Table. Major lipid-lowering trials in chronic kidney disease and dialysis populations.
| Trial | Number of patients | Population | Duration | Statin dose (fixed vs titrated) | Treatment– naïve* or treatment-experienced | Relative hazards for cardiovascular events | Absolute risk reduction in cardiovascular events | Changes in LDL |
|---|---|---|---|---|---|---|---|---|
| PREVEND IT 200433 | 864 | CKD (stage 1) | Mean 4 years | Pravastatin 40 mg | Naïve | HR 0.87 (95% CI 0.49–1.57), p=0.647 | 0.8% | LDL reduction 1.0 mmol/L at 4 years |
| AFCAPS/ TexCAPS34 | 304 | CKD (stages 3 and 4) | Mean 5.3 years | Lovastatin 20 mg dose titrated as per LDL levels at 3 months | Naïve | Adjusted HR 0.31 (95% CI 0.13–0.72), p≤0.01 Unadjusted HR 0.41 (95% CI 0.18– 0.91) |
7.7% | LDL reduction 1.1 mmol/L at study end |
| JUPITER 201035 | 3267 | CKD (stages 3 and 4) | Median 1.9 years | Rosuvastatin 20 mg | Naïve | HR 0.55 (95% CI 0.38–0.82), p=0.002 | 1.9% | LDL reduction 1.4 mmol/L at 4 years |
| ALLIANCE 200936 | 579 | CKD (stage 3) | Median 4.5 years | Atorvastatin 10 mg titrated to LDL every 4 weeks vs ‘usual care’, continuation of existing lipid-lowering drugs | Continuation without washout or run-in | HR 0.72 (95% CI 0.54–0.97), p=0.02 | 8.6% | LDL reduction 1.3 mmol/L at study end |
| LIPS substudy 200437 | 310 | CKD | Mean 3.8 years | Fluvastatin 40 mg twice a day | Naïve | HR 0.52 (CI not specified), p=0.004 | 14% | LDL reduction 0.8 mmol/L at 6 weeks |
| AURORA 200938 | 2776 | Dialysis | Median 3.8 years Mean 3.2 years |
Rosuvastatin 10 mg | Naïve | HR 0.96 (95% CI 0.84–1.11), p=0.59 | 0.3% | LDL reduction 1.1 mmol/L at 3 months |
| 4D 200539 | 1255 | Dialysis | Mean and median of 4 years | Atorvastatin 20 mg | Discontinued† with 4-week run-in | HR 0.92 (95% CI 0.77–1.10), p=0.37 | 1.4% | LDL reduction 1.3 mmol/L at 4 weeks‡ |
| SHARP 201132 | 9270 | Mixed | Median 4.9 years | Simvastatin 20 mg plus ezetimibe 10 mg | Discontinued† with 6-week run-in | HR 0.83 (95% CI 0.74–0.94), p=0.0021 | 2.1% | LDL reduction 0.85 mmol/L at study end |
CI confidence interval
CKD chronic kidney disease
HR hazard ratio
LDL low-density lipoprotein
* The statin is newly introduced to a patient who has never previously taken a statin.
† Any patient previously taking a statin at randomisation had their statin discontinued over a run-in period.
‡ Note that LDL levels also fell in the placebo group but more slowly.