KDIGO CLINICAL PRACTICE GUIDELINE FOR LIPID MANAGEMENT IN CHRONIC KIDNEY DISEASE. Supplemental Tables November 2013

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1 KDIGO CLINICAL PRACTICE GUIDELINE FOR LIPID MANAGEMENT IN CHRONIC KIDNEY DISEASE Supplemental Tables November 2013

2 Suppl Table 1: Summary table of RCT examining the effect of exercise in CKD 5HD patients [continuous outcomes] Suppl Table 2: Summary table of RCT examining low vs. moderate protein diet in CKD patients without [categorical outcomes] Suppl Table 3: Summary table of RCT examining low vs. moderate protein diet in CKD patients without [continuous outcomes] Suppl Table 4: Summary table of RCT examining statin therapy vs. lifestyle modification in kidney transplant recipients without [categorical outcomes] Suppl Table 5: Summary table of RCT examining statin therapy vs. lifestyle modification in kidney transplant recipients without [continuous outcomes] Suppl Table 6: Summary table of RCT examining statin therapy vs. usual care in patients with CKD without [categorical outcomes] Suppl Table 7: Summary table of RCT examining statin therapy vs. usual care in patients with CKD without [continuous outcomes] Suppl Table 8: Summary table of RCTs of statins vs. placebo in patients with CKD with a without [categorical outcomes] Suppl Table 9: Summary table of RCTs of statins vs. placebo in various stages of CKD with a without [continuous outcomes] Suppl Table 10: Evidence profile of RCTs examining the effect of statins vs. placebo in patients with CKD with a without Suppl Table 11: Summary table of RCTs of statins vs. placebo in dialysis patients with a without [categorical outcomes] Suppl Table 12: Summary table of RCTs of statins vs. placebo in dialysis patients with a without [continuous outcomes] Suppl Table 13: Evidence profile of RCTs examining the effect of statins vs. placebo in dialysis patients with a without Suppl Table 14: Summary table of RCT examining statin vs. placebo in patients with ADPKD [continuous outcomes] Suppl Table 15: Summary table of RCT examining simvastatin/ezetimibe combination vs. simvastatin/placebo in CKD patients without [categorical outcomes] Suppl Table 16: Summary table of RCT examining simvastatin/ezetimibe combination vs. simvastatin/placebo in CKD patients without [continuous outcomes] Suppl Table 17: Summary table of RCT of statin + ezetimibe vs. placebo in CKD patients [categorical outcomes] Suppl Table 18: Summary table of RCT examining the effect of dose of atorvastatin in CKD patients with [categorical outcomes] Suppl Table 19: Drug interactions Suppl Table 20: Effects of grapefruit juice on statin pharmacokinetics a recommeations Suppl Table 21: Patients on statin + fibrate therapy reporting any adverse event Suppl Table 22: Patients receiving statin + fibrate therapy reporting other iividual adverse events Suppl Table 23: Patients on statin + fibrate therapy reporting treatment related adverse events Suppl Table 24: Patients on statin + fibrate therapy discontinuing due to adverse events Suppl Table 25: Patients on statin + fibrate therapy with increased ALT or AST Suppl Table 26: Patients on statin + fibrate therapy with increased CK Suppl Table 27: Patients on statin + fibrate therapy with increased serum creatinine Suppl Table 28: Patients receiving statin + fibrate therapy reporting rhabdomyolysis Suppl Table 29: Summary table of RCTs of statin vs. placebo in kidney transplant patients [categorical outcomes] Suppl Table 30: Summary table of RCTs of statin vs. placebo in kidney transplant patients [continuous outcomes] Suppl Table 31: Evidence profile of RCTs examining the effect of statins vs. placebo in kidney transplant recipients Suppl Table 32: Summary table of RCTs of statins vs. placebo in children with CKD without [continuous outcomes]

3 Supplemental Table 1: Summary table of RCT examining the effect of exercise in CKD 5HD patients [continuous outcomes] (Units) Lipid levels Author, Year Description No. Analyzed (Enrolled) Control Control GFR or SCr Proteinuria (Control) Results (Lipids) Final (Control) (Control) Net (95% CI) P value Quality Total cholesterol, mmol/l van Vlsteren 2005 The Netherlas 1 3 mo (3 mo) Exercise program Control 53 (60) 43 (43) CKD 5HD 4.6 (4.7) 4.6 (4.6) 0 (-0.1) 0.1 Supplemental Table 2: Summary table of RCT examining low vs. moderate protein diet in CKD patients without [categorical outcomes] Mortality All-cause mortality ESRD Author, Year Cianciaruso 2009 Italy 2 Cianciaruso 2009 Italy 2 4 y (3 y) 4 y (3 y) Description No. Analyzed (Enrolled) Results Control Control GFR Low-protein diet Low-protein diet Moderateprotein diet Moderateprotein diet 212 (212) 212 (212) 211 (211) 211 (211) 16 (17) ml/min/ 1.73 m 2 16 (17) ml/min/ 1.73 m 2 (%) 11 (13) 11 (13) TC LDL HDL Tg 125 (124) 125 (124) Events 23 (11%) [25 (12%)] 42 (20) [41 (19)] RR/OR/HR (95% CI) 1 HR 1.12 (0.64, 1.99) HR 1.00 (0.65, 1.55) P value Quality 1 Adjusted for age, sex, comorbidity score iex, a basal estimated glomerular filtration rate; as well as time-variant covariates including estimated glomerular filtration rate, protein intake, serum phosphate level, therapy with erythropoiesis-stimulating agents, a therapy with angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or both. 3

4 Supplemental Table 3: Summary table of RCT examining low vs. moderate protein diet in CKD patients without [continuous outcomes] Lipid levels LDL, Author, Year Cianciaruso 2009 Italy 2 6 mo (3 y) 1 y (3 y) 2 y (3 y) 2 y (3 y) 3 y (3 y) 3 y (3 y) 4 y (3 y) 4 y (3 y) Description No. Analyzed (Enrolled) Results (Lipids) Control Control GFR Low-protein diet Moderateprotein diet 206 (212) 199 (212) 189 (212) 181 (212) 167 (212) 146 (212) 132 (212) 127 (212) 198 (211) 191 (211) 187 (211) 178 (211) 164 (211) 147 (211) 139 (211) 124 (211) 16 (17) ml/min/ 1.73 m 2 (%) 11 (13) (Control) 125 (124) Final (Control) 118 (122) 118 (120) 116 (115) 111 (123) 110 (121) 118 (124) 112 (121) 113 (111) (Control) -7 (-2) -7 (-4) -9 (-9) -14 (-1) -15 (-3) (3) -12 (-13) Net (95% CI) -5 (-13, 3) -3 (-10, 5) 0 (-7, 7) -13 (-21, -5) -12 (-20, -4) -7 (-15, 1) -10 (-17, 2) 1 (-7, 9) P value Quality (0.07)

