@article{d7098c181fe84789a155f9c16b2e2e57,
title = "Rationale, design and baseline characteristics of a large, simple, randomized trial of combined folic acid and vitamins B 6 and B 12 in high-risk patients: The Heart Outcomes Prevention Evaluation (HOPE)-2 trial",
abstract = " BACKGROUND: Epidemiological studies suggest that mild to moderate elevation in plasma homocysteine concentration is associated with increased risk of atherothrombotic cardiovascular (CV) disease. Simple, inexpensive and nontoxic therapy with folic acid and vitamins B 6 and B 12 reduces plasma homocysteine levels by approximately 25% to 30% and may reduce CV events. Therefore, a large, randomized clinical trial - the Heart Outcomes Prevention Evaluation (HOPE)-2 study - is being conducted to evaluate this therapy in patients at high risk for CV events. OBJECTIVES: To evaluate whether long-term therapy with folic acid and vitamins B 6 and B 12 reduces the risk of major CV events in a high-risk population. The primary study outcome is the composite of death from CV causes, myocardial infarction and stroke. METHODS: A total of 5522 patients aged 55 years or older with preexisting CV disease or with diabetes and additional risk factor(s) at 145 centres in 13 countries were randomly assigned to daily therapy with combined folic acid 2.5 mg, vitamin B 6 50 mg and vitamin B 12 1 mg, or to placebo. Follow-up will average five years, to be completed by the end of 2005. RESULTS: The patients' baseline characteristics confirmed their high-risk status. Baseline homocysteine levels varied between countries and regions. HOPE-2 is one of the largest trials of folate and vitamins B 6 and B 12 and is expected to significantly contribute to the evaluation of the role of homocysteine lowering in CV prevention. ",
keywords = "Atherosclerosis, Clinical trials, Coronary disease, Homocysteine, Myocardial infarction, Stroke",
author = "{The HOPE-2 Investigators writing group} and E. Lonn and C. Held and Arnold, {J. M.O.} and J. Probstfield and M. McQueen and M. Micks and J. Pogue and P. Sheridan and J. Bosch and J. Genest and S. Yusuf and A. Avezum and J. Choy and G. Dagenais and R. Davies and M. Fisher and G. Fodor and T. Hamalainen and G. Heyndrickx and R. Hoeschen and W. Klein and R. Kuritzky and J. Mann and K. Teo and B. Mitchell and J. Ostergren and L. Piegas and P. Sleight and G. Spinas and B. Sussex and L. Title and R. Tsuyuki and A. Arnold and P. Auger and I. Bata and V. Bernstein and M. Bourassa and D. Meldrum and C. Pilon and C. Ross and R. Starra and R. Roccaforte and J. Grover and J. Mathew and D. Sackett and W. Taylor and R. Collins and B. Pitt and C. Furberg and R. Zolty",
note = "Funding Information: HOPE-2 is a multicentre, international study. The trial is coordinated and monitored by the Population Health Research Institute at McMaster University (Hamilton, Ontario). A Steering Committee, with representation from national leaders, oversees the conduct of the trial and takes overall responsibility. Central adjudication of primary and secondary outcome events is conducted by an Events Adjudication Committee, and a Substudies and Publications Committee oversees the conduct of substudies, additional analyses and publications. The study is sponsored by the Canadian Institutes of Health Research, and in-kind contributions are provided by Jamieson Laboratories (Canada). The study sponsors are not involved in the study design and have no influence on the execution of the study, the analyses and the reporting of the trial results. An independent Data Safety and Monitoring Board consisting of scientists with content and methodological expertise meets yearly and is monitoring the trial for safety of the study participants and overall quality and scientific integrity of the study.",
year = "2006",
month = jan,
day = "1",
doi = "10.1016/S0828-282X(06)70238-0",
language = "English (US)",
volume = "22",
pages = "47--53",
journal = "Canadian Journal of Cardiology",
issn = "0828-282X",
publisher = "Pulsus Group Inc.",
number = "1",
}