CLINICAL STUDY
Randomized trial of a medical food for the dietary management of chronic, stable angina
Andrew J. Maxwell, MD, FACC*,*,
Michael P. Zapien, BS*,
Greg L. Pearce, MS ,
Gail MacCallum, BS and
Peter H. Stone, MD, FACC
* Division of Research and Development, Cooke Pharma, Inc., Belmont, California, USA
GLP Statistical Consulting, Brigham & Women’s Hospital, Boston, Massachusetts, USA
Brigham & Women’s Hospital, Boston, Massachusetts, USA
Manuscript received March 26, 2001;
revised manuscript received August 8, 2001,
accepted September 20, 2001.
* Reprint requests and correspondence: Dr. Andrew J. Maxwell, Cooke Pharma, 6167 Jarvis Avenue #244, Newark, California 94560, USA.
amaxwell{at}ntgr8.com
OBJECTIVES: We determined the electrocardiographic, vascular and clinical effects of a medical food bar enriched with L-arginine and a combination of other nutrients known to enhance endothelium-derived nitric oxide (NO) in patients with stable angina.
BACKGROUND: Enhancement of vascular NO by supplementation with L-arginine and other nutrients has been shown to have clinical benefits in patients with angina secondary to atherosclerotic coronary artery disease (CAD). However, the amounts and combinations of these nutrients required to achieve a clinical effect make traditional delivery by capsules and pills less suitable than alternative delivery methods such as a specially formulated nutrition bar.
METHODS: Thirty-six stable outpatients with CAD and class II or III angina participated in a randomized, double-blind, placebo-controlled, crossover trial with two treatment periods each of two weeks’ duration (two active bars or two placebo bars per day). Flow-mediated brachial artery dilation was measured by ultrasound. Electrocardiographic measures of ischemia, exercise capacity and angina onset time were measured by treadmill exercise testing and by Holter monitor during routine daily activities. Quality of life was assessed by SF-36 and Seattle Angina Questionnaires and by diary.
RESULTS: The medical food improved flow-mediated vasodilation (from 5.5 ± 4.5 to 8.0 ± 4.9, p = 0.004), treadmill exercise time (by 20% over placebo, p = 0.05) and quality-of-life scores (SF-36 summary score; 68 ± 13 vs. 63 ± 21 after placebo, p = 0.04, Seattle Angina Questionnaire summary score; 67 ± 10 vs. 62 ± 18, p = 0.04) without affecting electrocardiographic manifestations of ischemia or angina onset time.
CONCLUSIONS: These findings reveal that this arginine-rich medical food, when used as an adjunct to traditional therapy, improves vascular function, exercise capacity and aspects of quality of life in patients with stable angina.
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Abbreviations and Acronyms
| | ACIP | | Asymptomatic Cardiac Ischemia Pilot study | | CAD | | coronary artery disease | | MET | | metabolic equivalent of the task | | NO | | nitric oxide | | SF-36 | | Medical Outcomes Study Health Survey |
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