5 Supplemental Table 4: Summary table of RCT examining statin therapy vs. lifestyle modification in kidney transplant recipients without [categorical outcomes] CV events Focal cerebellar infarctions Author, Year Nart 2009 Turkey 3 4 y (4 y) Description No. Analyzed (Enrolled) Control Control GFR or SCr Fluvastatin 40 mg NCEP modified Step 1 diet 90 (90) * Results are for adjusted analysis if provided. If unadjusted results are different please annotate. 53 (53) GFR 71.3 (69.7) ml/min SCr 1.32 (1.43) (%) TC LDL HDL Tg 231 (187) 135 (99) () 63 (56) 170 (139) Events 2 (2%) Results RR/OR/HR (95% CI) P value Quality Supplemental Table 5: Summary table of RCT examining statin therapy vs. lifestyle modification in kidney transplant recipients without [continuous outcomes] Lipid levels LDL, HDL, Triglycerides, Total cholesterol, Author, Year Nart 2009 Turkey 3 Description No. Analyzed (Enrolled) Control Control GFR or SCr (%) (Control) 1 y (4 y) 4 y 135 (99.2) (4 y) 1 y (4 y) 4 y NCEP GFR 71.3 (69.7) 63 (56) (4 y) Fluvastatin modified ml/min 1 y 40 mg Step 1 (90) (53) SCr y (4 y) diet (1.43) 170 (139) (4 y) 1 y (4 y) y (187.3) (4 y) Results (Lipids) Final (Control) (96.2) (101.3) 53.2) (49.2) 48.9 (46.1) (143.4) (145.3) (172.7) (177.7) (Control) (-3.0) (+2.1) -9.7 (-6.5) (-9.6) -0.6 (+4.7) -7.3 (+6.6) (-14.6) (-9.6) Net (95% CI) P value Quality < <

6 Supplemental Table 6: Summary table of RCT examining statin therapy vs. usual care in patients with CKD without [categorical outcomes] Composite outcome ESRD or Halving of GFR ESRD or 25% decline in GFR Kidney function ESRD Author, Year ALLHAT (CKD subgp) Rahman 2008 Multi 4 ALLHAT (CKD subgp) Rahman 2008 Multi 4 () () Description No. Analyzed (Enrolled) Control Control GFR or SCr Pravastatin 40 mg/d Pravastatin 40 mg/d Usual care Usual care 779 (779) 779 (779) * Results are for adjusted analysis if provided. If unadjusted results are different please annotate. 778 (778) 778 (778) GFR 50.8 (50.6) ml/min/1.73 m 2 GFR 50.8 (50.6) ml/min/1.73 m 2 (%) 32 (30) TC LDL HDL Tg 226 (224) 226 (224) 147 (145) 147 (145) () 46 (46) 2 46 (46) (164) 165 (164) Events 52 (7) [50 (6)] 156 (20) [154 (20]) 32 (4) [31 (4)] Results RR/OR/HR (95% CI) RR 0.97 (0.66, 1.43) RR 0.98 (0.79, 1.22) RR 1.05 (0.64, 1.73) P value Quality Estimated from graph 3 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 4 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 5 Estimated from graph 6 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 6

7 Supplemental Table 7: Summary table of RCT examining statin therapy vs. usual care in patients with CKD without [continuous outcomes] Lipid levels Total cholesterol, HDL, Author, Year ALLHAT (CKD subgp) Rahman 2008 Multi 4 () Description No. Analyzed (Enrolled) Control Control GFR or SCr Pravastatin 40 mg/d Usual care 779 (779) 778 (778) GFR 50.8 (50.6) ml/min/1.73 m 2 (%) 32 (30) (Control) 226 (224) 46 (46) 9 Results (Lipids) Final (Control) 178 (198) 7 56 (38) 10 (Control) (-26.1) +10 (-8) Net (95% CI) P value Quality Estimated from graph 8 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 9 Estimated from graph 10 Estimated from graph 11 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 7

8 Supplemental Table 8: Summary table of RCTs of statins vs. placebo in patients with CKD with a without [categorical outcomes] CKD with Composite outcomes Coronary heart disease death, nonfatal MI, CABG, or PTCA (primary) Coronary heart disease death, nonfatal MI, CABG, PTCA, or stroke Coronary heart disease death or nonfatal MI Mortality All-cause mortality Author, Year CARE, LIPID, WOSCOPS (CKD subgp) Tonelli 2005 Multi 5 CARE, LIPID, WOSCOPS (CKD subgp) Tonelli 2005 Multi 5 () () Description No. Analyzed (Enrolled) Results Control Control Pravastatin Pravastatin 571 (571) 571 (571) GFR or SCr egfr 58 ml/min/1.73 m 2 SCr 1.3 egfr 58 ml/min/1.73 m 2 SCr 1.3 (%) 100 (100) 100 (100) TC LDL HDL Tg Events RR/OR/HR (95% CI) HR (0.57, 0.98) HR (0.62, 1.03) HR (0.60, 1.18) HR (0.69, 1.39) P value Quality <0.05 (0.06) 12 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 13 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 14 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 15 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 8

9 All cause mortality CV events CABG or PTCA Any stroke Author, Year CARDS (CKD subgp) Colhoun, 2009 UK Irela 6 CARE, LIPID, WOSCOPS (CKD subgp) Tonelli 2005 Multi 5 4 y (4 y) () Description No. Analyzed (Enrolled) Results Control Control Atorvastatin Pravastatin 482 (482) 571 (571) 488 (488) GFR or SCr egfr 53.5 (54.1) ml/min/1. 73 m 2 egfr 58 ml/min/1.73 m 2 SCr 1.3 (%) 100 (100) 100 (100) TC LDL HDL Tg 210 (212) 120 (120) 56 (56) 600 ( 60 0) Events 27 (6%) [30 (6%)] RR/OR/HR (95% CI) HR (0.51, 1.45) HR (0.47, 1.01) HR (0.63,1.97) P value (0.06) Quality Major CV disease Stroke CARDS (CKD subgp) Calhoun, 2009 UK Irela 6 Coronary heart disease Coronary revascularizatio n CKD without Composite outcomes 4 y (4 y) Atorvastatin 482 (482) 488 (488) egfr 53.5 (54.1) ml/min/1. 73 m (100) 210 (212) 120 (120) 56 (56) 600 ( 60 0) 25 (5%) [42 (9%)] 6 (1%) [15 (3%)] 18 (4%) [27 (6%)] 5 (1%) [12 (2%)] HR (0.35, 0.94) HR (0.15, 0.99) HR (0.36, 1.17) HR (0.14, 1.15) (0.07) 16 Adjusted for age, sex a treatment group 17 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 18 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 19 Adjusted for age, sex a treatment group 20 Adjusted for age, sex a treatment group 21 Adjusted for age, sex a treatment group 22 Adjusted for age, sex a treatment group 9

