OBJECTIVE: To investigate the effect of intensive lipid lowering with high-dose 
atorvastatin on the incidence of major cardiovascular events compared with 
low-dose atorvastatin in patients with coronary artery disease and type 2 
diabetes, with and without chronic kidney disease (CKD).
PATIENTS AND METHODS: Following 8 weeks' open-label therapy with atorvastatin 
(10 mg/d), 10,001 patients with coronary artery disease were randomized to 
receive double-blind therapy with either 80 mg/d or 10 mg/d of atorvastatin 
between July 1, 1998, and December 31, 1999. Of 1501 patients with diabetes, 
renal data were available for 1431. Patients with CKD were defined as having a 
baseline estimated glomerular filtration rate (eGFR) below 60 mL/min per 1.73 
m2, using the Modification of Diet in Renal Disease equation.
RESULTS: After a median follow-up of 4.8 years, 95 (17.4%) of 546 patients with 
diabetes and CKD experienced a major cardiovascular event vs 119 (13.4%) of 885 
patients with diabetes and normal eGFRs (hazard ratio [HR], 1.32; 95% confidence 
interval [CI], 1.00-1.72; P<.05). Compared with 10 mg of atorvastatin, 80 mg of 
atorvastatin reduced the relative risk of major cardiovascular events by 35% in 
patients with diabetes and CKD (20.9% [57/273] vs 13.9% [38/273]; HR, 0.65; 95% 
CI, 0.43-0.98; P=.04) and by 10% in patients with diabetes and normal eGFR 
(14.1% [62/441] vs 12.8% [57/444]; HR, 0.90; 95% CI, 0.63-1.29; P=.56). The 
absolute risk reduction in patients with diabetes and CKD was substantial, 
yielding a number needed to treat of 14 to prevent 1 major cardiovascular event 
over 4.8 years. Both treatments were well tolerated.
CONCLUSION: Patients with diabetes, stable coronary artery disease, and mild to 
moderate CKD experience marked reduction in cardiovascular events with intensive 
lipid lowering, in contrast to previous observations in patients with diabetes 
and end-stage renal disease.
TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT00327691.