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Hankey, GJ; Eikelboom, JW; Yi, Q; Lees, KR; Chen, C; Xavier, D; Navarro, JC; Ranawaka, UK; Uddin, W; Ricci, S; Gommans, J; Schmidt, R; on behalf of the VITAmins TO Prevent Stroke (VITATOPS) Trial Study Group.
Treatment With B Vitamins and Incidence of Cancer in Patients With Previous Stroke or Transient Ischemic Attack: Results of a Randomized Placebo-Controlled Trial.
Stroke. 2012; 43(6):1572-1577
Doi: 10.1161/STROKEAHA.111.641613
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Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
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Schmidt Reinhold
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- Abstract:
- Background and Purpose-To determine the effect of B vitamin treatment on the incidence of cancer among patients with stroke or transient ischemic attack. Methods-A total of 8164 patients with recent stroke or transient ischemic attack were randomly allocated to double-blind treatment with 1 tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B-6, 500 mu g vitamin B-12) and followed for a median of 3.4 years for any cancer as an adverse event. Results-There was no significant difference in the incidence of any cancer among participants assigned B vitamins compared with placebo (4.04% versus 4.59%; risk ratio, 0.86; 95% CI, 0.70-1.07) and no difference in cancer mortality (2.35% versus 2.09%; risk ratio, 1.09; 0.81-1.46). Among 1899 patients with diabetes, the incidence of cancer was higher among participants assigned B vitamins compared with placebo (5.35% versus 3.28%; adjusted risk ratio, 2.21; 1.31-3.73), whereas among 6168 patients without diabetes, the incidence of cancer was lower among participants assigned B vitamins compared with placebo (3.66% versus 5.03%; adjusted risk ratio, 0.67; 0.51-0.87; P for interaction=0.0001). Conclusions-Daily administration of folic acid, vitamin B-6, and vitamin B-12 to 8164 patients with recent stroke or transient ischemic attack for a median of 3.4 years had no significant effect, compared with placebo, on cancer incidence or mortality. However, a post hoc subgroup analysis raises the hypothesis that folic acid treatment may increase the incidence of cancer among diabetics and reduce the incidence of cancer among nondiabetics with a history of stroke or transient ischemic attack.
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Double-Blind Method -
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Female -
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Humans -
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Ischemic Attack, Transient - complications Ischemic Attack, Transient - mortality
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Male -
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Neoplasms - mortality Neoplasms - prevention and control
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Stroke - complications Stroke - mortality
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Vitamin B Complex - administration and dosage
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prevention
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randomized controlled trials