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Lancet Neurol. 2010 Sep;9(9):855-65. doi: 10.1016/S1474-4422(10)70187-3. Epub 2010 Aug 3.

B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial.

Collaborators (385)

Hankey GJ, Eikelboom JW, Baker RI, Gelavis A, Hickling SC, Jamrozik K, van Bockxmeer FM, Vasikaran S, Chen C, Eikelboom JW, Lees KR, Yi Q, Hankey GJ, Algra A, Chen C, Wong MC, Cheung R, Wong I, Divjak I, Ferro J, de Freitas G, Gommans J, Groppa S, Hill M, Spence JD, Lees KR, Lisheng L, Navarro J, Ranawaka U, Ricci S, Schmidt R, Slivka A, Tan A, Tsiskaridze A, Uddin W, Vanhooren G, Xavier D, Armitage J, Hobbs M, Le M, Sudlow C, Wheatley K, Yi Q, Brown W, Bulder M, Eikelboom JW, Hankey GJ, Ho WK, Jamrozik K, Klijn CJ, Koedam E, Langton P, Nijboer E, Tuch P, Pizzi J, Tang M, Alaparthi R, Antenucci M, Chew Y, Chinnery C, Cockayne C, Holt R, Loh K, McMullin L, Mulholland G, Nahoo B, Read E, Smith F, Yip CY, Hankey GJ, Loh K, Crimmins D, Davis T, England M, Rakic V, Schultz DW, Frayne J, Bladin C, Kokkinos J, Dunbabin D, Harper J, Rees P, Warden D, Levi C, Parsons M, Russell M, Spratt N, Clayton P, Nayagam P, Sharp J, Grainger K, de Wytt C, McDougall A, Donnan GA, Grimley R, Neynens E, Reinhart B, Ropele S, Schmidt R, Stögerer E, Dedeken P, Schelstraete C, Vanhooren G, Veyt A, Andre C, de Freitas GR, Gomes SE, Mok VC, Wong A, Wong LK, Cheung RT, Li LS, Pais P, Xavier D, Joshi S, Parthasaradhi S, Roy AK, Varghese RV, Kochar K, Panwar RB, Chidambaram N, Rajasekaharan U, Bala S, Pandian JD, Singh Y, Karadan U, Salam A, Shivkumar S, Sundararajan A, Joshi R, Kalantri SP, Singh H, Rath A, Balasubramanian NT, Kalanidhi A, Babu K, Bharani A, Choudhary P, Jain M, Agarwal A, Singh M, Agarwal RR, Gupta R, Kothari S, Mijar S, Wadia RS, Paul SK, Sekhar Nandi S, Mehndiratta MM, Tukaram U, Mittal K, Rohatgi A, Kumar S, Vinayan KP, Muralidharan RS, Celani MG, Favorito I, Mazzoli T, Ricci S, Righetti E, Blundo M, Carnemolla A, D'Asta A, Giordano A, Iemolo F, Favorito L, Mazzoli T, Ricci S, Righetti E, Gresele P, Guercini F, Caporalini R, De Dominicis L, Giovagnetti M, Giuliani G, Paoletti S, Pucci E, Cavallini A, Persico A, Casoni F, Costa A, Magoni M, Spezi R, Tortorella R, Venturelli E, Vergani V, Caprioli S, Provisione M, Zanotta D, Abdullah JM, Damitri T, Idris B, Sayuthi S, Hong JJ, Tan CT, Tan KS, Dutca G, Grigor V, Groppa S, Manea D, Achterberg S, Algra A, Halkes PH, Kappelle LJ, Boon AM, Doelman JC, Sips R, Visscher F, Kwa VI, Ternede OA, van der Sande JJ, Frendin T, Gommans J, Anderson NE, Bennett P, Charleston A, Spriggs D, Singh J, Bourke J, Bucknell R, McNaughton H, Anwar A, Murtaza H, Uddin W, Ismail J, Khan NU, Navarro JC, Amor VG, Canete MT, Lim C, Ravelo EB, Siguenza M, Villahermosa MO, Canete MT, Cardino MJ, Cenabre R, Gara M, Salas Z, Batac A, Canete MT, Conde L, Dumdum P, Garcia FS, Libarnes S, Matig-a N, Olanda N, Arcenas R, Canete MT, Loraña A, Surdilla A, Araullo ML, Lokin J, Maylem G, Marques E, Veloso M, Correia M, Lopes G, Canhão P, Ferro JM, Melo TP, Dias A, Sousa AP, Tsiskaridze A, Vashadze T, Divjak I, Divjak I, Papic V, Chang HM, Chen CP, De Silva DA, Tan EK, Ranawaka UK, Wijesekera JC, de Silva HA, Ranawaka UK, Wijekoon CN, Dawson UK, Higgins P, Lees KR, MacDonald L, McArthur K, McIlvenna Y, Quinn T, Walters M, Curless R, Dickson J, Murdy J, Scott A, Cameron S, Darnley K, Dennis M, Lyle D, Hunter A, Watt M, Wiggam I, Murdy J, Rodgers H, Dick F, Macleod M, McKenzie A, Jones P, Jones S, Hussain M, Albazzaz MK, Elliott K, Hardware B, Bacabac E, Martin H, Sharma A, Sutton V, Baht H, Cowie L, Gunathilagan G, Hargrove DR, Smithard DG, Adrian M, Bath P, Hammonds F, Maguire H, Roff C, Datta-chaudhuri M, Diyazee K, Krishnamoorthy S, McNulty K, Okwera J, Hilaire C, Kelly D, Barron L, James M, Wedge N, Bruce M, Macleod M, Barber M, Esson D, Ames D, Chataway J, Bulley S, Jenkins K, Rashed K, Dafalla BE, Venugopalan TC, Ball M, Punnoose S, Justin F, Sekaran L, Sethuraman S, Goddard H, Howard J, McIlmoyle J, Diver-Hall C, McCarron M, McNicholl MP, Clamp B, Hunter J, Oke A, Weaver A, Fraser P, McAlpine C, Chambers J, Dymond H, Saunders G, Langhorne P, Stott D, Wright F, Adie K, Bland R, Courtauld G, Harrington F, James A, Mate A, Schofield C, Wroath C, Duberley S, Punekar S, Niranjan K, Sandler D, Krishna P, Moussouttas M, Notestine MA, Slivka A, Vallini D, Hwang T, Saverance M, Booth K, Murphy D.

