See also:

ASPEN (primary prevention sub group) study, 2006	TRC9788
	download pdf: atorvastatin | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	atorvastatin 10mg
Control treatment	placebo
Treatments description	total cholesterol change -19.8%  LDL change -30.5%  HDL change +1.9%

Patients

Patients	subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets; primary prevention subgroup
Inclusion criteria	male and female subjects, aged 40�75 years, type 2 diabetes by the World; Health Organization definition (17) 3 years before screening. LDL cholesterol criteria were 1) LDL cholesterol <=140 mg/dl (3.6 mmol/l) if subjects had documented myocardial infarction or an interventional procedure >=3 months before screening or 2) LDL cholesterol <=160 mg/dl (4.1 mmol/l) if not. Triglyceride levels were required to be >=600 mg/dl (6.8 mmol/l) at all visits.
Exclusion criteria	diabetes; myocardial infarction, interventional procedure, or episodes of unstable angina3 months before screening; HbA1c (A1C) 10%; active liver disease or hepatic dysfunction (aspartate or alanine aminotransferase levels 1.5 the upper limit of normal); severe renal dysfunction or nephrotic syndrome; congestive heart failure treated with digoxin; creatine phosphokinase 3 the upper limit of normal; blood pressure 160/100 mmHg; BMI35 kg/m2; abuse of alcohol and/or drugs; hypersensitivity to the study medication;placebo run-in compliance rate 80%; current or planned pregnancy; or use of excluded medications
Baseline characteristics	Age (mean), yrs 61y (range 40-75)  Women (%) 38%  prior MI or CHD (%) 0%  Total cholesterol (mmol/l) 5.0 mmol/l  LDL (mmol/l) 3.0 mmol/l  HDL (mmol/l) 1.2 mmol/L  Triglycerides (mg/dl) 1.6 mmol/l  Diabetes(%) 100%  BMI (kg/m2) 28.9  Stroke history 5%  History of hypertension (%) 52%

Method and design

Randomized effectives	959 / 947 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	4 year
Number of centre	70
Geographic area	14 countries
Hypothesis	Superiority
Primary endpoint	cardiovascular events
Remarks

Remarks / Comments

Results

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

Coronary event

100 / 959
102 / 946
0,97 [0,75;1,26]

All cause death

44 / 959
41 / 946
1,06 [0,70;1,60]

Cardiovascular death

24 / 959
19 / 946
classic 1,25 [0,69;2,26]

cardiovascular events

100 / 959
102 / 946
0,97 [0,75;1,26]

stroke (fatal and non fatal)

27 / 959
29 / 946
0,92 [0,55;1,54]

non cardiovascular death

20 / 959
22 / 946
0,90 [0,49;1,63] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Coronary event	100 / 959 (10,4%)	102 / 946 (10,8%)	0,97	[0,75;1,26]		11051
All cause death	44 / 959 (4,6%)	41 / 946 (4,3%)	1,06	[0,70;1,60]		11048
Cardiovascular death	24 / 959 (2,5%)	19 / 946 (2,0%)	1,25	[0,69;2,26]		11051
cardiovascular events	100 / 959 (10,4%)	102 / 946 (10,8%)	0,97	[0,75;1,26]		11051
stroke (fatal and non fatal)	27 / 959 (2,8%)	29 / 946 (3,1%)	0,92	[0,55;1,54]		11048
non cardiovascular death	20 / 959 (2,1%)	22 / 946 (2,3%)	0,90	[0,49;1,63]		11051
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 11048: Brugts JJ, Yetgin T, Hoeks SE, Gotto AM, Shepherd J, Westendorp RG, de Craen AJ, Knopp RH, Nakamura H, Ridker P, van Domburg R, Deckers JWThe benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials.BMJ 2009 Jun 30;338:b2376 11051: Knopp RH, d'Emden M, Smilde JG, Pocock SJEfficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN).Diabetes Care 2006;29:1478-85 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 4 year)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
Coronary event	10,43%	10,78%	-0,35%
All cause death	4,59%	4,33%	0,25%
Cardiovascular death	2,50%	2,01%	0,49%
cardiovascular events	10,43%	10,78%	-0,35%
stroke (fatal and non fatal)	2,82%	3,07%	-0,25%
non cardiovascular death	2,09%	2,33%	-0,24%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for primary prevention

Reference(s)

TrialResults-center ID	TRC9788
Trials register #	NA

• Knopp RH, d'Emden M, Smilde JG, Pocock SJ. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN).. Diabetes Care 2006;29:1478-85 - 10.2337/dc05-2415
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