10 Nonfatal MI, nonfatal stroke, hospital stay for unstable angina, arterial revascularizatio n, or confirmed CV death (primary) MI, stroke, or confirmed CV death Nonfatal MI, nonfatal stroke, hospital stay for unstable angina, arterial revascularizatio n, or confirmed CV death a all-cause mortality Nonfatal MI, nonfatal stroke, hospital stay for unstable angina, arterial revascularizatio n, or confirmed CV death a all-cause mortality a venous thromboemboli sm Author, Year JUPITER Ridker 2010 Multi 7 2 y (2 y) Description No. Analyzed (Enrolled) Results Control Control Rosuvastati n 1638 (1638) 1629 (1629) GFR or SCr egfr 56 ml/min/1. 73 m 2 (%) 0 TC LDL HDL Tg Events 40 (2%) [71 (4%)] 24 (2%) [40 (3%)] 64 (4%) [114 (7%)] 69 (4%) [127 (8%)] RR/OR/HR (95% CI) HR 0.55 (0.38, 0.82) HR 0.59 (0.36, 0.99) HR 0.55 (0.41, 0.75) HR 0.53 (0.40, 0.71) P value Quality <

11 Coronary heart disease death, nonfatal MI, CABG, or PTCA (primary) Coronary heart disease death, nonfatal MI, CABG, PTCA, or stroke Coronary heart disease death or nonfatal MI First primary CV event including cardiac death, nonfatal MI, resuscitated cardiac arrest, cardiac revascularizatio n or unstable angina requiring hospitalization Nonfatal MI or cardiac death Author, Year CARE, LIPID, WOSCOPS (CKD subgp) Tonelli 2005 Multi 5 ALLIANCE (CKD subgp) Koren 2009 US 8 Median () () Description No. Analyzed (Enrolled) Results Control Control Pravastain Atorvastatin Usual care 286 (286) 4099 (4099) 293 (293) GFR or SCr egfr 56.5 ml/min/1. 73 m 2 SCr 1.3 egfr 51.3 (51.1) ml/min/1. 73 m 2 (%) 0 30 (26) TC LDL HDL Tg Events (227) 148 (146) 40 (40) 200 (207) 78 (27%) [105 (36%)] 32 (11%) [54 (18%)] RR/OR/HR (95% CI) HR (0.68, 0.87) HR (0.71, 0.90) HR (0.73, 1.00) HR 0.72 (0.54, 0.97) HR 0.55 (0.35, 0.85) P value Quality <0.05 < Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 24 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 25 Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 11

12 CV mortality a hospitalization for CV morbidity (primary) Author, Year PREVEND IT Asselbergs 2004 Netherlas 9 4 y (4 y) Description No. Analyzed (Enrolled) Results Control Control Pravastatin 433 (433) 431 (431) GFR or SCr SCr 91 (90) µmol/l (%) 3 (2) TC LDL HDL Tg 5.8 (5.8) mmol/ L 4.1 (4.0) mmol /L 1.0 (1.0) mm ol/l 1.4 (1.3) mmol /L Events 22 (5%) [25 (6%)] RR/OR/HR (95% CI) HR 0.87 (0.49, 1.57) P value Quality Cardiac death or MI All cause death or MI Unstable angina, fatal a nonfatal MI, a sudden death Mortality All-cause mortality LIPS (CKD subgp) Lemos 2005 Multi 10 AFCAPS/Te xcaps (CKD subgp) Kerick 2010 US 11 JUPITER Ridker 2010 Multi 7 4 y (4 y) () 2 y (2 y) Fluvastatin Lovastatin Rosuvastati n 150 (150) 145 (145) 1638 (1638) 160 (160) 159 (159) 1629 (1629) SCr 1.33 CrCl <47 ml/min GFR 53 (53) ml/min/1. 73 m 2 SCr 1.4 (1.4) egfr 56 ml/min/1. 73 m 2 Total (2) (220) 151 (151) 39 (39) 177 (168) (5%) [13 (8%)] 7 (5%) [13 (8%)] 5 (3.4%) 17 (7.5%) 34 (2%) [61 (4%)] RR 0.57 (0.24, 1.40) RR 0.57 (0.24, 1.40) RR 0.32 (0.10, 1.11) HR 0.56 (0.37, 0.85) (0.06) Study graded due to unbalance in baseline characteristics. No info on treatment vs. placebo among the 310 renal impairment patients. Consider downgrading further in EP due to being unable to locate interaction results. 27 Study graded due to unbalance in baseline characteristics. No info on treatment vs. placebo among the 310 renal impairment patients. Consider downgrading further in EP due to being unable to locate interaction results. 28 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 12

13 All-cause mortality Author, Year CARE, LIPID, WOSCOPS (CKD subgp) Tonelli 2005 Multi 5 () Description No. Analyzed (Enrolled) Results Control Control Pravastain 4099 (4099) GFR or SCr egfr 56.5 ml/min/1. 73 m 2 SCr 1.3 (%) 0 TC LDL HDL Tg Events RR/OR/HR (95% CI) HR (0.82, 1.15) P value Quality All-cause mortality All-cause mortality ALLIANCE (CKD subgp) Koren 2009 US 8 PREVEND IT Asselbergs 2005 Netherla 9 s () 4 y (4 y) Atorvastatin Pravastatin Usual care 286 (286) 433 (433) 293 (293) 431 (431) egfr 51.3 (51.1) ml/min/1. 73 m 2 SCr 91 (90) µmol/l 30 (26) 3 (2) 228 (227) 5.8 (5.8) mmol/ L 148 (146) 4.1 (4.0) mmol /L 40 (40) 1.0 (1.0) mm ol/l 200 (207) 1.4 (1.3) mmol /L 47 (16%) [59 (20%)] 6 (1%) [4 (1%)] RR 0.82 (0.58, 1.15) 30 RR 1.49 ( ) 31 All-cause mortality Noncardiac death LIPS (CKD subgp) Lemos 2005 Multi 10 4 y (4 y) Fluvastatin 150 (150) 160 (160) SCr 1.33 CrCl <47 ml/min Total (2%) [3 (2%)] RR 1.07 (0.22, 5.20) Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 30 Calculated by the ERT 32 Study graded due to unbalance in baseline characteristics. No info on treatment vs. placebo among the 310 renal impairment patients. Consider downgrading further in EP due to being unable to locate interaction results. 33 Study graded fair due to unbalance in baseline characteristics. No info on treatment vs. placebo among the 310 renal impairment patients. Consider downgrading further in EP due to being unable to locate interaction results. 13

