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This study compared high vs. low-dose simvastatin and folate + vitamin B12 vs. placebo in patients with recent myocardial infarction. No significant differences in major vascular events were found between the groups. However, there was an increased risk of myopathy in the high-dose simvastatin group. The trial design was a 2x2 factorial study, with patients followed for around 6.7 years. The overall conclusion suggests that neither high-dose simvastatin nor folate + vitamin B12 is effective in reducing major vascular events in recent MI patients.
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SEARCH No difference in the incidence of major vascular events between high- vs. low-dose simvastatin, or folate + vitamin B12 vs. placebo (p > 0.05 for both) No difference in individual outcomes studied ↑ risk of myopathy in high-dose vs. low-dose simvastatin arms (0.88% vs. 0.05%, p < 0.05) (p > 0.05) (p > 0.05) Trial design: A 2 x 2 factorial study in which patients with a recent MI were randomized to either simvastatin 80 mg or 20 mg daily, and folic acid + vitamin B12 or placebo. Patients were followed for a mean of 6.7 years. Results 50 50 % % 25.7 24.5 25.5 24.8 0 0 Conclusions Major vascular events • Neither high-dose (vs. low-dose) simvastatin nor folate + vitamin B12 (vs. placebo) effective in reducing major vascular events in patients with a recent MI • Statin data contrary to other trials on this topic, folate + vitamin B12 data similar Folate/ Vit B12 n = 6,033 Simvastatin 80 mg n = 6,031 Simvastatin 20 mg n = 6,033 Placebo n = 6,031 Presented by Dr. Rory Collins at AHA 2008