See also:

ACCORD lipid study, 2010	TRC10352
[NCT00000620]	download pdf: fenofibrate | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	fenofibrate on top simvastatin 160 mg per day adjusted according to the estimated glomerular filtration rate
Control treatment	placebo (on top simvastatine)
Remarks	participants were also randomized to either intensive or standard glycemic control and to either intensive or standard blood-pressure control. Glycemic-control ACCORD study was stopped early, in February 2008, because of higher mortality in the intensive-glycemic-control group. All patients were then transferred to a standard glycemia-control regimen

Patients

Patients

high-risk patients with type 2 diabetes

Inclusion criteria

type 2 diabetes; glycated hemoglobin level of 7.5% or more; LDL cholesterol level of 60 to 180 mg per deciliter; HDL cholesterol level below 55 mg per deciliter for women and blacks or below 50 mg per deciliter for all other groups, and a triglyceride level below 750 mg per deciliter if they were not receiving lipid therapy or below 400 mg per deciliter (4.5 mmol per liter) if they were receiving lipid therapy; age between 40 to 79 y in case of evidence of clinical cardiovascular disease;

Method and design

Randomized effectives	2765 / 2753 (studied vs. control)
Design	Factorial plan
Blinding	double-blind
Follow-up duration	4.7y
Number of centre	77
Geographic area	United States and Canada
Hypothesis	Superiority
Primary endpoint	fatal cardiovascular events, nonfatal MI, or nonfatal stroke

Results

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

Cardiovascular death

99 / 2765
114 / 2753
0,86 [0,66;1,13]

stroke (fatal and non fatal)

51 / 2765
48 / 2753
1,06 [0,72;1,56]

All cause death

203 / 2765
221 / 2753
0,91 [0,76;1,10]

cardiovascular events

291 / 2765
310 / 2753
0,93 [0,80;1,09]

Coronary event

332 / 2765
353 / 2753
0,94 [0,81;1,08] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
stroke (fatal and non fatal)	51 / 2765 (1,8%)	48 / 2753 (1,7%)	1,06	[0,72;1,56]
cardiovascular events	291 / 2765 (10,5%)	310 / 2753 (11,3%)	0,93	[0,80;1,09]	fatal and non ftala cardiovascular event
All cause death	203 / 2765 (7,3%)	221 / 2753 (8,0%)	0,91	[0,76;1,10]
Coronary event	332 / 2765 (12,0%)	353 / 2753 (12,8%)	0,94	[0,81;1,08]	fatal coronary events, non fatla MI, unstable angina
Cardiovascular death	99 / 2765 (3,6%)	114 / 2753 (4,1%)	0,86	[0,66;1,13]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 4.7y)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
stroke (fatal and non fatal)	1,84%	1,74%	0,10%
cardiovascular events	10,52%	11,26%	-0,74%
All cause death	7,34%	8,03%	-0,69%
Coronary event	12,01%	12,82%	-0,82%
Cardiovascular death	3,58%	4,14%	-0,56%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

cholesterol lowering intervention in cardiovascular prevention for diabetic patients

cholesterol lowering intervention in diabetes type 2 for diabetic patients with or withour hypercholesterolemia

HDL increasing drugs in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC10352
Trials register #	NCT00000620
Study web site link	http://www.theheart.org/coverage/acc-2010.do

• . Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus.. N Engl J Med 2010 Mar 14;: - 10.1056/NEJMoa1001282
  Pubmed | Hubmed | Fulltext
• . Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes.. N Engl J Med 2010 Jun 29;: - 10.1056/NEJMoa1001288
  Pubmed | Hubmed | Fulltext
• Ismail-Beigi F, Craven T, Banerji MA, Basile J, Calles J, Cohen RM, Cuddihy R, Cushman WC, Genuth S, Grimm RH Jr, Hamilton BP, Hoogwerf B, Karl D, Katz L, Krikorian A, O'Connor P, Pop-Busui R, Schubart U, Simmons D, Taylor H, Thomas A, Weiss D, Hramiak I. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial.. Lancet 2010 Jun 29;: - 10.1016/S0140-6736(10)60576-4
  Pubmed | Hubmed | Fulltext

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