Effects of Lowering LDL Cholesterol on Progression of Kidney Disease

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1 Effects of Lowering LDL Cholesterol on Progression of Kidney Disease Richard Haynes, David Lewis, Jonathan Emberson, Christina Reith, Lawrence Agodoa, Alan Cass, Jonathan C. Craig, Dick de Zeeuw, Bo Feldt-Rasmussen, Bengt Fellström, Adeera Levin, David C. Wheeler, Rob Walker, William G. Herrington, Colin Baigent and Martin J. Landray for the SHARP Collaborative Group J Am Soc Nephrol, doi: /ASN

2 Baseline characteristics by treatment allocation, among 6245 patients not on dialysis at randomisation Simvastatin plus ezetimibe (n=3116) (n=3129) Age at randomization (years)* 63 (12) 63 (12) Men 1953 (63%) 1929 (62%) Prior vascular disease* 473 (15%) 459 (15%) Diabetes* 718 (23%) 708 (23%) Current smoker* 383 (12%) 379 (12%) Systolic blood pressure (mm Hg)* 139 (21) 139 (21) Diastolic blood pressure (mm Hg)* 80 (12) 80 (12) Total cholesterol (mmol/l)* 5.01 (1.18) 5.01 (1.15) LDL cholesterol (mmol/l)* 2.87 (0.87) 2.86 (0.85) HDL cholesterol (mmol/l)* 1.14 (0.34) 1.12 (0.34) Triglycerides (mmol/l)* 2.31 (1.63) 2.34 (1.68) Body mass index (kg/m²)* 27.4 (5.5) 27.4 (5.4) Ethnicity # White 2248 (72%) 2235 (71%) Black 62 (2%) 57 (2%) Asian 748 (24%) 774 (25%) Other/not specified 58 (2%) 63 (2%) Co-medication *# Antiplatelet therapy 614 (20%) 617 (20%) Oral anticoagulant therapy 82 (3%) 93 (3%) ACE inhibitor or ARB 1912 (61%) 1902 (61%) Beta blocker 1119 (36%) 1202 (38%) Calcium channel blocker 1388 (45%) 1356 (43%) Diuretic 1397 (45%) 1384 (44%) Erythropoiesis stimulating agent 409 (13%) 359 (11%) Sevelamer 40 (1%) 24 (<1%) Data are n (%), mean (SD), or median (IQR). *Variables updated at 1 year for patients originally allocated simvastatin only who were rerandomised to ezetimibe/simvastatin or placebo. Percentages exclude participants for whom data were not available for that category. #Not a pre-specified category for subgroup analyses.

3 Baseline characteristics by treatment allocation, among 6245 patients not on dialysis at randomisation contd. MDRD-estimated GFR (ml/min/1.73m²)* Simvastatin plus ezetimibe (n=3116) (n=3129) Mean (SD) 26.6 (12.9) 26.6 (13.1) (1%) 44 (1%) 30 to < (37%) 1055 (35%) 15 to < (41%) 1319 (44%) < (20%) 606 (20%) Not available Urinary albumin:creatinine ratio (mg/g) Median (IQR) 217 (44-787) 196 (43-746) < (20%) 562 (20%) 30 to (37%) 1076 (39%) > (43%) 1155 (41%) Not available Renal diagnosis # Glomerulonephritis 528 (18%) 521 (17%) Diabetic nephropathy 445 (15%) 441 (15%) Hypertensive/renovascular 641 (21%) 661 (22%) Cystic kidney disease 329 (11%) 346 (12%) Pyelonephritis 198 (7%) 206 (7%) Other known cause 452 (15%) 434 (15%) Unknown cause 405 (14%) 383 (13%) Not available Data are n (%), mean (SD), or median (IQR). *Variables updated at 1 year for patients originally allocated simvastatin only who were rerandomised to ezetimibe/simvastatin or placebo. Percentages exclude participants for whom data were not available for that category. #Not a pre-specified category for subgroup analyses.

