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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - plasma homocysteine lowering intervention - all type of patients


Related trials

CSPPT, 2015 - folic acid vs placebo

VITATOPS, 2010 - folic acid, vit B12 and vit B6 vs placebo

WAFACS, 2008 - folic acid, vit B12 and vit B6 vs placebo

WENBIT (vit B6), 2008 - vit B6 vs placebo

WENBIT (folic ac,B12), 2008 - folic acid, B12 vs placebo

SEARCH, 2007 - folic acid, B12 vs placebo

HOPE-2 (Lonn), 2006 - folic acid, vit B12 and vit B6 vs placebo

NORVIT (folic acid + B12) (Bonaa), 2006 - folic acid, B12 vs control

NORVIT (folic acid, B12 and vit B6) (Bonaa), 2006 - folic acid, vit B12 and vit B6 vs control

NORVIT (vit B6) (Bonaa), 2006 - vit B6 vs control

FOLARDA (Liem), 2004 - folic acid vs control

VISP (Toole), 2004 - high dose - folic acid, vit B12 and vit B6 vs low dose - folic acid, vit B12 and vit B6

GOES (Liem), 2003 - folic acid vs control

CHAOS-2, 2002 - folic acid vs placebo

SU.FOL.OM3, - folic acid, vit B12 and vit B6 vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of plasma homocysteine lowering intervention
  • All clinical trials of folic acid, vit B12 and vit B6
  •  
     HOPE-2 (Lonn) study, 2006 TRC8856 
    [NCT00106886] download pdf: folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment folic acid, 2.5 mg, vitamin B6,50 mg and vitamin B12, 1mg
    Control treatment placebo

    Patients

    Patients patients 55 years of age or older who had vascular disease or diabetes and additional risk factors for atherosclerosis
    Exclusion criteria current use of vitamin supplements with a high content of folic acid and vitamins B6 and B12; presence of other illnesses or conditions expected to limit compliance and/or impact on patients’ ability to complete the study
    Baseline characteristics
    Age (yr) 68.8 y 
    Male sex 72% 
    BMI 29.6% 
    diabetes (%) 40% 

    Method and design

    Randomized effectives 2758 / 2764 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration Jan 2000 - dec 2000
    Number of centre 145
    Geographic area 13 countries
    Hypothesis Superiority
    Primary endpoint cardiovascular events


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    cardiovascular deaths, MI, stroke 519 / 2758 (18,8%) 547 / 2764 (19,8%) 0,95 [0,85;1,06]
    Death from cardiovascular causes 276 / 2758 (10,0%) 291 / 2764 (10,5%) 0,95 [0,81;1,11]
    Myocardial infarction 341 / 2758 (12,4%) 349 / 2764 (12,6%) 0,98 [0,85;1,13]
    Stroke 111 / 2758 (4,0%) 147 / 2764 (5,3%) 0,76 [0,59;0,96]
    Total ischemic events 900 / 2758 (32,6%) 890 / 2764 (32,2%) 1,01 [0,94;1,09]
    Death from any cause 470 / 2758 (17,0%) 475 / 2764 (17,2%) 0,99 [0,88;1,11]
    Hospitalization for unstable angina 268 / 2758 (9,7%) 219 / 2764 (7,9%) 1,23 [1,03;1,45]
    Hospitalization for heart failure 202 / 2758 (7,3%) 174 / 2764 (6,3%) 1,16 [0,96;1,41]
    Revascularization 458 / 2758 (16,6%) 422 / 2764 (15,3%) 1,09 [0,96;1,23]
    Incident cancer 358 / 2758 (13,0%) 340 / 2764 (12,3%) 1,06 [0,92;1,21]
    Colon cancer 50 / 2758 (1,8%) 37 / 2764 (1,3%) 1,35 [0,89;2,06]
    Lung cancer 52 / 2758 (1,9%) 45 / 2764 (1,6%) 1,16 [0,78;1,72]
    Breast cancer 11 / 2758 (0,4%) 10 / 2764 (0,4%) 1,10 [0,47;2,59]
    Prostate cancer 70 / 2758 (2,5%) 58 / 2764 (2,1%) 1,21 [0,86;1,71]
    Melanoma cancer 5 / 2758 (0,2%) 12 / 2764 (0,4%) 0,42 [0,15;1,18]
    Death due to cancer 94 / 2758 (3,4%) 95 / 2764 (3,4%) 0,99 [0,75;1,31]
    Transient ischemic attack 131 / 2758 (4,7%) 120 / 2764 (4,3%) 1,09 [0,86;1,39]
    Venous thromboembolism (pulmonary embolism and deep-vein thrombosis) 37 / 2758 (1,3%) 40 / 2764 (1,4%) 0,93 [0,59;1,45]
    Fractures 246 / 2758 (8,9%) 235 / 2764 (8,5%) 1,05 [0,88;1,24]

