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Efficacy of folic acid when added to statin therapy in patients with hypercholesterolemia following acute myocardial infarction: a randomised pilot trial.
Int J Cardiol. 2004 Feb; 93(2-3):175-9.IJ

Abstract

BACKGROUND

Folic acid is assumed to have favourable effects on vascular endothelium, directly as well as indirectly through its effect on homocysteine metabolism. However, the clinical value of folic acid in secondary prevention after acute myocardial infarction (MI) has never been tested. Thus, a randomised, open-label, multicentre trial was performed in order to study the effect of folic acid 5 mg o.d. when added to statin therapy on the incidence of recurrent major clinical events up to 1 year post-MI.

METHODS

A total of 283 patients with a total cholesterol >6.5 mmol/l (251 mg/dl) (mean 7.3 mmol/l) were included. All patients received 40 fluvastatin. In 140 of the 283 patients, folic acid (5 mg o.d.) was instituted at discharge, and the remaining 143 patients served as controls. Other secondary prevention measures for both groups were advocated. The primary endpoint was a composite consisting of all vascular events, including death, recurrent MI, strokes, and unplanned invasive coronary interventions.

RESULTS

At baseline, the two groups were well-matched for all clinical and demographic parameters. After 1 year of treatment, no difference was noticed in the primary endpoint between the two groups. These endpoints occurred in 43 patients (31%) in the folic acid group, as opposed to 45 patients (31%) in the control group. All separate cardiovascular events were also equally distributed between both groups. Total cholesterol levels decreased to a similar extent in the two groups (to 5.5 and 5.7 mmol/l, in folic acid and control groups, respectively).

CONCLUSIONS

In this medium-size pilot study, folic acid did not demonstrate any beneficial additive effects on cardiovascular mortality or morbidity in post-MI patients with hypercholesterolemia who were treated with statin therapy. Larger trials, possibly targeting at selected populations, must be awaited before definitive conclusions regarding the potentially favourable effects of folic acid supplementation in secondary prevention can be drawn.

Authors+Show Affiliations

Oosterschelde Ziekenhuizen, Goes, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14975544

Citation

Liem, A H., et al. "Efficacy of Folic Acid when Added to Statin Therapy in Patients With Hypercholesterolemia Following Acute Myocardial Infarction: a Randomised Pilot Trial." International Journal of Cardiology, vol. 93, no. 2-3, 2004, pp. 175-9.
Liem AH, van Boven AJ, Veeger NJ, et al. Efficacy of folic acid when added to statin therapy in patients with hypercholesterolemia following acute myocardial infarction: a randomised pilot trial. Int J Cardiol. 2004;93(2-3):175-9.
Liem, A. H., van Boven, A. J., Veeger, N. J., Withagen, A. J., Robles de Medina, R. M., Tijssen, J. G., & van Veldhuisen, D. J. (2004). Efficacy of folic acid when added to statin therapy in patients with hypercholesterolemia following acute myocardial infarction: a randomised pilot trial. International Journal of Cardiology, 93(2-3), 175-9.
Liem AH, et al. Efficacy of Folic Acid when Added to Statin Therapy in Patients With Hypercholesterolemia Following Acute Myocardial Infarction: a Randomised Pilot Trial. Int J Cardiol. 2004;93(2-3):175-9. PubMed PMID: 14975544.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of folic acid when added to statin therapy in patients with hypercholesterolemia following acute myocardial infarction: a randomised pilot trial. AU - Liem,A H, AU - van Boven,A J, AU - Veeger,N J G M, AU - Withagen,A J, AU - Robles de Medina,R M, AU - Tijssen,J G P, AU - van Veldhuisen,D J, AU - ,, PY - 2002/09/08/received PY - 2003/02/01/revised PY - 2003/02/13/accepted PY - 2004/2/21/pubmed PY - 2004/6/5/medline PY - 2004/2/21/entrez SP - 175 EP - 9 JF - International journal of cardiology JO - Int. J. Cardiol. VL - 93 IS - 2-3 N2 - BACKGROUND: Folic acid is assumed to have favourable effects on vascular endothelium, directly as well as indirectly through its effect on homocysteine metabolism. However, the clinical value of folic acid in secondary prevention after acute myocardial infarction (MI) has never been tested. Thus, a randomised, open-label, multicentre trial was performed in order to study the effect of folic acid 5 mg o.d. when added to statin therapy on the incidence of recurrent major clinical events up to 1 year post-MI. METHODS: A total of 283 patients with a total cholesterol >6.5 mmol/l (251 mg/dl) (mean 7.3 mmol/l) were included. All patients received 40 fluvastatin. In 140 of the 283 patients, folic acid (5 mg o.d.) was instituted at discharge, and the remaining 143 patients served as controls. Other secondary prevention measures for both groups were advocated. The primary endpoint was a composite consisting of all vascular events, including death, recurrent MI, strokes, and unplanned invasive coronary interventions. RESULTS: At baseline, the two groups were well-matched for all clinical and demographic parameters. After 1 year of treatment, no difference was noticed in the primary endpoint between the two groups. These endpoints occurred in 43 patients (31%) in the folic acid group, as opposed to 45 patients (31%) in the control group. All separate cardiovascular events were also equally distributed between both groups. Total cholesterol levels decreased to a similar extent in the two groups (to 5.5 and 5.7 mmol/l, in folic acid and control groups, respectively). CONCLUSIONS: In this medium-size pilot study, folic acid did not demonstrate any beneficial additive effects on cardiovascular mortality or morbidity in post-MI patients with hypercholesterolemia who were treated with statin therapy. Larger trials, possibly targeting at selected populations, must be awaited before definitive conclusions regarding the potentially favourable effects of folic acid supplementation in secondary prevention can be drawn. SN - 0167-5273 UR - https://www.unboundmedicine.com/medline/citation/14975544/Efficacy_of_folic_acid_when_added_to_statin_therapy_in_patients_with_hypercholesterolemia_following_acute_myocardial_infarction:_a_randomised_pilot_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0167527303002808 DB - PRIME DP - Unbound Medicine ER -