Norwegian Vitamin Trial

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Norwegian Vitamin Trial
NORVIT
Presented at The European Society of Cardiology
Congress 2005 Presented by Dr. Kaare Harold Bønaa
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NORVIT
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
Placebo n943
Combination Therapy (0.8 mg folic acid, 40 mg
vitamin B6 n937
Folic acid (0.8 mg n935)
High-dose Vitamin B6 (40 mg n934)

• 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

ACC 2005
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NORVIT Primary endpoint
Frequency of Recurrent MI or Stroke per 1000
Person-Years of Exposure

• 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

P0.029
Frequency
ACC 2005
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NORVIT Secondary Endpoints
There were no statistically significant
differences in mortality and MI between the four
treatment groups (Frequency / 1000 Patient Year
Exposure)

Frequency
ACC 2005
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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.

ACC 2005