B vitamins and magnetic resonance imaging-detected ischemic brain lesions in patients with recent transient ischemic attack or stroke: the VITAmins TO Prevent Stroke (VITATOPS) MRI-substudy.

Abstract

BACKGROUND AND PURPOSE:

Elevated concentrations of homocysteine are associated with cerebral small vessel disease (CSVD). B-vitamin supplementation with folate and vitamins B12 and B6 reduces homocysteine concentrations. In a substudy of the VITAmins TO Prevent Stroke (VITATOPS) trial, we assessed the hypothesis that the addition of once-daily supplements of B vitamins would reduce the progression of CSVD-related brain lesions.

METHODS:

A total of 359 patients with recent stroke or transient ischemic attack, who were randomly allocated to double-blind treatment with placebo or b vitamins, underwent brain MRI at randomization and after 2 years of B-vitamin supplementation. MR images were analyzed blinded to treatment allocation. Outcomes related to the prespecified hypothesis were progression of white matter hyperintensities and incident lacunes. We also explored the effect of B-vitamin supplementation on the incidence of other ischemic abnormalities.

RESULTS:

After 2 years of treatment with b vitamins or placebo, there was no significant difference in white matter hyperintensities volume change (0.08 vs 0.13 cm3; P=0.419) and incidence of lacunes (8.0% vs 5.9%, P=0.434; odds ratio=1.38). In a subanalysis of patients with MRI evidence of severe CSVD at baseline, b-vitamin supplementation was associated with a significant reduction in white matter hyperintensities volume change (0.3 vs 1.7 cm3; P=0.039).

CONCLUSIONS:

Daily B-vitamin supplementation for 2 years did not significantly reduce the progression of brain lesions resulting from presumed CSVD in all patients with recent stroke or transient ischemic attack but may do so in the subgroup of patients with recent stroke or transient ischemic attack and severe CSVD.

CLINICAL TRIAL REGISTRATION:

http://vitatops.highway1.com.au/. Unique identifier: NCT00097669 and ISRCTN74743444.

• Authors: Margherita Cavalieri, Reinhold Schmidt, Christopher Chen, Vincent Mok, Gabriel R de Freitas, Swithin Song, Qilong Yi, Stefan Ropele, Anja Grazer, Nina Homayoon, Christian Enzinger, Katherine Loh, Ka Sing Lawrence Wong, Adrian Wong, Yunyun Xiong, Hui Meng Chang, Meng Cheong Wong, Franz Fazekas, John W Eikelboom, Graeme J Hankey, VITATOPS Trial Study Group
• Journal: Stroke (Stroke) Vol. 43 Issue 12 Pg. 3266-70 (Dec 2012) ISSN: 1524-4628 [Electronic] United States
• PMID: 23093615 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Vitamin B Complex
• Vitamin B 6
• Folic Acid
• Vitamin B 12

Topics

• Aged
• Brain Ischemia (drug therapy, pathology, prevention & control)
• Cerebrovascular Circulation (drug effects)
• Disease Progression
• Double-Blind Method
• Female
• Folic Acid (administration & dosage)
• Humans
• Ischemic Attack, Transient (drug therapy, pathology, prevention & control)
• Leukoencephalopathies (drug therapy, pathology, prevention & control)
• Magnetic Resonance Imaging
• Male
• Middle Aged
• Placebos
• Stroke, Lacunar (drug therapy, pathology, prevention & control)
• Treatment Failure
• Vitamin B 12 (administration & dosage)
• Vitamin B 6 (administration & dosage)
• Vitamin B Complex (administration & dosage)