October 12, 2010
Poor Glucose Control is Associated with Cardiovascular Risk
Sanofi-aventis announced the baseline results of a worldwide prospective longitudinal epidemiologic study designed to assess the predictive value of risk factors for developing cardiovascular disease and Type 2 diabetes - INSPIRE-ME IAA (INternational Study of Prediction of Intra-abdominal adiposity and its RElationship with cardioMEtabolic risk/Intra-Abdominal Adiposity).
The key baseline results showed that increasingly poor glucose control is associated with an increased cardiovascular risk profile. Four categories of glucose control were studied: people with normal glucose control; those with impaired fasting glucose/impaired glucose tolerance (IFG/IGT); those with well-controlled diabetes; and those with poorly-controlled diabetes.
"Cardiovascular risk factors such as lipid parameters, blood pressure, inflammatory markers, and visceral fat volume were worsened as soon as glucose control began to deteriorate, starting with subjects with IFG/IGT," noted Jean-Pierre Despres, director of research, cardiology, Laval Universite, Canada, and principal investigator of the imaging study in INSPIRE ME IAA.
"There was clearly a gradient of severity in the cardiovascular risk factors across the four groups of patients, highlighting both the importance of identifying these patients as soon as possible and also the need to offer them pharmacological treatment to control their glucose metabolism and associated cardiovascular risk factors."
INSPIRE-ME IAA is an international, epidemiological study with a three-year follow up, involving more than 4500 patients, 297 physicians in 29 countries (including Brazil, China, France, Germany, Malaysia, Japan and US) across five continents.
"Aiming to better understand different diabetes patient types and patient profiles and their associated cardiovascular risk, Sanofi-aventis is committed to investigating the causes of, and risk factors associated with diabetes, as well as treatments for the disease," commented Dr Riccardo Perfetti, vice-president, medical affairs, global diabetes division, Sanofi-aventis.
One aim of this baseline analysis was to determine the relationship between cardiovascular risk factors and glucose tolerance status. Lipid profile, measures of overweight/obesity, including waist circumference, BMI and visceral adiposity (measured by CT scan) showed a significant relationship with decreasing glucose control, as did inflammatory markers and systolic blood pressure.
Of particular interest is the increase in cardiovascular risk for those with IFG/IGT, as well as those with established diabetes. Addressing cardiovascular risk in those with IFG/IGT is a key aim of the ongoing ORIGIN (Outcome Reduction with an Initial Glargine Intervention) trial.
The trial is investigating the effectiveness of two treatment options to reduce cardiovascular (CV) outcomes in people aged more than or equal 50 years with evidence of CV disease and either IFG, IGT, newly detected or established diabetes:
• once-daily injection of the long-acting basal insulin analogue, Lantus (insulin glargine), compared with standard glycemic care.
• w-3 polyunsaturated fatty acids (1g consisting of EPA 465 mg and DHA 375mg), compared with placebo.
"From our better understanding of the patient characteristics of those at risk of cardiovascular disease, shown in the INSPIRE-ME IAA study, we can reaffirm the hypothesis of ORIGIN and the benefits of insulin glargine intervention for different patient profiles, including for those with IFG/IGT, " added Dr Perfetti.
The primary outcome for the insulin arm is CV events and for the w-3 fatty acid arms is CV death. Results from the trial are expected in 2012.