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Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis.
Stroke 2013; 44(8):2232-9S

Abstract

BACKGROUND AND PURPOSE

High plasma total homocysteine (tHcy) has been associated with cognitive impairment but lowering tHcy with B-vitamins has produced equivocal results. We aimed to determine whether B-vitamin supplementation would reduce tHcy and the incidence of new cognitive impairment among individuals with stroke or transient ischemic attack≥6 months previously.

METHODS

A total of 8164 patients with stroke or transient ischemic attack were randomly allocated to double-blind treatment with one tablet daily of B-vitamins (folic acid, 2 mg; vitamin B6, 25 mg; vitamin B12, 500 μg) or placebo and followed up for 3.4 years (median) in the VITAmins TO Prevent Stroke (VITATOPS) trial. For this prespecified secondary analysis of VITATOPS, the primary outcome was a new diagnosis of cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score<24 on ≥2 follow-up visits. Secondary outcomes were cognitive decline, and the mean tHcy and MMSE at final follow-up.

RESULTS

A total of 3089 participants (38%) voluntarily undertook the MMSE>6 months after the qualifying stroke; 2608 participants were cognitively unimpaired (MMSE≥24), of whom 2214 participants (1110 B-vitamins versus 1104 placebo) had follow-up MMSEs during 2.8 years (median). At final follow-up, allocation to B-vitamins, compared with placebo, was associated with a reduction in mean tHcy (10.2 μmol/L versus 14.2 μmol/L; P<0.001) but no change from baseline in the mean MMSE score (-0.22 points versus -0.25 points; difference, 0.03; 95% confidence interval, -0.13 to 0.19; P=0.726) and no difference in the incidence of cognitive impairment (5.51% versus 5.47%; risk ratio, 1.01; 95% confidence interval, 0.69-1.48; P=0.976), cognitive decline (9.1% versus 10.3%; risk ratio, 0.89; 0.67-1.18; P=0.414), or cognitive impairment or decline (11.0% versus 11.3%; risk ratio, 0.98; 0.75-1.27; P=0.855).

CONCLUSIONS

Daily supplementation with folic acid, vitamin B6, and vitamin B12 to a self-selected clinical trial cohort of cognitively unimpaired patients with previous stroke or transient ischemic attack lowered mean tHcy but had no effect on the incidence of cognitive impairment or cognitive decline, as measured by the MMSE, during a median of 2.8 years.

CLINICAL TRIAL REGISTRATION

URL: http://www.controlled-trials.com. Unique identifier: ISRCTN74743444; URL: http://www.clinicaltrials.gov. Unique identifier: NCT00097669.

Authors+Show Affiliations

School of Medicine and Pharmacology, The University of Western Australia, Perth, Western Australia, Australia. graeme.hankey@uwa.edu.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23765945

Citation

Hankey, Graeme J., et al. "Effect of B Vitamins and Lowering Homocysteine On Cognitive Impairment in Patients With Previous Stroke or Transient Ischemic Attack: a Prespecified Secondary Analysis of a Randomized, Placebo-controlled Trial and Meta-analysis." Stroke, vol. 44, no. 8, 2013, pp. 2232-9.
Hankey GJ, Ford AH, Yi Q, et al. Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis. Stroke. 2013;44(8):2232-9.
Hankey, G. J., Ford, A. H., Yi, Q., Eikelboom, J. W., Lees, K. R., Chen, C., ... van Bockxmeer, F. M. (2013). Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis. Stroke, 44(8), pp. 2232-9. doi:10.1161/STROKEAHA.113.001886.
Hankey GJ, et al. Effect of B Vitamins and Lowering Homocysteine On Cognitive Impairment in Patients With Previous Stroke or Transient Ischemic Attack: a Prespecified Secondary Analysis of a Randomized, Placebo-controlled Trial and Meta-analysis. Stroke. 2013;44(8):2232-9. PubMed PMID: 23765945.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis. AU - Hankey,Graeme J, AU - Ford,Andrew H, AU - Yi,Qilong, AU - Eikelboom,John W, AU - Lees,Kennedy R, AU - Chen,Christopher, AU - Xavier,Denis, AU - Navarro,Jose C, AU - Ranawaka,Udaya K, AU - Uddin,Wasim, AU - Ricci,Stefano, AU - Gommans,John, AU - Schmidt,Reinhold, AU - Almeida,Osvaldo P, AU - van Bockxmeer,Frank M, AU - ,, Y1 - 2013/06/13/ PY - 2013/6/15/entrez PY - 2013/6/15/pubmed PY - 2013/9/27/medline KW - clinical trial KW - cognitive impairment KW - homocysteine KW - vitamin B complex SP - 2232 EP - 9 JF - Stroke JO - Stroke VL - 44 IS - 8 N2 - BACKGROUND AND PURPOSE: High plasma total homocysteine (tHcy) has been associated with cognitive impairment but lowering tHcy with B-vitamins has produced equivocal results. We aimed to determine whether B-vitamin supplementation would reduce tHcy and the incidence of new cognitive impairment among individuals with stroke or transient ischemic attack≥6 months previously. METHODS: A total of 8164 patients with stroke or transient ischemic attack were randomly allocated to double-blind treatment with one tablet daily of B-vitamins (folic acid, 2 mg; vitamin B6, 25 mg; vitamin B12, 500 μg) or placebo and followed up for 3.4 years (median) in the VITAmins TO Prevent Stroke (VITATOPS) trial. For this prespecified secondary analysis of VITATOPS, the primary outcome was a new diagnosis of cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score<24 on ≥2 follow-up visits. Secondary outcomes were cognitive decline, and the mean tHcy and MMSE at final follow-up. RESULTS: A total of 3089 participants (38%) voluntarily undertook the MMSE>6 months after the qualifying stroke; 2608 participants were cognitively unimpaired (MMSE≥24), of whom 2214 participants (1110 B-vitamins versus 1104 placebo) had follow-up MMSEs during 2.8 years (median). At final follow-up, allocation to B-vitamins, compared with placebo, was associated with a reduction in mean tHcy (10.2 μmol/L versus 14.2 μmol/L; P<0.001) but no change from baseline in the mean MMSE score (-0.22 points versus -0.25 points; difference, 0.03; 95% confidence interval, -0.13 to 0.19; P=0.726) and no difference in the incidence of cognitive impairment (5.51% versus 5.47%; risk ratio, 1.01; 95% confidence interval, 0.69-1.48; P=0.976), cognitive decline (9.1% versus 10.3%; risk ratio, 0.89; 0.67-1.18; P=0.414), or cognitive impairment or decline (11.0% versus 11.3%; risk ratio, 0.98; 0.75-1.27; P=0.855). CONCLUSIONS: Daily supplementation with folic acid, vitamin B6, and vitamin B12 to a self-selected clinical trial cohort of cognitively unimpaired patients with previous stroke or transient ischemic attack lowered mean tHcy but had no effect on the incidence of cognitive impairment or cognitive decline, as measured by the MMSE, during a median of 2.8 years. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN74743444; URL: http://www.clinicaltrials.gov. Unique identifier: NCT00097669. SN - 1524-4628 UR - https://www.unboundmedicine.com/medline/citation/23765945/Effect_of_B_vitamins_and_lowering_homocysteine_on_cognitive_impairment_in_patients_with_previous_stroke_or_transient_ischemic_attack:_a_prespecified_secondary_analysis_of_a_randomized_placebo_controlled_trial_and_meta_analysis_ L2 - http://www.ahajournals.org/doi/full/10.1161/STROKEAHA.113.001886?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -