In this third up date of the Cochrane review , there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6 , B9 or B12 given alone or in combination comparing with placebo on myocardial infa rct ion , death from any cause or adverse events .
BACKGROUND Cardiovascular disease , which includes coronary artery disease , stroke and peripheral vascular disease , is a leading cause of death worldwide .
Homocysteine is an amino acid with biological functions in methionine metabolism .
A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level .
The impact of homocysteine-lowering interventions , given to patients in the form of vitamins B6 , B9 or B12 supplements , on cardiovascular events has been investigated .
This is an up date of a review previously published in 2009 , 2013 , and 2015 .
OBJECTIVES To determine whether homocysteine-lowering interventions , provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events , as well as reducing all-cause mortality , and to evaluate their safety .
VITATOPS, the VITAmins TO Prevent Stroke Trial: Rationale and Design of a Randomised Trial of B-Vitamin Therapy in Patients with Recent Transient Ischaemic Attack or Stroke (NCT00097669) (ISRCTN74743444)
Background Epidemiological studies suggest that raised plasma concentrations of total homocysteine ( tHcy ) may be a common , causal and treatable risk factor for atherothromboembolic ischaemic stroke , dementia and depression . Although tHcy can be lowered effectively with small doses of folic acid , vitamin B12 and vitamin B6 , it is not known whether lowering tHcy , by means of B vitamin therapy , can prevent stroke and other major atherothromboembolic vascular events . Aim To determine whether the addition of B-vitamin supplements ( folic acid 2 mg , B6 25 mg , B12 500 μg ) to best medical and surgical management will reduce the combined incidence of stroke , myocardial infa rct ion ( MI ) and vascular death in patients with recent stroke or transient ischaemic attack ( TIA ) of the brain or eye . Design A prospect i ve , international , multicentre , r and omised , double blind , placebo-controlled clinical trial . Setting One hundred and four medical centres in 20 countries on five continents . Subjects Eight thous and ( 6600 recruited as of 5 January , 2006 ) patients with recent ( 7 months ) stroke ( ischaemic or haemorrhagic ) or TIA ( brain or eye ) . R and omisation R and omisation and data collection are performed by means of a central telephone service or secure internet site . Intervention One tablet daily of either placebo or B vitamins ( folic acid 2 mg , B6 25 mg , B12 500 μg ) . Primary outcome The composite of stroke , MI or death from any vascular cause , whichever occurs first . Outcome and serious adverse events are adjudicated blinded to treatment allocation . Secondary outcomes TIA , unstable angina , revascularisation procedures , dementia , depression . Statistical power With 8000 patients followed up for a median of 2 years and an annual incidence of the primary outcome of 8 % among patients assigned placebo , the study will have at least 80 % power to detect a relative reduction of 15 % in the incidence of the primary outcome among patients assigned B vitamins ( to 6·8%/year ) , applying a two-tailed level of significance of 5 % . Conclusion VITATOPS aims to recruit and follow-up 8000 patients between 1998 and 2008 , and provide a reliable estimate of the safety and effectiveness of folic acid , vitamin B12 , and vitamin B6 supplementation in reducing recurrent serious vascular events among a wide range of patients with TIA and stroke throughout the world
In this third up date of the Cochrane review , there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6 , B9 or B12 given alone or in combination comparing with placebo on myocardial infa rct ion , death from any cause or adverse events .
BACKGROUND Cardiovascular disease , which includes coronary artery disease , stroke and peripheral vascular disease , is a leading cause of death worldwide .
Homocysteine is an amino acid with biological functions in methionine metabolism .
A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level .
The impact of homocysteine-lowering interventions , given to patients in the form of vitamins B6 , B9 or B12 supplements , on cardiovascular events has been investigated .
This is an up date of a review previously published in 2009 , 2013 , and 2015 .
OBJECTIVES To determine whether homocysteine-lowering interventions , provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events , as well as reducing all-cause mortality , and to evaluate their safety .