See also:

SANDS study, 2008	TRC8901
[NCT00047424]	download pdf: aggressive treatment | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment

aggressive targets of LDL-C of 70 mg/dL or lower and SBP of 115 mm Hg or lower for achieving lipid goals, if lifestyle modification was unsuccessful, use of a statin drug was initiated. If the LDL-C goal was not reached with statin use, combination therapy with ezetimibe was initiated. In addition, the non�HDL-C goals were addressed using fish oil, fenofibrate, or niacin. For achieving BP goals, step 1 drugs were angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB), in case of intolerance to ACE inhibitors. Step 2 was use of hydrochlorothiazide. Steps 3 to 5 added calcium channel blockers, -blockers, and then -blockers and other vasodilators.

Control treatment

standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower

Patients

Patients	adults with type 2 diabetes
Inclusion criteria	men and women with type 2 diabetes; aged 40 years or older; documented type 2 diabetes, plus LDL-C of at least 100 mg/dL and SBP greater than 130 mm Hg within the previous 12 months
Exclusion criteria	New York Heart Association class III or IV heart failure, SBP greater than 180mmHg, liver transaminase levels more than twice the upper limit of normal, or diagnosis of primary hyperlipidemia or hypercholesterolemia due to hyperthyroidism or nephrotic syndrome
Baseline characteristics	Age (mean), yrs 56 y  Women (%) 66%  Total cholesterol (mmol/l) 184 mg/dL  LDL (mmol/l) 104 mg/dL  HDL (mmol/l) 46 mg/dL  Triglycerides (mg/dl) 163 mg/dL  Diabetes(%) 100%  BMI (kg/m2) 33

Method and design

Randomized effectives	252 / 247 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	3 years
Number of centre	4
Geographic area	US
Hypothesis	Superiority
Primary endpoint	common carotid artery intimal medial thickness (IMT)

Results

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

cardiovascular events

11 / 252
8 / 247
classic 1,35 [0,55;3,29]

Adverse events

74 / 252
55 / 247
1,32 [0,98;1,78]

non cardiovascular death

2 / 252
4 / 247
classic 0,49 [0,09;2,65] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
cardiovascular events	11 / 252 (4,4%)	8 / 247 (3,2%)	1,35	[0,55;3,29]		0
Adverse events	74 / 252 (29,4%)	55 / 247 (22,3%)	1,32	[0,98;1,78]	serious adverse events	0
non cardiovascular death	2 / 252 (0,8%)	4 / 247 (1,6%)	0,49	[0,09;2,65]		0
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 3 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
cardiovascular events	4,37%	3,24%	1,1%
Adverse events	29,37%	22,27%	7,1%
non cardiovascular death	7,94‰	1,62%	-0,83%

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

Reference(s)

TrialResults-center ID	TRC8901
Trials register #	NCT00047424

• Fleg JL, Mete M, Howard BV, Umans JG, Roman MJ, Ratner RE, Silverman A, Galloway JM, Henderson JA, Weir MR, Wilson C, Stylianou M, Howard WJ. Effect of Statins Alone Versus Statins Plus Ezetimibe on Carotid Atherosclerosis in Type 2 Diabetes The SANDS (Stop Atherosclerosis in Native Diabetics Study) Trial.. J Am Coll Cardiol 2008 Dec 16;52:2198-205 - 10.1016/j.jacc.2008.10.031
  Pubmed | Hubmed | Fulltext
• Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial.. JAMA 2008;299:1678-89
  Pubmed | Hubmed | Fulltext

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