FOLARDA (Liem) trial

FOLARDA (Liem) study, 2004	TRC9989
	download pdf: folic acid \| plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	folic acid 5 mg per day for 1 year
Control treatment	usual care

Patients

patients with acute MI and total cholesterol >6.5 mmol/l

Inclusion criteria

total cholesterol value, taken at admission or within 24 h after onset of symptoms, was > 6.5 mmol/l;

Exclusion criteria

age < 18 years; use of lipid lowering agents within the previous 3 months; high triglyceride level > 4.5 mmol/l; known familial dyslipidaemia, low vitamin B12 level, previously known hyperhomocysteinaemia (total plasma homocysteine > 18 �mol/l); known disturbed methionine loading test (total plasmahomocysteine > 47 Amol/l); severe renal failure (serum creatinine >180 �mol/l); known hepatic disease; signs and symptoms of severe heart failure (NYHA class IV), and a scheduled percutaneous coronary intervention or coronary artery bypass graft

Baseline characteristics

Age (yr)	59 y
Male sex	69%

Method and design

Randomized effectives	140 / 143 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	1 year
Number of centre	multicentre
Geographic area	The Netherlands
Hypothesis	Superiority
Primary endpoint	not defined
Remarks	pilot trial

Results

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

All cause death

6 / 140
7 / 143
classic 0,88 [0,30;2,54]

stroke (fatal and non fatal)

1 / 140
0 / 143
classic 5,11 [0,07;371,84]

Non fatal MI

8 / 140
10 / 143
classic 0,82 [0,33;2,01] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
All cause death	6 / 140 (4,3%)	7 / 143 (4,9%)	0,88	[0,30;2,54]		11305
Non fatal MI	8 / 140 (5,7%)	10 / 143 (7,0%)	0,82	[0,33;2,01]		11305
stroke (fatal and non fatal)	1 / 140 (0,7%)	0 / 143 (0,3%)	2,04	[0,07;60,41]		11305
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 11305: Mart�-Carvajal AJ, Sol� I, Lathyris D, Salanti GHomocysteine lowering interventions for preventing cardiovascular events.Cochrane Database Syst Rev 2009 Oct 7;:CD006612 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 1 year)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	4,29%	4,90%	-0,61%
Non fatal MI	5,71%	6,99%	-1,28%

Meta-analysis of all similar trials:

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

Reference(s)

TrialResults-center ID	TRC9989
Trials register #	NA