14 All-cause mortality (primary) Total mortality CV Mortality Death from CHD or nonfatal MI (primary) Total mortality Cardiac death Author, Year 4S (CKD subgp) Chonchol 2007 Scainavia n countries 12 MEGA (CKD subgp) Nakamura 2009 Japan 13 CARE (CKD subgp) Tonelli 2003 US & Canada 14 LIPS (CKD subgp) Lemos 2005 Multi 10 () () () 4 y (4 y) Description No. Analyzed (Enrolled) Results Control Control Simvastatin Pravastatin + NCEP Step 1 Diet Pravastatin Fluvastatin NCEP Step 1 Diet 1143 (1143) 1462 (1462) 844 (844) 150 (150) 1171 (1171) 1516 (1516) 867 (867) 160 (160) GFR or SCr GFR 65.2 (65.2) ml/min) 34 SCr 1.15 (1.14) GFR 52.6 (52.5) ml/min/m 2 CrCl 61.2 (61.3) ml/min 37 Scr 61.2 (61.3) µmol/l SCr 1.33 CrCl CrCl <47 ml/min (%) 5 (4) Total (15) TC LDL HDL Tg 261 (261) 6.3 mmol/ L 209 (209) 189 (189) 4.0 mmol /L 138 (139) 46 (46) 1.5 mm ol/l 41 (41) 131 (134) 1.5 mmol /L 149 (149) Total Events Total 246 (11%) 16 (1%) [34 (2%)] 89 (11%) [126 (15%)] 86 (10%) [111 (13%)] 3 (2%) [3 (2%)] RR/OR/HR (95% CI) HR 0.69 (0.54, 0.89) HR 0.49 (0.27, 0.89) HR (0.55, 0.95) HR (0.61, 1.08) RR 1.07 (0.22, 5.20) P value Quality Mild chronic renal insufficiency is defined as egfr <75 ml/min/1.73m 2 (<1.25 ml/s) or creatinine clearance <75 ml/min (1.25 ml/s) 35 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 36 Study is graded due to the fact that baseline characteristics by intervention were not provided in the CKD subgroup. Consider downgrading again in EP due to not being able to fi interaction results. 37 Mild chronic renal insufficiency is defined as creatinine clearance <75 ml/min 38 Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 39 Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 40 Study graded due to unbalance in baseline characteristics. No info on treatment vs. placebo among the 310 renal impairment patients. Consider downgrading further in EP due to being unable to locate interaction results. 14

15 CV mortality CV mortality Author, Year AFCAPS/Te xcaps (CKD subgp) Kerick 2010 US 11 PREVEND IT Asselbergs 2005 Netherlas 9 () 4 y (4 y) Description No. Analyzed (Enrolled) Results Control Control Lovastatin Pravastatin 145 (145) 433 (433) 159 (159) 431 (431) GFR or SCr GFR 53 (53) ml/min/1. 73m 2 SCr 1.4 (1.4) SCr 91 (90) µmol/l (%) 1 (2) 3 (2) TC LDL HDL Tg 224 (220) 5.8 (5.8) mmol/ L 151 (151) 4.1 (4.0) mmol /L 39 (39) 1.0 (1.0) mm ol/l 177 (168) 1.4 (1.3) mmol /L Events [1 (0.6%)] 4 (1%) [4 (1%)] RR/OR/HR (95% CI) P value Quality CV events MI Stroke Arterial revascularizatio n Venous thromboemboli sm Major coronary event Fatal MI or confirmed nonfatal MI JUPITER Ridker 2010 Multi 7 CARE Tonelli 2003 US & Canada 14 2 y (2 y) () Rosuvastatin Pravastatin 1638 (1638) 844 (844) 1629 (1629) 867 (867) egfr 56 ml/min/1. 73 m 2 CrCl 61.2 (61.3) ml/min 42 Scr 61.2 (61.3) 0 13 (15) (209) 138 (139) 41 (41) 149 (149) 8 (1%) [20 (1%)] 10 (1%) [14 (1%)] 19 (1%) [39 (1%)] 6 (0.3%) [17 (1%)] 171 (20%) [234 (27%)] 65 (8%) [90 (10%)] HR 0.40 (0.17, 0.90) HR 0.71 (0.31, 1.59) HR 0.48 (0.28, 0.83) HR 0.34 (0.14, 0.88) HR (0.59, 0.88) HR (0.52, 1.01) (0.06) 41 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 42 Mild chronic renal insufficiency is defined as creatinine clearance <75 ml/min 43 Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 44 Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 15

16 CABG or PTCA Unstable angina Stroke Major coronary event in subgroup of CKD a proteinuria Major coronary event in subgroup with CrCl >75 ml/min Major coronary event in subgroup with CrCl 75 ml/min Author, Year Description No. Analyzed (Enrolled) Results Control Control 255 (255) 1139 (1139) 844 (844) 268 (268) 1164 (1164) 867 (867) GFR or SCr (%) TC LDL HDL Tg Events µmol/l 105 (12%) [153 (18%)] 133 (16%) [142 (16%)] 29 (3%) [46 (5%)] CrCl >75 ml/min CrCl 75 ml/min Dipstick + 65 (26%) [81 (30%)] 244 (21%) [315 (27%)] 171 (20%) [234 (27%)] RR/OR/HR (95% CI) HR (0.50, 0.83) HR (0.73, 1.18) HR (0.39, 1.00) Unadjusted absolute reduction in cumulative incidence 4.7 Unadjusted absolute reduction in cumulative incidence 5.7 Unadjusted absolute reduction in cumulative incidence 6.7 P value Quality Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 46 Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 47 Adjusted for age; sex; history of HTN; smoking at baseline; ; previous CHF; use of ACEi, CCB, β-adrenergic blockers, a aspirin; proteinuria; SBP a DBP; baseline HDL a LDL, cholesterol levels; baseline Tg; serum albumin levels; BSA; a pravastatin use. 16

17 Major coronary event in subgroup with CrCl ml/min Major coronary event in subgroup with CrCl ml/min Major coronary event in subgroup with CrCl 60 ml/min Major coronary event in subgroup with CrCl 50 ml/min CABG or PTCA Author, Year CARE, LIPID, () Description No. Analyzed (Enrolled) Results Control Control Pravastain 524 (524) 719 (719) 320 (320) 125 (125) 4099 (4099) 518 (518) 736 (736) 349 (349) 131 (131) GFR or SCr CrCl ml/min CrCl ml/min CrCl 60 ml/min CrCl 50 ml/min egfr 56.5 (%) 0 TC LDL HDL Tg Events 103 (20%) [143 (28%)] 140 (20%) [207 (28%)] 68 (21%) [91 (26%)] 31 (25%) [27 (21%)] RR/OR/HR (95% CI) Unadjusted absolute reduction in cumulative incidence 7.9 Unadjusted absolute reduction in cumulative incidence 8.6 Unadjusted absolute reduction in cumulative incidence 4.8 P value Quality -- HR (0.61, 0.86) < Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 17

