Featured Landmark Study - Lifestyle and Obesity Management


STRADIVARIUS: Effect of Rimonabant on Progression of Atherosclerosis in Patients with Abdominal Obesity and Coronary Artery Disease. The STRADIVARIUS randomized controlled trial

OUTCOME

  • Progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS).

TOTAL ENROLLMENT

  • 839 patients with abdominal obesity associated with current smoking and/or metabolic syndrome, and angiographic evidence of coronary heart disease.

COMPARISONS

  • Rimonabant 20 mg/d vs placebo.

STUDY DESIGN

  • Randomized, double-blind, placebo control, parallel assignment.

 

Featured 2009 Ongoing Trial - Hypoglycaemic Agents

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

OUTCOME

  • Time to reach the combined endpoint of cardiovascular death and/or cardiovascular hospitalization.

NUMBER OF PATIENTS RANDOMIZED

  • 4458 type 2 diabetes patients (7% < HbA1c < 9%); oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening; BMI > 25.0 kg/m2.

COMPARISONS

  • Add-on rosiglitazone, metformin or sulphonylurea, with dose titration to a target HbA1c of < 7%. If confirmed HbA1c rises to > 8.5%, either third glucose-lowering drug added (rosiglitazone-treated group) or insulin started (non-rosiglitazone group). Same criterion for failure of triple oral drug therapy in the rosiglitazone-treated group used for starting insulin in this group.

STUDY DESIGN

  • Randomized, open label, active control, parallel assignment.

 

 
Coordinated by Dr. Scott Grundy, Past-President of the IAS