The macrovascular REALIST survey was designed to determine, in patients at goal for LDL-C (less than or equal to 130 mg/dL whether treated or untreated for elevated LDL-C) with a first or subsequent coronary event, whether low HDL-C and/or elevated TG levels are associated with a significant risk of coronary event after adjustment for other risk factors. Adult male or female patients admitted to coronary care units (CCUs) or explored in cardiac catheter laboratories were matched with controls hospitalized for other reasons.
The microvascular REALIST survey was designed to determine whether low HDL-C and/or elevated TG levels are associated with a significant residual risk of microvascular complications. Data will be adjusted for other risk factors such as age, gender, diabetes duration, HbA1C, LDL-C levels, blood pressure, BMI and smoking status in patients with type 2 diabetes nearly at goal for LDL-C and presenting with incident microvascular complication (retinopathy, maculopathy or nephropathy). Diabetic neuropathy is an exploratory disease due to difficulties in establishing it with certainty in retrospective analysis. The REALIST surveys are currently being conducted in Belgium, Croatia, France, Italy, Japan, Philippines, Poland, Saudi Arabia, Spain, Thailand, Turkey and the U.S.
What is residual vascular risk?
Residual vascular risk is defined as the significant residual risk of macrovascular events and microvascular complications which persists in most patients despite current standards of care including achievement of low-density lipoprotein (LDL-C) goal and intensive control of blood pressure and blood glucose.
Although statin therapy is the cornerstone of dyslipidemia management, LDL-C lowering with statins reduces the risk of major coronary events by approximately one-quarter, with 77 percent of the relative risk of events still occurring.[3]
Multifactorial intensive therapy (including statins) is insufficient to prevent the development or progression of microvascular disease (retinopathy, nephropathy, neuropathy) in up to 50 percent of patients with type 2 diabetes.[4]
Atherogenic Dyslipidemia and Residual Vascular Risk
Atherogenic dyslipidemia is characterized by elevated TG and low levels of HDL-C.
In the past three decades in the U.S., while the prevalence of abnormal levels of LDL-C has decreased, the prevalence of combined abnormal TG (greater than or equal to 150 mg/dL) and HDL-C (<40 mg/dL) has doubled and the prevalence of elevated TG (greater than or equal to 150 mg/dL) has increased five-fold.[5] Elevated TG (>150 mg/dL) is also common, affecting about 50 percent of adults with prior CVD.[6]
Atherogenic dyslipidemia contributes to the increased risk of macrovascular events such as myocardial infarction and stroke, and may be implicated in microvascular complications such as diabetic eye, kidney and lower limb disease.[7]
- Among patients achieving LDL-C <70 mg/dL with a statin, CVD risk is
almost 60 percent greater for patients with TG >200 mg/dL[8]
- In patients achieving LDL-C <70 mg/dL with a statin, CV risk was higher
in patients with a low HDL-C (HDL-C <37 mg/dL vs. those with a
HDL-C >55 mg/dL)[9]
The mission of R3i
To reduce the significant residual risk of macrovascular events and microvascular complications which persists in most patients despite current standards of care including achievement of low density lipoprotein goal and intensive control of blood pressure and blood glucose.
R3i board of trustees
Professor Jean-Charles Fruchart, President Institut Pasteur de
Lille Universite, Lille2,
Lille, France
Professor Frank Sacks, Vice-President Harvard School of Public
Health and Harvard Medical
School, Boston, USA
Professor Michel P. Hermans, Cliniques Universitaires
General Secretary Saint-Luc, Brussels, Belgium
References:
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[1] Fruchart JC, Sacks F, Hermans MP, Assmann G, Brown WV, Ceska R, et al. The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am J Cardiol. 2008;102 (Suppl):1K-34K.
[2] Fruchart JC, Sacks F, Hermans MP, Assmann G, Brown WV, Ceska R, et al. The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Diab Vasc Dis Res. 2008; 5:319-35.
[3] Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, et al; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267-78
[4] Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348:383-393
[5] Alsheikh-Ali AA, Lin JL, Abourjaily P, Ahearn D, Kuvin JT, Karas RH. Prevalence of low highdensity lipoprotein cholesterol in patients with documented coronary heart disease or riskequivalent and controlled low-density lipoprotein cholesterol. Am J Cardiol. 2007;100:1499-1501
[6] Ninomiya JK, L'Italien G, Criqui MH, Whyte JL, Gamst A, Chen RS. Association of the metabolic syndrome with history of myocardial infarction and stroke in the Third National Health and Nutrition Examination Survey. Circulation. 2004;109:42-46
[7] Isomaa B, Almgren P, Tuomi T, Forsen B, Lahti K, Nissen M, Taskinen MR, Groop L. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care. 2001;24:683-689
[8] Miller M, Cannon CP, Murphy SA, Qin J, Ray KK, Braunwald E. Impact of triglyceride levels beyond low-density lipoprotein cholesterol after acute coronary syndrome in the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2008;51:724-730
[9] Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007;357:1301-1310
For further information please contact: Denis Abbonato, MS&L, Phone: +44-20-7878-3129, Mobile: +44-7932-483-904, E-mail: denis.abbonato@mslworldwide.com