4 Average use of study simvastatin plus ezetimibe or non-study statin among 6245 patients not on dialysis at randomisation, and average change in plasma LDL cholesterol from baseline, by period of follow-up LDL-cholesterol-lowering drug use LDL-cholesterol difference (mmol/l)* Follow-up (months) Simvastatin plus ezetimibe Absolute difference Simvastatin plus ezetimibe Absolute difference % 3% 76% ± % 8% 65% ± % 13% 57% ± 0.07

5 Effect of allocation to simvastatin plus ezetimibe on annual reduction in egfr among 5037 patients not on dialysis at randomisation and with at least 3 follow-up egfrs Qualifying criteria for analysis Number INCLUDED in analysis Number EXCLUDED from analysis Estimated annual rate of change in egfr (ml/min/1.73m²) P- value S/E PBO S/E PBO S/E PBO Difference Main analysis Patients with average deviation from own fitted line <9.0 ml/min/1.73m² (p 99 ) (0.07) (0.07) 0.17 (0.10) 0.10 Sensitivity analyses Patients with average deviation from own fitted line <5.1 ml/min/1.73m² (p 95 ) (0.07) (0.07) 0.17 (0.10) 0.09 Patients with average deviation from own fitted line <3.9 ml/min/1.73m² (p 90 ) (0.07) (0.07) 0.15 (0.10) 0.12 Patients with average deviation from own fitted line <3.3 ml/min/1.73m² (p 85 ) (0.07) (0.07) 0.18 (0.10) 0.07 Number of patients or mean (SE) shown. S/E = simvastatin plus ezetimibe. PBO =. p x is the Xth percentile of the average deviations from individuals' fitted slopes.

6 Effects of allocation to simvastatin plus ezetimibe on renal outcomes among 6245 patients not on dialysis at randomisation Simvastatin plus ezetimibe (n=3116) (n=3129) Risk ratio (95% CI) p value Initiation of dialysis 975 (31.3%) 1016 (32.5%) 0.95 ( ) 0.22 Renal transplantation 265 (8.5%) 242 (7.7%) 1.10 ( ) 0.28 End-stage renal disease 1057 (33.9%) 1084 (34.6%) 0.97 ( ) 0.41 Death 635 (20.4%) 635 (20.3%) 1.01 ( ) 0.93 ESRD or death 1476 (47.4%) 1512 (48.3%) 0.97 ( ) 0.34 Doubling of creatinine 370 (11.9%) 415 (13.3%) 0.89 ( ) 0.11 ESRD or 2 x creatinine 1189 (38.2%) 1257 (40.2%) 0.93 ( ) Simvastatin plus better ezetimibe better

7 Effects of allocation to simvastatin plus ezetimibe on end stage renal disease by baseline egfr, among 6245 patients not on dialysis at randomisation Simvastatin plus ezetimibe better (n=3116) (n=3129) Risk ratio (95% CI) MDRD estimated egfr (ml/min/1.73m 2 2 ) ( c 1 =0.18; p=0.67) 60 2/44 (4.5%) 0/44 (0.0%) ( ) 30 <60 94/1100 (8.5%) 83/1055 (7.9%) 1.08 ( ) 15 <30 454/1246 (36.4%) 489/1319 (37.1%) 0.96 ( ) <15 471/613 (76.8%) 473/606 (78.1%) 0.98 ( ) All patients not on dialysis 1057/3116 (33.9%) 1084/3129 (34.6%) 0.97 ( ) Simvastatin plus better ezetimibe better

8 Effect of allocation to simvastatin plus ezetimibe on rate of change in egfr among 5037 patients not on dialysis at randomisation and with at least 3 follow up egfrs, by baseline (a) egfr and (b) albuminuria Annual rate of change in egfr (±SE) (ml/min/1.73m 2 ) Annual rate of change in egfr (± SE) (ml/min/1.73m2) (a) Baseline MDRD egfr (ml/min/1.73m 2 ) to <30 <15 0 (b) 0 Baseline albuminuria (mg/g) < > =0.04 (0.18) -2 =0.00 (0.18) -2 =0.05 (0.13) -3-4 =0.24 (0.14) =0.30 (0.19) P for trend in across groups = 0.24 Simvastatin plus ezetimibe -3-4 P for trend in across groups = 0.13 Simvastatin plus ezetimibe =0.42 (0.20) Median time to ESRD No. (%) reaching ESRD >6 years ~6 years ~1 year 179 (8%) 943 (37%) 944 (77%) Median time to ESRD No (%) reaching ESRD >6 years >6 years ~4 years 141 (13%) 604 (29%) 1223 (52%)

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