Abstract

BACKGROUND:

Epidemiological studies suggest that raised plasma concentrations of total homocysteine might be a risk factor for major vascular events. Whether lowering total homocysteine with B vitamins prevents major vascular events in patients with previous stroke or transient ischaemic attack is unknown. We aimed to assess whether the addition of once-daily supplements of B vitamins to usual medical care would lower total homocysteine and reduce the combined incidence of non-fatal stroke, non-fatal myocardial infarction, and death attributable to vascular causes in patients with recent stroke or transient ischaemic attack of the brain or eye.

METHODS:

In this randomised, double-blind, parallel, placebo-controlled trial, we assigned patients with recent stroke or transient ischaemic attack (within the past 7 months) from 123 medical centres in 20 countries to receive one tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B6, and 0.5 mg vitamin B12). Patients were randomly allocated by means of a central 24-h telephone service or an interactive website, and allocation was by use of random permuted blocks stratified by hospital. Participants, clinicians, carers, and investigators who assessed outcomes were masked to the assigned intervention. The primary endpoint was the composite of stroke, myocardial infarction, or vascular death. All patients randomly allocated to a group were included in the analysis of the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT00097669, and Current Controlled Trials, ISRCTN74743444.

FINDINGS:

Between Nov 19, 1998, and Dec 31, 2008, 8164 patients were randomly assigned to receive B vitamins (n=4089) or placebo (n=4075). Patients were followed up for a median duration of 3.4 years (IQR 2.0-5.5). 616 (15%) patients assigned to B vitamins and 678 (17%) assigned to placebo reached the primary endpoint (risk ratio [RR] 0.91, 95% CI 0.82 to 1.00, p=0.05; absolute risk reduction 1.56%, -0.01 to 3.16). There were no unexpected serious adverse reactions and no significant differences in common adverse effects between the treatment groups.

INTERPRETATION:

Daily administration of folic acid, vitamin B6, and vitamin B12 to patients with recent stroke or transient ischaemic attack was safe but did not seem to be more effective than placebo in reducing the incidence of major vascular events. These results do not support the use of B vitamins to prevent recurrent stroke. The results of ongoing trials and an individual patient data meta-analysis will add statistical power and precision to present estimates of the effect of B vitamins.

FUNDING:

Australia National Health and Medical Research Council, UK Medical Research Council, Singapore Biomedical Research Council, Singapore National Medical Research Council, Australia National Heart Foundation, Royal Perth Hospital Medical Research Foundation, and Health Department of Western Australia.

Copyright 2010 Elsevier Ltd. All rights reserved.

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PMID:
20688574
[PubMed - indexed for MEDLINE]
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