18 Any stroke Author, Year WOSCOPS (CKD subgp) Tonelli 2005 Multi 5 Description No. Analyzed (Enrolled) Results Control Control GFR or SCr ml/min/1. 73 m 2 SCr 1.3 (%) TC LDL HDL Tg Events RR/OR/HR (95% CI) HR (0.71, 1.30) P value Quality Non-fatal MI Stroke Cardiac death Fatal a non fatal CV events Fatal a non fatal MI Major coronary events ALLIANCE (CKD subgp) Koren 2009 US 8 AFCAPS/Te xcaps (CKD subgp) Kerick 2010 US 11 4S (CKD subgp) Chonchol () () () Atorvastatin Lovastatin Simvastatin Usual care 286 (286) 145 (145) 1143 (1143) 293 (293) 159 (159) 1171 (1171) egfr 51.3 (51.1) ml/min/1. 73 m 2 GFR 53 (53) ml/min/1. 73 m 2 SCr 1.4 (1.4) 30 (26) 1 (2) GFR 65.2 (65.2) ml/min) 55 5 (4) 228 (227) 224 (220) 261 (261) 148 (146) 151 (151) 189 (189) 40 (40) 39 (39) 46 (46) 200 (207) 177 (168) 131 (134) 17 (6%) [29 (10%)] 11 (4%) [12 (4%)] 17 (6%) [27 (9%)] 8 (6%) [21 (13%)] 2 (1%) [6 (4%)] Total (24%) HR 0.54 (0.30, 0.99) RR 0.94 (0.42, 2.09) 50 RR 0.65 (0.36,1.16) 51 RR 0.39 (0.16, 0.93) RR 0.10 (0.01, 1.32) HR 0.67 (0.56, 0.79) (0.08) Hazards ratio have been adjusted for age; SBP; HDL; LDL; triglyceride; an iicator for trial (CARE, LIPID, or WOSCOPS); current smoking status; history of stroke; history of coronary disease; insulin depeence; a baseline use of aspirin, β blockers, ACEi, a CCB 50 Calculated by the ERT 51 Calculated by the ERT 52 Fully adjusted model 53 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 54 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 55 Mild chronic renal insufficiency is defined as egfr <75 ml/min/1.73m 2 (<1.25 ml/s) or creatinine clearance <75 ml/min (1.25 ml/s) 56 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 18

19 Nonfatal MI Author, Year 2007 Scainavia n countries 12 Description No. Analyzed (Enrolled) Results Control Control GFR or SCr SCr 1.15 (1.14) (%) TC LDL HDL Tg Events RR/OR/HR (95% CI) HR 0.65 (0.55, 0.78) P value Quality 57 Coronary revascularizatio n CV events Stroke Kidney function Doubling of SCr 25% MDRDeGFR in patients with mild CKD Acute renal failure in patients with mild CKD PREVEND IT Asselbergs 2005 Netherlas 9 MEGA (CKD subgp) Nakamura 2009 Japan 13 JUPITER Ridker 2010 Multi 7 CARE, LIPID, WOSCOPS (CKD subgp) Tonelli 2005 Multi 15 4 y (4 y) () 2 y (2 y) Median () Pravastatin Pravastatin + NCEP Step 1 Diet Rosuvastati n Pravastain NCEP Step 1 Diet 433 (433) 1462 (1462) 1638 (1638) 6479 (6479) 431 (431) 1516 (1516) 1629 (1629) 6364 (6364) SCr 91 (90) µmol/l GFR 52.6 (52.5) ml/min/m 2 egfr 56 ml/min/1. 73 m 2 egfr 73.8 (73.8) ml/min/1.73 m 2 SCr 1.08 (1.08) 3 (2) Total (6) 5.8 (5.8) mmol /L 6.3 mm ol/l 4.1 (4.0) mmol/ L 4.0 mmol/l 1.0 (1.0) mm ol/l 1.5 mm ol/l 1.4 (1.3) mmol /L 1.5 mmol /L (236) 163 (163) 40 (40) 160 (158) HR 0.62 (0.49, 0.77) 18 (4%) [21 (5%)] 8 (1%) [29 (2%)] 3 (0.2%) (10%) [ (11%)] (0.2%) [ [0.5%)] HR 0.27 (0.12, 0.59) RR 0.94 (0.85, 1.03) RR 0.42 (0.22, 0.78) Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 58 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 59 Study is graded due to the fact that baseline characteristics by intervention were not provided in the CKD subgroup. Consider downgrading again in EP due to not being able to fi interaction results. 19

20 egfr 60 ml/min/1.73m 2 in patients with mild CKD 25% CGeGFR in patients with mild CKD egfr 25% GFR 25% Author, Year AFCAPS/Te xcaps (CKD subgp) Kerick 2010 US 11 4S (CKD subgp) Huskey 2009 Scainavia n countries 16 () 6 y (6 y) Description No. Analyzed (Enrolled) Results Control Control Lovastatin Simvastatin <6479 (<6479) 145 (145) 199 (199) <6364 (<6364) 159 (159) 210 (210) GFR or SCr GFR 53 (53) ml/min/1. 73 m 2 SCr 1.4 (1.4) GFR 55 (55) ml/min/1. 73 m 261 (%) 6 (6) 1 (2) 4 (1) TC LDL HDL Tg 224 (220) 265 (265 ) 151 (151) 192 (191) 39 (39) 47 (48) 177 (168) 133 (134) Events (27%) [ [29%)] (9%) [ (10%)] 4% [3%] 5 (3%) [13 (6%)] RR/OR/HR (95% CI) RR 0.95 (0.90, 1.00) RR 0.88 (0.78, 0.91) P value (0.06) Quality OR 0.21 (0.05, 0.94) Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 61 Mild chronic renal insufficiency is defined as egfr <60 ml/min/1.73m 2 62 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 20

