Effect of rosuvastatin or atorvastatin on urinary albumin excretion and renal function in type 2 diabetic patients.

Author(s): Sorof J, Berne C, Siewert-Delle A, Jorgensen L, Sager P, URANUS study investigators

Affiliation(s): Cardiovascular Clinical Research, AstraZeneca LP, C4B-717, 1800 Concord Pike, Wilmington, DE 19803, USA. Jonathan.Sorof@astrazeneca.com

Publication date & source: 2006-04, Diabetes Res Clin Pract., 72(1):81-7. Epub 2005 Oct 24.

Publication type: Multicenter Study; Randomized Controlled Trial

The effect of rosuvastatin or atorvastatin on urinary albumin excretion (UAE) was determined in type 2 diabetic patients. A randomized, double-blind, parallel-group, response-based design compared rosuvastatin 10mg (titrated to 40 mg) with atorvastatin 10mg (titrated to 80 mg) in type 2 diabetic patients with dyslipidemia, with dose titration to an LDL-C target of <3.0 mmol/L. Overnight timed urine collections were obtained at baseline, 8 and 16 weeks to UAE. Glomerular filtration rate (GFR) was determined using the Modification of Diet in Renal Disease formula. Patients with paired, UAE collections of at least 8h duration were analyzed (n=344). No significant change from baseline in UAE was observed for either treatment group or between-treatment groups at 16 weeks, and median UAE for both treatment groups remained within normal limits (rosuvastatin 4.5 microg/min, atorvastatin 5.0 microg/min). A similar absence of change from baseline was observed for 51 patients with UAE above the normal range at study entry (>20 microg/min). No significant change in GFR from baseline after 16 weeks was observed for either treatment group. These data provide reassurance that type 2 diabetic patients can be treated with higher efficacy statins without clinically meaningful effects on urinary albumin excretion.