By Ed Susman
NEW ORLEANS -- November 10, 2008 -- Researchers across the United Kingdom found no benefit to using folic acid supplementation for prevention of cardiovascular events in patients who had previously experienced a myocardial infarction.
In the same cohort of high-risk patients, researchers with the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) also found that use of high-dose simvastatin did not translate into a statistically significant reduction in cardiovascular events in these patients compared with low-dose simvastatin.
Rory Collins, MBBS, Oxford University, Oxford, United Kingdom, and colleagues at 88 sites randomly assigned 6,033 patients to receive folate supplementation, while another 5,783 patients were given placebo in the factorial design study presented at the American Heart Association (AHA) Scientific Sessions.
Results showed that patients who were in the placebo arm had slightly better outcomes -- with 24.8% of placebo patients experiencing a cardiovascular event compared with 25.5% of those given folic acid. The difference was not statistically significant.
"This is a robustly negative result," said co-author Jane M Armitage, BM, BChBSc, MBBS, Oxford University, who presented results at a press briefing on November 9.
"We saw no subgroups in whom there was any benefit," Dr. Armitage said. However, she added that the results after 6.7 years of follow-up saw no suggestion of an emerging trend of cancer with use of folic acid.
In addition, among 6,031 patients randomised to receive simvastatin 80 mg and 6,033 patients randomised to simvastatin 20 mg, 10.6% of the high-dose group died during the course of the study compared with 11.2% of the placebo arm, but the difference failed to achieve statistical significance.
In his oral plenary presentation, Dr. Armitage reported a 14-mg/dL reduction in LDL cholesterol with the 80-mg simvastatin group compared with the 20-mg group and a further 6% reduction in clinical events (P = .10).
He used the SEARCH results as part of a mega-analysis of similar "more versus less" trials to show that while not statistically significant, the LDL cholesterol-lowering effects of simvastatin were in line with what would have been anticipated.
[Presentation title: Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). Late Breaker Presentation]
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