21 Supplemental Table 9: Summary table of RCTs of statins vs. placebo in various stages of CKD with a without [continuous outcomes] (Units) CKD without Lipid levels Median LDL, Median HDL, Median Triglycerides, LDL, Total cholesterol, % Total cholesterol, LDL, % HDL, % Triglycerides, Total cholesterol, mmol/l LDL cholesterol, mmol/l Author, Year JUPITER Ridker 2010 Multi 7 CARE Tonelli US & Canada ALLIANCE (CKD subgp) Koren 2009 US 8 PREVEND IT Asselbergs 2004 Netherlas 9 2 y (2 y) () () 4 y (4 y) Description No. Analyzed (Enrolled) Results (Lipids) Control Control Rosuvastati n Pravastatin Atorvastatin Pravastatin Usual care 1638 (1638) 345 (345) 271 (286) 376 (433) 375 (433) 1629 (1629) 345 (345) 158 (293) 21 GFR or SCr egfr 56 ml/min/1.73 m 2 GFR 53.2 (52.5) ml/min/ 1.73 m 2 SCr 1.4 (1.4) egfr 51.3 (51.1) ml/min/ 1.73 m (431) SCr (431) (90) µmol/l 63 Estimated from figure 64 Estimated from figure 65 Estimated from figure 66 Results of in total cholesterol from baseline to 3 months, 1 year, 2 years a 3 years was also statistically significant. 67 Results of in LDL from baseline to 3 months, 1 year, 2 years a 3 years was also statistically significant. (%) 0 14 (17) 30 (26) 3 (2) (Control) 189 (189) 49 (49) 130 (130) (138.7) (209.9) (227.0) (146.0) 40.2 (40.3) (207.3) 5.8 (5.8) mmol/l 4.1 (4.0) mmol/l Final (Control) 55 (108) 53 (50) 99 (129) 92.2 (106.1) 4.8 (5.6) mmol/l 3.1 (3.9) mmol/l (Control) -134 (-81) 4 (1) -31 (-1) -41 () -41 () -24 (-15) (-24.2) +4 (+8) 64-8 (-4) 65-1 (-0.2) -1 (-0.1) Net (95% CI) P value Quality -53 < < < < <

22 (Units) Total cholesterol, HDL, LDL, Triglycerides, Total cholesterol, HDL, LDL, Triglycerides, Author, Year AFCAPS/Tex CAPS (CKD subgp) Kerick 2010 US 11 4S (CKD subgp) Chonchol 2007 Scainavian countries 12 () () Description No. Analyzed (Enrolled) Results (Lipids) Control Control Lovastatin Simvastatin 145 (145) 1143 (1143) 159 (159) 1171 (1171) GFR or SCr GFR 53 (53) ml/min/ 1.73 m 2 SCr 1.4 (1.4) GFR 65.2 (65.2) ml/min) 72 SCr 1.15 (1.14) (%) 1 (2) 5 (4) (Control) 224 (220) 39 (39) 151 (151) 177 (168) 261 (261) 46 (46) 189 (189) 131 (134) Final (Control) 233 (261) 52 (43) 151 (186) 115 (136) (Control) -20% (+1.5%) +7.4% (+1.1%) -27% (+1.9%) -15% (+4.2%) -28% (0%) +6% (-3%) -38% (+2%) -16% (+2%) Net (95% CI) P value Quality -18.5% % % % 71-28% 73 +3% 74-36% 75-14% Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 69 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 70 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 71 Study is graded, however consider downgrading in EP due to the fact that for all clinical events, the effects of lovastatin did not differ significantly between subgroups with a without CKD(P>0.1) for all interaction tests. 72 Mild chronic renal insufficiency is defined as egfr <75 ml/min/1.73m 2 (<1.25 ml/s) or creatinine clearance <75 ml/min (1.25 ml/s) 73 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 74 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 75 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 76 Study is graded however consider downgrading in EP due to inconsistency in interaction test results (P=0.05 for total mortality a P=0.84 for major coronary events). 22

23 Supplemental Table 10: Evidence profile of RCTs examining the effect of statins vs. placebo in patients with CKD with a without Composite outcomes Mortality CV mortality CV events ESRD Kidney function (categorical) Lipid levels (continuous) Adverse events Total Non Non # of studies a study design MA of 3 RCTs (High) MA of 3 RCTs + 5 RCTs (High) MA of 3 RCTs + 1 RCT (High) MA of 3 RCTs + 6 RCTs (High) Total N (treatment) 571 () 9423 ( ) 1541 (482 + ) ( ) Methodological quality of studies per outcome Some limitations (-1) No limitations No limitations No limitations Consistency across studies NA No important inconsistencies No important inconsistencies Important inconsistencies (-1) Directness of the evidence generalizability/ applicability Uncertainty about directness (-1) Uncertainty about directness (-1) Uncertainty about directness (-1) Uncertainty about directness (-1) 23 Other considerations None None None None Quality of evidence for outcome Low Moderate Moderate 0 RCTs Important Uncertainty about Non 4 RCTs 3186 No limitations None inconsistencies directness Low (High) (1572) (-1) (-1) Non MA of 3 RCTs + 1 RCT (High) MA of 3 RCTs + 7 RCTs (High) 1541 (482 + ) ( ) No limitations No limitations No important inconsistencies No important inconsistencies Uncertainty about directness (-1) Uncertainty about directness (-1) 0 RCTs Non 0 RCTs None None Low Moderate Moderate 0 RCTs Non MA of 3 RCTs + 3 RCTs (High) (9405) Some limitations (-1) No important inconsistencies Uncertainty about directness (-1) 0 RCTs No important Uncertainty about Non 6 RCTs 7762 No limitations None inconsistencies directness Moderate (High) (3918) (-1) MA of 3 RCTs + 8 RCTs (High) MA of 3 RCTs + 8 RCTs (High) ( ) ( ) None Low Summary of fiings Qualitative description of effect Possible benefit from statins in patients with Benefit from statins in patients without No difference in patients with Possible benefit from statins in patients without Possible benefit from statins in patients without Possible benefit from statins for patients with Benefit from statins in patients without Importance of outcome Critical Critical Critical Critical -- Critical Possible benefit from statins in patients without Benefit from statins in patients without No difference High Moderate Moderate

24 # of studies a study design Total N (treatment) Methodological quality of studies per outcome Balance of potential benefits a harms: Possible benefit Consistency across studies Directness of the evidence generalizability/ applicability Other considerations Quality of evidence for outcome Summary of fiings Qualitative description of effect Quality of overall evidence: Low Importance of outcome 24

