BACKGROUND: Patients with Type 2 diabetes mellitus have increased levels of hemostatic risk variables for cardiovascular disease, such as fibrinogen, von Willebrand factor (VWF), factor (F)VIIa, d-dimer and plasminogen activator inhibitor-1 (PAI-1). OBJECTIVES: To evaluate the effect of aggressive vs. standard dose atorvastatin on hemostatic cardiovascular risk factors in patients with Type 2 diabetes mellitus. Patients and methods: The effect of 30 weeks of treatment with atorvastatin 10 and 80 mg on hemostatic cardiovascular risk factors was assessed in a randomized double-blind placebo-controlled trial on 217 patients with Type 2 diabetes mellitus and dyslipidemia. RESULTS AND CONCLUSIONS: Atorvastatin 10 and 80 mg dose-dependently reduced d-dimer (7.4% and 8.5%, respectively, P for trend = 0.004) and PAI-1 antigen levels (9.0% and 18%, respectively, P for trend = 0.021). Levels of fibrinogen, VWF, tissue-type plasminogen activator and FVIIa were not influenced by atorvastatin. In conclusion, in patients with Type 2 diabetes mellitus, atorvastatin dose-dependently improved the levels of the hemostatic risk variables d-dimer and PAI-1. Chemicals/CAS: atorvastatin, 134523-00-5, 134523-03-8; fibrinogen, 9001-32-5; tissue plasminogen activator, 105913-11-9; von Willebrand factor, 109319-16-6; atorvastatin, 110862-48-1; Factor VIIIa, 72175-66-7; Fibrinogen, 9001-32-5; Hemostatics; Heptanoic Acids; Placebos; Pyrroles; Tissue Plasminogen Activator, EC 3.4.21.68; von Willebrand Factor