Table 2.

Effect of allocation to simvastatin plus ezetimibe on changes in lipid concentrations between baseline and study midpoint (2.5 years), overall and by baseline eGFR

LipidNMean Baseline ValueaMean Absolute Change (SEM) at 2.5 yrbRelative Difference in Percentage Changes (95% CI)P Valuec
Simvastatin Plus EzetimibePlacebo
Triglycerides, mg/dl
 eGFR≥30 ml/min per 1.73 m22043215.6−52.0 (3.6)−24.2 (4.7)−13% (−18% to −8%)0.17
 eGFR<30 ml/min per 1.73 m23265200.3−47.7 (3.1)−19.7 (2.6)−14% (−18% to −10%)
 On dialysis2398205.3−37.1 (4.9)−22.9 (3.9)−7% (−13% to −0.9%)
 All participants7706205.7−45.5 (2.2)−21.9 (2.0)−12% (−14% to −9%)
HDL cholesterol, mg/dl
 eGFR≥30 ml/min per 1.73 m2204343.90.60 (0.25)0.26 (0.29)0.8% (−0.9% to 3%)0.73
 eGFR<30 ml/min per 1.73 m2326443.70.69 (0.23)0.30 (0.23)0.9% (−0.6% to 2%)
 On dialysis239841.70.61 (0.32)0.52 (0.31)0.2% (−2% to 2%)
 All participants770543.10.64 (0.16)0.36 (0.16)0.7% (−0.4% to 1.7%)
LDL cholesterol, mg/dl
 eGFR≥30 ml/min per 1.73 m22043112.4−43.2 (1.1)−5.10 (0.86)−34% (−36% to −31%)<0.001
 eGFR<30 ml/min per 1.73 m23265109.8−42.8 (0.9)−6.12 (0.71)−33% (−36% to −31%)
 On dialysis240099.6−29.0 (1.1)−5.99 (0.85)−23% (−26% to −20%)
 All participants7708107.1−38.6 (0.6)−5.81 (0.46)−31% (−32% to −29%)
Non-HDL cholesterol, mg/dl
 eGFR≥30 ml/min per 1.73 m22043151.0−54.6 (1.4)−7.16 (1.06)−31% (−34% to −29%)<0.001
 eGFR<30 ml/min per 1.73 m23264149.0−54.7 (1.2)−8.15 (0.87)−31% (−33% to −29%)
 On dialysis2398136.9−37.2 (1.4)−7.71 (1.09)−22% (−24% to −19%)
 All participants7705145.5−49.2 (0.8)−7.75 (0.57)−28% (−30% to −27%)
Apo-B, mg/dl
 eGFR≥30 ml/min per 1.73 m2204099.4−29.3 (0.8)−3.16 (0.61)−26% (−28% to −24%)<0.001
 eGFR<30 ml/min per 1.73 m2325897.9−29.2 (0.7)−3.93 (0.52)−26% (−28% to −24%)
 On dialysis240291.8−20.4 (0.8)−4.21 (0.65)−18% (−20% to −15%)
 All participants770296.3−26.4 (0.4)−3.81 (0.34)−23% (−25% to −22%)
TRL cholesterol, mg/dl
 eGFR≥30 ml/min per 1.73 m2204338.5−11.3 (0.5)−2.07 (0.49)−24% (−27% to −21%)0.01
 eGFR<30 ml/min per 1.73 m2326439.2−11.9 (0.4)−2.03 (0.36)−25% (−28% to −22%)
 On dialysis239837.3−8.18 (0.51)−1.72 (0.47)−17% (−21% to −14%)
 All participants770538.4−10.6 (0.3)−1.94 (0.25)−22% (−24% to −21%)
TG/HDLc ratio
 eGFR≥30 ml/min per 1.73 m220432.66−0.68 (0.07)−0.56 (0.21)−5% (−21% to 12%)0.64
 eGFR<30 ml/min per 1.73 m232642.35−0.54 (0.07)−0.20 (0.05)−14% (−22% to −7%)
 On dialysis23962.67−0.44 (0.13)−0.34 (0.10)−4% (−16% to 8%)
 All participants77032.53−0.55 (0.06)−0.34 (0.07)−8% (−15% to −2%)
  • Average adherence to allocated treatment was about 65% in those not on dialysis at randomization (irrespective of baseline eGFR) and about 55% in those on dialysis at randomization. 95% CI, 95% confidence interval; TRL, triglyceride-rich lipoprotein; TRL cholesterol, total cholesterol minus LDL cholesterol minus HDL cholesterol; TG/HDLc, triglyceride to HDL cholesterol ratio.

  • a Simvastatin plus ezetimibe and placebo arms combined.

  • b In patients initially allocated to simvastatin, samples scheduled for collection at 2.5 yr were collected at 1.5 yr after rerandomization.

  • c Test for trend across categories of eGFR.