25 Supplemental Table 11: Summary table of RCTs of statins vs. placebo in dialysis patients with a without [categorical outcomes] Dialysis with Composite outcomes Composite of cardiac death, nonfatal MI, or stroke (primary) Composite of cardiac death, nonfatal MI, or stroke for CRP quartile 1 ( 2.3 mg/l) Composite of cardiac death, nonfatal MI, or stroke for CRP quartile 2 (>2.3-5 mg/l) Composite of cardiac death, nonfatal MI, or stroke for CRP quartile 3 (> mg/l) Composite of cardiac death, nonfatal MI, or stroke for CRP quartile 4 (>12.4 mg/l) Primary outcome in 2 a 3 rd CRP quartiles combined Author, Year 4D Wanner 2005 Germany 18 4D Krane 2008 Germany 19 4 y (2 y) 4 y (2 y) Description No. Analyzed (Enrolled) Results Control Control Atorvastatin 619 (619) 316 (316) 310 (310) 312 (312) 311 (311) 622 (622) 636 (636) GFR or SCr CKD 5HD (%) 100 (100) TC LDL HDL Tg 218 (220) 125 (127) (36) 261 (267) Events 226 (37%) [243 (38%)] 60 [50] 50 [56] 52 [78] 62 [57] RR/OR/HR (95% CI) RR 0.92 (0.77, 1.10) HR 1.19 (0.81,1.76) HR 0.75 (0.50, 1.10) HR 0.79 (0.55, 1.13) HR 1.06 (0.73, 1.54) HR 0.85 (0.65, 1.10) P value Quality 25

26 Major CV event, defined as nonfatal MI, nonfatal stroke, or death from CV causes Composite cardiac epoint of cardiac death or nonfatal MI Cardiac death, nonfatal MA, fatal or nonfatal stroke Mortality Death from all causes Death from causes other than CV or cerebrovascula r disease All-cause mortality for CRP quartile 1 ( 2.3 mg/l) All-cause mortality for CRP quartile 2 (>2.3-5 mg/l) All-cause mortality for CRP quartile 3 (> mg/l) Author, Year AURORA Fellstrom subgp with 2009 Multi 20 AURORA Holdaas subgp with Multi 4D Wanner 2005 Germany 18 4D Krane 2008 Germany 19 Median 4 y (2 y) 3 y (2 y) 4 y (2 y) 4 y (2 y) Description No. Analyzed (Enrolled) Results Control Control Rosuvastati n Rosuvastati n Atorvastatin 388 (388) 388 ( (619) 316 (316) 310 (310) 312 (312) 343 (343) 343 (343) 636 (636) GFR or SCr CKD 5HD (%) 100 (100) CKD 5HD 100% CKD 5HD 100 (100) TC LDL HDL Tg 4.49 (4.35) mmol /L 218 (220) 2.51 (2.43) mmol /L 125 (127) (1.08) mmol /L 36 (36) 1.90 (1.85) mmol /L 261 (267) Events 135 (13%) [136 (15%)] 85 (22%) [104 (30%)] Risk reduction 16.2% for 297 (48) [320 (50%)] 149 (24%) [158 (25%)] 64 [55] 67 [77] 63 [94] RR/OR/HR (95% CI) RR 0.88 (0.73, 1.06) 77 HR 0.68 (0.51, 0.90) HR (0.654, 1.074) RR 0.93 (0.79, 1.08) RR 0.95 (0.76, 1.18) HR 1.07 (0.74, 1.55) HR 0.73 (0.53, 1.02) HR 0.79 (0.57, 1.11) P value Quality (0.067) 77 Calculated by ERT 26

27 All-cause mortality for CRP quartile 4 (>12.4 mg/l) All-cause mortality in 2 a 3 rd CRP quartiles combined Death from any cause CV Mortality Cardiac mortality Deaths attributable to cardiac disease Fatal cardiac events CV events Nonfatal MI Fatal stroke Nonfatal stroke All cardiac events combined All cerebrovascula r events combined Stroke Author, Year AURORA Holdaas subgp with Multi 4D Wanner 2005 Germany 18 AURORA Holdaas subgp with Multi 4D Wanner 2005 Germany 18 3 y (2 y) 4 y (2 y) 3 y (2 y) 4 y (2 y) Description No. Analyzed (Enrolled) Results Control Control Rosuvastati n Atorvastatin Rosuvastati n Atorvastatin 388 (388) 619 (619) 388 (388) 619 (619) 311 (311) 622 (622) 343 (343) 636 (636) 343 (343) 636 (636) GFR or SCr (%) CKD 5HD 100% CKD 5HD 100 (100) CKD 5HD 100% CKD 5HD 100 (100) TC LDL HDL Tg 4.49 (4.35) mmol /L 218 (220) 4.49 (4.35) mmol /L 218 (220) (2.43) mmol /L 125 (127) 2.51 (2.43) mmol /L 125 (127) 1.11 (1.08) mmol /L 36 (36) 1.11 (1.08) mmol /L 36 (36) 1.90 (1.85) mmol /L 261 (267) 1.90 (1.85) mmol /L 261 (267) Events 101 [91] 130 [171] 219 (56%) [213 (62%)] 121 (20%) [149 (23%)] 35% [47%] 64% [71%] 70 (11%) [79 (12%)] 27 (4%) [13 (2%)] 33 (5%) [32 (5%)] 205 (33%) [246 (39%)] 79 (13%) [70 (11%)] 59 (10%) [44 (7%)] RR/OR/HR (95% CI) HR 1.02 (0.77, 1.37) HR 0.78 (0.62, 0.99) HR 0.86 (0.71, 1.04) RR 0.81 (0.64, 1.03) P value Quality (0.08) RR 0.88 (0.64, 1.21) RR 2.03 (1.05, 3.93) RR 1.04 (0.64, 1.69) RR 0.82 (0.68, 0.99) RR 1.12 (0.81, 1.55) RR 1.33 (0.90, 1.97)

28 Hemorrhagic stroke Stroke Fatal stroke Hemorrhagic strokes Author, Year AURORA Fellstrom subgp with 2009 Multi 20 AURORA Holdaas subgp with Multi Dialysis without Composite outcome Time to CV event defined as a nonfatal MI, nonfatal stroke, or death from CV cause (primary) CV event defined as a nonfatal MI, nonfatal stroke, or death from CV cause (primary) Mortality Time to death from any cause Death from any cause AURORA Fellstrom 2009 Multi 20 AURORA Fellstrom 2009 Multi 20 Median 4 y (2 y) 3 y (2 y) Median 4 y (2 y) Median 4 y (2 y) Description No. Analyzed (Enrolled) Results Control Control Rosuvastati n Rosuvastati n Rosuvastati n Rosuvastati n 388 (388) 388 ( (1391) 1389 (1391) 343 (343) 343 (343) 1384 (1385) 1384 (1385) GFR or SCr CKD 5HD (%) 100 (100) CKD 5HD 100% CKD 5HD CKD 5HD 21 (18) 21 (18) TC LDL HDL Tg 4.49 (4.35) mmol /L 176 (174) 176 (174) 2.51 (2.43) mmol /L 100 (99) 100 (99) 1.11 (1.08) mmol /L 45 (45) 45 (45) 1.90 (1.85) mmol /L 157 (154) 157 (154) Events 12 (4%) [2 (1%)] 38 (10%) [20 (6%)] 18 (5%) [11 (3%)] 12 (3%) [2 (0.6%)] 9.2/100 pt-y [9.5/100 pty] 396 (29%) [408 (29%)] 13.5/100 pty [14.0/100 pty] 636 (46%) [660 (48%)] RR/OR/HR (95% CI) RR 5.30 ( ) 78 HR 1.65 (0.96, 2.83) HR 1.41 (0.67, 2.99) HR 5.21 (1.17, 23.27) P value Quality 0.07 (0.07) HR 0.96 (0.84, 1.11) HR 0.96 (0.86, 1.07) 78 Calculated by ERT 28

