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 increased risk of cardiovascular mortality and morbidity and thus are an excellent group in whom to evaluate the feasibility and the effect of an aggressive multifactorial intervention on atherosclerotic vascular disease risk factors. The Arterial Disease Multiple Intervention Trial (ADMIT) was designed to determine the efficacy, safety, and compliance of an multifactorial therapy on selected atherosclerotic disease risk factors in patients with PAD.


METHODS
By a 2 x 2 x 2 factorial design, eligible participants (N = 468) were 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 LDL cholesterol to recommended levels.


RESULTS
Niacin increased HDL cholesterol levels by 30%, with the majority of effect achieved at a dosage of 500 mg twice daily. Warfarin had an anticoagulant 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 combination therapy in patients with PAD.
Garg
R
R
Division of Epidemiology and Clinical Applications, National Heart Lung and Blood Institute, Bethesda, MD, USA. garg_rekha@lilly.com
Elam
M B
MB
Crouse
J R
JR
Davis
K B
KB
Kennedy
J W
JW
Egan
D
D
Herd
J A
JA
Hunninghake
D B
DB
Johnson
W C
WC
Kostis
J B
JB
Sheps
D S
DS
Applegate
W B
WB
D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D000925:Anticoagulants / Q000627:therapeutic use*; D000975:Antioxidants / Q000627:therapeutic use*; D001161:Arteriosclerosis / Q000097:blood / Q000209:etiology* / Q000517:prevention & control*; D001241:Aspirin / Q000008:administration & dosage; D008078:Cholesterol, LDL / Q000097:blood; D005240:Feasibility Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D017035:Pravastatin / Q000627:therapeutic use; D012307:Risk Factors; D012651:Self Medication; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D014815:Vitamins / Q000627:therapeutic use*; D014859:Warfarin / Q000627:therapeutic use*
D000924:Anticholesteremic Agents; D000925:Anticoagulants; D000975:Antioxidants; D008078:Cholesterol, LDL; D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors; D014280:Triglycerides; D014815:Vitamins; D009525:Niacin; D014859:Warfarin; D017035:Pravastatin; D001241:Aspirin