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Homocysteine-lowering trials for prevention of vascular disease: protocol for a collaborative meta-analysis

R Clarke1, J Armitage, S Lewington

  • 1Clinical Trial Service Unit, University of Oxford, Oxford, UK. robert.clarke@ctsu.ox.ac.uk

Clinical Chemistry and Laboratory Medicine
|February 12, 2008
PubMed

Insights

Elevated homocysteine is a cardiovascular disease risk factor. B-vitamin supplementation trials show mixed results, necessitating a comprehensive meta-analysis to clarify vascular risk reduction benefits.

Area of Science:

  • Cardiovascular disease research
  • Nutritional science
  • Epidemiology

Background:

  • Elevated plasma total homocysteine is a known risk factor for cardiovascular disease (CVD).
  • Previous randomized trials of B-vitamin supplementation to lower homocysteine have yielded inconclusive evidence regarding vascular risk reduction.

Purpose of the Study:

  • To conduct a cumulative meta-analysis of all randomized trials investigating the impact of B-vitamins on homocysteine levels and subsequent vascular risk.
  • To maximize statistical power for assessing predicted differences in vascular risk by analyzing individual patient data.

Main Methods:

  • Individual patient data meta-analysis of 12 randomized homocysteine-lowering trials for CVD prevention.
  • Inclusion of over 52,000 participants, including those with prior CVD and renal disease.
  • Pre-specified design and analyses to assess major vascular events (MVE), stroke, major coronary events (MCE), venous thrombosis, cancer, and fractures.

Main Results:

  • Analysis will assess effects on major vascular events (MVE), stroke, and major coronary events (MCE).
  • Subgroup analyses will explore outcomes based on population, prior disease, homocysteine reduction, vitamin status, and demographics.
  • Evaluation of non-vascular outcomes including cancer and fractures is planned.

Conclusions:

  • A cumulative meta-analysis of homocysteine-lowering trials is expected to provide reliable evidence.
  • This approach will clarify the effects of homocysteine reduction on both vascular and non-vascular outcomes.
Abstract

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