TABLE 5
FROM:
The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease
D Charytan and R E Kuntz
BACK TO ARTICLETable 5. Statin trials
| Trial | Intervention | ESRD excluded | Exclusion creatinine (mg|[sol]|dl) | Other conditions excluded | Renal function reported | All other conditions reported |
|---|---|---|---|---|---|---|
| ALERT11 | Fluvastatin vs placebo | Y | CrCl<20 | N | N | Y |
| ALLHAT-LLT69 | Pravastatin vs placebo | Y | >2.0 | N | N | Y |
| ALLIANCE70 | Atorvastatin vs usual care | Investigator discretion | Investigator discretion | N | N | y |
| AFCAPS|[sol]|TexCAPS71 | Lovastatin vs placebo | Y | Investigator discretion | N | N | Y |
| ASCOT-LLA72 | Atorvastatin vs placebo | Y | >2.2 | N | Y | Y |
| Atorvastatin Comparitive Cholesterol Efficacy73 | Atorvastatin vs fluvastatin vs lovastatin vs pravastatin | Y | >2.0 | N | N | S, D, H |
| A to Z74 | Aggressive vs conservative simvastatin | Y | >2.0 | N | N | Y |
| Bays, et al. 75 | Vytorin vs ezetimibe or simvastatin | N | NA | N | N | S, D, H |
| Bruckert, et al. 76 | Fluvastatin vs placebo | Y | CrCl<30 | N | N | Y |
| CARDS77 | Atorvastatin vs placebo | Y | >1.6 | N | Y | Y |
| Cerivastatin Pivotal Trial78 | High dose cerivasatin vs low dose vs placebo | Y | Significant abnormality | D | N | Da |
| CHALLENGE79 | Atovastatin vs simvastatin | Y | >2.0 | N | N | H |
| Dujovne, et al. 80 | Cerivastatin vs pravastatin | Y | >2.0 | D | N | Da, H |
| Discovery81 | Atorvastatin vs rosuvastatin | Y | >2.5 | N | N | Y |
| FLARE82 | Fluvastatin vs placebo | N | N | N | N | Y |
| GREACE83 | Atovastatin vs usual care | Y | >1.3 | N | Y | S |
| Heart Protection Study84 | Simvastatin vs placebo | Y | >2 |[times]| ULN | N | N | S |
| Kyushu Lipid Intervention85 | Pravastatin vs placebo | Y | >2.0 | N | N | Y |
| Lipid Intervention in Kyoto86 | Pravastatin vs conventional Lipid-lowering drugs | Y | |[lsquo]|Severe|[rsquo]| | N | N | D, H |
| LIPID87 | Pravastatin vs placebo | Y | >1.8 | N | N | Y |
| LIPS88 | Fluvastatin vs placebo | Y | >1.8 | N | N | Y |
| MIRACL89 | Atorvastatin vs placebo | Y | N | N | N | Y |
| MERCURY I90 | Rosuvastatin vs atorvastatin vs simvastatin vs pravastatin | Y | >2.5 | N | N | S, D, H |
| Olsson, et al. 91 | Extended release fluvastatin vs immediate release | Y | >1.5 | D | N | S, Da, H |
| PACT92 | Pravastatin vs placebo | Y | |[lsquo]|Severe renal disease|[rsquo]| | N | N | H |
| PaCT93 | Pravastatin vs cholestyramine | N | N | N | N | Y |
| PROSPER94 | Pravastatin vs placebo | Y | >2.3 | N | N | Y |
| STELLAR95 | Rosuvastatin vs atorvastatin vs simvastatin vs pravastatin | Y | >2.0 | N | N | H, S |
| TARGET TANGIBLE96 | Atorvastatin vs simvastatin | Y | >1.8 | N | N | Y |
| TIMI-2297 | Pravastatin vs atorvastatin | Y | >2.0 | N | N | Y |
CrCl, creatinine clearance; D, diabetic patients excluded or percent of patients with diabetes not reported; ESRD, end-stage renal disease; H, hypertension excluded or percent of patients with hypertension not reported; N, no; NA, not applicable; S, smokers excluded or percent of smokers not reported; ULN, upper limit of normal; Y, yes.
Note: To convert serum creatinine in mg|[sol]|dl to |[mu]|mol|[sol]|l multiply by 88.4.
a Patients with diabetes excluded from participation.