650 Background: Estrogens (Es) favorably modify the lipid profile. Aromatase inhibitors reduce Es; LDL and triglycerides (tri) increase have been observed (Elisaf, EJC 2001). We report the effect of exemestane (E, Aromasin), a steroidal aromatase inactivator, on lipid profile and coagulation in postmenopausal early breast cancer (EBC) patients (pts). Methods: We conducted a randomized, double blind study on the effect of E on bone metabolism, endocrinological and metabolic parameters in postmenopausal pT1N0 or T2N0 (with no other risk factors) or ductal carcinoma in situ (DCIS) pts. ER and/or PgR+ve or unknown pts with bone mineral density (BMD) within 2 SD of the mean for 65-years (yrs) women were randomized to E 25 mg day or placebo (P) p.o. for 2 yrs, with a 1-yr follow-up. Primary objective was non-inferiority on BMD. Planned sample size was 128 BMD-evaluable pts. Cholesterol (Chol), HDL-cholesterol (HDL-c), tri, Apo-AI, Lipoprotein A (Lipo-AI), Apo B, PT, APTT, fibrinogen (Fib) and homocysteine (hoc)...