Effective and safe modification of multiple atherosclerotic risk factors in patients with peripheral arterial disease

Background Patients with peripheral arterial disease (PAD) are at an increa sed risk of cardiovascular mortality and morbidity and thus are an excellen t group in whom to evaluate the feasibility and the effect of an aggressive multifactorial intervention on atherosclerotic vascular disease risk facto rs. The Arterial Disease Multiple intervention Trial (ADMIT) was designed t o determine the efficacy, safety, and compliance of an multifactorial thera py on selected atherosclerotic disease risk factors in patients with PAD. Methods Br a 2 X 2 X 2 factorial design, eligible participants (N = 468) we re randomly assigned to low-dose warfarin, antioxidant vitamins, and niacin or its corresponding placebo, and followed up for 1 year. All participants were encouraged to use aspirin. Pravastatin was added to the drug regimen for those who needed to reduce LDI cholesterol to recommended levels. Results Niacin increased HDL cholesterol levels by 30%, with the majority o f effect achieved at a dosage of 500 mg twice daily. Warfarin had an antico agulant effect. The antioxidant vitamins resulted in a significant increase in vitamin E, C, and beta-carotene plasma levels. Overall, compliance was high and few adverse effects were reported. Conclusions ADMIT demonstrates that it is both feasible and safe to modify multiple atherosclerotic disease risk factors effectively with intensive co mbination therapy in patients with PAD.