29 Time to death from non-cv cause Death from non-cv cause CV mortality Time to CV mortality CV mortality CV events Time to nonfatal MI Nonfatal MI Time to nonfatal stroke Nonfatal stroke Author, Year AURORA Fellstrom 2009 Multi 20 AURORA Fellstrom 2009 Multi 20 Median 4 y (2 y) Median 4 y (2 y) Description No. Analyzed (Enrolled) Results Control Control Rosuvastati n Rosuvastati n 1389 (1391) 1389 (1391) 1384 (1385) 1384 (1385) GFR or SCr CKD 5HD CKD 5HD (%) 21 (18) 21 (18) TC LDL HDL Tg 176 (174) 176 (174) 100 (99) 100 (99) 45 (45) 45 (45) 157 (154) 157 (154) Events 5.5/100 pt-y [6.0/100 pty] 248 (18%) [268 (19%)] 7.2/100 pt-y [7.3/100 pty] 324 (23%) [324 (23%)] 2.1/100 pt-y [2.5/100 pty] 91 (7%) [107 (8%)] 1.2/100 pt-y [1.1/100 pty] 53 (4%) [45 (3%)] RR/OR/HR (95% CI) P value Quality HR 0.92 (0.77, 1.09) HR 1.00 (0.85, 1.16) HR 0.84 (0.64, 1.11) HR 1.17 (0.79, 1.75) 29

30 Supplemental Table 12: Summary table of RCTs of statins vs. placebo in dialysis patients with a without [continuous outcomes] (Units) Dialysis with Lipid levels LDL, LDL, mmo/l Total cholesterol, mmol/l Dialysis without Lipid levels LDL, Total cholesterol, Triglycerides, HDL, LDL, Triglycerides, Author, Year 4D Wanner 2005 Germany 18 AURORA Holdaas subgp with Multi AURORA Fellstrom 2009 Multi 20 4 wk (2 y) (2 y) 3 mo (2 y) Median 4y (2 y) Description No. Analyzed (Enrolled) Results (Lipids) Control Control GFR or SCr Atorvastatin Rosuvastatin Rosuvastatin 619 (619) 44 (619) 388 ( (1391) 636 (636) 37 (636) 343 (343) 1384 (1385) CKD 5HD (%) 100 (100) CKD 5HD 100 CKD 5HD 21 (18) (Control) 125 (127) 2.51 (2.43) 4.49 (4.35) 100 (99) 176 (174) 157 (154) 45 (45) 147 (145) 165 (164) Final (Control) 72 (120) (92) 1.41 (2.43) 3.29 () 58 (97.1) 129 (173) 131 (155.8) 46.2 (44.6) 98 (135) (165) 82 (Control) -53 (-7) -55 (-35) () -42 (-1.9) -47 (-1) -26 (+1.8) +1.2 (+0.4) (-9.5) (+1) Net (95% CI) P value Quality < < < Estimated from figure 80 Estimated from graph 81 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 82 Estimated from graph 83 Study is graded however consider downgrading in EP due to the fact that there was no significant interaction of baseline egfr a treatment group. 30

31 Supplemental Table 13: Evidence profile of RCTs examining the effect of statins vs. placebo in dialysis patients with a without Composite outcomes Mortality CV mortality CV events ESRD Kidney function (categorical) Lipid levels (continuous) Adverse events Total Non Non Non # of studies a study design 2 RCTs (High) 1 RCT (High 2 RCTs (High) 1 RCT (High 2 RCTs (High) 1 RCT (High 2 RCTs (High) Total N (treatment) 1986 (1007) 2773 (1389) 1986 (1007) 2773 (1389) 1986 (1007) 2773 (1389) 1790 (905) Methodological quality of studies per outcome No limitations No limitations No limitations No limitations No limitations No limitations No limitations Consistency across studies No important inconsistencies NA No important inconsistencies NA No important inconsistencies NA No important inconsistencies Directness of the evidence generalizability/ applicability Direct Direct Direct Direct Direct Direct Direct Other considerations None Sparse (-1) Sparse (-1) Sparse (-1) Sparse (-1) Sparse (-1) None Quality of evidence for outcome High Moderate Moderate Moderate Moderate Moderate Moderate Non 1 RCT 2773 No limitations Direct Sparse NA (High (1389) (-1) Moderate 0 RCTs Non 0 RCTs RCTs Non Non 0 RCTs RCTs (High) 1 RCT (High 1986 (1007) 2773 (1389) Some limitations (-1) No limitations RCTs (2396) RCTs (2396) Balance of potential benefits a harms: No difference No important inconsistencies NA Uncertainty about directness (-1) Uncertainty about directness (-1) None Sparse (-1) Low Low Summary of fiings Qualitative a quantitative description of effect No difference in patients with No difference in patients without No difference in patients with No difference in patients without Possible benefit from statins in patients with No difference in patients without Possible benefit from statins for patients with No difference in patients without Importance of outcome Critical Critical Critical Critical -- Critical -- High Benefit from statins in patients with Benefit from statins in patients without No difference in AEs for patients with a without Quality of overall evidence: Moderate Moderate Moderate 31

32 Supplemental Table 14: Summary table of RCT examining statin vs. placebo in patients with ADPKD [continuous outcomes] Lipid levels Total cholesterol, mmol/l LDL, mmol/l HDL, mmol/l Triglycerides, mmol/l Author, Year Fasset 2010 Australia 22 2 y (2 y) Description No. Analyzed (Enrolled) Control Control GFR or SCr Pravastatin 20 mg/day Control 29 (31) 20 (29) GFR 58.5 (49.9) ml/min/1.73 m 2 (%) (Control) 5.22 (4.91) 3.52 (3.08) 1.08 (1.38) 1.65 (1.19) Results (Lipids) Final (Control) 4.91 (4.95) 2.98 (2.92) 1.29 (1.50) 1.47 (1.30) (Control) (0.04) (-0.16) 0.10 (0.11) (0.11) Net (95% CI) P value Quality

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