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ADMIT
Arterial Disease Multiple Intervention Trial
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Author(s) |
(a)Egan DA, Garg R, Wilt TJ, Pettinger MB, Davis KB, Crouse J, Herd JA, Hunninghake DB, Sheps DS, Kostis JB, Probstfield J, Waclawiw MA, Applegate W, Elam MB
(b) Garg R, Elam MB, Crouse JR, Davis KB, Ward Kennedy J, Egan D, Herd JA, Hunninghake DB, Craig Johnson W, Kostis JB, Sheps DS, Applegate WB |
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Title(s) |
(a) Rationale and design of the Arterial Disease Multiple Intervention Trial (ADMIT) pilot study
(b) Effective and safe modification of multiple atherosclerotic risk factors in patients with peripheral arterial disease |
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Reference(s) |
(a) Am J Cardiol 1999;83:569-75 (b) Am Heart J 2000;140:792–803
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Disease |
Peripheral artery disease
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Purpose |
To evaluate the feasibility of recruiting patients with peripheral arterial disease, to measure the efficacy and safety of HDL-raising and LDL-lowering treatments, antioxidant therapy, antithrombotic therapy, and their combinations, and to assess compliance with a multiple-drug regimen
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Study design |
Randomised, double-blind, placebo-controlled, 2 × 2 × 2 factorial
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Follow-up |
1 year
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Patients |
468 patients, aged ≥ 30 years, with symptomatic or documented peripheral artery disease and LDL < 190 mg/dl
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Treatment regimen |
Niacin, maximum tolerated dose up to 3000 mg/day, plus pravastatin, 10 or 20 mg/day from week 18 onwards titrated to LDL < 115 mg/dl, or placebo
Antioxidants (beta-carotene, 24 mg/day, vitamin E, 800 U/day, and vitamin C, 1.0 g/day) in 2 capsules bid, or placebo
Warfarin to target international normalised ratio 1.5-2.0 (maximum 4 mg/day), or placebo
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Concomitant therapy |
ASA, 325 mg/day, strongly recommended. NCEP dietary advice given
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Results |
Niacin increased HDL levels by 30% and decreased LDL by 12%. Addition of pravastatin did not affect HDL, but resulted in an additional 10% reduction of LDL in the niacin group and 16% in the placebo group. Warfarin had an anticoagulant effect with no significant difference in the incidence of bleeding episodes between the warfarin and the placebo groups (4% vs 2%). Occurrence of hyperuricaemia was significantly reduced in the antioxidant 21 group compared to placebo (p = 0.002). Overall, compliance was high |
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Comments |
Data on the effect of niacin treatment on plasma lipoproteins and glycaemic status in ADMIT participants with diabetes have been published in JAMA 2000;284:1263–70 |
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