ASPEN trial

ASPEN study, 2006	TRC6716
	download pdf: atorvastatin \| cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment

atorvastatin 10mg

Control treatment

placebo
placebo

Treatments description

total cholesterol change	-18%
LDL change	-29%
HDL change	+2.35%

Patients

subjects with type 2 diabetes and LDL cholesterol levels below contemporaryguideline targets

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
Women (%)	34%
prior MI or CHD (%)	17%
Total cholesterol (mmol/l)	194 mg/dl
LDL (mmol/l)	113 md/dl
HDL (mmol/l)	47 mg/dl
Triglycerides (mg/dl)	146 mg/dl
Diabetes(%)	100%
BMI (kg/m2)	28.8
Stroke history	5%
History of hypertension (%)	55%

Method and design

Randomized effectives	1211 / 1199 (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

Results

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

Coronary event

49 / 1211
66 / 1199
0,74 [0,51;1,05]

Cardiovascular death

38 / 1211
37 / 1199
1,02 [0,65;1,59]

cardiovascular events

166 / 1211
180 / 1199
0,91 [0,75;1,11]

stroke (fatal and non fatal)

34 / 1211
38 / 1199
0,89 [0,56;1,40]

MACE

166 / 1211
180 / 1199
0,91 [0,75;1,11] 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
Coronary event	49 / 1211 (4,0%)	66 / 1199 (5,5%)	0,74	[0,51;1,05]	fatal non fatal MI
Cardiovascular death	38 / 1211 (3,1%)	37 / 1199 (3,1%)	1,02	[0,65;1,59]
cardiovascular events	166 / 1211 (13,7%)	180 / 1199 (15,0%)	0,91	[0,75;1,11]		6911
stroke (fatal and non fatal)	34 / 1211 (2,8%)	38 / 1199 (3,2%)	0,89	[0,56;1,40]
MACE	166 / 1211 (13,7%)	180 / 1199 (15,0%)	0,91	[0,75;1,11]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0: 6911: 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

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 4 year)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Coronary event	4,05%	5,50%	-1,46%
Cardiovascular death	3,14%	3,09%	0,05%
cardiovascular events	13,71%	15,01%	-1,30%
stroke (fatal and non fatal)	2,81%	3,17%	-0,36%
MACE	13,71%	15,01%	-1,30%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in cardiovascular prevention for primary prevention

Reference(s)

TrialResults-center ID	TRC6716
Trials register #	NA