HATS trial

Related trials

Treatments

Studied treatment

antioxidant-therapy (vitamins)
antioxidants given twice daily for a total daily dose of 800 IU of vitamin E (as d-alpha-tocopherol), 1000 mg of vitamin C, 25 mg of natural beta carotene, and 100 ìg of selenium

Control treatment

placebo

Remarks

factorial design with simvastatin + niacin

Patients

patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol

Inclusion criteria

men (younger than 63 years of age) and women (younger than 70 years of age) with clinical coronary disease (defined as previous myocardial infarction, coronary interventions, or confirmed angina) and with at least three stenoses of at least 30 percent of the luminal diameter or one stenosis of at least 50 percent; low levels of HDL cholesterol (35 mg per deciliter [0.91 mmol per liter] or lower in men and 40 mg per deciliter [1.03 mmol per liter] in women), LDL cholesterol levels of 145 mg per deciliter (3.75 mmol per liter) or lower, and triglyceride levels below 400 mg per deciliter (4.52 mmol per liter)

Baseline characteristics

Women (%)	13%
age (yr)	53 y

Results

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

Cardiovascular death

1 / 84
1 / 76
classic 0,90 [0,06;14,22]

Non fatal stroke

2 / 84
2 / 76
classic 0,90 [0,13;6,27]

All cause death

1 / 84
1 / 76
classic 0,90 [0,06;14,22]

Non fatal MI

4 / 84
5 / 76
classic 0,72 [0,20;2,60]

cardiovascular events

6 / 84
8 / 76
0,68 [0,25;1,87] 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
Cardiovascular death	1 / 84 (1,2%)	1 / 76 (1,3%)	0,90	[0,06;14,22]		13138
Non fatal MI	4 / 84 (4,8%)	5 / 76 (6,6%)	0,72	[0,20;2,60]		13138
cardiovascular events	6 / 84 (7,1%)	8 / 76 (10,5%)	0,68	[0,25;1,87]		13138
All cause death	1 / 84 (1,2%)	1 / 76 (1,3%)	0,90	[0,06;14,22]		13138
Non fatal stroke	2 / 84 (2,4%)	2 / 76 (2,6%)	0,90	[0,13;6,27]	cerebral infarction	13138
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 13138: Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJSimvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.N Engl J Med 2001;345:1583-92 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Cardiovascular death	1,19%	1,32%	-1,3‰
Non fatal MI	4,76%	6,58%	-18,2‰
cardiovascular events	7,14%	10,53%	-33,8‰
All cause death	1,19%	1,32%	-1,3‰
Non fatal stroke	2,38%	2,63%	-2,5‰

Meta-analysis of all similar trials:

Reference(s)

Trials register #

Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.. N Engl J Med 2001;345:1583-92

Pubmed | Hubmed | Fulltext

HATS study, 2001

Treatments

Patients

Method and design

Results

Reference(s)

Digital discoveries