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J Am Coll Cardiol, 2001; 37:1858-1863
© 2001 by the American College of Cardiology Foundation
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CLINICAL STUDY: CORONARY ARTERY DISEASE

A randomized double-blind placebo-controlled trial of the effect of homocysteine-lowering therapy with folic acid on endothelial function in patients with coronary artery disease

Jeetendra Thambyrajah, BMedSci, MRCP*, Martin J. Landray, MRCP*, Heather J. Jones, RGN*, Fiona J. McGlynn, RGN{dagger}, David C. Wheeler, MD, FRCP{dagger} and Jonathan N. Townend, MD, MRCP*

* Division of Medical Sciences (Cardiology), University of Birmingham, Birmingham, United Kingdom
{dagger} Department of Nephrology, Queen Elizabeth Hospital, Birmingham, United Kingdom

Manuscript received May 11, 2000; revised manuscript received February 1, 2001, accepted February 15, 2001.

Reprint requests and correspondence: Dr. J. Thambyrajah, Department of Cardiovascular Medicine, University Hospital Birmingham NHS Trust, Birmingham B15 2TH, United Kingdom.
jeet{at}thambyrajah.freeserve.co.uk

OBJECTIVES

This study was designed to determine the effects of folic acid therapy on endothelial function in patients with coronary artery disease (CAD).

BACKGROUND

Hyperhomocysteinemia, a risk factor for CAD, may cause atherosclerosis by oxidative endothelial injury. Folic acid reduces plasma homocysteine, but the effect on adverse vascular events is unknown.

METHODS

In a double-blind placebo-controlled trial, 90 patients (mean age [range] 63 [46 to 79] years, 79 men) with CAD were randomized to either folic acid 5 mg or placebo daily for 12 weeks. Endothelial function was assessed by measuring: 1) flow-mediated endothelium-dependent dilation (EDD) of the brachial artery; 2) combined serum nitrite/nitrate (NOX) concentrations and; 3) plasma von Willebrand factor (vWF) concentration.

RESULTS

At the end of the study, plasma homocysteine was lower in the folic acid group compared with the placebo group (mean [95% confidence interval] 9.3 (8.5 to 10.1) vs. 12.3 [11.3 to 13.4] µmol/l, p < 0.001). Although there were no significant differences in EDD, serum NOX or plasma vWF between the two groups, there was a greater increase in EDD from baseline in the folic acid group compared to placebo (1.2 [0.7 to 1.8] vs. 0.4 [–0.3 to 1.1] %, p = 0.07).

CONCLUSIONS

Folic acid reduced plasma homocysteine and was associated with a trend toward improved endothelial function in patients with CAD. The absence of an unequivocally positive result may have been due to inadequate sample size or chance. This reinforces the need for the results of large randomized controlled trials before the implementation of routine folic acid supplementation.

Abbreviations and Acronyms
  CAD = coronary artery disease
  vWF = von Willebrand factor




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