Treating Homocysteine Levels With Folic Acid Fails to Reduce Risk of Stroke: Presented at ISC
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Treating Homocysteine Levels With Folic Acid Fails to Reduce Risk of Stroke: Presented at ISC

By Ed Susman

SAN ANTONIO, Tex -- February 27, 2010 -- A meta-analysis of randomised controlled trials (RCTs) that involved more than 39,000 patients failed to find a statistically significant impact in reducing the risk of stroke by treating homocysteine levels with folic acid.

“However, potential mild benefits were observed in primary stroke prevention, especially when folate is combined with B vitamins, and especially in male patients,” reported Meng Lee, MD, Chang Gung Memorial Hospital and University, Putzu, Taiwan, on February 24 here at the 2010 International Stroke Conference (ISC).

He noted that folate and vitamin B12 are important regulators in homocysteine metabolism. He said studies have shown an inverse relationship between folate intake and homocysteine level.

While observational studies have indicated that a 25% reduction in homocysteine levels translates to about an 11% lower ischaemic myocardial infarction (MI) risk and a 19% reduced stroke risk, RCTs have had mixed results.

Dr. Lee and colleagues performed a medical literature search and identified 13 clinical trials that met criteria for inclusion. All RCTs compared folic acid supplementation with or without other vitamins for at least 6 months. All trials reported the number of patients and the number of stroke events.

“The meta-analysis of completed trials does not demonstrate a major benefit of folic acid supplementation in averting stroke,” Dr. Lee said. “Across all trials, folic acid supplementation was associated with a trend toward mild benefit that did not reach statistical significance in reducing the risk of stroke,” he said. The overall relative risk reduction was about 7% (P = .16).

Dr. Lee also performed a subgroup analysis involving 6 trials which involved 19,768 patients. These studies included the use of combination therapy of folic acid plus vitamins B6 and B12. He observed a 17% relative risk reduction in averting stroke in these studies that did reach statistical significance (P = .02).

The researchers also observed a 12% benefit of folate supplementation treatment for male participants in 9 trials that enrolled 27,428 patients with a disproportionate number of men (P = .03).

[Presentation title: Efficacy of Homocysteine Lowering Therapy With Folic Acid in Stroke Prevention: A Meta-analysis of Randomized Controlled Trials. Abstract P140]

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