See also:

SAGE study, 2007	TRC6977
	download pdf: atorvastatin high dose | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	atorvastatin 80 mg daily
Control treatment	pravastatin(40 mg)
Treatments description	HDL change 55 v. 32%

Patients

Patients	Chronic coronary artery disease
Baseline characteristics	Age (mean), yrs 72  LDL (mmol/l) 3.78  Diabetes(%) 23

Method and design

Randomized effectives	446 / 445 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	1 years
Primary endpoint	Total duration of ischemia onambulatoryECG

Results

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

All cause death

6 / 446
18 / 445
0,33 [0,13;0,83]

Cardiovascular death

4 / 446
10 / 445
0,40 [0,13;1,26]

Coronary death

2 / 446
6 / 445
0,33 [0,07;1,64]

stroke (fatal and non fatal)

1 / 446
3 / 445
classic 0,33 [0,03;3,19]

MACE

36 / 446
50 / 445
0,72 [0,48;1,08]

Non fatal MI

16 / 446
17 / 445
0,94 [0,48;1,84]

Rhabdomyolysis

0 / 446
0 / 445
classic 1,00 [0,00;254,66]

Death from cancer

0 / 446
2 / 445
classic 0,11 [0,00;6,89]

Myopathy

0 / 446
0 / 445
classic 1,00 [0,00;254,66]

Coronary death and non fatal MI

22 / 446
27 / 445
0,81 [0,47;1,41]

Adverse events

48 / 446
46 / 445
1,04 [0,71;1,53]

non cardiovascular death

2 / 446
6 / 445
0,33 [0,07;1,64] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
All cause death	6 / 446 (1,3%)	18 / 445 (4,0%)	0,33	[0,13;0,83]	12 months
Cardiovascular death	4 / 446 (0,9%)	10 / 445 (2,2%)	0,40	[0,13;1,26]
Coronary death	2 / 446 (0,4%)	6 / 445 (1,3%)	0,33	[0,07;1,64]
stroke (fatal and non fatal)	1 / 446 (0,2%)	3 / 445 (0,7%)	0,33	[0,03;3,19]
MACE	36 / 446 (8,1%)	50 / 445 (11,2%)	0,72	[0,48;1,08]	MACE (with hospitalization for unstable nagina)
Non fatal MI	16 / 446 (3,6%)	17 / 445 (3,8%)	0,94	[0,48;1,84]
Rhabdomyolysis	0 / 446 (0,1%)	0 / 445 (0,1%)	1,00	[0,02;50,18]
Death from cancer	0 / 446 (0,1%)	2 / 445 (0,4%)	0,25	[0,01;5,52]
Myopathy	0 / 446 (0,1%)	0 / 445 (0,1%)	1,00	[0,02;50,18]		0
Coronary death and non fatal MI	22 / 446 (4,9%)	27 / 445 (6,1%)	0,81	[0,47;1,41]
Adverse events	48 / 446 (10,8%)	46 / 445 (10,3%)	1,04	[0,71;1,53]
non cardiovascular death	2 / 446 (0,4%)	6 / 445 (1,3%)	0,33	[0,07;1,64]
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 1 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	1,35%	4,04%	-2,70%
Cardiovascular death	8,97‰	2,25%	-1,35%
Coronary death	4,48‰	1,35%	-0,90%
stroke (fatal and non fatal)	2,24‰	6,74‰	-0,45%
MACE	8,07%	11,24%	-3,16%
Non fatal MI	3,59%	3,82%	-0,23%
Coronary death and non fatal MI	4,93%	6,07%	-1,13%
Adverse events	10,76%	10,34%	0,43%
non cardiovascular death	4,48‰	1,35%	-0,90%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD

cholesterol lowering intervention in post myocardial infarction for all type of patients

Reference(s)

TrialResults-center ID	TRC6977
Trials register #	NA

• Deedwania P, Stone PH, Bairey Merz CN, Cosin-Aguilar J, Koylan N, Luo D, Ouyang P, Piotrowicz R, Schenck-Gustafsson K, Sellier P, Stein JH, Thompson PL, Tzivoni D. Effects of intensive versus moderate lipid-lowering therapy on myocardial ischemia in older patients with coronary heart disease: results of the Study Assessing Goals in the Elderly (SAGE).. Circulation 2007;115:700-7
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