There is fair evidence that target lowering of proteinuria is more effective than non-targeted lowering of proteinuria in reducing the risk of progression to end-stage renal disease in patients with chronic kidney disease Clinical evidence found one RCT (306 people with creatinine 133442micromol/L; creatinine clearance 2070mL/minute/1.73m 2; non-diabetic kidney disease and at least 1g/day proteinuria for at least 3 months; age 4951 years; mean creatinine 239256 micromol/L; mean  HYPERLINK "http://clinicalevidence.bmj.com/ceweb/conditions/knd/2004/2004_G2.jsp" glomerular filtration rate [GFR] 3031mL/minute/1.73m 2; proportion with diabetes not specified; mean 24-hour urine protein excretion 1.42.1 g/day) comparing low-dose benazepril 10mg daily versus individualized up-titrated benazepril 40mg daily, or losartan 50mg daily versus individualized up-titrated losartan 200mg daily based on 24-hour urine protein with a mean follow-up of 3.7 years. The RCT is known as Renoprotection of Optimal Antiproteinuric Doses (ROAD). It assessed titrated treatment aimed at lowering 24-hour protein by 10% versus fixed low-dose treatment. The titration protocol involved initial doses of benazepril 10mg daily or losartan 50mg daily, with 2-weekly assessment of 24-hour urine for proteinuria and weekly assessment of blood pressure, creatinine, and potassium. In the individualized up-titration group, drug doses were up-titrated to the next level (benazepril 20, 20, 30, 40mg; losartan 50, 100, 150, 200mg) at 4-week intervals. The dose was down-titrated if the 24-hour urine protein did not fall by 10% or more over the past 4-week period, if hyperkalaemia refractory to medical therapy developed, or if systolic blood pressure decreased to less than 120mmHg. People who achieved maximal dose without observing a reduction in 24-hour urine protein of 10% or more resumed initial doses. At the end of up-titration, daily doses in the up-titration benazepril group were 20mg in 43/84 (61%) people, 30mg in 11/84 (16%) people, and 40mg in 6/84 (8%) people; 14/84 (17%) people were off treatment because of intolerance, implying 10 (29%) people were on 10mg; mean daily dose was 20.8mg. At the end of up-titration, daily doses in the up-titration losartan group were 100mg in 48/84 (57%) people, 150mg in 13/84 (14%) people, and 200mg in 12/84 (15%) people; 6/84 (7%) were off treatment because of intolerance, implying 9/84 (11%) people were on 50mg; mean daily dose was 118mg. The RCT found that up-titrated benazepril significantly reduced the risk of the composite outcome of doubling of serum creatinine,  HYPERLINK "http://clinicalevidence.bmj.com/ceweb/conditions/knd/2004/2004_G4.jsp" end-stage renal disease (ESRD), or death (15/84 [18%] with up-titrated benazepril v 26/83 [31%] with non-titrated benazepril; RR 0.51, 95% CI 0.05 to 0.73; P=0.02) compared with non-titrated benazepril. The RCT found that up-titrated losartan significantly reduced the risk of the composite outcome of doubling of serum creatinine, ESRD, or death (13/84 [16%] with up-titration losartan v 26/88 [30%] with non-titrated losartan; RR 0.53, 95% CI 0.05 to 0.74; P=0.02) compared with non-titrated losartan.  HYPERLINK "http://clinicalevidence.bmj.com/ceweb/conditions/knd/2004/2004_I7_COMMENT.jsp" \l "REF52#REF52" [52] The RCT reported similar rates of non-fatal cardiovascular events, MI, heart failure and stroke in each group; up-titrated benazepril; (5/90 [6%] with non-fatal CVD event, 2/90 [2%] with MI, 1/90 [1%] with heart failure, 1/90 [1%] with stroke); up-titrated losartan (4/90 [4%] with non-fatal CVD event, 2/90 [2%] with MI, 1/90 [1%] with heart failure, 1/90 [1%] with stroke); non-titrated benazepril (4/90 [4%] with non-fatal CVD event, 2/90 [2%] with MI, 1/90 [1%] with heart failure, 1/90 [1%] with stroke); non-titrated losartan (5/90 [6%] with non-fatal CVD event, 2/90 [2%] with MI, 2/90 [2%] with heart failure, 1/90 [1%] with stroke). No significance assessments between groups were reported. Methodology: Fair Evidence Reference: Hou F, Xie D, Zhang X, et al. Renoprotection of Optimal Antiproteinuric Doses (ROAD) Study: A Randomized Controlled Study of Benazepril and Losartan in Chronic Renal Insufficiency. J Am Soc Nephrol 2007;18:18891898. Blood Pressure Control There is good evidence that treating blood pressure to lower than standard targets of d" 140-160/90-100 mmHg does not reduce mortality or morbidity. These studies were done in non-diabetic patients with varying levels of proteinuria. Cochrane Database of systematic reviews found seven trials (22,089 subjects) comparing different diastolic BP targets were included. Despite a -4/-3 mmHg greater achieved reduction in systolic/diastolic BP, p< 0.001, attempting to achieve lower targets instead of standard targets did not change total mortality (RR 0.92, 95% CI 0.86-1.15), myocardial infarction (RR 0.90, 95% CI 0.74-1.09), stroke (RR 0.99, 95% CI 0.79-1.25) , congestive heart failure (RR 0.88, 95% CI 0.59-1.32), major cardiovascular events (RR 0.94, 95% CI 0.83-1.07), or end-stage renal disease (RR 1.01, 95% CI 0.81-1.27). Methodology: Good Evidence References: Arguedas JA, Perez MI, Wright JM. Treatment blood pressure targets for hypertension. