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Folic acid supplementation reduces stroke risk in patients with hypertension

Folic acid supplementation may have important implications for stroke prevention in patients with hypertension, according to results from the China Stroke Primary Prevention Trial (CSPPT).
Adding folic acid (0.8 mg/day) to enalapril (10 mg/day) reduced the risk of first stroke in Chinese adults with hypertension by 21 percent (p=0.003) compared to treatment with enalapril alone. The incidence of first stroke was 2.7 percent for folic acid-enalapril combination vs 3.4 percent for enalapril. [JAMA 2015;doi:101001/jama.2015.2274]
The findings were presented at the recent American College of Cardiology (ACC) 2015 Scientific Sessions. Importantly, patients with the lowest baseline levels of plasma folate (<5.6 ng/mL) had the greatest risk reduction, suggesting a greater benefit of folate supplementation in folate-deficient populations. The rate of first stroke in this subgroup was 2.8 percent in the folate arm vs 4.6 percent in the enalapril alone arm (hazard ratio [HR], 0.61). In addition, patients with methylenetetrahydrofolate (MTHFR TT) genotypes had a 28 percent reduction in first stroke after combination treatment with enalapril and folic acid.
Patients who received folic acid also had a lower risk of ischaemic stroke (2.2 percent vs 2.8 percent with enalapril only; HR, 0.76; p=0.002) and composite cardiovascular events consisting of cardiovascular death, MI, and stroke (3.1 percent vs 3.9 percent; HR, 0.80; p=0.002).
Due to the positive results, the study was terminated early, after a median of 48 months of treatment, based on recommendations of the data and safety monitoring board.
Commenting on the success of the study, lead investigator Dr. Yong Huo of the Peking University First Hospital in Beijing, China said: “We believe these findings are universal. They’re applicable not only to the Chinese population, but also to populations throughout the world, including the United States.”
Folate deficiency is estimated to affect 20-60 percent of the population in China and is prevalent across the globe, especially in regions without folate fortification programmes in place. [Food Nutr Bull 2008;29(suppl):S38-S51]
Additionally, the greater risk of stroke and lower plasma folate levels in people carrying the MTHFRTT genotype polymorphism (23.5 percent of study participants) suggest an opportunity for targeted intervention.
The trial, one of the largest on folic acid supplementation for the primary prevention of stroke with over 10,000 patients in each arm, was conducted from May 2008 to August 2013 in the Jiangsu and Anhui provinces in China. Patients had no previous history of stroke or MI, heart failure, coronary revascularization or congenital heart disease. Importantly, < 1 percent was on lipid-lowering treatment and < 3 percent were taking an antiplatelet agent.
Previous studies of folic acid for the prevention of vascular diseases did not show a benefit, noted discussant Dr. Heather Gornik of the Cleveland Clinic, Cleveland, Ohio, US. These studies were also done mostly in Western populations where folate fortification had been in effect.
“But this [study] really shows that in a Chinese hypertensive population [with folate deficiency], there are things that can be done in addition to blood-pressure control to prevent stroke,” she said. “It opens up a whole new area of investigation.”