Rationale and design of the arterial disease multiple intervention trial (ADMIT) pilot study

Debra A. Egan, Rekha Garg, Timothy J. Wilt, Mary B. Pettinger, Kathryn B. Davis, John Crouse, J. Alan Herd, Donald B. Hunninghake, David S. Sheps, John B. Kostis, Jeffrey Probstfield, Myron A. Waclawiw, William Applegate, Marshall Elam

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

The primary objectives of the pilot study were to: (1) evaluate the feasibility of recruiting patients with peripheral arterial disease (PAD); (2) measure the efficacy and safety of high-density lipoprotein (HDL)- raising treatment, low-density lipoprotein (LDL)-lowering therapy, antioxidant therapy, antithrombotic therapy, and their combinations; and (3) assess adherence to a complex multiple drug regimen. Secondary objectives included measurement of the effect of the interventions on pre-specified biochemical markers, maintenance of therapy masking (in particular with niacin), and measurement of the intervention's impact on functional status and on quality of life. To date, no secondary prevention trial has been conducted specifically among patients with PAD. Intermittent claudication affects about 0.5% to 1.0% of persons aged >35 years. There is a striking increase in incidence of PAD with age, particularly among those aged >50 years in both sexes, although men are twice as likely as women to develop PAD. The Arterial Disease Multiple Intervention Trial was a double-blind randomized pilot trial of 468 participants with documented PAD. A 2 x 2 x 2 factorial design was used to evaluate the effect of 3 interventions. The pilot incorporated several major novel design features: first, the use of a simple noninvasive method (measurement of ankle brachial index) to identify a population with either symptomatic or asymptomatic PAD; and second, a lipid modifying strategy to increase HDL with nicotinic acid in the intervention group while lowering LDL levels equally with an hydroxymethylglutaryl- coenzyme A reductase inhibitor as needed in the intervention and control group. Two other arms, the antioxidant arm (consisting of beta-carotene and vitamins E and C) and the antithrombotic arm (using warfarin) were also added. Adherence to therapy was measured by pill count, and success in treatment was measured by the proportion of values in target range for HDL, LDL, and the international normalized ratio.

Original languageEnglish (US)
Pages (from-to)569-575
Number of pages7
JournalAmerican Journal of Cardiology
Volume83
Issue number4
DOIs
StatePublished - Feb 15 1999

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Peripheral Arterial Disease
HDL Lipoproteins
LDL Lipoproteins
Niacin
Therapeutics
Antioxidants
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ankle Brachial Index
Intermittent Claudication
International Normalized Ratio
beta Carotene
Warfarin
Secondary Prevention
Vitamin E
Ascorbic Acid
Oxidoreductases
Biomarkers
Maintenance
Quality of Life
Lipids

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Rationale and design of the arterial disease multiple intervention trial (ADMIT) pilot study. / Egan, Debra A.; Garg, Rekha; Wilt, Timothy J.; Pettinger, Mary B.; Davis, Kathryn B.; Crouse, John; Herd, J. Alan; Hunninghake, Donald B.; Sheps, David S.; Kostis, John B.; Probstfield, Jeffrey; Waclawiw, Myron A.; Applegate, William; Elam, Marshall.

In: American Journal of Cardiology, Vol. 83, No. 4, 15.02.1999, p. 569-575.

Research output: Contribution to journalArticle

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, M 1999, 'Rationale and design of the arterial disease multiple intervention trial (ADMIT) pilot study', American Journal of Cardiology, vol. 83, no. 4, pp. 569-575. https://doi.org/10.1016/S0002-9149(98)00915-1
Egan, Debra A. ; Garg, Rekha ; Wilt, Timothy J. ; Pettinger, Mary B. ; Davis, Kathryn B. ; Crouse, John ; Herd, J. Alan ; Hunninghake, Donald B. ; Sheps, David S. ; Kostis, John B. ; Probstfield, Jeffrey ; Waclawiw, Myron A. ; Applegate, William ; Elam, Marshall. / Rationale and design of the arterial disease multiple intervention trial (ADMIT) pilot study. In: American Journal of Cardiology. 1999 ; Vol. 83, No. 4. pp. 569-575.
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