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD004349. DOI: 10.1002/14651858.CD004349.pub2. There is one RCT in people with type 2 diabetes, early nephropathy, and baseline blood pressure within the normal range, a lower diastolic blood pressure target significantly reduced progression from microalbuminuria to overt albuminuria over 5 years compared with a moderate diastolic blood pressure target (480 people aged 4074 years; P=0.02). The lower diastolic blood pressure target was 10mmHg below baseline diastolic blood pressure and moderate diastolic blood pressure target was 80mmHg to 89mmHg. Methodology: Fair Evidence References: Clinical Evidence summary for Diabetic nephropathy; search date November 2009 Schrier RW, Estacio RO, Esler A, et al. Effects of aggressive blood pressure control in normotensive type 2 diabetic patients on albuminuria, retinopathy and strokes. Kidney Int 2002;61:10861097. Diet There is insufficient evidence to conclude that low protein diets reduce the progression of CKD Cochrane Database of Systematic Reviews (Cochrane) found seven trials which evaluated the effect of low protein diets on the time to dialysis in non diabetics with moderate to severe nephropathy. No quality assessment of the studies was performed. Methodology: Insufficient Evidence regarding efficacy/effectivenessJudgment of CKD Guideline Team. Reference: Fouque D, Laville M. Low protein diets for chronic kidney disease in non diabetic adults. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD001892. DOI: 10.1002/14651858.CD001892.pub3. Cochrane also evaluated 12 studies of modified or restricted protein diets in type 1 or type 2 diabetics. There was no significant benefit noted of a restricted protein diet in diabetics. Actual protein intake in the intervention groups ranged from 0.7 to 1.1 g/kg/day. Methodology: Insufficient Evidence Reference: Robertson LM, Waugh N, Robertson A. Protein restriction for diabetic renal disease. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD002181. DOI: 10.1002/14651858.CD002181.pub2. Edited (no change to conclusions), published in Issue 1, 2009. Clinical Evidence found one small, non-blinded RCT comparing the effects on end stage renal disease of usual protein intake vs. a low protein diet in type 1 diabetics with late nephropathy and no RCTs in type 2 diabetics. Methodology: Insufficient Evidence to draw conclusions regarding efficacy/effectivenessJudgment of CKD Guideline Team. Reference: Clinical Evidence summary for Diabetic nephropathy; search date November 2009 Hansen HP, Tauber-Lassen E, Jensen BR, et al. Effect of dietary protein restriction on prognosis in patients with diabetic nephropathy. Kidney Int 2002;62:220228 There is insufficient evidence that salt restriction reduces progression of diabetic kidney disease Cochrane evaluated 13 studies (254 individuals) including individuals with type 1 and type 2 diabetes. There was no significant change in serum creatinine [-0.52 mcgmol/L (-4.74 to 3.71)] or GFR [-1.92 (-4.49-0.64). Salt restriction reduced CrCl by -6.33 ml/min (-10.47 to -2.19). Blood pressure was reduced with salt restriction in type 1 diabetics by -7.11/-3.13 mm Hg (systolic/diastolic); 95% CI: systolic BP (SBP) -9.13 to -5.10; diastolic BP (DBP) -4.28 to -1.98). 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The mean duration of salt restriction was one week in both type 1 and type 2 diabetes. Methodology: Good Reference: Suckling RJ, He FJ, MacGregor GA. Altered dietary salt intake for preventing and treating diabetic kidney disease. Cochrane Database of Systematic Reviews 2010, Issue 12. Art. No.: CD006763. DOI: 10.1002/14651858.CD006763.pub2. PMID: 21154374 Reducing dietary sodium to less than 2.4 grams per day is recommended as an adjunct to medical therapy in hypertensive patients. Methodology: Insufficient Evidence Reference: CMI Clinical Practice Guideline on Hypertension. May 2009. 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