 | | dal-PLAQUE study: Hope for CETP inhibition? |
|  | | Utility of atherosclerosis imaging in the evaluation of drug therapies |
|
|  | | dal-PLAQUE - Background |
|
 | | Initial Experience with CETPi |
|  | | Erik SG Stroes & Diederik F van Wijk Lancet 2011; 378: 1529-1530 |
|
 | | Lipid – Efficacy (% change from baseline) |
|  | | dal-PLAQUE - Rationale |
|
 | | Why MRI & FDG-PET? |
|  | | Measuring atherosclerosis MRI |
|
 | | MRI - Logistics |
|  | | Niacin MRI regression - Oxford study |
|
 | | Niacin MRI Regression - Oxford Study |
|  | | Measuring atherosclerosis PET/CT |
|
 | | FDG-PET/CT scan reproducibility |
|  | | Evaluating 18F-FDG-PET images of atherosclerosis |
|
 | | PET indices derived from the regions of interest (ROI) |
|  | | Attenuation of plaque inflammation by simvastatin by 18FDG PET/CT @ 3 months |
|
|  | | dal-PLAQUE study design and timeline of imaging assessments |
|
 | | dal-PLAQUE Sites: Multicenter FDG-PET & MRI Study |
|  | | dal-PLAQUE - Key Inclusion Criteria |
|
 | | dal-PLAQUE - Predefined Endpoints |
|  | | Baseline characteristics (Intent-to-Treat [ITT]) - Demography and CHD risk factors |
|
 | | Baseline characteristics (ITT) - Plasma lipid profile |
|  | | Mean change from baseline in plaque burden at 24 Months (MRI) and inflammation at 6 Months (PET/CT) |
|
 | | Summary of MRI & PET endpoints |
|  | | Sample MRI Images from a patient at baseline and treated with dalcetrapib 600 mg for 24 Months showing regression in Total Vessel Area (TVA) |
|
 | | Raw mean data limited to subjects that provided imaging data for all MRI imaging time points |
|  | | MRI Lumen Area – average carotid (ITT) No change with dalcetrapib vs significant increase with placebo |
|
 | | Raw mean data limited to subjects that provided imaging data for all PET imaging time points |
|  | | Association between HDL-C and arterial inflammation as measured by MDS TBR on PET/CT |
|
 | | Association between atherosclerotic burden (TVA on MRI) and arterial inflammation (MDS TBR on FDG-PET/CT) |
|  | | Changes in lipids, lipoproteins, and hs-CRP during the study period |
|
 | | Inflammatory Markers: Change from Baseline to 24 Months |
|  | | Safety variables |
|
 | | dal-PLAQUE – Overall conclusions |
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