Norwegian Vitamin Trial NORVITNORVIT Presented at The European Society of Cardiology Congress 2005 Presented by Dr. Kaare Harold Bønaa

www. Clinical trial results.org Folic acid (0.8 mg; n=935) Endpoints:  Primary– Composite endpoint of Myocardial Infarction (including sudden death) or stroke  Secondary – Individual components of the composite, mortality, PCI, CABG, hospitalization due to unstable angina Endpoints:  Primary– Composite endpoint of Myocardial Infarction (including sudden death) or stroke  Secondary – Individual components of the composite, mortality, PCI, CABG, hospitalization due to unstable angina NORVIT ACC 2005 Placebo n= patients with ST elevation myocardial infarction in prior 7 days Excluding those with ongoing vitamin B therapy, expected poor compliance, or other life- threatening diseases 3749 patients with ST elevation myocardial infarction in prior 7 days Excluding those with ongoing vitamin B therapy, expected poor compliance, or other life- threatening diseases Combination Therapy (0.8 mg folic acid, 40 mg vitamin B6; n=937 High-dose Vitamin B6 (40 mg; n=934)

www. Clinical trial results.org NORVIT: Primary endpoint Treatment with high-dose vitamin B or folic acid alone were not associated with differences in reinfarction or stroke compared with placebo Treatment with high-dose vitamin B or folic acid alone were not associated with differences in reinfarction or stroke compared with placebo Combination therapy of high-dose vitamin B and folic acid showed a significantly higher event rate Combination therapy of high-dose vitamin B and folic acid showed a significantly higher event rate Frequency of Recurrent MI or Stroke per 1000 Person-Years of Exposure ACC 2005 Frequency P=0.029

www. Clinical trial results.org NORVIT: Secondary Endpoints ACC 2005 There were no statistically significant differences in mortality and MI between the four treatment groups (Frequency / 1000 Patient Year Exposure) Frequency

www. Clinical trial results.org NORVIT: Summary Among patients with ST-elevation MI, treatment with high- dose vitamin B and/or folic acid alone was not associated with differences in reinfarction or stroke compared with placebo Combination therapy with both vitamin B and folic acid was associated with a significantly higher frequency of MI and stroke There were no statistically significant differences in either mortality or recurrent MI between groups. Among patients with ST-elevation MI, treatment with high- dose vitamin B and/or folic acid alone was not associated with differences in reinfarction or stroke compared with placebo Combination therapy with both vitamin B and folic acid was associated with a significantly higher frequency of MI and stroke There were no statistically significant differences in either mortality or recurrent MI between groups. ACC 2005