See also:

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
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• 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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