Norwegian Vitamin Trial NORVITNORVIT Presented at The European Society of Cardiology Congress 2005...
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Norwegian Vitamin Trial Norwegian Vitamin Trial NORVIT NORVIT Presented at Presented at The European Society of Cardiology The European Society of Cardiology Congress 2005 Congress 2005 Presented by Dr. Kaare Harold B Presented by Dr. Kaare Harold B ø ø naa naa
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Transcript of Norwegian Vitamin Trial NORVITNORVIT Presented at The European Society of Cardiology Congress 2005...
Norwegian Vitamin TrialNorwegian Vitamin Trial Norwegian Vitamin TrialNorwegian Vitamin Trial
NORVITNORVITNORVITNORVIT
Presented atPresented atThe European Society of Cardiology Congress The European Society of Cardiology Congress
20052005
Presented by Dr. Kaare Harold BPresented by Dr. Kaare Harold Bøønaanaa
www. Clinical trial results.org
Folic acid (0.8 mg; n=935)
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
NORVITNORVITNORVITNORVIT
ACC 2005ACC 2005
Placebo n=943Placebo n=943
3749 patients with ST elevation myocardial infarction in prior 7 daysExcluding those with ongoing vitamin B therapy, expected poor compliance, or other life-
threatening diseases
3749 patients with ST elevation myocardial infarction in prior 7 daysExcluding 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
Combination Therapy (0.8 mg folic acid, 40 mg vitamin B6; n=937
High-dose Vitamin B6 (40 mg; n=934) High-dose Vitamin B6 (40 mg; n=934)
www. Clinical trial results.org
NORVIT: Primary endpointNORVIT: Primary endpointNORVIT: Primary endpointNORVIT: Primary endpoint
• Treatment with high-dose Treatment with high-dose vitamin B or folic acid alone vitamin B or folic acid alone were not associated with were not associated with differences in reinfarction or differences in reinfarction or stroke compared with stroke compared with placeboplacebo• Combination therapy of Combination therapy of high-dose vitamin B and folic high-dose vitamin B and folic acid showed a significantly acid showed a significantly higher event ratehigher event rate
Frequency of Recurrent MI or Stroke per Frequency of Recurrent MI or Stroke per 1000 Person-Years of Exposure1000 Person-Years of Exposure
ACC 2005ACC 2005
70.1 66.9
81.6
67.2
0
10
20
30
40
50
60
70
80
90
100
Vitamin B6 Folic Acid Combination Placebo
70.1 66.9
81.6
67.2
0
10
20
30
40
50
60
70
80
90
100
Vitamin B6 Folic Acid Combination Placebo
Fre
quen
cy
Fre
quen
cy
P=0.029P=0.029
www. Clinical trial results.org
NORVIT: Secondary Endpoints NORVIT: Secondary Endpoints NORVIT: Secondary Endpoints NORVIT: Secondary Endpoints
ACC 2005ACC 2005
There were no statistically significant differences in mortality and MI There were no statistically significant differences in mortality and MI between the four treatment groups (Frequency / 1000 Patient Year Exposure)between the four treatment groups (Frequency / 1000 Patient Year Exposure)
64.0
28.7
57.5
37.5
73
31.7
59.2
33.4
0
10
20
30
40
50
60
70
80
90
100
Mortality MI
Vitamin B6 Folic Acid Combination Placebo
64.0
28.7
57.5
37.5
73
31.7
59.2
33.4
0
10
20
30
40
50
60
70
80
90
100
Mortality MI
Vitamin B6 Folic Acid Combination Placebo
Fre
quen
cy
Fre
quen
cy
www. Clinical trial results.org
NORVIT: SummaryNORVIT: SummaryNORVIT: SummaryNORVIT: 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 2005ACC 2005