    Endpoints used by the meta-analysis and data retained for this trial

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Non fatal MI

    341 / 2758
    349 / 2764
    0,98 [0,85;1,13]

    Death from cancer

    94 / 2758
    95 / 2764
    0,99 [0,75;1,31]

    Cardiovascular death

    276 / 2758
    291 / 2764
    0,95 [0,81;1,11]

    Cancer

    358 / 2758
    340 / 2764
    1,06 [0,92;1,21]

    All cause death

    470 / 2758
    475 / 2764
    0,99 [0,88;1,11]

    cardiovascular events

    519 / 2758
    547 / 2764
    0,95 [0,85;1,06]

    stroke (fatal and non fatal)

    111 / 2758
    147 / 2764
    0,76 [0,59;0,96]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Non fatal MI 341 / 2758 (12,4%) 349 / 2764 (12,6%) 0,98 [0,85;1,13] Myocardial infarction  0
    Death from cancer 94 / 2758 (3,4%) 95 / 2764 (3,4%) 0,99 [0,75;1,31] Death due to cancer  0
    Cardiovascular death 276 / 2758 (10,0%) 291 / 2764 (10,5%) 0,95 [0,81;1,11] Death from cardiovascular causes  0
    Cancer 358 / 2758 (13,0%) 340 / 2764 (12,3%) 1,06 [0,92;1,21] Incident cancer  0
    All cause death 470 / 2758 (17,0%) 475 / 2764 (17,2%) 0,99 [0,88;1,11] Death from any cause  0
    cardiovascular events 519 / 2758 (18,8%) 547 / 2764 (19,8%) 0,95 [0,85;1,06] cardiovascular deaths, MI, stroke  0
    stroke (fatal and non fatal) 111 / 2758 (4,0%) 147 / 2764 (5,3%) 0,76 [0,59;0,96] Stroke  0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of Jan 2000 - dec 2000)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Non fatal MI 12,36% 12,63% -0,26%
    Death from cancer 3,41% 3,44% -0,03%
    Cardiovascular death 10,01% 10,53% -0,52%
    Cancer 12,98% 12,30% 0,68%
    All cause death 17,04% 17,19% -0,14%
    cardiovascular events 18,82% 19,79% -0,97%
    stroke (fatal and non fatal) 4,02% 5,32% -1,29%

    Meta-analysis of all similar trials:

    plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC8856
    Trials register # NCT00106886
    • Lonn E, Yusuf S, Arnold MJ, Sheridan P, Pogue J, Micks M, McQueen MJ, Probstfield J, Fodor G, Held C, Genest J Jr. Homocysteine lowering with folic acid and B vitamins in vascular disease.. N Engl J Med 2006 Apr 13;354:1567-77
      Pubmed | Hubmed | Fulltext
    • Ray JG, Kearon C, Yi Q, Sheridan P, Lonn E. Homocysteine-lowering therapy and risk for venous thromboembolism: a randomized trial.. Ann Intern Med 2007 Jun 5;146:761-7
      Pubmed | Hubmed | Fulltext
    • Sawka AM, Ray JG, Yi Q, Josse RG, Lonn E. Randomized clinical trial of homocysteine level lowering therapy and fractures.. Arch Intern Med 2007 Oct 22;167:2136-9
      Pubmed | Hubmed | Fulltext
    • Mann JF, Sheridan P, McQueen MJ, Held C, Arnold JM, Fodor G, Yusuf S, Lonn EM. Homocysteine lowering with folic acid and B vitamins in people with chronic kidney disease--results of the renal Hope-2 study.. Nephrol Dial Transplant 2008 Feb;23:645-53
      Pubmed | Hubmed | Fulltext
    • Saposnik G, Ray JG, Sheridan P, McQueen M, Lonn E. Homocysteine-lowering therapy and stroke risk, severity, and disability: additional findings from the HOPE 2 trial.. Stroke 2009;40:1365-72
      Pubmed | Hubmed | Fulltext
    • Lonn E, Held C, Arnold JM, Probstfield J, McQueen M, Micks M, Pogue J, Sheridan P, Bosch J, Genest J, Yusuf S. Rationale, design and baseline characteristics of a large, simple, randomized trial of combined folic acid and vitamins B6 and B12 in high-risk patients: the Heart Outcomes Prevention Evaluation (HOPE)-2 trial.. Can J Cardiol 2006;22:47-53
      Pubmed | Hubmed | Fulltext

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