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SEARCH: Folic acid and B12 supplementation for homocysteine lowering did not lower cardiovascular events
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Using 2 mg of folic acid plus 1 mg of vitamin B12 daily for lowering homocysteine levels did not reduce major vascular events, according to results of the SEARCH study.
SEARCH was a randomized, factorial design trial comparing 80 mg vs. 20 mg daily simvastatin for LDL-lowering, and comparing 2 mg of folic acid plus 1 mg of vitamin B12 daily vs placebo.
Rory Collins, MBBS, Msc, professor of medicine and epidemiology at the Clinical Trial Service Unit at the University of Oxford, presented results of SEARCH in a late-breaking trial session.
SEARCH recruited 12,064 post-MI patients. All patients had had an MI at least three months prior to trial entry and had an indication for statin therapy. One-third of the patients were over 70 years; one-fifth of the patients were women.
The primary outcome of the study was major vascular events, including major coronary events (nonfatal MI, coronary death or coronary revascularization), stroke and coronary or noncoronary revascularization.
In the homocysteine-lowering comparison, homocysteine levels were reduced by an average of 28% in patients assigned folic acid plus vitamin B12 vs. those assigned placebo. However, no significant differences were observed between the groups in the outcomes of nonfatal MI, coronary revascularization, cardiac death, stroke and all-cause mortality.
In the simvastatin comparison, LDL ws reduced 14% with the 80-mg dose (n=6,031) vs. the 20-mg dose (n=6,033). No difference between the doses was observed in the outcomes of major vascular events, cardiac mortality, stroke or all-cause mortality. Risk for myopathy was significantly higher in patients assigned the 80-mg dose vs the 20-mg dose (0.88% vs 0.05%; P<.05).
"It is important to separate the question of lowering LDL cholesterol — for which there is good evidence of benefit — from the means by which one does it. It's clear that the 80-mg simvastatin regimen is associated with higher rates of myopathy. It is other more potent statins, or combinations of standard doses of statins with other types of ways of reducing LDL cholesterol ... that produces benefit more safely than 80 mg [of simvastatin]," Collins said.